J-01_StatementofWork_PDAC.doc

RFP-CMS-2007-0019 – Pricing, Data Analysis, and Coding (PDAC)

STATEMENT OF WORK

PRICING, DATA ANALYSIS AND CODING (PDAC) CONTRACTOR

A.

SCOPE

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work (SOW) below. The specific categories of requirements specified in this SOW include:

· Section B: Key personnel and other personnel requirements;

· Section C: Implementation and close-out requirements;

· Section D: General (cross-functional) requirements (e.g., systems security, etc.);

· Section E: Functional and technical requirements;

· Section F: Interface requirements; and,

· Section G: Quality assurance requirements.

A.1 Background

A.1.1

The Medicare Fee-For-Service Program

The Medicare program is an integral component of the federal government’s commitment to the health and welfare of the American people, which includes the Social Security system, the Medicaid program, and some other programs. The Medicare program provides affordable health insurance to (1) eligible individuals aged 65 and over; (2) certain individuals eligible for disability benefits under the Social Security system and their dependents; and (3) individuals with acute kidney failure (End Stage Renal Disease or ESRD). Approximately 44 million persons were enrolled for Medicare coverage in Fiscal Year (FY) 2007.

More than 80 percent of all Medicare beneficiaries – or about 35 million – participate in the traditional Medicare Fee-For-Service (FFS) program. For the next decade at least, a significant majority of all Medicare beneficiaries will likely remain enrolled in this program. Medicare FFS program coverage consists of two distinct parts: (1) Hospital Insurance (HI), which also provides coverage for inpatient services in hospitals and certain other providers; and, (2) Supplementary Medical Insurance (SMI), which provides coverage for “medical and other health services,” including the professional medical services of physicians and certain other licensed practitioners, as well as coverage for a variety of other outpatient health services and items (e.g., ambulance, diagnostic laboratory, ambulatory surgical centers, etc.). In common usage, the HI program is known as “Medicare Part A,” although both the Part A and B trust funds are used to reimburse facility claims. The SMI program is known as “Medicare Part B.”

A.1.2.

The Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Benefit & Its Administration The “medical and other health services” covered by Medicare Part B include durable medical equipment (see Section 1861(s)(6) of the Social Security Act (“the Act”)). Medicare Part B also covers prosthetics, prosthetic devices, orthotics, and medically-necessary supplies. These items and supplies (durable medical equipment, prosthetics, prosthetic devices, orthotics, and supplies) are collectively referred to as DMEPOS (see 42 CFR §421.210). The Medicare FFS payment policies for most types of DMEPOS are laid out in Section 1834 of the Act.

Over the years, the Centers for Medicare & Medicaid Services (CMS) has found the administration of the Medicare FFS DMEPOS benefit to be particularly challenging. Most states have few licensing requirements for DMEPOS suppliers, and it has been a major challenge to develop and implement consistent procedures for documenting the medical necessity of certain DMEPOS. As a result, the DMEPOS benefit has been subject to a high claims processing error rate as well as many documented cases of fraud and abuse.

As one element of a larger strategy for addressing these issues, CMS contracted in 1992 with four Durable Medical Equipment Regional Carriers (DMERCs) to perform a range of duties associated with the processing of claims for DMEPOS under Part B of the Medicare program. CMS also contracted with a single entity – the National Supplier Clearinghouse (NSC) – to be responsible for enrolling any and all DMEPOS suppliers nationally into the Medicare FFS program. In more recent years, CMS has contracted with entities whose primary focus is to develop strategies and tactics for improving the integrity of the Medicare DMEPOS benefit – these are called the DME Program Safeguard Contractors (or DME PSCs).

A.1.3 The Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) & Its Functions In 1992, CMS also contracted for certain additional Medicare FFS DMEPOS support functions. This support contract has been called the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC). The SADMERC’s operations have supported the DMERCs, DME PSCs, CMS, federal law enforcement agencies, and the NSC.

Specifically, the SADMERC performs the following functions:

· HCPCS Coding Process for DMEPOS

· Provide Medicare Coding Advice and Guidance

· Establish and Distribute Pricing Files for Certain Drugs and DMEPOS

· Statistical Analysis and Reporting

· Miscellaneous SADMERC Activities

CMS has required healthcare providers to use the Healthcare Common Procedure Coding System (HCPCS) to describe the items and services billed on Medicare claims for many years. More recently, the use of HCPCS by all health care entities engaging in electronic transactions was mandated by regulations published to fulfill the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA). The portion of the larger HCPCS code set that is used to describe and bill DMEPOS is known as “HCPCS Level II codes.”

Hence, the HCPCS Level II codes are the standard for public and private insurers’ use with electronic transactions involving DMEPOS. In October 2003, the Secretary of the Department of Health and Human Services (HHS) delegated to CMS the authority to maintain and distribute HCPCS Level II codes. In turn, CMS uses a body known as the Alpha-Numeric Workgroup (ANWG) to make ongoing recommendations on HCPCS Level II coding issues. The ANWG is responsible for making recommendations about additions, revisions and deletions to the permanent national alpha-numeric codes. The ANWG is comprised of representatives from private insurance agencies, the SADMERC, Medicaid and Medicare. If a HCPCS Level II code does not exist for a particular product; if the description for an existing code is not adequate or appropriate; or, an existing code needs to be deleted, the affected supplier or manufacturer may submit a request to modify the HCPCS.

In addition to its involvement with the ANWG, the SADMERC performs code verification reviews for products submitted by manufacturers. Further, the SADMERC provides assistance to suppliers and manufacturers that have questions about which HCPCS code to use when billing Medicare for DMEPOS.

The SADMERC also maintains processed claims data for DMEPOS; produces standard and ad-hoc reports; and chairs the Statistical Analysis Coordinating Committee (SACC) meetings. The SACC meetings (known as “DME Coordination Meetings” in this SOW) bring together a number of parties to review and address issues affecting the integrity of the Medicare DMEPOS benefit. SACC attendees include representatives from CMS, the DME PSCs, DME MACs, certain law enforcement staff and the NSC. The SADMERC provides data analysis and decision support to the DME MACs, DME PSCs, CMS, the NSC and law enforcement. These data analysis and decision support activities facilitate: the identification of over-utilization, abuse and fraud; policy development related to DMEPOS; medical review activities; enrollment of DMEPOS suppliers; and, other related activities.

The SADMERC also updates and maintains the NDC-HCPCS Crosswalk, a file that converts National Drug Codes (NDC) submitted by pharmacies to HCPCS codes for claims processing purposes. The NDC-HCPCS Crosswalk is distributed to the DME MACs for use in processing claims. In addition, the SADMERC updates and maintains pricing files for oral anti-cancer drugs (OACDs) for distribution to the DME MACs for use in processing claims. These activities are further described elsewhere in this SOW.

A.1.4

Medicare Contracting Reform & This Contract

On December 8, 2003, the President signed into law the Medicare Prescription Drug, Improvement, and Modernization Act (Public Law 108-173). Section 911 of this bill directed CMS to restructure its Medicare FFS contracting operations (this directive is known as Medicare contracting reform). Contracting reform requires the CMS use competitive procedures to replace its current fiscal intermediaries (FIs) and carriers, including their historical contract terms and conditions, with Medicare Administrative Contractors (MACs). Historically, FIs have handled claims processing and benefit payment functions for institutional providers under Part A and Part B of the Medicare FFS Program; while carriers have performed similar functions for medical professionals and suppliers under Part B.

Pursuant to this mandate, during FYs 2006 and 2007, CMS transitioned most claims processing and claims-related operational functions for DMEPOS from the DMERCs to Durable Medical Equipment Medicare Administrative Contractors (DME MACs). However, the DMEPOS-related medical review and anti-fraud/abuse (“benefit integrity” or “BI”) functions were transferred to the DME PSCs.

When CMS initially bid out the DME MAC contracts in FY 2005, the SADMERC contract was slightly rescoped and renamed as the “Data Analysis and Coding” (DAC) Contractor. This contract was solicited as an “option” to the DME MAC contracts. Ultimately, CMS was not able to award the DAC option due to circumstances stemming from a bid protest. The existing SADMERC contractor, Palmetto GBA, has agreed to an extension of its contract through June 2008 to allow appropriate time for CMS to conduct a re-procurement of this work.

A.1.5 Roles & Responsibilities of Various Entities Involved in Medicare DMEPOS Administration

The four DME MACs process DMEPOS claims based on a Medicare beneficiary’s principal residence. Their respective jurisdictions are:

Jurisdiction A (National Heritage Insurance Co.)

Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont

Jurisdiction B (National Govt Services) Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, Kentucky

Jurisdiction C (CIGNA Govt

Services) Alabama, Arkansas, Colorado, Florida, Georgia, Louisiana, Mississippi, New Mexico, North Carolina, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virgin Islands, Virginia, West Virginia

Jurisdiction D (Noridian Admin

Services) Alaska, Arizona, California, Guam, Hawaii, Idaho, Iowa, Kansas, Missouri, Montana, Nebraska, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming, Mariana Islands, American Samoa

The DME PSC jurisdictional boundaries are identical to those of the DME MACs. Jurisdictions A and B are overseen by a single DME PSC; a second DME PSC performs BI activities for Jurisdiction C and a third DME PSC performs BI activities for Jurisdiction D.

The DME PSCs presently perform all BI activities for Medicare DMEPOS claims. As of March 2008, the DME MACs perform the medical review and local coverage determination (LCD) functions as well as supplier outreach and education. The NSC enrolls all DMEPOS suppliers.

This SOW intends to support a contract for the Medicare FFS DMEPOS-related pricing, data analysis and coding support functions, many of which have historically been performed by the SADMERC. These functions support the activities performed by the DME MACs, DME PSCs, CMS, the NSC and law enforcement agencies. This Contractor will be a “national” Contractor.

NOTE #1: Reference is made throughout this SOW to required interactions with “PSCs” and “DME PSCs.” All such references shall be construed as including “Zone Program Integrity Contractors” (ZPICs) whose contracts CMS intends to award pursuant to CMS’ recent solicitation (RFP-CMS-2007-0027), to the extent such ZPIC contracts involve activities that need to be coordinated with this PDAC contract.

NOTE #2: CMS has recently transferred DMEPOS-related medical review and LCD development responsibilities from the DME PSCs to the DME MACs (March 2008). The DME PSCs will continue to perform BI-related activities. Any references in this SOW that direct the PDAC to support the DME PSCs with respect to medical review or LCD development responsibilities shall be construed as including DME MACs following this transfer.

NOTE #3: CMS is presently implementing a new MMA-mandated program under which DMEPOS suppliers will compete within defined market areas for the right to provide specified items to Medicare FFS beneficiaries. In support of this program, Palmetto GBA presently serves as CMS’ Competitive Bidding Implementation Contractor (CBIC). The SADMERC SOW does not presently provide analytical or other support to the CBIC, and no support levels are specified in this SOW. However, as CMS’ DMEPOS competitive bidding program evolves, CMS may modify this contract to require analytical and other support to the CBIC.

A.2 Purpose

The purpose of this contract is to obtain a Pricing, Data Analysis and Coding (PDAC) Contractor, hereinafter, referred to as the “Contractor” to provide specified services in support of the sound administration of the DMEPOS benefit within the “traditional” Medicare FFS program. The Contractor shall perform its responsibilities under the direction of CMS. The Contractor shall facilitate, coordinate, and support activities among various Medicare contractors with DMEPOS-related responsibilities (e.g., DME MACs, DME PSCs, NSCs, etc.) as well as other agencies (at the federal and state levels of government) and other stakeholders.

The Contractor shall perform the requirements of this contract in accordance with applicable laws, regulations, Medicare manuals (as specified in this SOW) and CMS requirements to ensure the financial integrity of the Medicare FFS program. The Medicare program’s legal, policy and operating environment is complex, and the Contractor shall utilize or interact with certain CMS-required systems, equipment and/or operational capabilities in the performance of its functions The Contractor shall receive and control Medicare national DMEPOS claims data from CMS. The Contractor conducts a variety of different supplier services, such as answering written inquiries and providing Medicare guidance and advice on coding of DMEPOS claims. The Contractor answers a wide-range of questions from DMEPOS suppliers and other stakeholders from across the country. The Contractor will operate and maintain a web-based tool used by suppliers and other stakeholders to facilitate coding claims for DMEPOS. The Contractor performs complex statistical analyses of Medicare FFS DMEPOS claims data and reports on trends, significant changes and other relevant factors. The Contractor stores and maintains this information in a data warehouse. The Contractor maintains statistical reports, data analyses and other statistical information in a web-based environment that is easily accessible to the DME PSCs, DME MACs, NSC, CMS and certain law enforcement staff. The Contractor controls access to this environment through user passwords and other physical, administrative, and technical safeguards. The Contractor develops and maintains a crosswalk for certain drugs from the NDC code to an appropriate HCPCS code. The Contractor codes and prices certain oral anti-cancer drugs. All of these functional activities have major component tasks as specified under Section E of this SOW.

A.3 Applicable Documents

Numerous statutes, regulations, CMS manuals, and documents are applicable to this PDAC contract. Some of the most significant of these are identified below.

A.3.1 Statutes

Within the scope of this SOW, the Contractor’s operations must comply with all applicable laws. These include, but are not limited to:

A.3.1.1 Social Security Act (Public Law 74-271)

The Social Security Act (“the Act”), as amended – particularly, Title XVIII but also Titles II and XI - provides most of the governing provisions for the Medicare FFS program. Congress frequently enacts amendments to the Medicare FFS statutes, and CMS must act to implement such legislation as timely and accurately as possible. Many of the laws and regulations affecting the Medicare program can be found at:

http://www.cms.hhs.gov/home/regsguidance.asp As noted above, most of the Medicare FFS program’s authorizing law is codified in Title XVIII of the Social Security Act (specifically, in Parts A, B, and E). An online copy of Title XVIII of the Act may be found at:

http://www.ssa.gov/OP_Home/ssact/title18/1800.htm A.3.1.2 Government-Wide Statutes

To the extent that there is no conflicting Medicare requirement, the administration of the Medicare FFS program is also governed by numerous statutes pertaining to the general administration of federal programs. General statutory authorities with broad implications for the traditional Medicare FFS program and this PDAC contract include, but are not limited to –

· Acquisition (e.g., the Federal Acquisition Regulation (FAR), etc.);

· Financial management and internal controls (e.g., the Federal Managers’ Financial Integrity Act of 1982 (FMFIA), the Chief Financial Officers’ Act of 1990, etc.);

· Federal Information Security Management Act of 2002 (FISMA);

· Government Performance and Results Act (GPRA);

· Personnel and civil rights law (e.g., the Drug-Free Workplace Act, the Americans with Disability Act, etc.); and

· Privacy and information technology requirements (e.g., the Privacy Act of 1974, the Information Technology Management Reform Act of 1996, etc.).

A.3.1.3 Medicare Prescription Drug, Improvement, and Modernization Act (MMA) (Public Law 108-173)

On December 8, 2003, the President signed into law the MMA. This statute makes the most sweeping changes in the structure of the Medicare program since its inception in 1966. The very significant changes made by this statute include:

· The establishment of a permanent Medicare prescription drug program;

· Significant new incentives to facilitate private plan participation in Medicare Advantage;

· The provision of certain preventative benefits under both traditional Medicare FFS and Medicare Advantage;

· The implementation of many changes in coverage and payment policy within traditional Medicare FFS;

· The implementation of many administrative and regulatory reforms within traditional Medicare FFS;

· Under Section 911 of the MMA, the restructuring of the acquisition statutes that govern traditional Medicare, commonly known as Medicare contracting reform;

· Under Section 912 of the MMA, the requirements for information security program and independent evaluations; and,

· Under Section 921 of the MMA, the provision of provider education and technical assistance.

The work under this contract shall be affected by many of these provisions; however, the primary authority governing the terms and conditions of this contract is Section 911.

A.3.1.4 The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Public Law 104-191)

HIPAA was enacted on August 21, 1996. Title II, Subtitle F, of HIPAA gives HHS the authority to mandate the use of standards for the electronic exchange of health care data; to specify what medical and administrative code sets (including HCPCS Level II codes) must be used within those standards; to require the use of national identification numbers for patients (individuals), covered health care providers, payers (or health plans), and employers (or sponsors); and to specify the types of measures required to protect the security and privacy of personally identifiable healthcare information. The identification number for patients is on hold.

A.3.1.5 Other Applicable Statutes

· The Rehabilitation Act of 1998, Section 508 Accessibility Standards (“Section 508”) www.section508.gov

· The Privacy Act of 1974, Public Law 93-579, as amended (“Privacy Act”), including HHS implementing regulations (at 45 CFR Part 5). The HIPAA Privacy Regulation (www.hhs.gov/ocr/hipaa/finalreg.html) is also applicable to this contract.

A.3.2 Regulations

Generally, Medicare regulations are located at Chapter 42 of the Code of Federal Regulations (42 CFR). The operations of the PDAC contractor shall comply with these regulations, as well as all other federal regulations that apply to activities performed in fulfillment of this SOW.

The regulations that most directly affect the administration of the Medicare FFS DMEPOS benefit include, but are not limited to:

· 42 CFR Part 410 (see especially §§ 410.10, 410.12, and 410.38);

· 42 CFR Part 414 (see especially Subpart D, §§ 414.200 and following);

· 42 CFR Part 421 (see especially §421.210 and 421.212); and,

· 42 CFR Part 424 (see especially §424.24, §424.57, and Subpart P) A.3.3 Medicare Manuals

Medicare manuals (e.g. Internet Only Manuals (IOMs)) are CMS program instructions, day-to-day operating instructions, policies, and procedures that are based on statutes and regulations, guidelines, models, and directives. CMS program components, providers, contractors, and State survey agencies use Medicare manuals to administer CMS programs. As CMS paper-based manuals are updated, the updated material is published in the IOM and eliminated from the outgoing old paper-based manuals. The IOM has precedence over paper-based manuals. CMS shall continue this phase-out/phase-in process until all manual instructions are included in the Internet-only manuals.

Internet Only Manuals can be found at: http://www.cms.hhs.gov/manuals/IOM/list.asp.

A.3.4 HCPCS Level II Code-Related References

The following references (including any files that can be directly accessed from them) are available on the Internet and are hereby incorporated with the same force and effect as if they were provided in full text herein.

http://www.cms.hhs.gov/MedHCPCSGenInfo/ http://www.cms.hhs.gov/MedHCPCSGenInfo/01a_Application_Form_and_Instructions.asp#TopOfPage http://www.cms.hhs.gov/MedHCPCSGenInfo/02_HCPCSCODINGPROCESS.asp#TopOfPage http://www.cms.hhs.gov/MedHCPCSGenInfo/08_HCPCSPublicMeetings.asp#TopOfPage http://www.cms.hhs.gov/MedHCPCSGenInfo/20_HCPCS_Coding_Questions.asp#TopOfPage http://www.cms.hhs.gov/MedHCPCSGenInfo/HCPCSTrans/list.asp#TopOfPage A.3.5 Other Manuals and Documents

For purposes of this contract, the Contractor shall also refer to the following:

www.cms.hhs.gov/center/coverage.asp www.cms.hhs.gov/manuals/IOM/list.asp

· Common Working File documentation website: http://cms.csc.com/cwf/default.htm.

· The American National Standards Institute (ANSI) X12 Implementation Guides adopted as national standards under HIPAA found at: www.wpc-edi.com/HIPAA

· The National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard and Batch Standard as published by that organization found at:

www.ncpdp.org/standards.asp A.3.6 Other References

The following references are available on the Internet and are hereby incorporated with the same force and effect as if they were provided in full text herein.

· Local Coverage Determinations www.cms.hhs.gov/mcd

· CMS Annual Freedom Of Information Act (FOIA) Report www.cms.hhs.gov/FOIA/05_annualreports.asp

· Freedom Of Information Act (FOIA) Request Form (CMS FORM 632) www.cms.hhs.gov/FOIA/02_requests.asp

· National Provider Identifier

IOM Pub. 100-08, Chapter 10; Pub. 100-20, OTNs and Confidentials; and, Pub. 100-04

For all of these, see:

http://www.cms.hhs.gov/Manuals/IOM/list.asp A.4 Additional Constraints Due to the complexity of the contract effort called for in this SOW, the Contractor must have current and direct access to and experience with Medicare DMEPOS claims data through one or more Medicare systems such as the Common Working File system and/or substantial experience in administering CMS-contracted Medicare activities involving DMEPOS.

This SOW specifies additional requirements and challenges that the Contractor must meet.

B.

PERSONNEL REQUIREMENTS

The positions identified at B.1 and B.2 below shall be considered “Key Personnel” for the purposes of this PDAC contract (ref: HHSAR 352.270-5, incorporated at Section G.23 of this contract). These two (2) Key Personnel are considered essential to the work being performed under this PDAC contract. Unless otherwise approved by the Contracting Officer, the Key Personnel required by B.1 and B.2 shall possess the specified minimum work experience and minimum educational requirements.

The positions identified at B.3 are positions required by this PDAC contract, but are not considered Key Personnel; this means that the Contractor may remove, replace, or divert individuals proposed for these positions without the written consent of the Contracting Officer.

B.1.

PDAC Program Director (Key Personnel) The Director shall be fully dedicated to the Contractor. The Program Director serves as the overall administrator of the Contractor. The Director has final responsibility and is accountable for assuring the Contractor effectively and efficiently carries out all of its contractual functions under this SOW and its administrative responsibilities under this contract. The Director is required to direct and oversee all activities and requirements outlined in this SOW, including all activities associated with implementation.

Minimum Work Experience

The Program Director shall possess ten or more years of professional experience with at least 3 years as a manager responsible for managing complex systems and work flow.

Minimum Educational Requirements

The Program Director shall possess a bachelor’s degree from an accredited institution.

B.2.

PDAC Medical Director (Key Personnel) The Medical Director of the Contractor is directly responsible and accountable for assuring that the HCPCS coding functions, as described in this SOW, are carried out. The Contractor Medical Director shall perform and/or participate in the following roles and functions:

· Participates in reviews of products submitted to the Contractor for coding

· Provides medical advice on complex reviews and research of products

· Responsible for acquiring consultant services; reviews and approves consultants’ work products prior to payment to consultant

· Attends select ANWG meetings in person; participates in all other ANWG meetings by conference call

· Coordinates with law enforcement on requests for coding, testimony and other assistance during the course of investigations and/or trials

· Participates in HCPCS conference calls with Medicare FFS Contractor Medical Directors (CMDs), HCPCS staff, etc, generally held weekly

· Participates in conference calls with CMS, DME MACs, DME PSCs for special projects or as needed

· Attends and participates in DMEPOS Coordination Meetings (DCMs)

· Oversees the development of the crosswalk of NDC Codes to HCPCS Codes

· Coordinates the efforts of consolidating the current “WW” codes for oral anti-cancer drugs

· Chairs and/or participates in various forums, panels and special projects, as requested by CMS

· Participates in national and/or regional conferences, as requested by CMS

The Medical Director must be a full time position and meet the following qualifications:

Minimum Work Experience

The Medical Director shall possess three or more years in the health insurance industry, a utilization review firm or other administrative experience in a health related field that involved developing coverage and coding policies and guidelines.

The Medical Director shall possess extensive knowledge of the Medicare program, in particular as it relates to coverage and/or coding policies and guidelines. Public relations experience, such as working with professional associations (i.e. medical, DME, physicians, etc) is a requirement also.

Minimum Educational Requirements

The Medical Director shall possess three or more years experience of practicing medicine as a board-certified doctor of medicine and must possess a current medical license.

B.3.

Other Required PDAC Personnel While the following personnel will not be subject to the Key Personnel requirement that applies to the PDAC Program Director and the PDAC Medical Director, the PDAC must also provide for the following full-time employees:

B.3.1 Orthotist/Prosthetist (O/P) Expert The O/P expert of the Contractor is directly responsible and accountable for assuring that the HCPCS coding functions pertaining to orthotics and prosthetics, as described in this SOW, are carried out. The O/P shall perform and/or participate in the following roles and functions:

· Participates in reviews of orthotic and prosthetic products submitted to the Contractor for coding

· Provides advice on complex orthotic and prosthetic reviews and research of products

· Reviews consultants’ comments on orthotic and prosthetic product reviews

· Attends select ANWG meetings in person; participates in all other ANWG meetings by conference call

· Coordinates with law enforcement on requests for orthotic and prosthetic coding, testimony and other assistance during the course of investigations and/or trials.

· Participates in HCPCS conference calls with CMDs, HCPCS staff, etc, generally held weekly

· Participates in conference calls with CMS, DME MACs, DME PSCs for special projects or as needed

· Provides guidance to Contractor staff regarding orthotic and prosthetic items

· Attends and participates in DMEPOS Coordination Meetings (DCMs), as necessary

· May be called upon by CMS to chair or participate in various forums, panels and special projects regarding orthotics and prosthetics.

· May be asked to represent the Medicare FFS policy viewpoint at national and/or regional conferences regarding orthotics and prosthetics

The O/P is a full time position and shall meet the following qualifications:

Minimum Work Experience

The O/P shall possess three or more years in the health insurance industry, a utilization review firm or other administrative experience in a health related field that involved developing coverage and/or coding policies and guidelines.

The O/P shall possess some knowledge of the Medicare program, preferably as it relates to coverage and/or coding policies and guidelines. Public relations experience, such as working with professional associations (i.e. medical, DME, physicians, etc) is also preferred.

Minimum Educational Requirements

The O/P shall possess three or more years experience as a certified Orthotist or Prosthetist. Certification can be from: the American Board for Certification in Orthotics, Prosthetics and Pedorthics, or the Board for Orthotist/Prosthetist Certification. The O/P must maintain an active certification.

B.3.2 Manager, HCPCS Coding

The Manager, HCPCS Coding is responsible for carrying out the day-to-day operations of the HCPCS coding function, as described at Section E.1 of this SOW. The Manager is also responsible for the supervision of any HCPCS coding staff.

Minimum Work Experience

The Manager, HCPCS Coding shall possess experience in the health industry, a utilization review firm or other administrative experience in a health related field that involved developing coverage and coding policies and guidelines.

The Manager, HCPCS Coding shall have a strong working knowledge of the Medicare program, in particular as it relates to coverage and/or coding policies and guidelines.

Minimum Educational Requirements

The Manager, HCPCS Coding must possess a minimum of a registered nurse license.

B.3.3 Manager, Reports and Analysis

The Manager, Reports and Analysis is responsible for carrying out the day to day operations of the reports and analyses function, as described at Section E.4. of this SOW, and is accountable for assuring these SOW requirements are met. The Manager is also responsible for the supervision of the statisticians, data analysts and other staff that perform these functions.

Minimum Work Experience

The Manager, Reports and Analysis shall possess experience in a health related field that involved a statistical analysis environment. A good working knowledge of the Medicare program, in particular as it relates to knowledge of health related claims data and analyses. The Manager shall have a minimum of three years management or related experience.

Minimum Educational Requirements

The manager shall have a bachelor’s degree in mathematics or statistics from an accredited institution.

B.3.4 Implementation Project Director

The Implementation Project Director’s activities will commence with contract award and continue through cutover until all implementation activities are completed. The Implementation Director may be the same individual as the Program Director or may be another person. The Implementation Project Director shall be accountable for ensuring a smooth and timely implementation (start-up) of the operations called for by this PDAC contract. The Implementation Project Director shall oversee the execution of the requirements in Section C.1 as well as many other portions of this SOW.

B.3.5.

Other Personnel The Contractor shall provide for certain “officer functions” specified in this SOW, including:

a. Chief Information Officer (see D.2.1 of this SOW)

b. Compliance Officer (see D.2.2 of this SOW)

c. Systems Security Officer (see D.2.1 of this SOW)

These personnel need not be dedicated solely to the PDAC, and their official corporate title may be different than the titles shown above so long as their actual scope of responsibility is equivalent to these positions. The Contractor must provide assurances to CMS that the functions carried out by these personnel are incorporated within its organization, and that the personnel fulfilling these positions are empowered to execute appropriate subject area certifications (NOTE: In some cases, this SOW specifies that a particular official of the Contractor must provide a particular certification; in other cases, for required certifications where this SOW does not specify the certifying official, the Contractor will certify based on the direction of the CMS Project Officer).

In addition, the Contractor shall hire and train (or otherwise provide directly or through subcontract) sufficient staff to fulfill all the requirements of this SOW, including but not limited to the specialized requirements specified under Section E.4 of this SOW.

C.

IMPLEMENTATION AND CLOSE-OUT REQUIREMENTS

In keeping with C.1 below, the Contractor shall efficiently and effectively implement its operational responsibilities (these are specified in Sections B, D, E, F, and G of this SOW). Upon the Government’s exercise of its unilateral option provided for in C.2 below, the Contractor shall efficiently and effectively support the transfer of its operational responsibilities to a successor contractor and close-out this PDAC contract.

C.1 PDAC Contract Implementation Requirements & Success Measures

During the implementation period of this contract, the term “transition” will be applied to activities that are performed by or involve multiple parties; i.e., the incoming Contractor as well as others involved in the project such as the outgoing Contractor, data center, etc. The term “implementation” will be used for those activities normally associated with just the incoming Contractor. However, in general usage, the term “transition” often will be applied to the incoming Contractor’s implementation activities. A “contract implementation” is defined as the entire scope of Contractor activities associated with moving Medicare FFS functions from the outgoing Contractor to its successor.

The PDAC Contractor shall carry out the orderly receipt of all Medicare data, records, work in progress, and operations that are presently maintained by the SADMERC contractor, including any software applications or other information technology developed by the SADMERC to perform its responsibilities to which the Government has title or rights.

CMS will consider the following measures in determining whether the transfer of Medicare FFS data, records, work in progress, and operational activities from the outgoing SADMERC to the incoming PDAC Contractor has been accomplished successfully:

· There is minimal disruption to the DME MACs, DME PSCs, NSC, CMS, law enforcement and other Medicare contractor stakeholders;

· There is minimal disruption to suppliers of DMEPOS and other stakeholders;

· There is no disruption of affected Medicare FFS operations;

· The implementation is completed within the required time period as stated in the Implementation Project Plan;

· Actual costs represent effective and efficient use of resources; and

· All parties with an interest in the implementation (whether direct or indirect) are kept informed of the implementation’s status and progress.

C.1.1 Implementation Requirements

The Contractor shall carry out the orderly transfer of all appropriate workload from the outgoing SADMERC. The Contractor shall provide sufficient staff to carry out the Implementation Project Plan and other project plans provided for in this SOW.

C.1.1.1 Implementation Project Plan

The Contractor shall carry out the implementation in accordance with an Implementation Project Plan. The Implementation Project Plan provides a detailed description of all activities required to transfer the appropriate SADMERC workload to the Contractor and implement the requirements of this PDAC contract (including the section 508 compliance requirement). The major task categories to be addressed in the Implementation Project Plan shall include, at a minimum:

· Project Management

· Network and Data Center Connectivity

· Site Acquisition and Facilities Preparation

· Hardware and Software Acquisition/Installation

· Testing

· Interface Set-Up (e.g., Joint Operating Agreements)

· Recruiting and Training

· Stakeholder Relations

· Cutover Execution

· Post-Cutover Monitoring The Contractor shall submit the initial Implementation Project Plan as part of its proposal. The Contractor shall provide CMS a revised Implementation Project Plan within 30 calendar days of contract award to reflect any changes in the Plan due to modification of the schedule or tasks.

The Contractor shall submit bi-weekly (every other week) updates to the Implementation Project Plan with an accompanying list of tasks completed and tasks that are not on schedule.

C.1.1.2 Cutover Project Plan

The Contractor shall prepare, maintain, and follow a Cutover Project Plan for implementation. The Cutover Project Plan must identify daily processes and procedures the Contractor shall follow during the “cutover period” (i.e., the period immediately surrounding the Operational Start Date (OSD) (see C.1.2. below)) to ensure a successful hand-off and start-up of PDAC operations. The Contractor shall submit the initial Cutover Project Plan at least 6 weeks before the OSD. The Contractor shall update the Cutover Project Plan daily during the cutover period.

C.1.1.3 Implementation Risk Management Plan

The Contractor shall develop, execute, and maintain an Implementation Risk Management Plan for this transition. The Contractor shall submit the initial Implementation Risk Management Plan as part of its proposal. The Implementation Risk Management Plan shall be updated by the Contractor every four (4) weeks and include periodic assessments of new risks and mitigation and contingency planning where appropriate.

C.1.1.4 Implementation Stakeholder Communications Plan The Contractor shall prepare, maintain, and follow a Stakeholder Communications Plan for this SOW. The Contractor shall submit the initial Stakeholder Communications Plan as part of its proposal and the Contractor shall provide CMS a revised Stakeholder Communications Plan within 30 calendar days of contract award to reflect any changes in activities. The Contractor shall update the Stakeholder Communications Plan on a bi-weekly basis.

The Stakeholder Communications Plan identifies the processes and procedures the Contractor shall follow to ensure that all transition stakeholders are informed of the implementation, its status and progress, and how changes may affect them. Transition stakeholders are those parties directly involved in the implementation such as the outgoing SADMERC, DME PSCs, DME MACs, NSC, DMEPOS suppliers, manufacturers, etc., as well as those with an interest in the implementation, such as governmental entities, professional societies and associations, etc.

All transition stakeholders shall be kept informed of the status and progress of the implementation and any changes that affect them in accordance with the Stakeholder Communications Plan.

C.1.2 Operational Start Date (OSD)

The Contractor shall conduct implementation activities for this SOW and cutover in accordance with the OSD of August 1 2008.

The Contractor shall be fully operational by the OSD, in accordance with the Implementation Project Plan. Fully operational is defined as the date when the Contractor is performing the full range of PDAC responsibilities in accordance with this SOW and this contract. The SADMERC will cease to operate on the OSD. Operational deliverables throughout this SOW commence on the OSD.

C.1.3 Implementation Progress Status Reports

The Contractor shall provide to the Project Officer and/or designees a bi-weekly (every other week) Implementation Project Status Report (due two business days before each scheduled bi-weekly Transition Status Meeting required under C.1.4) and narrative organized by the major implementation tasks. The Implementation Progress Status Report shall include a discussion of major accomplishments, outstanding issues, deliverables, problem resolution, and risk mitigation/contingency plans as appropriate.

The Contractor shall also submit special workload reports after cutover. These special workload reports shall reflect the Contractor’s receipts, processed, and completion metrics for its DMEPOS product review and customer service workloads, as well as other Contractor activities as directed by the CMS Project Officer. These special workload reports shall be weekly for at least the first four weeks after cutover; provided that, the CMS Project Officer has the discretion to require more or less frequent reporting based on the Contractor’s performance. These special workload reports shall follow a format to be mutually agreed upon between the Contractor and the CMS Project Officer. Following this four week period, the Contractor shall submit its standard monthly production/status reports required elsewhere in this SOW (Section D.4); provided that, the Project Officer may direct the Contractor to continue submission of special workload reports based upon the Contractor’s performance.

C.1.4 Transition Meetings The Contractor shall organize, host, and provide toll-free telecommunication lines and facilities for transition meetings. The Contractor shall determine who attends the transition meetings, which may include, but is not limited to the outgoing SADMERC and incoming Contractor staff, the CMS Project Officer and other CMS personnel, and any other affected stakeholders.

Transition meetings include the Kickoff Meeting, the management-level bi-weekly Transition Status Meetings, and weekly transition workgroup meetings discussed below. The meetings shall follow a prepared agenda. During these meetings, attendees shall discuss the status of the major tasks, issues, deliverables, schedule, delays, problem resolution, and risk mitigation and/or contingencies. The Contractor shall use its best efforts to ensure that all transition meetings reflect the coordination and cooperation of all parties.

The Contractor shall provide appropriate meeting agendas for all transition meetings at least two business days before each transition meeting.

A Kickoff Meeting shall be held within 10 days after contract award. The Contractor shall provide Kickoff Meeting minutes within two business days after the meeting.

The Contractor shall conduct bi-weekly (every other week) Transition Status Meetings for management levels of key stakeholders. These will ordinarily be teleconferences, but may be face-to-face meetings when approved as necessary by the CMS Project Officer The Contractor shall provide Transition Status Meeting minutes within two business days after each meeting.

Weekly transition workgroup teleconferences or meetings shall be held to work through issues at a staff level. The Contractor shall provide transition workgroup meeting minutes within two business days after each meeting.

C.1.5 Post-Project Review Meeting

A post-project review meeting shall be held six (6) weeks after cutover to discuss lessons learned from the transition. CMS will have the responsibility for organizing the meeting, obtaining any meeting space, and providing toll-free telephone lines. The meeting shall cover each major area of the transition and focus on the actions, methods, and processes used during the transition. Those activities that went well shall be discussed as well as those that need improvement. The goal of the meeting is to provide insight and generate ideas for the improvement of future transitions.

C.2 Contractor Responsibilities during the Closeout Period and at Contract End (CMS Option that may be exercised by CMS at end of the contract)

(Option includes C.2.1 through C.2.4 below)

Following the OSD, the Contractor shall continue to perform all the requirements of this SOW (except for completed “one-time implementation tasks” under Sections C.1 above and D below) for the Base Period and any optional periods of performance called for by this PDAC contract.

In addition, the Government shall have the unilateral option (under this Section C.2) to require the Contractor to fully support an orderly transfer of its operational responsibilities under this PDAC contract to a successor Contractor. This option may be exercised at the Government’s sole and complete discretion, and includes: (1) the performance of all the ongoing operational tasks and requirements set forth in all sections of this SOW (excluding tasks under C.1) for a three-month period until the successor Contractor commences operations and (2) the special close-out activities, tasks, and related deliverables, set forth below under C.2.1, C.2.2, C.2.3 and C.2.4. (Note: The Contractor may have additional obligations during this Closeout Period or following the end of the period of performance – for instance, the maintenance of payroll and accounting records - that may be imposed by other terms and conditions of this contract or by law.)

C.2.1 Transfer of PDAC Functions, Data and Operations (Included in CMS Option) The Contractor shall transfer to its successor all Medicare data, records, work in progress and operations, including any software applications or other information technology either received by the Contractor from the SADMERC or developed by the Contractor under this contract to which the Government has title or rights, and cease activities related to this PDAC contract. The Contractor shall cooperate fully with the successor/incoming Contractor during its closeout period and shall provide CMS with bi-weekly (every other week) closeout project status reports organized by major closeout tasks. The reports shall include a discussion of outstanding issues, deliverables, problem resolution, and risk mitigation/contingency plans as appropriate.

All Medicare-related data, records, work in progress and operations (including information technology to which the Government has title or rights) related to or developed under this SOW shall be delivered, transferred, or reassigned to the successor Contractor in accordance with the successor Contractor’s implementation project plan (as approved by CMS) and by the contract end date.

The Contractor shall destroy duplicate files and any Medicare data not required by the incoming Contractor in accordance with CMS data security requirements.

During the closeout period, the Contractor shall maintain an experienced closeout management team in addition to the Key Personnel specified at Sections B.1. and B.2 of this SOW.

C.2.2 Closeout Project Plan (Included in CMS Option) The Contractor shall develop, maintain, update, and follow a Closeout Project Plan to provide for the transfer of the PDAC functions included within this SOW to its successor Contractor and the closeout of PDAC operations at contract end. The Contractor shall provide the incoming Contractor with its Closeout Project Plan and shall coordinate the Plan and closeout activities with the incoming Contractor’s implementation activities and project plans. The Closeout Project Plan shall provide detailed tasks reflecting the activities necessary for the Contractor to transfer all Medicare data, records, work in progress and operations (including information technology to which the Government has title or rights) related to or developed under this SOW to the incoming Contractor, and to maintain operational standards during the implementation.

The Contractor shall submit the initial Closeout Project Plan within 4 weeks of: (1) contract award to the new Contractor; or, (2) the Government’s exercise of this option, whichever is later. The Contractor shall update the Closeout Project Plan bi-weekly and provide an accompanying list of tasks completed and tasks not on schedule.

C.2.3 Meetings (Included in CMS Option) The Contractor shall participate in implementation meetings during its closeout.

The Contractor shall attend meetings (may be done by teleconference, except the Kickoff Meeting and as directed by CMS) and provide appropriate staff to timely participate in the various functional workgroups that may be established during the implementation, including, but not limited to:

· The Kickoff Meeting organized by the incoming (successor) Contractor;

· Weekly implementation workgroup teleconferences or meetings;

· Bi-weekly implementation status teleconferences or meetings with the incoming Contractor;

· A lessons learned conference that shall be held by CMS or the new Contractor.

C.2.4…