AttachmentJ.6.AZone7TO1SOW.doc

Attachment J.6.A

ZONE PROGRAM INTEGRITY CONTRACTOR (ZPIC) TASK ORDER

STATEMENT OF WORK

Zone 7 – Parts A, B, DME and HH + H

I. SCOPE

The ZPIC shall perform fraud, waste and abuse detection, deterrence and prevention activities for Medicare claims processed within Zone 7 for the state of Florida and U.S territories Puerto Rico and the Virgin Islands.

A. Background

As a result of contracting reform, seven zones have been created based on the newly established Medicare Administrative Contractor (MAC) jurisdictions. As a result of the seven zones, new entities entitled Zone Program Integrity Contractors (ZPICs) have been created to perform program integrity functions for the Medicare Parts A, B, C, D, Durable Medical Equipment (DME), Home Health + Hospice (HH + H) and the Medicare Medicaid Data Match Project (Medi-Medi). Of the seven zones, the Centers for Medicare and Medicaid Services (CMS) have designated five zones as having high risk areas. This task order statement of work (SOW) is for all benefit integrity (BI) work for Medicare Parts A, B, DME, and HH + H.

The following provides background information on the current workload by functional area:

CMS Workload by Provider State from the National Database for the period January 1, 2006 through December 31, 2006 Demographic Statistics for Zone 7 Part A

Demographic Statistics for Zone 7 Part B

Demographic Statistics for Zone 7 DME

Total

7,755

Demographic Statistics for Zone 7 Part A (HH + H only)

Total

B.

Purpose The purpose of the ZPIC under this Task Order (TO) Statement of Work (SOW) is to perform comprehensive problem identification and research to identify potential fraud, waste and abuse in Zone 7. Additional responsibilities shall include coordination of benefit integrity activities among Affiliated Contractors (ACs), MACs, and other applicable Medicare and Medicaid Entities (MMEs) within its zone, and dissemination of relevant benefit integrity information to the respective AC and MAC. The ZPIC shall also coordinate benefit integrity activities among other ZPICs as applicable.

This task order shall have the following outcomes:

· Perform the potential fraud, waste and abuse detection, deterrence and prevention workload within the zone specified within this SOW;

· Establish and maintain a positive working and networking relationship with the AC and MAC and other internal or external stakeholders;

· Identification of appropriate corrective actions;

· Performance of quality investigations;

· Refer quality potential fraud cases to the Office of the Inspector General (OIG);

· Develop and introduce innovative data analysis methodologies for the early detection and prevention of abusive use of services, as well as possible fraud, waste and abuse schemes.

· Become fully operational for the BI workload for Medicare Parts A, B, DME, and HH + H on November 1, 2008.

· Address high risk areas in Miami-Dade, Broward and Palm Beach counties in the state of Florida IAW with the Program Integrity Manual (PIM).

· Coordinate with the appropriate AC and MAC.

· Coordinate with other ZPICs as applicable.

C. Technical Considerations

· The ZPIC shall assume that they will have read only access into the AC’s and MAC’s shared claims processing system(s), with the exception of DME for which they will have read and write access, as well as access to the Medicare Parts A, B, DME, and HH + H data available through the National Claims History File for the zone defined in this Task Order.

II.

REQUIREMENTS

The ZPIC umbrella SOW (USOW) is incorporated into this TO with the same force and effect as if it were provided in full text. Independently and not as an agent of the Government, the ZPIC shall furnish all of the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the ZPIC USOW requirements and this TO SOW requirements for this workload.

NOTE: This TO SOW may be modified to incorporate additional workload not currently identified herein, as well as incorporate umbrella SOW section exceptions below. The addition of such workload is in the interest of economy and efficiency and considered a logical follow-on to the work identified herein. Additionally, ZPIC workload reconfigurations may be necessary in order to comply with the efficient and effective implementation of Medicare contractor reform or other programs that may be enacted by legislation. For example, workload for a certain state may be eliminated or added in order to realign the ZPIC with a Medicare claims processing contractor's workload.

The ZPIC may utilize all of the ZPIC (USOW) requirements EXCEPT FOR THE FOLLOWING SECTIONS, at this time:

Section 1.1.7.2.4 – Cost Report Audit/Reimbursement Manager

Section 5 (entire section), Cost Report Audit, Settlement and Reimbursement Section 1.7.1 Only letter C applies, A, B, D, E and F are exempt.

Appendix A, Deliverables - Items 29 – 31, 40 & 41 Appendix G, Uniform Desk Review

Appendix I, ZPIC Edit Differentiation Chart Appendix L, Medi-Medi Polices and Procedures Manual

Appendix M, Part C and Part D Integrity Manual

Appendix N, Prescription Drug Event Data

Appendix P, Instructions for Completing the Medicare Prescription Drug Plan Bid Form for Contract Year 2006

Appendix Q, PDP Bid Pricing Tool

Appendix R, MARx User Information

Appendix S, Weekly Workload and Complaint Activity Report

Appendix T, Earned Value Management Industry Standard EIA – 748 Monthly EVMS Performance Reports

Appendix CC, Instructions for MA Bids

Appendix DD, MA-PD Bid Pricing Tools A. General Requirements:

The ZPIC shall ensure that the workload identified in this Task Order is transitioned from the outgoing Program Safeguard Contractors (PSCs) in accordance with the requirements identified herein and the ZPIC USOW by October 31, 2008, and that the ZPIC is fully operational no later than November 1, 2008.

Areas in Southern Florida including Miami-Dade, Broward and Palm Beach counties are CMS designated high risk areas. For requirements in high fraud areas, follow the PIM chapter 4, §§4.32-4.32.1 and chapter 10, §§10.20-10.20.1.

Because fraud in South Florida has demonstrated itself in numerous and diverse ways, differing counter approaches must continually change to anticipate and react if the fraud moves to other areas.

As such, the ZPIC shall assume all workload associated with this high risk area and coordinate with the AC and MAC through the JOA process for addressing high risk areas.

The ZPIC shall have a physical office located within the awarded zone where the majority of the work shall be performed.

Constraints/Assumptions:

The ZPICs are constrained by the fact that CMS cannot make any changes to the shared claims processing systems at this time to support ZPIC activities. The AC currently operates using the FISS shared claims processing system for Part A, MCS for Part B, and VMS for DME. The MAC will use the same shared systems.

Given the rampant fraud in South Florida and the presence of the CMS Miami Field Office which the ZPIC shall help to support, the ZPIC shall have a physical office in close proximity to the CMS Field Office. In addition, Puerto Rico law requires that if you do business in Puerto Rico, you must have a local presence.

B. Specific Requirements:

Specific tasks to be performed, which are not identified in the umbrella SOW, provide more detail, or are changed from the umbrella SOW, are as follows:

1. Transition activities:

The ZPIC shall work with the AC and MAC and the outgoing PSC to transition the fraud and abuse detection and prevention activities. As a part of the transition period, the ZPIC shall develop a project plan, conduct a kick-off meeting, and submit deliverables in accordance with the Umbrella SOW. The ZPIC shall lead regular transition meetings with CMS, the outgoing PSC, and the appropriate ACs and MACs and maintain minutes for those meetings.

The transition period shall begin May 15, 2008 and end October 31, 2008.

2. Special Studies The ZPIC shall perform Special Studies as required by CMS. Special Studies will be delineated in a separate SOW and incorporated as an Appendix to this task order SOW. All Special Studies will be funded and billed separately from the basic task order SOW. Special Studies costs will be tracked in a separate column in the basic task order cost structure in the CMS Analysis, Reporting & Tracking (CMS ART) system.

3. Zone Specific High Risk Area Projects and Demonstrations The ZPIC shall perform Zone Specific Projects and Demonstrations for high risk areas as required by CMS. Zone Specific Projects and Demonstrations for high risk areas may require periodic reporting to designated CMS individuals. The ZPIC shall perform the requirements in Appendix B for the Infusion Therapy Demonstration.

C. Reporting Requirements

Cost for Task 3 Florida Infusion Demonstration Project shall be identified and reported in a separate line item as Florida Infusion Demonstration Project.

D.

Personnel Requirements

Key Personnel:

The Key Personnel requirements for this Task Order are IAW ZPIC USOW Section 1.1.7. The following Key Personnel positions shall be employed by the prime contractor and be on-site where the majority of the work is being performed. The following are the Task Order requirements:

· Fee-For-Service (FFS) Task Order Manager – The (FFS) Task Order Manager shall be full-time.

· Benefit Integrity (BI) Manager – The BI Manager may be shared between the FFS and Medi-Medi Task Order in this zone.

· Medical Review (MR) for BI Manager – The MR for BI manager may be shared between the FFS and Medi-Medi Task Order in this zone.

The following Key Personnel positions are not required to be employed by the prime contractor. The following are the Task Order requirements:

· Medical Director – The Medical Director may be shared between the FFS and Medi-Medi Task Order in this zone.

· Chief Legal Counsel - Chief Legal Counsel is not required to be full-time.

· Chief Statistician – The Chief Statistician is

· required to be full-time.

In addition, Essential Personnel requirements for this Task Order are IAW ZPIC USOW Section 1.1.8. Essential Personnel required for this Task Order are as follows:

· BI Analyst

· Senior BI Analyst

· Data Analyst

· MAC Liaison

· Lead Claims Review Analyst

IV. Appendices to this Task Order SOW

Appendix A – ZPIC Deliverables Schedule Appendix B – Infusion Therapy Demonstration

APPENDIX B

Infusion Therapy Demonstration I.

SCOPE

The Zone Program Integrity Contractor (ZPIC) supports the Centers for Medicare & Medicaid Services (CMS) in its efforts to combat fraud and abuse in the Medicare program. Because a significant number of health care providers continue to submit fraudulent billings on a large scale in Florida, we are outlining additional activities to enhance efforts to protect the Medicare Trust Fund from such fraud, abuse, and waste.

As part of a comprehensive approach to attacking fraud in Florida, the ZPIC will participate in a Medicare demonstration project under Section 402(a)(1)(J), 42 U.S.C. § 1395b-1(a)(1)(J), of the Social Security Amendments of 1967, which permits the Secretary to “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act.” Pursuant to this authority, via this Scope of Work from the Centers for Medicare & Medicaid Services (CMS), the ZPIC will implement the above-referenced Demonstration project to assist in developing and demonstrating improved methods for the investigation and prosecution of fraud occurring among providers of infusion therapy (“infusion providers”). For purposes of the Demonstration, the project will focus on infusion providers that are clinics or solo practitioners providing intravenous infusion therapy and/or intramuscular and subcutaneous injections as well as those infusion providers shifting from infusion to other procedure codes to avoid detection and to bypass payment suspension and prepayment review. The proposed Demonstration will focus on infusion providers in South Florida (Miami-Dade, Broward and Palm Beach counties) and may be expanded to other high risk areas of the state as infusion providers relocate to avoid detection, as those locales are identified by CMS and federal law enforcement (the Office of Inspector General (OIG), the Federal Bureau of Investigation (FBI), and/or the Department of Justice (DOJ)). Under this Demonstration, CMS will waive existing provider enrollment and claims processing related requirements. The demonstration is a collaborative effort among CMS, the ZPIC and the AC/MAC (which is currently First Coast Service Options).

A.

Background

Fraudulent business practices of unscrupulous infusion providers continue to cost the Medicare Trust Fund more than a billion dollars annually in Florida. In 2003, CMS’ Miami Satellite Division (MSD), the Program Safeguard Contractor and the Medicare Carrier, initiated a Medicare Infusion Initiative in South Florida to address fraudulent billing of infused and injected drugs, which resulted in denial of claims in 2005-2006 in excess of $1.8 Billion. Nevertheless, the fraud in South Florida has continued.

We believe that in order to combat continuing Florida infusion fraud, additional regulatory authorities are needed to allow CMS to (1) reject new applications from, or deny Medicare billing privileges to, existing clinics and solo-practicing physicians known to be actively participating in fraud (i.e., who have had their billing privileges revoked, suspended, and/or deactivated) but who have not been formally excluded from the Program by the OIG;

(2) require high risk infusion providers to revalidate their enrollment by resubmitting their provider enrollment application within 30 days of CMS notification, shortened from the 60 days set forth in 42 C.F.R. § 424.515(a)(2); (3) report any changes in their enrollment information within 30 days, shortened from the 90 days required by 42 C.F.R. § 424.540(a)(2) and § 424.520(b), thereby enhancing CMS’ ability to revoke or deactivate the billing privileges of those applicants who fail to meet our existing requirements; and (4) perform onsite visits to clinics determined to be high risk (newly opened; linked to problem or suspended clinics through shared performing physicians, beneficiaries, owners, managing employees, street addresses and/or billing companies; or that have recently changed ownership), in order to assure the clinic is not a “phantom clinic,” and to assure no other fraudulent practices are occurring.

The goal of this proposed Demonstration is to develop and demonstrate improved methods for the investigation and prosecution of fraud committed by infusion providers by waiving current enrollment rules and evaluating the extent that improved methods of medical review, customer service, onsite reviews and other administrative actions assist in the identification and termination of fraudulent or abusive infusion providers from the Medicare program.

While CMS and its contractors and law enforcement have taken significant steps to address infusion fraud and abuse in South Florida, additional tools will be utilized under this proposed Demonstration to address this program vulnerability and develop improved methods for the investigation and prosecution of infusion providers in this geographic area. Additionally, we believe that the results of this Demonstration will provide CMS with additional tools to address, combat, and prevent similar types of fraud and abuse across the country.

The Infusion Demonstration is one of three demonstrations focused on developing improved methods for the investigation and prosecution of provider and supplier fraud in certain “high risk” areas, which has cost the Medicare program millions of dollars. The demonstrations will focus on (1) durable medical equipment (DME) suppliers in South Florida and Los Angeles, (2) Home Health Agency (HHA) providers in Houston and Los Angeles, and (3) infusion therapy providers in South Florida. All three demonstration projects (DME, HHA and Infusion) will waive current Medicare provider enrollment rules and will evaluate how these new methods assist in the identification and termination of unqualified providers from the Medicare program.

These measures aim to revoke billing privileges from unqualified Medicare providers and more closely monitor those who do qualify.

Demonstration Design

This Demonstration is focused on developing and determining improved methods for the investigation and prosecution of fraud committed by infusion providers. CMS proposes to accomplish this goal by waiving existing Medicare rules and regulations regarding provider enrollment and claims filing and implementing enhanced provider enrollment, medical review and customer service activities. With input from the ZPIC and the AC/MAC, CMS proposes to then evaluate the extent to which these changes assist in the Agency’s ability to detect and deter fraud.

The design of this Demonstration can be described in terms of its components:

1. Provider enrollment and revocations, site visits, data analysis and risk assessment

2. Medical review

3. Customer service

4. Other administrative actions; and

5. Evaluation

Each of these components can be further broken down into specific Demonstration activities. Resource limitations preclude the proposed utilization of an outside evaluation contractor to assist in the development of cost-avoidance measures, etc. All demonstration evaluation activities will be performed by CMS, the ZPIC, and the AC/MAC.

Following are examples of demonstration activities that will directly impact the ZPIC:

1. Provider Enrollment and Revocations

Tracking fraudulent infusion providers

Under the Demonstration, the ZPIC and the AC/MAC shall utilize data analysis to track fraudulent infusion providers including those whose billing “morphs” in response to containment measures and those engaging in identity theft. Therefore, traditional infusion providers, as well as those linked to infusion providers through shared beneficiaries, performing/ordering physicians, owners, managers, consultants, billing companies, street addresses and landlords, shall be tracked and prioritized for risk assessment. To implement this initiative, CMS intends to require the following:

· the ZPIC and the AC/MAC shall perform data analysis and conduct site visits as appropriate, based on indications such as infusion providers’ ping-ponging, sharing beneficiaries, morphing behavior, switching codes or diagnoses or geographic locations to avoid edits or to attempt to get claims paid.

2. Medical Review

Based on results of the provider enrollment risk assessment, data analysis and tracking processes, site visits, and expanded beneficiary complaint processes (see “Task 1: Implement Fraud Hotline” section below), the ZPIC may implement the following medical review actions as appropriate (list not exhaustive): prepayment edits recommended by the ZPIC and/or by the AC/MAC for selected codes and/or providers and/or performing physicians; complex medical review; auto denial edits; beneficiary-initiated edits; and preferred-provider edits. Medical records may be requested as part of an onsite review or via letter.

While medical review may be conducted as a result of provider enrollment actions, medical review results may also trigger enrollment actions by raising or lowering risk assessment.

B.

ZPIC Demonstration Scope of Work

The purpose of this Demonstration is to develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of infusion therapy services in Florida. The Demonstration’s improved provider enrollment and risk assessment methods will assist the OIG and other law enforcement agencies in the investigation and prosecution of infusion fraud in several ways. First, CMS believes that using administrative means for rooting out potentially fraudulent providers at the time of enrollment helps preserve the resources of the Medicare contractors as well as the investigative resources of the OIG and the prosecutorial resources of the DOJ. Additionally, information regarding revoked providers can be compiled and shared with law enforcement. Such information can be used to track fraudulent individuals/providers that try to bypass safeguards in the system by obtaining billing numbers without actually furnishing services to beneficiaries.

Under the Demonstration, the ZPIC shall be required to:

1. Establish, manage, and operate a toll-free Part B South Florida beneficiary infusion fraud complaint hotline.

2. Conduct proactive data analysis to track and prioritize and assess the risk associated with fraudulent infusion providers, including those whose billing “morphs” in response to containment measures and those engaging in identity theft, .

3. Conduct medical review based on results of the AC/MAC’s provider enrollment risk assessment, the ZPIC’s and the AC/MAC’s data analysis and tracking and prioritization processes, site visits, and expanded beneficiary complaint processes (see “Task 1: Implement Fraud Hotline” section below) and implement medical review actions as appropriate.

4. Conduct unannounced site visits to providers and home visits to beneficiaries.

5. Produce and submit quality referrals to law enforcement based on information generated from this Demonstration and recommend the imposition of administrative actions, such as payment suspensions.

6. Develop, track report and analyze Demonstration activities and metrics that will be utilized by CMS to assess the effectiveness of the Demonstration project.

7. Report to CMS on demonstration costs and task performance.

II.

Requirements a.

General Requirements: The ZPIC shall ensure that the workload identified in this demonstration is in accordance with the ZPIC SOW and the PIM, and that the ZPIC is fully operational upon approval. Below are specific tasks to be performed. The ZPIC shall:

TASK 1: Implement Fraud Hotline

Because the ZPIC’s receipt and analysis of claims data can be delayed, timely beneficiary complaints continue to be a major source of intelligence for identifying unscrupulous infusion providers and their geographic and programmatic shifts in billing. Based on this premise, the ZPIC shall establish, manage, and operate a toll-free Part B South Florida beneficiary infusion fraud complaint hotline. Trained staff shall field and route calls and acknowledge receipt of complaints. Scripts shall be jointly developed by the ZPIC and the AC/MAC to address beneficiary complaints regarding services not rendered as well as access and quality-of-care concerns related to auto denials, edits, etc. The ZPIC staff shall provide scripts to 1-800-Medicare Customer Service Representatives with instructions for forwarding infusion-related beneficiary complaints to the ZPIC’s dedicated toll-free Florida beneficiary infusion fraud complaint hotline. Provider-related information from beneficiary calls shall be forwarded to the ZPIC for administrative and provider enrollment action as well as beneficiary contact and complaint acknowledgement letters, development, and follow-up. Provider complaints shall be forwarded to the ZPIC per PIM requirements or to FCSO per the Demonstration script. Following are the tasks involved:

· operate a Part B Florida toll-free beneficiary infusion fraud complaint hotline to properly respond to their complaints and to assist in identification and prioritization of problem infusion providers;

· staff hotline and pay for and maintain toll-free line, IVR, rollover phones;

· use trained staff to field and route hotline calls, acknowledge receipt of complaints, track and report hotline statistics;

· develop the ZPIC hotline scripts, in coordination with the AC/MAC, to address beneficiary complaints (e.g., services not rendered, access, quality of care, edits and autodenials) as well as provider complaints to the hotline;

· develop scripts, instructions, and procedures, in coordination with AC/MAC, for:

· (1) 1-800-Medicare Customer Service representatives to forward to the ZPIC all infusion-related South Florida beneficiary and provider fraud complaints and to receive from the ZPIC misrouted, non-infusion beneficiary and provider calls not addressed in number 2, 3 and 4, which follow directly below;

· (2) the AC/MAC to receive Florida Part A and B non-fraud related beneficiary and provider complaints;

· (3) the ZPIC to route to other appropriate ZPIC(s) misrouted non-Demo related, non-infusion, non-Part A or B Florida fraud complaints (e.g., DME and HHA); and

· (4) the ZPIC to receive misrouted non-Demo related, non-infusion, Part A or B fraud complaints per the PIM;

· develop and implement procedures for issuance of complaint acknowledgement letters and complaint development and follow-up;

· investigate provider-related hotline information for administrative action, provider enrollment action, beneficiary contact, law enforcement referral, etc.

TASK 2: Perform Data Analysis Activities

The ZPIC shall conduct proactive data analysis to track fraudulent infusion providers, including those whose billing “morphs” in response to containment measures and those engaging in identity theft, and identify aberrant billing patterns and the providers who are responsible for such billings.

Under the Demonstration, the ZPIC shall implement the following data analysis activities:

· analyze claims data based on beneficiary and provider complaints; medical review (MR) edit results; spiked billing; risk assessment; shifts to non-infusion codes; AC/MAC feedback re: criminal background checks, validation/revalidation of provider enrollment and reassignment of benefits; the ZPIC and AC/MAC site visits; CMS leads, etc., to:

· (1) identify, prioritize and track fraudulent infusion providers and infusion providers who have “morphed” to avoid detection by changing codes, diagnoses, beneficiaries, provider types, geographic location, including analysis of cross-walked NPIs and PINs, etc.;

· (2) identify site visit targets;

· (3) validate indications such as infusion providers’ ping-ponging, sharing beneficiaries, morphing behavior to avoid edits or to attempt to get claims paid;

· (4) track traditional infusion providers, as well as those linked to infusion providers, through shared beneficiaries, performing/ordering physicians, owners, managers, consultants, billing companies, street addresses and landlords.

The ZPIC shall use such data analysis—gained from sources such as beneficiary complaints, spike billing/risk assessment/shifts to non-infusion therapy codes, and feedback from the AC/MAC regarding site visit revalidations—to identify providers for site visits and other administrative actions.

The ZPIC shall focus its data analysis activities on both local and, to the greatest extent possible, national information. The ZPIC shall also monitor infusion billings outside of Miami-Dade, Broward and Palm Beach Counties to ensure infusion fraud does not spread to other areas unchecked.

The ZPIC shall initiate proactive data analysis to review other potential areas of fraud that may stem from infusion therapy fraud (e.g., diagnostic testing, IDTFs, CORFs, ORFs, and OPPT).

The ZPIC shall evaluate reports prepared by the AC/MAC to consider in its proactive data analyses and case referrals workload. Processes will continue as outlined in the Program Integrity Manual.

To augment the waivers of authority (referenced in the “Background” section of this document and the attached Demonstration proposal) and CMS’ ability to develop and demonstrate improved methods for the investigation and prosecution of fraud, the ZPIC shall track National Provider Identifiers (NPIs) of billing companies, billing agents, and clearinghouses. As previously noted, presently, CMS cannot impose administrative actions upon these entities submitting fraudulent claims as the Agency has no contractual relationship with them. Tracking of NPIs and linking those NPIs to infusion practices would allow CMS to gather information on owners and clients. Such tracking would demonstrate an improved method for gathering the necessary information for referrals to law enforcement for the prosecution of racketeering and other criminal activities.

TASK 3: Conduct Medical Reviews

The ZPIC shall conduct medical review based on results of the AC/MAC’s provider enrollment risk assessment, the ZPIC’s data analysis, prioritization and tracking processes, site visits, and expanded beneficiary complaint processes (see “Task 1: Implement Fraud Hotline” section b) and implement medical review actions as appropriate.

Based on results of the provider enrollment risk assessment, data analysis and tracking processes, site visits, and expanded beneficiary complaint processes, the ZPIC should implement the following medical review actions as appropriate (list not exhaustive): prepayment edits recommended by the ZPIC and/or by the AC/MAC for selected codes and/or providers and/or performing/ordering/treating physicians; complex medical review; auto denial edits; beneficiary-initiated edits; and preferred-provider edits. Medical records may be requested as part of an onsite review or via letter.

While medical review may be conducted as a result of provider enrollment actions, medical review results may also trigger enrollment actions by raising or lowering risk assessment.

TASK 4: Perform Targeted Site Visit Activities

To augment the waivers of authority and CMS’ ability to develop and demonstrate improved methods for the investigation and prosecution of fraud, the ZPIC shall conduct targeted unannounced site visits (in addition to the AC/MAC’s provider enrollment site visits) to providers and home visits to beneficiaries. Reasons for site visits would include, but are not limited to, follow up of customer service leads and complaints, spikes in billings, re-enrollment in the program after more than a one-year absence, MR edit results and shifts in billing to non-infusion codes in an attempt to circumvent infusion payment safeguards.

To the extent possible, the ZPIC shall coordinate and/or conduct such visits with CMS’ Miami Field Office staff.

TASK 5: Perform Fraud Case Development and Related Activities

The ZPIC shall produce and submit quality referrals to law enforcement based on information generated from this demonstration and recommend the imposition of administrative actions, such as payment suspension, overpayment computation and recoupment, prepayment review, revocation or deactivation of Medicare provider numbers, as appropriate.

TASK 6: Develop, Track Report, and Analyze Demonstration Activities and Metrics

The ZPIC shall develop, track report and analyze demonstration activities and metrics that will be utilized by CMS to assess the effectiveness of the demonstration, which will include, among other things, analysis of:

· The Return on Investment (ROI) of dollars denied that are associated with fraudulent infusion providers’ claims versus medical review costs under the Demonstration (costs associated with clinical review, edit development, testing and effectiveness reviews, etc.) for a ROI goal ranging from $10-to-$1 to $15-to-$1.

· The effectiveness of customer service activities (toll-free infusion fraud hotline) and more frequent issuance of Medicare Summary Notices (from quarterly to monthly) as fraud identification tools by numbers and percentages of complaints that result in corrective actions, risk assessment, and provider enrollment actions.

· The effectiveness of medical review activities in targeting problem providers, including the extent that medical review activities assist in identifying fraudulent providers by looking at, among other things, medical review-related corrective actions (prepayment review edits results and savings, suspensions, revocations, and deactivations).

· The development of cost-avoidance measures to assess the impact of preventing future payments to existing fraudulent infusion providers.

· The extent to which Medicare infusion charges and payments are brought in line with national averages by developing comparative metrics of Florida to itself to the rest of the nation, such as enhancement and expansion of current the ZPIC’s metrics and FCSO South Florida Pilot metrics (e.g., drug metric which measures gap between actual and targeted drug payout).

· To the extent that the ZPIC can obtain national data, it will perform comparative data collection and analysis.

· The effectiveness of the enhanced review process to determine whether it should be made applicable to other high risk areas.

· The extent to which criminal background checks on infusion providers’ managing employees, owners, performing physicians, etc. resulted in a significant number of revocations and/or improved risk assessment and/or fraud investigations and law enforcement referrals. Based on the results, CMS may consider instituting criminal background checks on infusion providers’ managing employees, owners, performing physicians, etc. that fall into those risk categories in other parts of the country.

b.

General Reporting Requirements: Reporting Requirements for this Statement of Work are provided below. All written documents for this project shall be delivered via a single hard copy plus an electronic version via e-mail attachment, 3.5-inch diskette, or compact disk. The GTL, AGTL, and/or DPL may request additional hard copies as necessary. All electronic files shall be submitted in a format that is compatible with Microsoft Office 2003. This is subject to change and the ZPIC shall be prepared to submit deliverables in any new CMS standard.

All Reports under this requirement shall include reporting elements from each task. The ZPIC shall prepare narrative reports that include, at a minimum, detailed information on the ZPIC’s progress in performing tasks as follows:

· TASK 1: Reports should identify the number and percentage of hotline calls received, processed, acknowledged, referred (e.g., to 1-800-Medicare, to AC/MAC, and to other ZPICs); the number & percentage of hotline calls that appear to be actual South Florida infusion fraud leads; the number & percentage of hotline calls that appear to be fraud-related (non-infusion fraud); the number and percentage of hotline calls that appear to be non-fraud.

· TASK 2: Reports should identify types and results of data analysis, prioritization and risk assessment conducted, including the resulting number referrals for administrative action; investigations; and referrals to law enforcement.

· TASK 3: Reports should specify types and results of medical review conducted and identify the source (e.g., result of complaint or site visit); include the number of providers on review, the number of edits recommended and implemented; edit results (the number of claims or services suspended, denied, paid, reversed on appeal, etc.).

· TASK4: Reports should specify the number of site visits to providers and results (the number of recommendations for revocation, deactivation, prepay review, suspension, etc.); the number of beneficiary home visits conducted and results (e.g., provider suspension/revocation/deactivation; beneficiary placed on edit; referred to law enforcement to enhance existing case).

· TASK 5: Reports should include the number of referrals to law enforcement and the number of administrative actions such as payment suspension, overpayment computation and recoupment, and deactivation or revocation of provider numbers.

· TASK 6: Reports should specify the Demonstration activities tracked and how they are analyzed and include the ZPIC’s assessment of their effectiveness.

At the end of the Demonstration, the ZPIC shall prepare a final report to address the initiatives undertaken and to discuss the outcomes achieved through the increased efforts to fight infusion therapy fraud in Florida. The final report will document the ZPIC’s progress in implementing the Infusion Demonstration tasks, the ZPIC’s assessment of the effectiveness of its activities in fighting infusion therapy fraud, and its evaluation of the effectiveness of the Demonstration in achieving its goals.

c.

Specific Reporting Requirements

All written documents for this SOW shall be delivered to the CMS GTLs and Demonstration Project Lead via e-mail, hardcopy, and CMS ART. Reports containing privacy information shall be sent hard copy with a CD/DVD of electronic files. All electronic files shall be submitted in a format compatible with Microsoft Office 2003. The GTLs and the Demonstration Project Lead shall provide the ZPIC with comments on reports within two (2) weeks of receipt. The ZPIC shall submit the reports listed above, bearing in mind, that CMS may determine the need for an additional report or may choose to eliminate a report.

1.

Project Plan: The demonstration shall include, at a minimum, the followinginformation:

· Work Breakdown Structure;

· Key staff types devoted to each task or activity; and

· Key milestones signifying successful completion of each task and periodic internal assessment/progress reports planned.

2.

Monthly Status Report: The status report shall include at a minimum:

· A separate narrative report showing a summary of current activities in each of the 6 previously described demonstration tasks. See the “Requirements” section of this SOW.

3.

Cost Report: The ZPIC shall prepare a monthly cost report to show all costs associated with this demonstration in a separate column on the cost report. On a monthly basis, the ZPIC shall report all costs associated with this demonstration in a separate column on the CMS ART. In the separate cost report, a minimum of the following information shall be included:

· A summary of costs incurred during the previous month in a business proposal format.

· Cumulative costs incurred to date on this demonstration.

· Funds remaining to be incurred on this demonstration.

· Costs by Labor Category, Labor Hours, Labor Rates, Travel, Subcontracts, Overhead, Profit, etc.

· Itemization of Other Direct Costs incurred.

· A narrative report of expenditures that exceed 10% either above or below the estimated expenditures for the period of time that is being reported for this demonstration.

4.

Quarterly Report: The ZPIC shall prepare a quarterly report that outlines the

ZPIC’s progress in implementing the infusion demonstration tasks; the ZPIC’s assessment of the effectiveness of its activities in fighting infusion therapy fraud and its evaluation of the effectiveness of the Demonstration in achieving its goals. The quarterly reports will serve as a guide to prepare the final report at the conclusion of the Demonstration that will outline the ZPIC’s progress in implementing the infusion demonstration tasks, the ZPIC’s assessment of the effectiveness of its activities in fighting infusion therapy fraud, and its evaluation of the effectiveness of the demonstration in achieving its goals. The last quarterly report in the second year of this demonstration does not need to be prepared or submitted to CMS. Instead, the final report (discussed below) will serve as the last report for this demonstration.

5.

Annual Report: At the end of the first year of the demonstration, the ZPIC shall prepare an annual report that addresses all of the demonstration activities it has undertaken during the first year and discusses the outcomes of those initiatives. The annual report shall document the ZPIC’s progress in implementing the Infusion Demonstration tasks, the ZPIC’s assessment of the effectiveness of its activities in fighting infusion therapy fraud, and its evaluation of the effectiveness of the Demonstration in achieving its goals. The report shall include:

· Background

· Purpose

· Description of each of the 6 Demonstration tasks and of the ZPIC’s performance of each

· Assessment of the effectiveness of its activities in fighting infusion therapy fraud

· Evaluation of the effectiveness of the Demonstration in achieving its goals

· Lessons Learned

· Proposed approaches for preventing future infusion therapy fraud and other types of related fraud

6.

Final Report: At the end of the study, the ZPIC shall prepare a final report that addresses all of the demonstration activities it has undertaken and discusses the outcomes of those initiatives. The final report shall document the ZPIC’s progress in implementing the infusion demonstration tasks, the ZPIC’s assessment of the effectiveness of its activities in fighting infusion therapy fraud, and its evaluation of the effectiveness of the demonstration in achieving its goals. The report shall include:

· Background

· Purpose

· Description of each of the 6 Demonstration tasks and of the ZPIC’s performance of each

· Assessment of the effectiveness of its activities in fighting infusion therapy fraud

· Evaluation of the effectiveness of the Demonstration in achieving its goals

· Lessons Learned

· Proposed approaches for preventing future infusion therapy fraud and other types of related fraud d.

Personnel Requirements

All personnel working on this SOW must have a signed non-disclosure statement at the time of employment to participate on the demonstration. The ZPIC shall retain the non-disclosure statements on file. The personnel requirements shall conform to the ZPIC SOW for personnel requirements.

Quality Assurance

Quality assurance for this Task Order is governed by Section 6, of the umbrella ZPIC SOW, Quality Assurance and Improvement.

Period of Performance

The demonstration consists of a 12-month base period. The period of performance begins immediately upon CMS approval.

ITEMS TO BE FURNISHED AND DELIVERABLE SCHEDULE (APPENDIX B ONLY)

The ZPIC shall be required to submit all required reports and deliverables in accordance with the schedule below. Reports and/or deliverables submitted under this contract shall be in accordance with this Statement of Work.

GTL = Government Task Leader

AGTL = Associate Government Task Leader

CO = Contract Officer

PO = Project Officer

DPL= Demonstration Project Lead

Final: 60 calendar days after contract award

CO

20th of every month

Cover letter to CO Draft: 8/28/2009.

Final: 9/25/2009.

Cover letter to CO Draft: 8/28/2009.

Final: 9/25/2009.

� This information was obtained from the demonstration proposal that was submitted to and approved by CMS’ Acting Administrator.

� In an egregious example demonstrating the need for new authority, a physician had 29 different PINs and although actions had been taken on 19 of them (payment suspension, deactivation, revocation), not only did he still have 10 PINs in his “back pocket,” nothing allowed CMS to deny his applications for new numbers.