PCP_Final Rule_DRAFT PRA Supporting Statement 6-16-10

SUPPORTING STATEMENT

Collections of Information

under the

Permanent Certification Program for Health Information Technology

DRAFT

The Office of the National Coordinator for Health Information Technology

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5), was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and created “Title XXX – Health Information Technology and Quality” (Title XXX) to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT) and electronic health information exchange.

Section 3001(c)(5) of the PHSA requires the National Coordinator for Health Information Technology (the National Coordinator), in consultation with the Director of the National Institute of Standards and Technology (NIST), to “keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria” adopted by the Secretary under section 3004. In a notice of proposed rulemaking implementing section 3001(c)(5), the Office of the National Coordinator for Health Information Technology (ONC) proposed to establish two certification programs, a temporary certification program and a permanent certification program.

Under the permanent certification program, ONC has proposed application requirements for organizations that wish to become ONC-Authorized Certification Bodies (ONC-ACBs), application requirements for accreditation organizations that wish to become an ONC-Authorized Accreditor (ONC-AA), and collection and reporting requirements for ONC-ACBs.

1. Application for ONC-ACB Status

The application process for ONC-ACB status requires applicants to: (1) Identify the type of authorization they seek; (2) Provide general identifying information; (3) Provide documentation of accreditation by an ONC-AA to perform certification of Complete EHRs and/or EHR Modules; (4) Agree to adhere to the Principles of Proper Conduct for ONC-ACBs; and (5) Submit all of the information either electronically, via email (or web submission if available), or by regular or express mail.

2. Application for ONC-AA Status

As previously noted, ONC has proposed certain application requirements for applicants that wish to become ONC-ACBs, including providing documentation that an applicant has been accredited to perform certification of Complete EHRs and/or EHR Modules by an ONC-AA. ONC has proposed to select the ONC-AA by establishing a process for accreditation organizations to submit documentation to ONC of their qualifications and abilities to be an ONC-AA. In order to become an ONC-AA, an accreditation organization must submit a request in writing to the National Coordinator along with the following information to demonstrate its ability to serve as an ONC-AA: (1) A detailed description of the accreditation organization’s conformance to ISO/IEC 17011:2004 (ISO 17011) and experience evaluating the conformance of certification bodies to ISO/IEC Guide 65:1996 (Guide 65); (2) A detailed description of the accreditation organization’s accreditation requirements and how the requirements complement the Principles of Proper Conduct for ONC-ACBs; (3) Detailed information on the accreditation organization’s procedures that would be used to monitor ONC-ACBs; (4) Detailed information, including education and experience, about the key personnel who review organizations for accreditation; and (5) Procedures for responding to, and investigating, complaints against ONC-ACBs.

3. Collection and Reporting Requirements

ONC would require ONC-ACBs to provide ONC, no less frequently than weekly, a current list of Complete EHRs and/or EHR Modules that have been tested and certified as well as certain minimum information about each certified Complete EHR and/or EHR Module. Compliance with this collection of information is a proposed requirement for ONC-ACBs to maintain good standing under the permanent certification program.

2. Purpose and Use of Information Collection

1. Application for ONC-ACB Status

The information collected through the application process would be used to assess the qualifications and abilities of applicants for ONC-ACB status under the permanent certification program. ONC would utilize the contact information provided for an applicant’s authorized representative to communicate and correspond with the applicant about the application. ONC would continue to utilize the authorized representative’s contact information to communicate and correspond with the applicant if the applicant becomes an ONC-ACB.

If an applicant is granted ONC-ACB status, ONC intends to post its name and the fact that it has been granted ONC-ACB status on ONC’s website.

2. Application for ONC-AA Status

The information collected would be used to assess the qualifications and abilities of accreditation organizations to become an ONC-AA under the permanent certification program.

3. Collection and Reporting Requirements

The information collected would be used to provide the public and the Centers for Medicare and Medicaid Services (CMS) with an aggregate list of certified Complete EHRs and EHR Modules.

3. Use of Improved Information Technology and Burden Reduction

1. Application for ONC-ACB Status

The application process includes provisions that permit the use of electronic media for communication and correspondence. Applicants are permitted and encouraged to submit applications by email to ONC and to communicate with ONC via email. ONC also intends to conduct most of its communications related to the application process by email. These communications would include identifying any deficiencies in the application, requesting clarifications and requesting additional information.

2. Application for ONC-AA Status

Accreditation organizations interested in becoming an ONC-AA are encouraged to submit applications by email to ONC and to communicate with ONC via email. ONC also intends to conduct most of its communications by email and issue correspondence by email.

3. Collection and Reporting Requirements

ONC anticipates that ONC-ACBs would electronically collect and store the requested information about Complete EHRs and EHR Modules. Additionally, ONC anticipates that the information would be electronically transmitted to ONC.

4. Efforts to Identify Duplication and use of Similar Information

1. Application for ONC-ACB Status

The collection of information for the application process would not be duplicative of any other information collections. In addition, as ONC did within the temporary certification program, ONC would subsume within the permanent certification program application process the Department of Health and Human Services’ application process to “recognize certification bodies” (RCB) specified in guidance issued by ONC in August 2006 entitled “Interim Guidance Regarding the Recognition of Certification Bodies.” This guidance specified how ONC would evaluate applications for “recognized certification body” status and provided the information a body would need to apply for and obtain such status. By including the RCB application process in the permanent certification program application process, ONC would be continuing the process it began with the temporary certification program and would be creating efficiencies and eliminating any potential duplication.

2. Application of ONC-AA Status

The collection of information is not duplicative of any other collection of information.

3. Collection and Reporting Requirements

The collection of information is not duplicative of any other collection of information.

5. Impact on Small Businesses or Other Small Entities

All three collections of information under the permanent certification program require the same collection of information from any applicant that applies for ONC-ACB or ONC-AA status as well as any ONC-ACB, regardless of the applicant’s or ONC-ACB’s size. ONC believes that it has established the minimum amount of information collection requirements that are necessary for it to properly assess the qualifications and abilities of applicants for ONC-ACB and ONC-AA status and to obtain the information necessary to achieve its goal of expeditiously notifying the public about certified Complete EHRs and EHR Modules so that eligible professionals and eligible hospitals can confidently and quickly adopt Certified EHR Technology. In this regard, if some applicants for ONC-ACB or ONC-AA status or ONC-ACBs could be classified as small entities, ONC does not believe that any appropriate alternatives exist to lessen the information collection burden for these entities.

6. Consequences of Collecting the Information Less Frequently

1. Application for ONC-ACB Status

An applicant would only need to apply once under ONC’s permanent certification program. An applicant would be required to seek renewal of its status every two years and would have to submit a renewal application that is substantively the same as the initial application for ONC-ACB status.

2. Application for ONC-AA

An accreditation organization would only need to submit the required documentation once under the permanent certification program to be considered for ONC-AA status. ONC has proposed to accept applications for ONC-AA status approximately every three years after selecting the first ONC-AA for the permanent certification program. At the time ONC begins to accept applications again, an accreditation organization could again submit the required application materials to be considered for ONC-AA status.

3. Collection and Reporting Requirements

If the information was collected less frequently, ONC believes that eligible professionals and eligible hospitals who seek to become meaningful users under CMS’ proposed Medicare and Medicaid EHR Incentive Programs may have difficulty determining what Complete EHRs and/or EHR Modules have been certified and are available for them to adopt. ONC’s proposed weekly collection of information would ensure that information about certified Complete EHRs and EHR Modules is available to the public in a timely manner.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

1. Application for ONC-ACB Status

Organizations that apply for ONC-ACB status may potentially submit information they identify or consider to be proprietary, a trade secret, or other confidential information. ONC would protect the information to the extent permitted by law.

2. Application of ONC-AA Status

Accreditation organizations that seek ONC-AA status may potentially submit information they identify or consider to be proprietary, a trade secret, or other confidential information. ONC would protect the information to the extent permitted by law.

3. Collection and Reporting Requirements

As previously specified, ONC would require that the information be provided on a weekly basis so that appropriate parties and entities are fully aware of the Complete EHRs and/or EHR Modules that have been certified as soon as practical. This would require the information to be prepared in less than 30 days each time it is reported. However, as previously noted, ONC anticipates that the information would be collected, stored and transmitted electronically. The use of electronic media would substantially reduce the burden on ONC-ACBs and would allow them to readily meet the weekly reporting requirements. The collection of information is otherwise fully compliant with 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice/Outside Consultations

1. Application for ONC-ACB Status

ONC sought comment on this collection of information in a notice of proposed rulemaking that was published in the Federal Register on March 10, 2010, Vol. 75, No. 46; pp 11352-55 (see attached Proposed Establishment of Certification Programs for Health Information Technology; Proposed Rule). The notice of proposed rulemaking was published with a 60-day request for public comment on this collection of information.

Outside Consultations

ONC consulted with NIST in developing the application requirements.

2. Application for ONC-AA Status

ONC sought comment on this collection of information in a notice of proposed rulemaking that was published in the Federal Register on March 10, 2010, Vol. 75, No. 46; pp 11352-55 (see attached Proposed Establishment of Certification Programs for Health Information Technology; Proposed Rule). The notice of proposed rulemaking was published with a 60-day request for public comment on this collection of information.

Outside Consultations

ONC consulted with NIST in developing the application requirements.

3. Collection and Reporting Requirements

ONC sought comment on this collection of information in a notice of proposed rulemaking that was published in the Federal Register on March 10, 2010, Vol. 75, No. 46; pp 11352-55 (see attached Proposed Establishment of Certification Programs for Health Information Technology; Proposed Rule). The notice of proposed rulemaking was published with a 60-day request for public comment on this collection of information.

9. Explanation of any Payment/Gift to Respondents

1. Application for ONC-ACB Status

Applicants for ONC-ACB status (respondents) would not receive any payments or gifts for applying.

2. Application for ONC-AA Status

Applicants for ONC-AA status (respondents) would not receive any payments or gifts for applying.

3. Collection and Reporting Requirements

ONC-ACBs would not receive any payments or gifts for collecting and reporting information on certified Complete EHRs and/or EHR Modules. Compliance with this collection of information is a proposed requirement for maintaining good standing under the permanent certification program.

10. Assurance of Confidentiality Provided to Respondents

With respect to the information collected, ONC does not intend to disclose the information to any other party outside of the Federal government. ONC would protect the information to the extent permitted by law.

11. Justification for Sensitive Questions

These collections of information do not require the disclosure of any sensitive information.

12A. Estimated Annualized Burden Hours

1. Application for ONC-ACB Status

Under the proposed permanent certification program, an applicant who voluntarily applies to become an ONC-ACB would be required to submit an application to the National Coordinator. ONC estimates that there will be no more than 6 applicants for ONC-ACB status under the permanent certification program. While ONC believes that the business case for entering the HIT market to perform the certification of Complete EHRs and EHR Modules could increase as health IT adoption rates increase, ONC believes that it is unlikely (given the expertise needed to perform the certification of Complete EHRs and EHR Modules) that the number of applicants would extend into the tens of applicants.

ONC estimates that it would take no appreciable time for an applicant to identify what type of authorization it sought, but that it would take approximately: 10 minutes for an applicant to provide the general identifying information requested in the application; 30 minutes to assemble the information necessary to provide documentation of accreditation by an ONC-AA; and 20 minutes to review and agree to the “Principles of Proper Conduct for ONC-ACBs”. These estimates equate to 1 hour to complete and submit the application for ONC-ACB status and are expressed in such totality in the table below.

Estimated Annualized Burden Hours

Type of Respondent	Number of Respondents	Number of Responses per Respondent	Burden Hours per Response	Total Burden Hours
Applicant	6	1	1	6
Total				6

2. Application for ONC-AA Status

ONC proposes to require accreditation organizations who apply to become an ONC-AA to submit information to the National Coordinator to demonstrate their ability to accredit certification bodies that would eventually apply for ONC-ACB status. ONC assumes that there will only be two accreditation organizations that will prepare and submit the information sought by the National Coordinator. ONC believes this will be the case based on its knowledge of the HIT market and consultations with NIST related to the existence of potential accreditation organizations that could seek the National Coordinator’s approval.

The submission requirements include documentation of information that ONC estimates would take an hour for each accreditation organization to complete. More specifically, ONC estimates that it would take approximately 20 minutes for an accreditation organization to provide a detailed description of the accreditation organization’s conformance to ISO 17011 and experience evaluating the conformance of certification bodies to Guide 65; 20 minutes to provide a detailed comparison of the accreditation organization’s accreditation requirements and how the requirements complement the Principles of Proper Conduct for ONC-ACBs; 5 minutes for an accreditation organization to provide a copy of the procedures that would be used to monitor ONC-ACBs; 10 minutes for an accreditation organization to provide detailed information, including education and experience, about the key personnel who review certification bodies for accreditation; and 5 minutes for an accreditation organization to provide a copy of the procedures for responding to, and investigating, complaints against ONC-ACBs. ONC’s estimates are expressed in the table below.

Type of Respondent	Number of Respondents	Number of Responses per Respondent	Burden Hours per Response	Total Burden Hours
Accreditation Organization	2	1	1	2
Total				2

3. Collection and Reporting Requirements

For the purposes of estimating the potential burden, ONC assumes that all of the estimated number of applicants for the permanent certification program (i.e., six) would apply and become ONC-ACBs. ONC also assumes, per the requirement for no less frequently than weekly reporting, that ONC-ACBs would report weekly (i.e., respondents will respond 52 times per year). Finally, ONC assumes that the information collection would be accomplished through electronic data collection and storage and that such collection and storage would be part of ONC-ACBs normal course of business. Therefore, with respect to this collection of information, the estimated burden is limited to the actual electronic reporting of the requested information to ONC. ONC’s estimates are expressed in the table below.

Estimated Annualized Burden Hours

Type of Respondent	Number of Respondents	Number of Responses per Respondent	Average Burden Hours per Response	Total Burden Hours
ONC-ACB Certification Results	6	52	1	312

12B. Estimated Annualized Respondent Costs

1. Application for ONC-ACB Status

Based on consultations with NIST and ONC’s own calculations, ONC believes that an employee equivalent to the Federal Salary Classification of GS-9 Step 1 could provide the general information requested in the application and documentation of accreditation status. ONC also believes that an employee equivalent to the Federal Salary Classification of GS-15 step 1 would be responsible for reviewing and agreeing to the “Principles of Proper Conduct for ONC-ACBs.” ONC has taken these employee assumptions and utilized the corresponding employee hourly rates for the locality pay area of Washington, D.C., as published by the U.S. Office of Personnel Management, to calculate the cost estimates. ONC has also calculated the costs of an employee’s benefits while completing the application. ONC has calculated these costs by assuming that an applicant expends thirty-six percent (36%) of an employee’s hourly wage on benefits for the employee. ONC has concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. ONC’s “Hourly Wage Rate with Benefits” is an average of a GS-9 Step 1 hourly wage with benefits ($30.45) attributed to the specified tasks for the specified time and a GS-15 Step 1 hourly wage with benefits ($80.65) attributed to the specified task for the specified time. ONC’s calculations are expressed in table below.

Type of Respondent	Total Burden Hours	Hourly Wage Rate with Benefits	Total Applicant Costs
Applicant	6	$47.18	$283.08

ONC based its cost estimates on the amount of applicants that ONC previously noted it believes will apply over the life of the permanent certification program (i.e., six applicants). ONC assumes that all applicants will apply during the first year of the program and thus all application costs should be attributed to the first year of the program. However, it is possible that one or more applicants may choose to apply in the second year of the program. Therefore, the annualized cost to complete the application for ONC-ACB status, over a two-year period, would be approximately $142.

2. Application for ONC-AA Status

Based on consultations with NIST and ONC’s own calculations, ONC believes that an employee equivalent to the Federal Salary Classification of GS-15 Step 1 would be responsible for preparing and submitting all the required information. ONC has taken this employee assumption and utilized the corresponding employee hourly rate for the locality pay area of Washington, D.C., as published by the U.S. Office of Personnel Management, to calculate the cost estimates. ONC has also calculated the costs of the employee’s benefits while preparing and submitting the documentation. ONC has calculated these costs by assuming that an accreditation organization expends thirty-six percent (36%) of an employee’s hourly wage on benefits for the employee. ONC has concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. ONC’s calculations are expressed in table below.

Type of Respondent	Total Burden Hours	Hourly Wage Rate with Benefits	Total Applicant Costs
Accreditation Organization	2	$80.65	$161.30

Based on ONC’s estimate of two accreditation organizations submitting the required documentation to be considered for ONC-AA status and on ONC’s proposal that it would seek to select an ONC-AA every three years, ONC estimates the annualized cost to be $54.

3. Collection and Reporting Requirements

As previously stated, ONC anticipates requiring the reporting of this information on a weekly basis and that it would take ONC-ACBs about an hour to prepare and electronically transmit the information to ONC each week (i.e., respondents will respond 52 times per year).

ONC believes that an employee equivalent to the Federal Classification of GS-9 Step 1 could complete the transmissions of the requested information to ONC. ONC has taken this employee assumption and utilized the corresponding employee hourly rate for the locality pay area of Washington, D.C., as published by the U.S. Office of Personnel Management, to calculate the cost estimates. ONC has also calculated the costs of the employee’s benefits while completing the transmissions of the requested information. ONC has calculated these costs by assuming that an ONC-ATCB will expend thirty-six percent (36%) of an employee’s hourly wage on benefits for the employee. ONC has concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. ONC’s calculations are expressed in the table below.

Type of Respondent	Total Burden Hours	Hourly Wage Rate with Benefits	Total Annual Reporting Costs
ONC-ACB Certification Results	312	$30.45	$9,500.40

13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

1. Application for ONC-ATCB Status

There are no capital costs associated with this collection of information.

2. Application for ONC-AA Status

There are no capital costs associated with this collection of information.

3. Collection and Reporting Requirements

ONC does not believe that there are any specific recordkeeping or capital costs associated with this collection of information. ONC-ACBs would need to maintain databases that collect and store the information ONC is proposing to require that they report as part of the normal course of business for such entities. ONC understands from its consultations with NIST that it is standard industry practice to maintain such information related to certification. Therefore, ONC believes that the only costs attributable to this collection of information are those associated with the electronic transmission of the information to ONC, which ONC has accounted for in the estimated annualized burden costs.

14. Annualized Cost to Federal Government

1. Application for ONC-ACB Status

ONC estimates the cost to develop the ONC-ACB application to be $350 based on the 5 hours of work that was required by a Federal Salary Classification GS-14 Step 1 employee located in Washington, D.C. to develop the application requirements. ONC anticipates that there would be costs associated with reviewing applications under the permanent certification program. ONC believes that a GS-15 Step 1 employee would review the applications and the National Coordinator (or designated representative) would issue final decisions on all applications. ONC anticipates that it would take approximately 20 hours to review and reach a final decision on each application. This estimate assumes a satisfactory application (i.e., no formal deficiency notifications) and includes the time necessary to verify the information in each application and prepare a briefing for the National Coordinator. ONC estimates the cost for the application review process to be $10,392. As a result, ONC estimates the Federal government’s overall cost for administering the entire application process at approximately $10,742. However, based on the possibility that one or more applicants may choose to apply in the second year of the permanent certification program, ONC estimates that the annualized cost to the Federal government, over a two-year period, would be $5,371.

As previously noted, ONC will also post the names of applicants granted ONC-ACB status its website. ONC believes that there will be minimal cost associated with this action and has calculated the potential cost to be approximately $312 on an annual basis for posting and maintaining the information on ONC’s website. This estimate is based on a maximum of 6 hours of work for a Federal Salary Classification GS-12 Step 1 employee located in Washington, D.C.

2. Application for ONC-AA Status

ONC anticipates that there will be some costs associated with reviewing applications for ONC-AA status under the permanent certification program. ONC believes that a GS-15 Step 1 employee would review the submissions and that the National Coordinator (or designated representative) would issue final decisions on all submissions. ONC anticipates that it would take 10 hours to review and reach a final decision on selecting an ONC-AA. This estimate includes the time necessary to verify the information in each submission and prepare a briefing for the National Coordinator. ONC estimates the Federal government’s overall cost to review two applications and select an ONC-AA, which would include the time of the GS-15 Step 1 employee, time of senior level officials and the time of the National Coordinator to be $1,732. Based on ONC’s proposal to select an ONC-AA every three years, the annualized cost to the Federal government for processing applications for ONC-AA status would be approximately $577. If ONC notifies the public of the selection of the ONC-AA by posting the information on its website, ONC believes that it would incur negligible costs from this action.

3. Collection and Reporting Requirements

ONC would use the reported information to post an aggregate list of certified Complete EHRs and EHR Modules on its website. ONC believes that there would be minimal cost associated with this action and has calculated the potential cost, including weekly updates, to be $5,392 on an annualized basis. This amount is based on 104 hours of yearly work of a Federal Salary Classification GS-12 Step 1 employee located in Washington, D.C.

15. Explanation for Program Changes or Adjustments

These are new collections of information.

16. Plans for Tabulation and Publication and Project Time Schedule

1. Application for ONC-ACB Status

ONC would publish on its website the names of those applicants that are granted ONC-ACB status and their associated authorization for the purpose of public notification.

ONC has not proposed in its rule a finite application period or a sunset date for the permanent certification program. Therefore, ONC anticipates that it would continue to accept applications, including renewal applications, and collect information as long as the permanent certification program remains in existence.

2. Application for ONC-AA Status

ONC would publish on its website the name of the accreditation organization that is selected to be an ONC-AA for the purpose of public notification.

ONC has not proposed a sunset date for the permanent certification program. Therefore, ONC intends to maintain an ONC-AA as long as the permanent certification program remains in existence. As previously mentioned, ONC has proposed to accept requests for ONC-AA status approximately every three years after selecting the first ONC-AA for the permanent certification program.

3. Collection and Reporting Requirements

ONC would publish all reported certified Complete EHRs and EHR Modules on its website and maintain the information on its website consistent with the specifications of the permanent certification program.

17. Reason Display of OMB Expiration Date is Inappropriate

ONC does not seek this exception. The OMB expiration date may be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

B. Collection of Information Employing Statistical Methods

Not applicable. The collections of information required above in part A do not require nor lend themselves to the application of statistical methods.

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