CMS-10276.Supporting Statement Part A

Supporting Statement for the Physician Quality Reporting Initiative (PQRI) and the Electronic Prescribing (E-Prescribing) Incentive Program

A. Background

The Physician Quality Reporting Initiative (PQRI) was established by section 101(b) of Division B of the Tax Relief and Health Care Act of 2006 – Medicare Improvements and Extension Act of 2006 (MIEA-TRHCA) and is codified in sections 1848(k) and (m) of the Social Security Act (the Act). The MIEA-TRHCA was amended in December 2007 by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) and on July 15, 2008, by the enactment of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

In accordance with section 1848(k)(2) of the Act, an eligible professional or group practice who satisfactorily submits data on quality measures for covered professional services furnished in 2010 as part of the PQRI can qualify to receive an incentive payment. The criteria for satisfactory reporting for the 2010 PQRI are specified in the CY 2010 Physician Fee Schedule (PFS) final rule with comment period.

In addition, the MIPPA authorized a new incentive program for successful electronic prescribers beginning in 2009. In order to be considered a successful electronic prescriber for 2010, an eligible professional or group practice must successfully report the electronic prescribing measure in accordance with the criteria for determining a successful electronic prescriber specified in the CY 2010 PFS final rule with comment period.

B. Justification

1. Need and Legal Basis

Collection of this information is voluntary and only applies to eligible professionals or group practices who wish to participate in the 2010 PQRI and/or the 2010 Electronic Prescribing (E-Prescribing) Incentive Program.

For the 2010 PQRI, eligible professionals or group practices who satisfactorily report data on quality measures for covered professional services furnished during the 2010 PQRI reporting period may qualify to receive an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted by no later than 2 months after the end of the reporting period. There are three mechanisms that individual eligible professionals can use to report data on quality measures for the 2010 PQRI. An individual eligible professional can choose to report data on quality measures through claims-based reporting, through a qualified PQRI registry, or through a qualified EHR product. In addition, individual eligible professionals have the option of reporting data on individual quality measures or on measures groups. The criteria for satisfactory reporting of data on individual quality measures and measures groups for the 2010 PQRI are described in the CY 2010 PFS final rule with comment period. For the group practice reporting option, there is one reporting mechanism that the group practice can use to report data on a specified set of PQRI quality measures.

In order for registries to submit PQRI quality measures results and numerator and denominator data on individual PQRI quality measures or measures groups on behalf of eligible professionals in 2010, a registry will need to self-nominate to become a “qualified” PQRI registry unless the registry was qualified for the 2009 PQRI and successfully submits 2009 PQRI quality measure results and numerator and denominator data on quality measures on behalf of their participants by March 31, 2010.

In order for an eligible professional to submit clinical quality data from an EHR for the purpose of qualifying to earn a PQRI incentive payment for 2010, the eligible professional must select a qualified EHR product. EHR vendors must have self-nominated to have one or more their products designated as a “qualified” PQRI EHR product by February 13, 2009.

While individual eligible professionals do not need to sign up or pre-register to begin participating in the 2010 PQRI, group practices interested in participating in the PQRI group practice reporting option must meet certain requirements to participate in PQRI as a group and submit a self-nomination letter by January 31, 2010.

For the 2010 E-Prescribing Incentive Program, eligible professionals or group practices who successfully report the electronic prescribing measure established under the PQRI in accordance with section 1848(m)(3)(B)(ii) of the Act are considered to be successful electronic prescribers. Successful electronic prescribers are eligible to receive an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted by no later than 2 months after the end of the reporting period. For 2010, data on the electronic prescribing measure is reportable through claims, a qualified registry, or a qualified EHR product. The electronic prescribing incentive payment is separate from the PQRI incentive payment.

This clearance request is for the information collected from eligible professionals and group practices who wish to participate in the 2010 PQRI and/or the 2010 E-Prescribing Incentive Program, registries who wish to become a “qualified” registry for the 2010 PQRI and E-Prescribing Incentive Program, and EHR vendors who wish to have their EHR product(s) designated as a “qualified” EHR product.

2. Information Users

The data on PQRI quality measures and/or the electronic prescribing measure collected from eligible professionals or group practices in 2010 will be used by CMS to: (1) determine whether an eligible professional or group practice meets the criteria for satisfactory reporting of quality measures data for the 2010 PQRI and/or the criteria for successful electronic prescribers for the 2010 E-Prescribing Incentive Program, (2) to calculate and make incentive payments in 2010 to eligible professionals and group practices who meet the criteria for satisfactory reporting of quality measures data and/or eligible professionals and group practices who are successful electronic prescribers, and (3) publicly post the names of eligible professionals and group practices who satisfactorily report PQRI quality measures data and/or who are successful electronic prescribers on the CMS Web site.

The information collected from registries through the registry self-nomination process will be used by CMS to determine whether the registry meets the PQRI registry requirements for 2010 and is qualified to submit quality measures results and numerator and denominator data on PQRI individual quality measures, measures groups, and the electronic prescribing measure on behalf of eligible professionals.

The information collected from EHR vendors through the EHR self-nomination process will be used by CMS to determine whether the vendor’s EHR product(s) meet the PQRI EHR requirements for 2010 and can be designated as qualified for the purpose of an eligible professional using clinical data extracted from the EHR to submit data on a subset of the PQRI measures and the electronic prescribing measure.

Participation in the PQRI and/or the E-Prescribing Incentive Program is voluntary in nature. Only eligible professionals or group practices that voluntarily respond and elect to participate in these incentive programs will submit the quality measures and/or electronic prescribing measure data. Similarly, only registries and EHR vendors that are interested in participating in the PQRI and group practices interested in participating in the group practice reporting option will self-nominate. For the E-Prescribing Incentive Program, only registries and EHR products qualified for the 2010 PQRI are eligible to be qualified for the 2010 E-Prescribing Incentive Program and only group practices participating in the PQRI group practice reporting option will be eligible to participate in the electronic prescribing group practice reporting option.

2. Improved Information Technology

For claims-based reporting, the normal Medicare Part B claims submission process is used to collect data on PQRI quality measures and/or the electronic prescribing measure from eligible professionals. Individual eligible professionals are not asked to provide any documentation by CD or hardcopy. For registry-based reporting, registries submit PQRI quality measures results and numerator and denominator data on PQRI measures or measures groups and the electronic prescribing measure results and numerator and denominator on the electronic prescribing measure to us electronically. For EHR-based reporting, eligible professionals submit data on PQRI quality measures and the electronic prescribing measure to us electronically through an EHR.

There is no application for registries that wish to self-nominate to become a qualified PQRI registry. Registries are asked to submit a self-nomination letter requesting inclusion in the 2010 PQRI. After a registry passes an initial qualification process that consists of interviews with CMS officials, the registry will be requested to successfully submit a “test” file in XML format to our data warehouse.

Similarly, there is no application for EHR vendors that wish to self-nominate one or more of their EHR products to become a qualified EHR product. EHR vendors were asked to submit a self-nomination letter requesting inclusion in the 2009 EHR Testing Program. Vendors who successfully complete the 2009 EHR Testing Program will be considered qualified for purposes of the 2010 PQRI. After an EHR vendor passes an initial qualification process that consists of interviews with CMS officials, the vendor will be requested to successfully submit a “test” file to our data warehouse.

For group practices participating in the PQRI group practice reporting option, the collection of information will be done using a currently OMB-approved data collection tool (see OMB Control Number 0938-0941- Form 10136). This tool is an automated, electronic tool developed and refined with industry input. Referred to as “PAT,” or Performance Assessment Tool, it was developed explicitly for specific Medicare demonstrations and has been used successfully over the past 3 years for these demonstrations. Similar to its use in the Physician Group Practice (PGP) demonstration and the Medicare Care Management Performance (MCMP) demonstration, PAT is not an EHR. Rather, it is an Access form and database used to collect numerator and denominator information required to calculate specific clinical quality measures. PAT is used to facilitate collection and scoring of the clinical quality measure data which can be provided by a physician practice from either a paper chart or an EHR system. Initially, PAT will be pre-populated by our contractor based on claims data. PQRI group practice reporting option participants will only have to supplement the claims data by providing information that is available only from the practice’s medical record. The tool will reduce the administrative burden in collecting and reporting information.

Practices participating in the PQRI group practice reporting option may input the data directly into the tool using their computer or, alternatively, the tool is able to import data electronically from an EHR, patient registry, or other electronic file. Once completed, the PAT file is then returned to CMS for scoring.

2. Duplication of Similar Information

To minimize duplication of similar information, registries who were qualified to submit PQRI quality measures results and numerator and denominator data on quality measures for the 2009 PQRI, will not need to undergo the self-nomination process for the 2010 PQRI or the 2010 E-Prescribing Incentive Program unless a registry fails to submit 2009 PQRI quality measures results and numerator and denominator data by March 31, 2010.

In addition, section 1848(m)(3)(C)(iii) of the Act specifies that there shall be no double payments to eligible professionals in a group practice that receives a PQRI incentive payment for satisfactorily reporting under the group practice reporting option. Furthermore, in 2007, CMS’ Office of Research, Development, and Information sought and was granted, from OMB, a waiver for practices participating in the PGP and MCMP demonstrations that would allow these practices to earn a PQRI incentive through their participation in the demonstration. By doing so, we are rewarding those practices that voluntarily agreed to participate in the demonstration and reduced the reporting burden they would otherwise have had if they had to submit duplicate clinical quality data using two different systems.

2. Small Businesses

The collection of information will primarily affect small entities (e.g., individual eligible professionals). We have attempted to minimize the burden on eligible professionals by providing eligible professionals with multiple reporting options for submitting PQRI quality measures data, including a group practice reporting option. We believe that a majority of the group practices participating under the group practice reporting option will not be small businesses since we have limited participation under the group practice reporting option to groups with 200 or more individual eligible professionals.

6. Less Frequent Collection

If data on PQRI quality measures and/or the electronic prescribing measure is not collected from individual eligible professionals or group practices, CMS will have no mechanism to: (1) determine whether an eligible professional or group practice meets the criteria for satisfactory reporting of quality measures data for the 2010 PQRI and/or the criteria for successful electronic prescribers for the 2010 E-Prescribing Incentive Program, (2) to calculate and make incentive payments to eligible professionals or group practices who meet the 2010 criteria for satisfactory reporting of quality measures data and/or eligible professionals or group practices who are successful electronic prescribers for 2010, and (3) publicly post the names of eligible professionals and group practices who satisfactorily report PQRI quality measures data and/or who are successful electronic prescribers on the CMS Web site.

If registries are not required to submit a self-nomination letter for the PQRI, CMS will have no mechanism to determine which registries wish to participate in the 2010 PQRI. Similarly, if EHR vendors and group practices are not required to submit a self-nomination letter for the PQRI, CMS will have no mechanism to determine which EHR vendors wish to have their EHR product(s) included in the 2010 PQRI or wish to participate in the group practice reporting option, respectively.

7. Special Circumstances

There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:

• Report information to the agency more often than quarterly;

• Prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• Submit more than an original and two copies of any docu­ment;

• Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• Collect data in connection with a statistical survey that is not designed to produce valid and reli­able results that can be generalized to the universe of study,

• Use a statistical data classi­fication that has not been reviewed and approved by OMB;

• Include a pledge of confidentiality that is not supported by authority estab­lished in statue or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• Submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

8. Federal Register Notice/Outside Consultation

The CY 2010 PFS propose rule soliciting public comment for this collection was published in the Federal Register on July 13, 2009. The comment period ended on August 31, 2009.

The final rule with comment period was put on public display at the Office of the Federal Register on October 30 2009. The final rule with comment period published on November 25, 2009. The comment period ends December 29, 2009.

9. Payment/Gift To Respondent

As authorized under section 1848(m)(1)(A) of the Act, eligible professionals or group practices (in the case of group practices participating in PQRI under the group practice reporting option) who satisfactorily report data on quality measures for covered professional services furnished during the 2010 PQRI reporting period may qualify to earn an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted not later than 2 months after the end of the reporting period for all covered professional services furnished during the 2010 PQRI reporting period.

As authorized under section 1848(m)(2)(A) of the Act, eligible professionals or group practices (in the case of group practices participating in the E-Prescribing Incentive Program under the group practice reporting option) who are successful electronic prescribers for 2010 may qualify to earn an incentive payment equal to 2.0 percent of the total estimated allowed charges submitted not later than 2 months after the end of the reporting period for all covered professional services furnished during the 2010 electronic prescribing reporting period.

10. Confidentiality

Consistent with federal government and CMS policies, CMS will protect the confidentiality of the requested proprietary information. Specifically, any confidential information (as such terms are interpreted under the Freedom of Information Act, the Privacy Act of 1974, and other applicable Federal government rules and regulations) will be protected from release by CMS under 5 U.S.C. § 552a(b).

11. Sensitive Questions

Other than the labeled information noted above in section 10, there are no sensitive questions included in the information request.

12. Burden Estimate (Total Hours & Wages)

The annual burden estimate is calculated separately for each incentive program. In addition, within each program, the annual burden estimate is calculated separately for individual eligible professionals and group practices participating under the group practice reporting option.

Burden Estimate for PQRI Reporting by Individual Eligible Professionals

With respect to the PQRI, the burden associated with the requirements of this voluntary reporting initiative is the time and effort associated with individual eligible professionals identifying applicable PQRI quality measures for which they can report the necessary information and the time and effort associated with eligible professionals selecting a reporting option. It is difficult to accurately quantify the burden because it would vary with each eligible professional by the number of measures applicable to the eligible professional, the eligible professional’s familiarity and understanding of the PQRI, and experience with participating in the PQRI. In addition, eligible professionals may employ different methods for incorporating quality measures reporting into the office work flows and are given flexibility for determining which reporting option best fits their needs. We believe the burden associated with participating in the PQRI has declined for those familiar with the program and who have satisfactorily participated in the 2007 PQRI and/or the 2008 PQRI. However, because we anticipate even greater participation in the 2010 PQRI, including participation by eligible professionals who are participating in PQRI for the first time in 2010, we will assign 5 hours as the amount of time needed for eligible professionals to review the list of PQRI quality measures and measures groups, identify the applicable measures or measures group for which they can report the necessary information, review the measure specifications for those measures or measures group applicable to the eligible professional, incorporate reporting of the measures or measures group selected by the eligible professional into the office work flows, and select a 2010 PQRI reporting option. Information from the Physician Voluntary Reporting Program (PVRP) indicated an average labor cost of $50 per hour per practice. To account for salary increases over time, we will use an average practice labor cost of $55 per hour in our estimates. Thus, we estimate the cost for an eligible professional to review the list of PQRI quality measures or measures group, identify the applicable measures or measures group for which they can report the necessary information, incorporate reporting of the selected measures or measures group into the office work flows, and select a 2010 PQRI reporting option to be approximately $275 per eligible professional ($55 per hour x 5 hours). We continue to expect the ongoing costs associated with PQRI participation to decline based on an eligible professional’s familiarity with and understanding of the PQRI, experience with participating in the PQRI, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices.

In addition, for claims-based reporting, eligible professionals must gather the required information, select the appropriate quality data codes, and include the appropriate quality data codes on the claims they submit for payment. The PQRI will collect quality data codes as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500. We do not anticipate any new forms or modifications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2010.

Because this is a voluntary program, it is difficult for us to accurately estimate how many eligible professionals will opt to participate in the PQRI in CY 2010. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS website at http://www.cms.hhs.gov/PQRI, indicates that nearly 110,000 unique TIN/NPI combinations attempted to submit PQRI quality measures data via claims for the 2007 PQRI. Therefore, for purposes of conducting a burden analysis for the 2010 PQRI, we will assume that all eligible professionals who attempted to participate in the 2007 PQRI will also attempt to participate in the 2010 PQRI.

Moreover, the time needed for an eligible professional to review the quality measures and other information, select measures or a measures group applicable to his or her patients and the services he or she furnishes to them, incorporate reporting of the selected measures or measures group into the office work flows, and select a 2010 PQRI reporting option is expected to vary along with the number of measures that are potentially applicable to a given professional’s practice. Since eligible professionals are generally required to report on at least 3 measures to earn a PQRI incentive, we will assume that each eligible professional who attempts to submit PQRI quality measures data is attempting to earn a PQRI incentive payment and that each eligible professional reports on an average of 3 measures for this burden analysis.

Based on our experience with the PVRP, we estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality data code(s) for a measure) on claims ranges from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. With an average practice labor cost of $55 per hour, the cost associated with this burden ranges from $0.23 in labor time to about $11.00 in labor time for more complicated cases and/or measures, with the cost for the median practice being $1.44.

The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data is reported. Results from the 2007 PQRI indicate that eligible professionals reported on 1 to 3,331 eligible instances per measure. For all 2007 PQRI measures, the median number of eligible instances reported on per measure was less than 60. On average, the median number of eligible instances reported on per measure was about 9. Therefore, for this burden analysis, we estimate, for each measure on which an eligible professional reports, the eligible professional reports the quality data on 9 cases.

The actual number of cases on which an eligible professional would be required to report quality measures data will vary, however, with the eligible professional’s patient population, the types of measures on which the eligible professional chooses to report (each measure’s specifications includes a required reporting frequency), and the reporting period on which the eligible professional chooses to report.

Based on the assumptions discussed above, Table 1 provides an estimate of the range of total annual burden hours and total annual cost burden associated with claims-based reporting for individual eligible professionals.

Table 1

	Minimum Burden Estimate	Maximum Burden Estimate
Estimated # of Participating Eligible Professionals in 2010 (a)	110,000	110,000
Estimated # of Measures Per Eligible Professional Per Year (b)	3	3
Estimated # of Cases Per Measure Per Eligible Professional Per Year (c)	9	9
Total Estimated # of Cases Per Eligible Professional Per Year (d) = (b)*(c)	27	27
Estimated Burden Hours Per Case (e)	0.00415	0.19992
Estimated Total Burden Hours For Measures Per Eligible Professional Per Year (f) = (d)*(e)	0.11205	5.39784
Estimated Burden Hours Per Eligible Professional to Review 2010 PQRI quality measures (g)	5	5
Estimated Total Annual Burden Hours Per Eligible Professional (h) = (f)+(g)	5.11205	10.39784
Estimated Total Annual Burden Hours (i) = (a)*(h)	562,326	1,143,762
Estimated Cost Per Case (j)	$0.23	$11.00
Total Estimated Cost of Cases Per Eligible Professional Per Year (k) = (d)*(j)	$6.21	$297.00
Estimated Cost Per Eligible Professional to Review 2010 PQRI quality measures (l)	$275	$275
Estimated Total Annual Cost Per Eligible Professional (m) = (k) + (l)	$281.21	$572.00
Estimated Total Annual Burden Cost (n) = (a)*(m)	$30,933,100	$62,920,000

For registry-based reporting, we estimate that it would cost an eligible professional approximately $1,000 to participate in a registry. This takes into account the participation fee that may be charged by a registry and the fact that this fee often includes services above and beyond what is required for PQRI. We note, however, that registries vary in their participation fees as some registries do not charge a participation fee at all or charge only nominal fees. Eligible professionals also would need to authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each eligible professional that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf.

Registries interested in submitting quality measure results and numerator and denominator data on quality measures to CMS on their participants’ behalf in 2010 will need to complete a self‑nomination process in order to be considered “qualified” to submit on behalf of eligible professionals unless the registry was “qualified” to submit on behalf of eligible professionals for the 2009 PQRI and does so successfully. Based on the number of registries that have self-nominated to become a qualified PQRI registry in prior program years, we estimate that approximately 50 additional registries will self-nominate to be considered a qualified registry for the 2010 PQRI. We anticipate that as the PQRI program matures, the number of registries seeking to become a qualified registry will decrease over time. We estimate that the self-nomination process for qualifying additional registries to submit on behalf of eligible professionals for the 2010 PQRI involves approximately 1 hour per registry to draft the letter of intent for self-nomination. It is estimated that each self-nominated entity will also spend 2 hours for the interview with CMS officials and 2 hours for the development of a measure flow. However, the time it takes to complete the measure flow could vary depending on the registry’s experience. Additionally, part of the self-nomination process involves the completion of an XML submission by the registry, which is estimated to take approximately 5 hours, but may vary depending on the registry’s experience. We estimate that the registry staff involved in the registry self-nomination process has an average labor cost of $50 per hour. Therefore, assuming the total burden hours per registry associated with the registry self-nomination process is 10 hours, we estimate the total cost to a registry associated with the registry self-nomination process to be approximately $500 ($50 per hour x 10 hours per registry).

Based on the assumptions discussed above, Table 2 provides an estimate of total annual burden hours and total annual cost burden associated with a registry self-nominating in order to be considered “qualified” for the purpose of submitting quality measures results and numerator and denominator data on PQRI individual quality measures or measures groups on behalf of individual eligible professionals.

Table 2

	Burden Estimate
Estimated # of Registries Self-Nominating for the 2010 PQRI (a)	50
Estimated Total Annual Burden Hours Per Registry (b)	10
Estimated Total Annual Burden Hours For Registries (c) = (a)*(b)	500
Estimated Cost Per Registry (d)	$500
Estimated Total Annual Burden Cost For Registries (e) = (a)*(d)	$25,000

The burden associated with the registry-based submission requirements of this voluntary reporting initiative is the time and effort associated with the registry calculating quality measure results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. The time needed for a registry to review the quality measures and other information, calculate the measures results, and submit the measures results and numerator and denominator data on the quality measures on their participants’ behalf is expected to vary along with the number of eligible professionals reporting data to the registry and the number of applicable measures. However, we believe that registries already perform many of these activities for their participants. The number of measures that the registry intends to report to CMS and how similar the registry’s measures are to CMS’ PQRI measures will determine the time burden to the registry.

For EHR-based reporting, the eligible professional must review the quality measures on which we will be accepting PQRI data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. Because this manner of reporting quality data to CMS will be new to PQRI for 2010 and participation in this reporting initiative is voluntary, we believe it is difficult to estimate with any degree of accuracy how many eligible professionals will opt to participate in the PQRI through the EHR mechanism in CY 2010. The time needed for an eligible professional to review the quality measures and other information, select measures applicable to his or her patients and the services he or she furnishes to them is expected to be similar for EHR-based reporting and claims-based reporting. Once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional associated with submission of data on PQRI quality measures should be minimal.

An EHR vendor interested in having their product(s) be used by eligible professionals to submit PQRI quality measures data to CMS were required to complete a self‑nomination process in order for the vendor’s product(s) to be considered “qualified” for 2010. It is difficult for us to accurately quantify the burden associated with the EHR self-nomination process as there is variation regarding the technical capabilities and experience among vendors. For purposes of this burden analysis, however, we estimate that the time required for an EHR vendor to complete the self-nomination process will be similar to the time required for registries to self-nominate, that is, approximately 10 hours at $50 per hour for a total of $500 per EHR vendor ($50 per hour x 10 hours per EHR vendor).

The burden associated with the EHR-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting 2010 PQRI quality measures. The time needed for an EHR vendor to review the quality measures and other information and program each qualified EHR product to enable eligible professionals to submit PQRI quality measures data to the CMS-designated clinical data warehouse will be dependent on the EHR vendor’s familiarity with PQRI, the vendor’s system capabilities, as well as the vendor’s programming capabilities. Some vendors already have these necessary capabilities and for such vendors, we estimate the total burden hours to be 40 hours at a rate of $50 per hour for a total burden estimate of $2,000 ($50 per hour x 40 hours per vendor). However, given the variability in the capabilities of the vendors, we believe a more conservative estimate for those vendors with minimal experience would be approximately 200 hours at $50 per hour, for a total estimate of $10,000 per vendor ($50 per hour x 200 hours per EHR vendor).

Based on the assumptions discussed above, Table 3 provides an estimate of total annual burden hours and total annual cost burden associated with an EHR vendor self-nominating in order to have one or more of their EHR products considered “qualified” for the purpose of eligible professionals being able to qualify to earn a PQRI incentive by submitting clinical quality data from the EHR product.

Table 3

	Burden Estimate
Estimated # of EHR Vendors Self-Nominating for the 2010 PQRI (a)	15
Estimated Total Annual Burden Hours Per Vendor (b)	200
Estimated Total Annual Burden Hours for EHR Vendors (c) = (a)*(b)	3,000
Estimated Cost Per Vendor (d)	$10,000
Estimated Total Annual Burden Cost for EHR Vendors (e) = (a)*(d)	$150,000

Burden Estimate for PQRI Reporting by Group Practices

With respect to the process for group practices to be treated as satisfactorily submitting quality measures data under the 2010 PQRI, group practices interested in participating in the 2010 PQRI through the group practice reporting option must complete a self‑nomination process similar to the self-nomination process required of registries and EHR vendors. Therefore, we estimate that the self-nomination process for the group practices for the 2010 PQRI involves approximately 2 hours per group practice to review the 2010 PQRI group practice reporting option and make the decision to participate as a group rather than individually and an additional 2 hours per group practice to draft the letter of intent for self-nomination, gather the requested TIN and NPI information, and provide this requested information. It is estimated that each self-nominated entity will also spend 2 hours undergoing the vetting process with CMS officials. We assume that the group practice staff involved in the group practice self-nomination process have an average practice labor cost of $55 per hour. Therefore, assuming the total burden hours per group practice associated with the group practice self-nomination process is 6 hours, we estimate the total cost to a group practice associated with the group practice self-nomination process to be approximately $330 ($55 per hour x 6 hours per group practice). We have reason to believe that approximately 200 TINs meet our definition of “group practice.” For purposes of this burden analysis we will assume that all TINs that meet our definition of “group practice” will self-nominate to participate in the PQRI under the group practice reporting option.

The burden associated with the group practice reporting requirements of this voluntary reporting initiative is the time and effort associated with the group practice submitting the quality measures data. For physician group practices, this would be the time associated with the physician group completing the PAT. As stated above, the information collection components of the PAT have been reviewed by OMB and are currently approved under OMB control number 0938-0941- Form 10136, with an expiration date of December 31, 2011 for use in the PGP, MCMP, and EHR demonstrations. The only modification that we intend to make to the PAT for use in the PQRI is to add a screen that provides group practices with information on completeness of their reporting and their quality measure results and numerator and denominator data. Since these changes will not have any impact on the information collection requirements associated with the PAT and we will be using the same data submission process used in the PGP demonstration, we estimate that the burden associated with a group practice completing the PAT for PQRI will be the same as for the group practice to complete the PAT for the PGP demonstration. In other words, we estimate that, on average, it will take each group practice 79 hours to complete the PAT at a cost of $55 per hour. Therefore, the total estimated annual cost per group practice is estimated to be approximately $4,345.

Based on the assumptions discussed above, Table 4 provides an estimate of the range of total annual burden hours and total annual cost burden associated group practice reporting of PQRI quality measures.

Table 4

	Burden Estimate
Estimated # of Eligible Group Practices in 2010 (a)	200
Estimated # of Burden Hours Per Group Practice to Self-Nominate to Participate in PQRI Under the Group Practice Reporting Option (b)	6
Estimated # of Burden Hours Per Group Practice to Complete the PAT (c)	79
Estimated Total Annual Burden Hours Per Group Practice (d) = (b)+(c)	85
Estimated Total Annual Burden Hours (e) = (a)*(d)	17,000
Estimated Cost Per Group Practice to Self-Nominate to Participate in PQRI Under the Group Practice Reporting Option (f)	$330
Estimated Cost Per Group Practice to Complete the PAT (g)	$4,345
Estimated Total Annual Cost Per Group Practice (h) = (f) + (g)	$4,675
Estimated Total Annual Burden Cost (i) = (a)*(h)	$935,000

Burden Estimate for E-Prescribing Reporting by Individual Eligible Professionals

With respect to the E-Prescribing Incentive Program, it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program in CY 2010. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS website at http://www.cms.hhhs.gov/PQRI, indicates that nearly 110,000 unique TIN/NPI combinations attempted to submit PQRI quality measures data via claims for the 2007 PQRI. Therefore, for purposes of conducting a burden analysis for the 2010 E-Prescribing Incentive Program, we will assume that as many eligible professionals who attempted to participate in the 2007 PQRI will attempt to participate in the 2010 E-Prescribing Incentive Program. As such, we can estimate that nearly 110,000 unique TIN/NPI combinations will participate in the 2010 E-Prescribing Incentive Program.

For the 2010 E-Prescribing Incentive Program, each eligible professional will need to report the 2010 electronic prescribing measure, which indicates that at least 1 prescription created during an eligible encounter was generated and transmitted electronically using a qualified electronic prescribing system. Similar to PQRI, this measure will be reportable through claims, a qualified registry, or a qualified EHR.

Similar to claims-based reporting for the PQRI, we estimate the burden associated with the requirements of this incentive program is the time and effort associated with eligible professionals determining whether the electronic prescribing measure is applicable to them, gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims they submit for payment. Since the E-Prescribing Incentive Program consists of only 1 quality measure, we will assign 1 hour as the amount of time needed for eligible professionals to review the electronic prescribing measure and incorporate reporting of the measure into their office work flows and an additional hour as the amount of time needed for eligible professionals to select an appropriate reporting mechanism for them. At an average cost of approximately $55 per hour, we estimate the total cost to eligible professionals for reviewing the electronic prescribing measure, incorporating the reporting of the measure into the office work flows, and selecting an appropriate reporting mechanism to be approximately $110 ($55 per hour X 2 hours).

For claims-based reporting, the quality data codes will be collected as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500. We do not anticipate any new forms or modifications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2010. Based on our experience with the PVRP described above, we estimate that the time needed to perform all the steps necessary to report the electronic prescribing measure via claims to be 1.75 minutes per reporting instance. We also estimate the cost to perform all the steps necessary to report the electronic prescribing measure to be $1.44 per reporting instance based on an average practice labor cost of $55 per hour.

For 2010, we are changing the criteria for successful reporting of the electronic prescribing measure to require each eligible professional to report that he or she electronically prescribed for at least 25 instances during the reporting period, that is, to require each eligible professional to report the measure for at least 25 instances during the reporting period. Based on the required number of reporting instances, or cases, we estimate the total annual burden per eligible professional who chooses to participate in the 2010 E-Prescribing Incentive Program through claims-based reporting of the electronic prescribing measure to be 163.75 minutes, or 2.73 hours [(1.75 minutes per reporting instance per measure x 1 measure x 25 cases per measure) + 2 hour]. The total estimated cost per eligible professional to report the electronic prescribing measure is $146.00 [($1.44 per reporting instance per measure x 1 measure x 25 cases per measure) + $110]

Table 5 provides an estimate of the total annual burden hours and total annual burden costs per individual eligible professional associated with claims-based reporting of the electronic prescribing measure.

Table 5

	Burden Estimate
Estimated # of Participating Eligible Professionals in 2010 (a)	110,000
# of Measures Per Eligible Professional Per Year (b)	1
Estimated # of Cases For Measures Per Eligible Professional Per Year (c)	25
Total Estimated # of Cases Per Eligible Professional Per Year (d) = (b)*(c)	25
Estimated Burden Hours Per Case(e)	0.029167
Estimated Total Burden Hours Per Measure Per Eligible Professional Per Year (f) = (d)*(e)	.729175
Estimated Burden Hours Per Eligible Professional to Review 2010 electronic prescribing quality measure (g)	2
Estimated Total Annual Burden Hours Per Eligible Professional (h) = (f)+(g)	2.729175
Estimated Total Annual Burden Hours (i) = (a)*(h)	300,209
Estimated Cost Per Case (j)	$1.44
Total Estimated Cost of Cases Per Eligible Professional Per Year (k) = (d)*(j)	$36.00
Estimated Cost Per Eligible Professional to Review 2010 e-prescribing quality measures (l)	$110
Estimated Total Annual Cost Per Eligible Professional (m) = (k) + (l)	$146.00
Annual Burden Cost (n) = (a)*(m)	$16,060,000

Because registry-based reporting of the electronic prescribing measure to CMS would be new for 2010 and participation in this reporting initiative is voluntary, it is impossible to estimate with any degree of accuracy how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the registry-based reporting mechanism in CY 2010. We do not anticipate, however, any additional burden for eligible professionals to report data to a registry as eligible professionals opting for registry-based reporting would more than likely already be reporting data to the registry for other purposes (particularly eligible professionals who are already participating in PQRI via the registry-based reporting mechanism). Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2010 E-Prescribing Incentive Program. However, in addition to the 2 hours estimated for the time needed by eligible professionals to review the applicability of the electronic prescribing measure, incorporate reporting of the measure in their practice work flows, and review the available reporting mechanisms to select the registry reporting measure, incorporate reporting of the measure in their practice work flows, and review the available reporting mechanisms to select the registry reporting mechanism, eligible professionals will need to instruct or authorize the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each eligible professional that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf.

Based on our policy to consider only registries qualified to submit quality measures results and numerator and denominator data on quality measures to CMS on their participants’ behalf for the 2010 PQRI to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program, there will be no need for a registry to undergo a separate self-nomination process for the E-Prescribing Incentive Program other than to indicate to us its desire to become a qualified registry for the E-Prescribing Incentive Program at the time that it does so for PQRI. Therefore, we estimate that any additional burden associated with the registry self-nomination process would be minimal.

The burden associated with the registry-based reporting requirements of this voluntary reporting initiative is the time and effort associate with the registry calculating results for the e-prescribing measure from the data submitted to the registry by its participants and submitting the e-prescribing measure results and numerator and denominator data on their participants’ behalf is expected to vary along with the number of eligible professionals reporting data to whom the measure applies. However, we believe that registries already perform many of these activities for their participants. Since the E-Prescribing Incentive Program consists of only one measure, we believe that the burden associated with the registry reporting the measure’s results and numerator and denominator to CMS on behalf of their participants would be minimal.

For EHR-based reporting, the eligible professional must review the electronic prescribing measure, extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. Because this manner of reporting quality data to CMS will be new for 2010 and participation in this reporting initiative is voluntary, it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the EHR-based reporting mechanism in CY 2010. The time needed for an eligible professional to review the electronic prescribing measure and other information and determine whether the measure is applicable to his or her patients and the services her or she furnishes to them and to review the available reporting mechanisms to select the EHR reporting mechanism is expected to be similar for EHR-based reporting and claims-based reporting. Once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional associated with submission of data on the electronic prescribing measure should be minimal.

Based on our policy to consider only EHR products qualified for the 2010 PQRI to be qualified for the 2010 E-Prescribing Incentive Program, there will be no need for EHR vendors to undergo a separate self-nomination process for the E-Prescribing Incentive Program and therefore, no additional burden associated with the self-nomination process.

The burden associated with the EHR-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting the 2010 electronic prescribing measure. The time needed for an EHR vendor to review the measure and other information and program each qualified EHR product to enable eligible professionals to submit data on the measure to the CMS-designated clinical data warehouse will be dependent on the EHR vendor’s familiarity with the electronic prescribing measure, the vendor’s system capabilities, as well as the vendor’s programming capabilities. Since only EHR products qualified for the 2010 PQRI will be qualified for the 2010 E-Prescribing Incentive Program and the E-Prescribing Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable eligible professionals to submit data on the electronic prescribing measure to the CMS-designated clinical data warehouse would be minimal.

Burden Estimate for E-Prescribing Reporting by Group Practices

With respect to the process for group practices to be treated as successful electronic prescribers under the 2010 E-Prescribing Incentive Program, a group practice will be required to report the electronic prescribing measure in at least 2,500 instances. Group practices have the same options as individual eligible professionals in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices have the option of reporting measure through claims, a qualified registry, or a qualified EHR product). The only difference between an individual eligible professional and group practice reporting of the electronic prescribing measure is the number of times that a group practice is required to report the electronic prescribing measure. Reporting of the electronic prescribing measure can continue to occur at the individual eligible professional level under the electronic prescribing group practice reporting option. In our analysis of the reported information, however, we will aggregate all of the information reported by the eligible professionals within the group practice to determine whether the group practice reported the measure a sufficient number of times.

For group practices who are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through claims-based reporting of the electronic prescribing measure, we estimate the total annual burden to be 74.92 hours per group practice [(1.75 minutes per measure x 1 measure x 2,500 cases per measure) + 2 hour]. The total estimated cost per group practice to report the electronic prescribing measure through claims-based reporting is estimated to be $3,710 [($1.44 per measure x 1 measure x 2,500 cases per measure) + $110]. Since we are limiting participation in the E-Prescribing Incentive Program group practice reporting option to those group practices participating in the PQRI group practice reporting option, we will assume, for the purpose of this burden analysis, that the estimated number of group practices participating in the E-Prescribing Incentive Program group practice reporting option is the same as the estimated number of group practices participating in the PQRI group practice reporting option. There will not be a separate self-nomination process for group practices who wish to participate in the E-Prescribing Incentive Program group practice reporting option.

Table 6 provides an estimate of the total annual burden hours and total annual burden costs per group practice associated with claims-based reporting of the electronic prescribing measure.

Table 6

	Burden Estimate
Estimated # of Participating Group Practices in 2010 (a)	200
# of Measures Per Group Practice Per Year (b)	1
Estimated # of Cases For Measures Per Group Practice Per Year (c)	2,500
Total Estimated # of Cases Per Group Practice Per Year (d) = (b)*(c)	2,500
Estimated Burden Hours Per Case (e)	0.029167
Estimated Total Burden Hours Per Measure Per Group Practice Per Year (f) = (d)*(e)	72.9175
Estimated Burden Hours Per Group Practice to Review 2010 e-prescribing quality measure (g)	2
Estimated Total Annual Burden Hours Per Group Practice (h) = (f)+(g)	74.9175
Estimated Total Annual Burden Hours (i) = (a)*(h)	14,984
Estimated Cost Per Case (j)	$1.44
Total Estimated Cost of Cases Per Group Practice Per Year (k) = (d)*(j)	$3,600
Estimated Cost Per Group Practice to Review 2010 electronic prescribing quality measures (l)	$110
Estimated Total Annual Cost Per Group Practice (m) = (k) + (l)	$3,710
Annual Burden Cost (n) = (a)*(m)	$742,000

For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through registry-based reporting of the electronic prescribing measure, we do not anticipate any additional burden to report data to a registry as group practices opting for registry-based reporting would more than likely already be reporting to the registry for other purposes, such as for the PQRI. Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2010 E-Prescribing Incentive Program. However, in addition to the 2 hours estimated for the time needed by group practices to review the electronic prescribing measure to determine its applicability to the practice, incorporate reporting of the electronic prescribing measure into the practice’s work flows, and review available reporting mechanisms to select group practice reporting of the measure through a qualified registry, the group practices will need to authorize or instruct the registry to submit the measure results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each group practice that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf.

For group practices who are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through the EHR-based reporting mechanism, once the practice’s EHR is programmed by the vendor to allow data submission to CMS, the burden to the group practice associated with submission of data on the e-prescribing measure should be minimal.

Total Estimated Burden of this Information Collection Requirement

It is difficult to accurately estimate the total annual burden hours and total annual burden costs associated with the submission of the quality measures data for the PQRI and the E-Prescribing Incentive Program. Since the two programs are separate initiatives and both are voluntary, it is difficult to accurately determine whether, for a particular year, eligible professionals who participate in one program will also participate in the other program. In addition, there are a number of reporting mechanisms available that eligible professionals can choose to use to report the PQRI measures and/or electronic prescribing measure. It may be more burdensome for some practices to use some reporting mechanisms to report the PQRI measures and/or electronic prescribing measure than others. This will vary with each practice. We have no way of determining which reporting mechanism an individual eligible professional will use in a given year. Furthermore, we have no way of knowing whether an eligible professional will choose to participate in the PQRI and/or the E-Prescribing Incentive Program as an individual eligible professional or as a group practice. Therefore, Table 7 provides a range of estimates for individual eligible professionals. The lower range of the estimate assumes that eligible professionals will only participate in the E-Prescribing Incentive Program and represents the estimated burden hours and burden cost per eligible professional from Table 5, respectively. The upper range assumes that eligible professionals participate in both the E-Prescribing Incentive Program and the PQRI during 2010 and represents the sum of the estimated maximum burden hours and burden cost per eligible professional from Tables 1 and 5 above. All of our estimates assume that availability of a group practice reporting option does not impact the number of individual eligible professionals who choose to participate in the PQRI and/or the E-Prescribing Incentive Program. These estimates also assume that the number of respondents remain the same regardless of whether an eligible professional is participating in one or both programs. We are, however, requesting approval for the upper range of the estimates provided in Table 7.

Table 7

	Minimum Burden Estimate	Maximum Burden Estimate
Estimated # of Participating Eligible Professionals in 2010	110,000	110,000
Estimated # of Measures Per Eligible Professional Per Year	1	4
Estimated Total Burden Hours For Measures Per Eligible Professional Per Year	0.729175	6.127015
Estimated Burden Hours Per Eligible Professional to Review 2010 Quality Measures for PQRI and/or the E-Prescribing Incentive Program	2	7
Estimated Total Annual Burden Hours Per Eligible Professional	2.729175	13.127015
Estimated Total Annual Burden Hours for Individual Eligible Professionals	300,209	1,443,972
Total Estimated Cost of Cases Per Eligible Professional Per Year	$36.00	$333.00
Estimated Cost Per Eligible Professional to Review 2010 quality measures for PQRI and/or the E-Prescribing Incentive Program	$110	$385.00
Estimated Total Annual Cost Per Eligible Professional	$146.00	$718.00
Annual Burden Cost for Individual Eligible Professionals	$16,060,000	$78,980,000

Since group practices are required to participate in both the PQRI and E-Prescribing Incentive Program, Table 8 provides an estimate for group practices to participate in both the E-Prescribing Incentive Program and the PQRI under the group practice reporting option during 2010 (that is, sum of Tables 4 and 6).

Table 8

	Maximum Burden Estimate
Estimated # of Participating Group Practices in 2010	200
Estimated # of Burden Hours Per Group Practice to Self-Nominate to Participate in PQRI and the E-Prescribing Incentive Program Under the Group Practice Reporting Option	6
Estimated # of Burden Hours Per Group Practice to Report PQRI Quality Measures and the E-Prescribing Measure	151.9175
Estimated Burden Hours Per Group Practice to Review 2010 Electronic Prescribing Measure	2
Estimated Total Annual Burden Hours Per Group Practice	159.9175
Estimated Total Annual Burden Hours for Group Practices	31,984
Estimated Cost Per Group Practice to Self-Nominate to Participate in PQRI and/or the E-Prescribing Incentive Program Under the Group Practice Reporting Option	$330
Estimated Cost Per Group Practice to Report PQRI Quality Measures and/or E-Prescribing Quality Measure	$7,945
Estimated Cost Per Group Practice to Review the E-Prescribing Measure	$110
Estimated Total Annual Cost Per Group Practice	$8,385
Annual Burden Cost for Group Practices	$1,677,000

13. Capital Costs (Maintenance of Capital Costs)

CMS requirements do not require the acquisition of new systems or the development of new technology to participate in the PQRI. However, to the extent an eligible professional decides to participate in the PQRI through the EHR-based reporting mechanism and he or she does not already have an EHR, he or she will need to purchase one. The cost of purchasing an EHR product can range anywhere from as low as $500 to well over $50,000. We estimate that, on average, it costs between $15,000 and $25,000 to purchase an EHR product.

In addition, in order to report the electronic prescribing measure, the electronic prescribing measure requires eligible professionals to have and use a “qualified” electronic prescribing system. There are currently many commercial packages available for electronic prescribing. One study indicated that a mid-range complete electronic medical record costs $2500 per license with an annual fee of $90 per license for quarterly updates of the drug database after setup costs while a standalone prescribing, messaging, and problem list system costs $1200 per physician per year after setup costs. Hardware costs and setup fees substantially add to the final cost of any software package. (Corley, S.T. (2003). "Electronic prescribing: a review of costs and benefits." Topics in Health Information Management 24(1): 29-38.). The cost to an eligible professional of obtaining and utilizing an electronic prescribing system varies not only by the commercial software package selected but also by the level at which the professional currently employs information technology in his or her practice and the level of training needed.

14. Cost to Federal Government

In CY 2010, incentive payments will be made to eligible professionals who satisfactorily submit data on PQRI quality measures for the 2009 PQRI as well as to eligible professionals who are successful electronic prescribers for the 2009 E-Prescribing Incentive Program. For the PQRI, the only information we have on the number of eligible professionals who qualify for an incentive payment is from the 2007 PQRI, the first year of the program. Incentive payments for the 2008 PQRI have just started and we are just starting to receive results from the 2008 PQRI. Based on the preliminary information we have on the 2008 PQRI, we expect the number of eligible professionals who qualify for a PQRI incentive to increase as a result of the lessons learned from the 2007 PQRI, an increase in the use of the registry-based reporting mechanism, and a more targeted provider education campaign. For purposes of this burden analysis, we can only assume that those who attempt to participate in the 2009 PQRI do so satisfactorily and qualify to earn an incentive payment for a full-year. Thus, the estimated cost of incentive payments made to eligible professionals in CY 2010 for the 2009 PQRI is expected to be approximately $93 million based on a 2.0 percent incentive payment. This estimate is based on the average incentive amount per NPI/TIN for the 2007 PQRI, which was a 1.5% incentive for a 6-month reporting period.

For the E-Prescribing Incentive Program, CY 2010 would be the first year in which incentive payments would be paid to eligible professionals for being successful electronic prescribers in 2009. If we apply the same assumptions we used for PQRI, then the estimated cost of incentive payments made to eligible professionals in CY 2010 for the 2009 E-Prescribing Incentive Program is expected to be approximately $93 million based on a 2.0 percent incentive payment for a full-year. Thus, the combined cost of incentive payments in CY 2010 for both incentive programs is estimated to be approximately $186 million.

14. Program or Burden Changes

The changes in the estimated burden in this PRA application, since the original submission, are due to the following:

• An increase in the number of eligible professionals expected to participate in the PQRI and/or E-Prescribing Incentive Programs from 101,000 to 110,000 based on our expectations of increased participation as more eligible professionals become aware of the incentive programs and an increase in the number of reporting mechanisms and reporting options.

• An increase in the average practice labor rate from $50 to $55 due to general increases in labor costs since 2006, when the PVRP was in place.

• A decrease in the number of reporting instances for the E-Prescribing Incentive Program from 60 to 25 as a result of the revised reporting criteria for the electronic prescribing measure for the 2010 E-Prescribing Incentive Program.

• The addition of burden hours associated with reviewing and selecting a PQRI and E-Prescribing Incentive Program reporting option for 2010.

• The addition of burden for registries associated with the self-nomination process.

• The implementation of a new EHR-based reporting mechanism for the PQRI.

• The implementation of a new group practice reporting option for the PQRI and the E-Prescribing Incentive Program.

14. Publication and Tabulation Dates

As required by the MIPPA, the names of eligible professionals and group practices who satisfactorily report data on PQRI quality measures and who are successful electronic prescribers for 2010 will be posted on the CMS website at www.medicare.gov in 2011 following completion of the 2010 incentive payments.

17. Expiration Date

CMS would like approval for this information collection for a period of 3 years from the expiration of the current PQRI approval (12/31/2009). There are no paper forms involved in this data collection activity.

18. Certification Statement

There are no exceptions to the certification statement.

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