CMS Regional Office 9th SOW Update AHQA Meeting February 2009

1. 1 CMS Regional Office 9th SOW UpdateAHQA MeetingFebruary 2009 Teresa Titus-Howard, MSW, MHA Associate Regional Administrator Division of Quality Improvement, Mid-Western Region Centers for Medicare & Medicaid Services Good Afternoon, Thank you for the opportunity to speak with you today on behalf of CMS and the Division of Quality Improvement Regional Offices. We always look forward to the opportunity to meet with our contractors to share with you the Regional Office perspective for the overall monitoring of the QIO Program. I hope you find the information presented to be helpful to you to better understand the Regional Office roles and responsibilities. Good Afternoon, Thank you for the opportunity to speak with you today on behalf of CMS and the Division of Quality Improvement Regional Offices. We always look forward to the opportunity to meet with our contractors to share with you the Regional Office perspective for the overall monitoring of the QIO Program. I hope you find the information presented to be helpful to you to better understand the Regional Office roles and responsibilities.

2. 2 Today’s Objectives To review: Regional Office (RO) monitoring and oversight responsibilities. QIO performance and Performance Improvement Plans (PIPs) Expectations for routine assessments QIO collaboration for GPRA Goals Relevant End State Renal Disease (ESRD) program updates CMS internal controls and process improvement measures. For today’s presentation, I would like to accomplish the following objectives: To review: 1. Regional Office monitoring and oversight responsibilities for the QIO program. 2. Trends in QIO performance (i.e. PIPs) and a discussion of PIP process 3. Expectations for routine assessments – the term routine assessment is much broader than the ‘site visits.’ 4. QIO collaboration for GPRA Goals (i.e. Patient Safety). 5. Relevant ESRD updates (i.e. CKD) 6. CMS internal controls and process improvement measures. A lot of what I will be discussing is many aspects of what goes on behind the scenes that may or not be apparent to you, but an important part of the overall contract monitoring process. For today’s presentation, I would like to accomplish the following objectives: To review: 1. Regional Office monitoring and oversight responsibilities for the QIO program. 2. Trends in QIO performance (i.e. PIPs) and a discussion of PIP process 3. Expectations for routine assessments – the term routine assessment is much broader than the ‘site visits.’ 4. QIO collaboration for GPRA Goals (i.e. Patient Safety). 5. Relevant ESRD updates (i.e. CKD) 6. CMS internal controls and process improvement measures. A lot of what I will be discussing is many aspects of what goes on behind the scenes that may or not be apparent to you, but an important part of the overall contract monitoring process.

3. 3 RO QIO monitoring and oversight Regional Office and Central Office (CO) collaboration Consortium Structure Consortium for Quality Improvement Survey and Certification Operations (CQISCO) Four Division of Quality Improvement (DQI) Regional Offices Project Officer assignments New assignments Will continue to evaluate Monthly QIO calls At least one per month Cover ALL themes Content experts encouraged to attend Deliverable review and approval Monthly, Quarterly and as needed If not met, PO will investigate Important point: Just a reminder that although the items discussed today are primarily performed by RO they are not done in isolation. There is extensive communication and collaboration happening between the RO and CO. Consortium Structure At the beginning of any new SOW, there is always an opportunity to revaluate staff resources and assignments. The 9SOW was no different. Over two years ago, CMS RO’s changed from a regionally-based to consortium-based operation. All ten regional offices remain in place, however, the product lines based within the ROs were realigned into a consortium structure. Therefore, the Division of Quality Improvement and Division of Survey and Certification are now under one consortium titled, CQISCO which is managed by Dr. Randy Farris in the Dallas RO. The consortium structure provided an ample opportunity to revaluate staffing and Project Officer assignments at the beginning of the 9SOW. New PO Assignments Therefore, based on staffing resources the KC regional office acquired two additional states and Boston RO acquired one additional state to account for the staffing shortage in the Dallas RO. Other PO reassignments were made as needed. We will continue to evaluate PO assignments on an as needed basis. Monthly QIO calls Project Officers are expected to have at least one monthly call with each of their QIO contracts. During these monthly calls all Themes are expected to be covered with the QIO. Highly encourage all relevant staff to be involved in these calls that can provide PO information that is needed. This call does not necessarily need to be a “CEO or Senior Leadership” type call. It is desirable for the content experts present. Deliverable review and approval Completed on a monthly and quarterly basis When it appears that a QIO has not met a performance metric or non-timely deliverable submission the first action is that the PO investigates. But the PO will expect documentation that supports QIO rationale and if not sufficient then a PIP may be warranted. Important point: Just a reminder that although the items discussed today are primarily performed by RO they are not done in isolation. There is extensive communication and collaboration happening between the RO and CO. Consortium Structure At the beginning of any new SOW, there is always an opportunity to revaluate staff resources and assignments. The 9SOW was no different. Over two years ago, CMS RO’s changed from a regionally-based to consortium-based operation. All ten regional offices remain in place, however, the product lines based within the ROs were realigned into a consortium structure. Therefore, the Division of Quality Improvement and Division of Survey and Certification are now under one consortium titled, CQISCO which is managed by Dr. Randy Farris in the Dallas RO. The consortium structure provided an ample opportunity to revaluate staffing and Project Officer assignments at the beginning of the 9SOW. New PO Assignments Therefore, based on staffing resources the KC regional office acquired two additional states and Boston RO acquired one additional state to account for the staffing shortage in the Dallas RO. Other PO reassignments were made as needed. We will continue to evaluate PO assignments on an as needed basis. Monthly QIO calls Project Officers are expected to have at least one monthly call with each of their QIO contracts. During these monthly calls all Themes are expected to be covered with the QIO. Highly encourage all relevant staff to be involved in these calls that can provide PO information that is needed. This call does not necessarily need to be a “CEO or Senior Leadership” type call. It is desirable for the content experts present. Deliverable review and approval Completed on a monthly and quarterly basis When it appears that a QIO has not met a performance metric or non-timely deliverable submission the first action is that the PO investigates. But the PO will expect documentation that supports QIO rationale and if not sufficient then a PIP may be warranted.

4. 4 RO QIO monitoring and oversight QIO Surveillance calls (CMS staff only) Led by Theme Lead/GTL Review QIO Performance Guidance to Project Officers Contracting Officer Calls Contract changes and issues SDPS memos Voucher review and certification QIO to submit monthly PO to review and take action within 8 days Timeliness of supplemental materials is important Surveillance calls These calls are organized and led by the Theme Leads and GTL’s on a quarterly basis. All Project Officers and other identified staff are required to attend. These calls give us a national snap shot on a quarterly basis on QIO performance. Also, the Theme Leads give guidance to the POs about upcoming deliverables or other Theme specific guidance to assist the POs with contract oversight. Voucher review and certification QIOs are asked to submit financial vouchers on a timely basis approximately the same time each month. CMS POs are required to review the vouchers within eight days of authorization. If the voucher is deemed appropriate then the PO will certify the voucher and submit it to CO for the CS to review and approve. If the PO does not receive the full supplemental material from the QIO this can create delays in the certification process and potential delay in payment to the QIO. Reasons why a PO might deny a voucher.  What is looked at or for in the voucher.  Maybe give them the process for voucher denial.  PO and/or CS has/have a concern.  PO gets more info from QIO.  If not sufficient or inappropriate, etc., PO may recommend denial.  CS reviews and may also recommend denial.   CO determines if voucher to be paid or not. Surveillance calls These calls are organized and led by the Theme Leads and GTL’s on a quarterly basis. All Project Officers and other identified staff are required to attend. These calls give us a national snap shot on a quarterly basis on QIO performance. Also, the Theme Leads give guidance to the POs about upcoming deliverables or other Theme specific guidance to assist the POs with contract oversight. Voucher review and certification QIOs are asked to submit financial vouchers on a timely basis approximately the same time each month. CMS POs are required to review the vouchers within eight days of authorization. If the voucher is deemed appropriate then the PO will certify the voucher and submit it to CO for the CS to review and approve. If the PO does not receive the full supplemental material from the QIO this can create delays in the certification process and potential delay in payment to the QIO. Reasons why a PO might deny a voucher.  What is looked at or for in the voucher.  Maybe give them the process for voucher denial.  PO and/or CS has/have a concern.  PO gets more info from QIO.  If not sufficient or inappropriate, etc., PO may recommend denial.  CS reviews and may also recommend denial.   CO determines if voucher to be paid or not.

5. 5 RO QIO monitoring and oversight Routine Assessment of QIO performance Broader definition More than the traditional annual “site visit” Monitoring Improvement Outcomes 18th and 28th month evaluations are critical Routine Assessments In the past, we have used the term “site visit” to refer to our annual routine assessment. We are moving away from this narrow definition to a more broader definition of what is a routine assessment. In other words, the QIOs will be more routinely assessed on their performance (i.e. deliverable reviews, voucher reviews, etc) and the site visit wil be considered as just one component of Routine Assessments. Performance expectations As many of you are aware, the 9SOW is a completely new “ball game” in regards to many aspects including that QIOs are expected to meet the evaluation measure outcomes as outlined in the SOW. The 18th and 28th months are CRITICAL! PIPs will happen and some are already in place, which I will discuss later. Change Control Process New Process Multiple levels of approval Can not automatically assume PO can give 60 day extension. Routine Assessments In the past, we have used the term “site visit” to refer to our annual routine assessment. We are moving away from this narrow definition to a more broader definition of what is a routine assessment. In other words, the QIOs will be more routinely assessed on their performance (i.e. deliverable reviews, voucher reviews, etc) and the site visit wil be considered as just one component of Routine Assessments. Performance expectations As many of you are aware, the 9SOW is a completely new “ball game” in regards to many aspects including that QIOs are expected to meet the evaluation measure outcomes as outlined in the SOW. The 18th and 28th months are CRITICAL! PIPs will happen and some are already in place, which I will discuss later. Change Control Process New Process Multiple levels of approval Can not automatically assume PO can give 60 day extension.

6. 6 QIO Performance Overall, QIOs are doing well! PIPs Primary reasons Recruitment in Disparities Recruitment of practices in Prevention Participating Non-participating Education of participating practices in Prevention Timeliness in Beneficiary Protection Beneficiary participation in satisfaction survey Doing Well! Overall, the QIOs are doing very well in regards to meeting the current deliverable schedule. It is to early to predict outcome of evaluation measures. Very pleased PIPs Curently, we do have three QIOs who have been placed on PIPs The primary reason for the PIPs is that they have not met performance expectation in the following areas. Recruitment in Disparities Recruitment in Prevention Education in Prevention Timeliness in Beneficiary Protection We might see other PIP areas as we refine the results of the 2nd qtr. Doing Well! Overall, the QIOs are doing very well in regards to meeting the current deliverable schedule. It is to early to predict outcome of evaluation measures. Very pleased PIPs Curently, we do have three QIOs who have been placed on PIPs The primary reason for the PIPs is that they have not met performance expectation in the following areas. Recruitment in Disparities Recruitment in Prevention Education in Prevention Timeliness in Beneficiary Protection We might see other PIP areas as we refine the results of the 2nd qtr.

7. 7 PIP Process Deficiency identified By Project Officer (PO)/Theme Lead/GTL E.g. deliverable not met PO contacts QIO To investigate, clarify and confirm deficiency If confirmed, PIP is initiated by PO or Contracting Officer Letter is sent to QIO “Alert” is sent to leadership, et. al Issue Identified By Project Officer/Theme Lead/GTL Deliverable not met (typically, at this stage) Project Officer contacts QIO Clarify and confirm deficiency If confirmed, PIP is initiated by Project Officer Letter is sent to QIO “Alert” is sent to leadership, et. al QIO has five days to respondIssue Identified By Project Officer/Theme Lead/GTL Deliverable not met (typically, at this stage) Project Officer contacts QIO Clarify and confirm deficiency If confirmed, PIP is initiated by Project Officer Letter is sent to QIO “Alert” is sent to leadership, et. al QIO has five days to respond

8. 8 PIP Process, cont. QIO response Submit written response to Project Officer Root Cause Analysis Plan of correction to address deficiency The more details the better Project Officer response Approve or not approve Ongoing monitoring Leadership updates on QIO progress QIO response Submit written response to Project Officer Root Cause Analysis Plan of correction to address deficiency – MUST address specific actions that will rectify and prevent the deficiency from happening again. Important to include key staff that will oversee the plan of correction. The more details the better Project Officer response Approval – If approve then the QIO can proceed the implementing the PIP and the PO will monitor the QIO progress Non-approval – If the PIP is not approved the QIO has another five days to resubmit the PIP. If the Project officer does not approve it the second time then the POwill contact the Contract Officer for potential contract action. QIO response Submit written response to Project Officer Root Cause Analysis Plan of correction to address deficiency – MUST address specific actions that will rectify and prevent the deficiency from happening again. Important to include key staff that will oversee the plan of correction. The more details the better Project Officer response Approval – If approve then the QIO can proceed the implementing the PIP and the PO will monitor the QIO progress Non-approval – If the PIP is not approved the QIO has another five days to resubmit the PIP. If the Project officer does not approve it the second time then the POwill contact the Contract Officer for potential contract action.

9. 9 Routine Assessments Main Objectives: To provide comprehensive ongoing monitoring of contractors to ensure contractors are meeting requirements of the contract. To assess aspects of contractor performance that can only be assessed onsite (i.e. validation of information and security processes).

10. 10 Routine Assessments How are routine assessments conducted? Off-site assessments Monthly calls Deliverable review Desk top documentation review Pre-site visit evaluation grid review How are routine assessments achieved? Off-site assessments Monthly calls Deliverable review Desk top documentation review Pre-site visit evaluation grid review On-site assessments How are routine assessments achieved? Off-site assessments Monthly calls Deliverable review Desk top documentation review Pre-site visit evaluation grid review On-site assessments

11. 11 Routine Assessments On-Site Assessments 1st 9th SOW site visit September 2008 2009 on-site assessments June (11th mth) – November (16th mth) The majority, if not all, completed by September 30, 2009 2 full days -- Monitoring to ensure contractors are meeting requirements of the contract. Performance expectations and other contractural requirements. -- Monitoring to ensure contractors are meeting requirements of the contract. Performance expectations and other contractural requirements.

12. 12 Routine Assessments On-Site Assessments, cont. Format Opening session Theme Team interviews Need content experts! Report Tools and Checklists Will be revised QIO feedback included Greg Schieke, Sara Medley, Misty Daffron and Karen Kennedy Case Review File Review Information validation (e.g. Participation agreements) Closing session Format: Opening and Closing sessions; Theme Team interviews – again content experts are encouraged to attend Report Tools and Checklists Many of the tools are under revisions based on feedback from September 08 site visits Some changes, some questions removed, some added and improvement in clarity for specific questions. Does include QIO members (i.e. NE - Greg S, WA - Sara Medley, IN – Mitsy Daffron Karen Kennedy) – Invaluable insight and input!! Thank you Will send out ahead of time to be completed CMS completion sections only Return to PO and review May have some discussions and clarifying questions before onsite visit. May include GTL/Theme Lead for a given theme for specific questions and issues. Case Review File Review Will be standardizing the process Information validation Consent/participation agreement forms,etc. Format: Opening and Closing sessions; Theme Team interviews – again content experts are encouraged to attend Report Tools and Checklists Many of the tools are under revisions based on feedback from September 08 site visits Some changes, some questions removed, some added and improvement in clarity for specific questions. Does include QIO members (i.e. NE - Greg S, WA - Sara Medley, IN – Mitsy Daffron Karen Kennedy) – Invaluable insight and input!! Thank you Will send out ahead of time to be completed CMS completion sections only Return to PO and review May have some discussions and clarifying questions before onsite visit. May include GTL/Theme Lead for a given theme for specific questions and issues. Case Review File Review Will be standardizing the process Information validation Consent/participation agreement forms,etc.

13. 13 Routine Assessments On-Site Assessments, cont. Post site visit Clarification follow-up Site visit letters Site visit outcomes Aggregated Results reported internally to CMS leadership. On-Site Assessments, cont. Post site visit Clarification follow-up Site visit letters Site visit outcomes Aggregated Results reported internally to CMS leadership. On-Site Assessments, cont. Post site visit Clarification follow-up Site visit letters Site visit outcomes Aggregated Results reported internally to CMS leadership.

14. 14 Routine Assessment First 9th SOW site visit Theme findings: Organizational structures are in place Appropriate staff skill sets available Spending levels are appropriate Timeliness of QIO activities on target Administrative findings: Some concerns about staff vacancies (15%) Conflict of Interest and Security policies and procedures in place Confidentiality plan, IQC, websites in place Compliance with article submission to CMS is an area for growth 1, Does the QIO’s organizational structure for this Theme provide a reasonable expectation for successful completion of the work? 2. Do the QIO’s staff in this task have the necessary skill sets to provide a reasonable expectation of success? 3. Are the QIO’s spending levels in this theme appropriate for the activities planned? Administrative Are there any concerns related to critical staff vacancies? Did the QIO meet all requirements for COI, Compliance plan, and governance checklist Does the QIO have a functional confidentiality plan addressing appropriate training and recertification for staff and all subcontractors. Did the QIO’s follow all procedures required for their websites. Did the QIO meet all requirements as assessed in Security checklist? 1, Does the QIO’s organizational structure for this Theme provide a reasonable expectation for successful completion of the work? 2. Do the QIO’s staff in this task have the necessary skill sets to provide a reasonable expectation of success? 3. Are the QIO’s spending levels in this theme appropriate for the activities planned? Administrative Are there any concerns related to critical staff vacancies? Did the QIO meet all requirements for COI, Compliance plan, and governance checklist Does the QIO have a functional confidentiality plan addressing appropriate training and recertification for staff and all subcontractors. Did the QIO’s follow all procedures required for their websites. Did the QIO meet all requirements as assessed in Security checklist?

15. 15 QIO collaboration for GPRA Goals Collaboration Meetings Focus: Pressure Ulcer and Restraints Meetings in each DQI region Attendees Survey and Certification State Agencies Provider Associations Ombudsman Excellent attendance and leadership by QIOs! CMS Survey and Certification State GPRA Enforcement Letters Collaboration Meetings Focus: Pressure Ulcer and Restraints Meetings in each DQI region Attendees Survey and Certification State Agencies Provider Associations Ombudsman Excellent attendance and leadership by QIOs State GPRA Enforcement LettersCollaboration Meetings Focus: Pressure Ulcer and Restraints Meetings in each DQI region Attendees Survey and Certification State Agencies Provider Associations Ombudsman Excellent attendance and leadership by QIOs State GPRA Enforcement Letters

16. 16 Relevant ESRD updates Chronic Kidney Disease NW’s are interested in collaborating with QIOs Fistula First Reimbursement changes – 30% payment increase Fistula First Breakthrough Initiative (FFBI) Contract awarded Disaster planning Kidney Community Emergency Response (KCER) Data sharing between QIO’s and NW’s Actively being addressed CROWN memo to be expected CKD Subnational work <???> Fistula First Reimbursement changes – 30% payment increase Disaster planning Issues to be resolved Data sharing between QIO and NWCKD Subnational work <???> Fistula First Reimbursement changes – 30% payment increase Disaster planning Issues to be resolved Data sharing between QIO and NW

17. 17 Relevant ESRD updates ESRD Redesign Work Group Changes in ESRD program similar to QIO program Attribution is the key word CROWN Web Phase I – 4 NW’s Phase II – Summer 09, tentative Additional information – www.ESRDncc.org ESRD Redesign Work Group Changes in ESRD program similar to QIO program – addressing OMB, attribution and other critics. CROWN Web Phase I – 4 NW’s ESRD Redesign Work Group Changes in ESRD program similar to QIO program – addressing OMB, attribution and other critics. CROWN Web Phase I – 4 NW’s

18. 18 Internal Controls  We have an Internal Quality Control (IQC) program, too. Internal Quality Improvement Program Team (I.Q.I.P.T.) Performance Measures High standards – most thresholds at 100% Proposed – Customer satisfaction (i.e. QIOs) We have our own IQC! Internal Quality Improvement Program Team (I.Q.I.P.T.) Performance Measures We have our own IQC! Internal Quality Improvement Program Team (I.Q.I.P.T.) Performance Measures

19. 19 Internal Controls  Who is involved? Office Clinical Standards and Quality (OCSQ) Division of Quality Improvement in Regional Offices Office of Acqusition and Grants Management Monitored Quarterly Results 1st Qtr - Met all of thresholds except for timeliness of FIVS voucher review Root Cause Analysis Corrective Action Plans Who is involved? OCSQ, DQI RO OAGM (working on definitions) Monitored Quarterly QIO contracts quarter Results Met all of thresholds except for one (i.e. FIVS voucher review) Root Cause Analysis Corrective Action Plans Communication (RO with OCSQ and other depts) Who is involved? OCSQ, DQI RO OAGM (working on definitions) Monitored Quarterly QIO contracts quarter Results Met all of thresholds except for one (i.e. FIVS voucher review) Root Cause Analysis Corrective Action Plans Communication (RO with OCSQ and other depts)

20. 20 Standardization Efforts RO Consortium model has led to improvements: Communication among ROs Communication with Central Office Improved efficiencies Examples Red ALERT process (e.g. PIPs) Survey/Certification and DQI Communication QIO Publication Review Policy QIO Data Use Agreement Work Group EMTALA physician review process Central Office and Regional Office Change Control Approval Request (CCAR) Regional Office Consortium model = improvements in: Communication among ROs Communication with Central Office Efficiencies Standardization Examples Red ALERT process (e.g. PIPs) Survey/Certification and DQI Communication QIO Publication Review Policy QIO Data Use Agreement Work Group EMTALA Central Office and Regional Office Change Control Approval Request (CCAR)Regional Office Consortium model = improvements in: Communication among ROs Communication with Central Office Efficiencies Standardization Examples Red ALERT process (e.g. PIPs) Survey/Certification and DQI Communication QIO Publication Review Policy QIO Data Use Agreement Work Group EMTALA Central Office and Regional Office Change Control Approval Request (CCAR)

21. 21 Conclusion Continue to expect close monitoring Include content experts in PO discussions High performance expectations PIPs will happen Call your PO and/or Contracting Officer early and call often ARA support Thank you for your commitment to quality!

22. 22 Questions? Contact Information: Phone: 816-426-6355 Email: teresa.titus-howard@cms.hhs.gov