Attachment_J.01_Statement_of_Work.docx

75FCMC18R0010 – Pricing, Data Analysis, and Coding (PDAC) Attachment J-01 STATEMENT OF WORK dated 12/01/2017

Durable Medical Equipment

(DME)

PRICING, DATA ANALYSIS, and CODING (PDAC) CONTRACT

Attachment J-01 - Statement of Work (SOW)

DME PDAC

12/01/2017

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Attachment J-01 STATEMENT OF WORK dated 12/01/2017 Amendment 1

Attachment J-01 STATEMENT OF WORK dated 12/01/2017

A. SCOPE

Independently and not as an agent of the Government, the Contractor shall 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 transition-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 (which is primarily administered by the states), and 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 48 million persons were enrolled for Medicare coverage in 2011.

Nearly all Medicare beneficiaries may access their insurance benefits through one of two health care delivery systems. First, in all areas of the country, a beneficiary may enroll in the “traditional” Medicare program, known as the Medicare Fee-For-Service (FFS) program, under which benefits are largely provided in keeping with an indemnity insurance model. That is, the beneficiary chooses his/her health care providers, the provider bills for its services to the appropriate Medicare claims administrator, and payment is made to the provider based on the Medicare Hospital Insurance (HI) and/or Supplementary Medical Insurance (SMI) program’s eligibility, coverage and payment rules. The federal government bears all financial (underwriting) risk for the cost of program benefits under this program, and develops detailed administrative requirements and processes to support the claim administration process. As a national entitlement program, there is a strong imperative to provide a common level of benefits and service in all areas of the country while maintaining adequate flexibility to account for local/regional medical practices.

Second, in many areas of the country, beneficiaries have the option to enroll in one or more privately-sponsored Medicare plans under the “Medicare Advantage” (formerly Medicare+Choice) program. These private Medicare plans may organize themselves in keeping with one of several health care delivery and payment models (e.g., Health Maintenance Organizations, Preferred Provider Organizations, etc.). These private Medicare plans are required to cover the same basic benefits that the traditional Medicare program offers, but they are given fairly broad responsibility and latitude to set up their internal requirements and processes as they see fit. About 25% of Medicare beneficiaries were enrolled in Medicare Advantage in 2011.

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. The Medicare FFS payment policies for most types of DMEPOS are defined 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 contracts with four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) to perform a range of duties associated with the processing of claims for DMEPOS under Part B of the Medicare program. CMS also contracts 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 [see 42 CFR §421.210(d)(3)]. CMS also contracts with entities whose primary focus is to develop strategies and tactics for protecting the integrity of the Medicare DMEPOS benefit. These entities are called the Zone Program Integrity Contractors (ZPICs) and Unified Program Integrity Contractors (UPICs).

A.1.3 The Pricing and Data Analysis Coding (PDAC) Contract & Its Functions

The PDAC’s contract operations support the DME MACs, ZPICs, UPICs, CMS, federal law enforcement agencies, and the NSC.

Specifically, the PDAC contractor performs the following functions:

1. Certain Coding Processes for DMEPOS Items

2. Provide Medicare Coding Advice and Guidance for DMEPOS Items

3. Establish and Distribute Pricing Files for Certain Drugs and DMEPOS Items

4. Statistical Analysis and Reporting

5. Support the Integrity of the Medicare DMEPOS Benefit

6. Other Contractor 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. 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 the HCPCS Level II codes.

The HCPCS Level II codes are the standard for public and private insurers’ use of 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. Within CMS, there is a CMS HCPCS Workgroup comprised of representatives of the major components of CMS, as well as other consultants from pertinent Federal agencies. The PDAC contractor is also a participating member of the CMS HCPCS Workgroup. The CMS HCPCS Workgroup is responsible for maintaining the permanent, national HCPCS Level II codes. 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, any interested party may submit a request to the CMS HCPCS Workgroup to modify the HCPCS.

In addition to its involvement with the CMS HCPCS Workgroup, the PDAC contractor performs code verification reviews for DMEPOS products submitted by manufacturers or distributors. For example, allowing manufacturers or distributers to travel on site and present their products allowing the PDAC to familiarize themselves with DMEPOS products. Furthermore, the PDAC contractor provides assistance to suppliers and manufacturers that have questions about HCPCS Level II coding for the purposes of billing Medicare for DMEPOS items.

The PDAC contractor also maintains processed claims data for DMEPOS, produces standard and ad-hoc reports, and assists in planning, facilitating and coordinating the DME Coordination Meetings (DCMs). The DCMs bring together a number of parties to review and address issues affecting the integrity of the Medicare DMEPOS benefit. DCM attendees include representatives from CMS, ZPICs, UPICs, DME MACs, certain law enforcement staff and the NSC. The PDAC contractor provides data analysis and decision support to the DME MACs, ZPICs, UPICs, CMS, the NSC and law enforcement. These data analysis and decision support activities facilitates the identification of over-utilization, potential fraud and abuse; policy development related to DMEPOS; medical review activities; enrollment of DMEPOS suppliers; and other related activities.

The PDAC contractor also updates and maintains a file that converts National Drug Codes (NDCs) submitted on Medicare claims to HCPCS Level II codes for claims processing purposes. This file, known as the NDC-HCPCS Crosswalk, is distributed to the DME MACs for use in processing claims. In addition, the PDAC contractor updates and maintains pricing files for certain 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

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.

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

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

Jurisdiction A

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

Jurisdiction B

Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, Kentucky

Jurisdiction C

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

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

This SOW intends to support a contract for the Medicare FFS DMEPOS-related pricing, data analysis and coding support functions. These functions support the activities performed by the DME MACs, ZPICs, UPICs, CMS, the NSC and law enforcement agencies. This Contractor will be a “national” Contractor.

A.2 Purpose

The purpose of this SOW and contract is to re-procure 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 under the 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, including the DME MACs, ZPICs, UPICs, and the NSC. The Contractor shall also perform these facilitation and support activities for other Medicare contractors at the direction of CMS. In addition, the Contractor shall perform facilitation and support activities for Federal and State agencies, and other stakeholders, as defined and directed by CMS.

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 shall also conduct a variety of different customer service activities, such as answering written inquiries and providing Medicare guidance and advice on coding of DMEPOS items that are billed to the DME MACs. The Contractor shall answer a wide range of questions from DMEPOS manufacturers, distributors, suppliers and other stakeholders from across the country. The Contractor shall operate and maintain an Internet-based tool used by DMEPOS manufacturers, distributors, suppliers and other stakeholders to facilitate product identification and coding of DMEPOS items that are billed to the DME MACs. The Contractor shall perform complex statistical analyses of Medicare FFS DMEPOS claims data and create reports on trends, significant changes and other relevant factors. The Contractor shall store and maintain this information in a data warehouse. The Contractor shall maintain statistical reports, data analyses and other statistical information in a web-based environment that is easily accessible to the ZPICs, UPICs, DME MACs, NSC, CMS and specific Health & Human Services Office of Inspector General (OIG) personnel limited to the Office of Audit Services (OAS) and Office of Evaluation and Inspections (OEI). The Contractor shall control access to this environment through user passwords and other physical, administrative, and technical safeguards. The Contractor shall develop and maintain a crosswalk for certain drugs from the NDC code to an appropriate HCPCS Level II code. The Contractor shall code and price certain oral anti-cancer drugs. All of these functional activities are specified in detail under Section E of this SOW.

A.3 Applicable Documents

Numerous statutes, regulations, CMS manuals, and documents are applicable to this 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 shall 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 Part A – Hospital Insurance Benefits, Part B – Supplemental Medical Insurance Benefits, and Part E – Miscellaneous Provisions). 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 contract include, but are not limited to:

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

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

3. Federal Information Security Management Act of 2002 (FISMA).

4. Government Performance and Results Act (GPRA).

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

6. 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:

1. The establishment of a permanent Medicare prescription drug program.

2. Significant new incentives to facilitate private plan participation in Medicare via the newly-established Medicare Advantage program.

3. The provision of certain preventative benefits under both traditional Medicare FFS and Medicare Advantage.

4. The implementation of many changes in coverage and payment policy within traditional Medicare FFS.

5. The implementation of many administrative and regulatory reforms within traditional Medicare FFS.

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

7. Under Section 912 of the MMA, the requirements for information security program and independent evaluations.

8. 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

1. The Rehabilitation Act of 1998, Section 508 Accessibility Standards (“Section 508”) http://www.section508.gov/.

2. 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 (http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html) is also applicable to this contract.

3. Executive Order 13410: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs.

To the extent applicable and practical, the Contractor shall follow Executive Order 13410: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs. This Executive Order promotes the efficient delivery of quality health care through the use of health information technology, transparency regarding health care quality and price, and incentives to promote the widespread adoption of health information technology and quality of care. To support this mission, the Contractor shall use recognized health information interoperability standards at the time of this contract, in all relevant information technology systems supported, in whole or in part, through this contract.

This includes existing standards from the Health Information Technology Standards Panel (HITSP) that have been recognized by the Secretary of HHS. Specific information regarding the HITSP standards can be found at http://www.hitsp.org/.

A.3.2 Regulations

Generally, Medicare regulations are located at Chapter 42 of the Code of Federal Regulations (42 CFR). The operations of the 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:

1. 42 CFR Part 410 (see especially §§ 410.10, 410.12, and 410.38).

2. 42 CFR Part 414 (see especially Subpart D, §§ 414.200 and following).

3. 42 CFR Part 421 (see especially §421.210 and 421.212).

4. 42 CFR Part 424 (see especially §424.24, §424.57, §424.58 and §424.500 Subpart P).

A.3.3 Medicare Manuals

Medicare manuals, accessible on the CMS website and known as 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 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.

CMS Internet Only Manuals can be found at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html.

Manual System website contains six subsections:

1. Internet-Only Manuals (IOMs): Manuals that have been transitioned to the Internet-Only format

2. Future Updates to the IOM: Future revisions to the IOMs, organized by implementation dates

3. CMS Transmittals: Transmittals that are organized by year of publication

4. Crosswalks: Information on where material from the Paper-Based Manuals was incorporated in the IOMs

5. Paper-Based-Manuals: Used only for reference purposes, and

6. Program Memoranda: Used only for reference purposes.

As CMS updates manual instructions, revised materials will be updated into the Internet-Only Manuals on the implementation date of the instruction. The current policy and future policy for the Medicare and Medicaid programs are contained in the IOM, future updates to the IOM and the transmittal page on the CMS Online Manual System which is updated weekly.

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:

1. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html

2. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Application_Form_and_Instructions.html

3. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSCODINGPROCESS.html

4. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings.html

5. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCS_Coding_Questions.html

A.3.5 Other Manuals and Documents

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

1. https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html

2. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/index.html

3. Common Working File documentation website https://cwf.2020llc.com/login

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

5. The National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard and Batch Standard as published by that organization found at http://www.ncpdp.org/standards.aspx

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:

1. Local Coverage Determinations http://www.cms.gov/medicare-coverage-database/indexes/national-and-local-indexes.aspx

2. CMS Annual Freedom Of Information Act (FOIA) Report http://www.cms.gov/Regulations-and-Guidance/Legislation/FOIA/index.html

3. Freedom Of Information Act (FOIA) Request Instructions http://www.cms.gov/Regulations-and-Guidance/Legislation/FOIA/filehow.html

4. CMS FOIA and Policy and Procedural Guide www.cms.gov/FOIA/downloads/CMSFOIAPolicyProceduralGuide.pdf

5. National Provider Identifier IOM Pub. 100-08, Chapter 10; Pub. 100-20, OTNs and Confidentials; and, Pub. 100-04 http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/index.html

A.4 Additional Constraints

Due to the complexity of the contract effort called for in this SOW, the Contractor shall 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 shall meet.

B. PERSONNEL REQUIREMENTS

The positions identified at B.1, B.2, B.3, B.4, B.5, and B.6 below shall be considered “Key Personnel” for the purposes of this PDAC contract. These six (6) 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, B.2, B.3, B.4, B.5, and B.6 shall possess the specified minimum work experience and minimum educational requirements.

The positions identified at B.7 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 Program Director (Key Personnel)

The Program Director shall be fully dedicated to the Contractor. The Program Director serves as the overall administrator of the Contractor. The Program 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 Program Director is required to direct and oversee all activities and requirements outlined in this SOW, including all activities associated with implementation.

The Program Director shall be a full time position and meet the following qualifications:

1. Minimum Work Experience The Program Director shall possess extensive knowledge of the Medicare program. 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. Management experience as a manager under a Medicare program contract is preferred.

2. Minimum Educational Requirements The Program Director shall possess a bachelor’s degree from an accredited institution.

B.2 Medical Director (Key Personnel)

The Medical Director shall be fully dedicated to the Contractor. The Medical Director of the Contractor is directly responsible and accountable for assuring that the HCPCS Level II 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:

1. Participates in reviews of products submitted to the Contractor for coding.

2. Provides medical advice on complex reviews and research of products.

3. Responsible for acquiring consultant services.

4. Reviews and approves consultants’ work products prior to payment to consultants.

5. Attends select CMS HCPCS Workgroup meetings in person; participates in all other CMS HCPCS Workgroup meetings by conference call.

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

7. Participates in HCPCS conference calls with Medicare FFS Contractor Medical Directors (CMDs), including DME MAC Medical Directors (DMDs), HCPCS staff, etc., generally held weekly.

8. Participates in conference calls with CMS, DME MACs, ZPICs, and UPICs for special projects, or as needed.

9. Attends and participates in DME Coordination Meetings (DCMs).

10. Oversees the development of the crosswalk of NDC Codes to HCPCS Level II Codes.

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

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

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

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

1. 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. Experience involving development of coverage and coding policies and guidelines under a Medicare program contract is preferred.

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.

2. Minimum Educational Requirements The Medical Director shall possess three or more years of experience practicing medicine as a board-certified doctor of medicine or doctor of osteopathy, and shall possess a current medical license.

B.3 Special Projects Coordinator (Key Personnel)

The Special Projects Coordinator shall be fully dedicated to the Contractor. The Special Projects Coordinator is directly responsible and accountable for assuring that special projects as described in this SOW are carried out. The Special Projects Coordinator shall perform and/or participate in the following roles and functions:

1. Assist CMS and other stakeholders in carrying out project plans.

2. Responsible for acquiring consultant services.

3. Reviews and approves consultants’ work products prior to payment to consultants, as necessary, to carry out special projects.

4. Coordinates with law enforcement, ZPICs, UPICs, and other stakeholders to carry out project plans.

5. Participates in conference calls with CMS, DME MACs, ZPICs, UPICs, and other stakeholders, as necessary.

6. Coordinates the development and implementation of a web-based environment and fully interactive data warehouse and reporting tool for use by specified stakeholders.

7. Coordinates the development of enhanced statistical analyses to support special projects.

8. Coordinates and assures ad-hoc reports are provided in specified time frames.

9. Provide status reports, as required by, CMS.

The Special Projects Coordinator shall be a full time position and meet the following qualifications:

Minimum Work Experience The Special Projects Coordinator shall have one or more years of experience managing complex projects involving multiple entities. Experience managing complex projects involving multiple entities under a Medicare program contract is preferred.

B.4 HCPCS Coding Specialist (Key Personnel)

The HCPCS Coding Specialist shall be fully dedicated to the Contractor. The HCPCS Coding Specialist is accountable for assuring the HCPCS Level II coding functions as described in Sections E.1 and E.2 of this SOW are met. The HCPCS Coding Specialist shall perform and/or participate in the following roles and functions:

1. Oversee the coding verification review process and assure the accuracy, consistency, and adherence to regulatory requirements in the assignment of HCPCS codes.

2. Attends select CMS HCPCS Workgroup meetings in person; participates in all other CMS HCPCS Workgroup meetings by conference call.

3. Maintains ongoing records and documentation from the CMS HCPCS Workgroup process to assure a historic resource for HCPCS coding decisions.

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

5. Participates in HCPCS conference calls with DMDs, HCPCS staff, and other relevant participants.

6. Participates in conference calls with CMS, DME MACs, ZPICs, and UPICs for special projects where coding advice or guidance is needed.

7. May attend and participate in DME Coordination Meetings (DCMs).

The HCPCS Coding Specialist shall be a full time position and meet the following qualifications:

1. Minimum Work Experience The HCPCS Coding Specialist shall possess a minimum of three years of 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. Experience involving development of coverage and coding policies and guidelines under a Medicare program contract is preferred. Clinical experience as a registered nurse is preferred.

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

2. Minimum Educational Requirements The HCPCS Coding Specialist shall possess, at a minimum, state licensure as a registered nurse, with a bachelor’s degree in nursing preferred. The HCPCS Coding Specialist shall maintain active and current licensure as a registered nurse. Certification as a certified professional coder is preferred.

B.5 Orthotist/Prosthetist (O/P) (Key Personnel)

The Orthotist/Prosthetist shall be fully dedicated to the Contractor. The Orthotist/Prosthetist (O/P) of the Contractor is directly responsible and accountable for assuring that the HCPCS Level II 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:

1. Participates in reviews of orthotic and prosthetic products submitted to the Contractor for HCPCS Level II coding.

2. Provides advice on complex orthotic and prosthetic coding reviews and coding research of products conducted by the Contractor.

3. Reviews consultants’ comments on orthotic and prosthetic product reviews.

4. Attends select CMS HCPCS Workgroup meetings, either in person or via conference call.

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

6. Participates in HCPCS conference calls with DMDs, HCPCS staff, and other relevant participants.

7. Participates in conference calls with CMS, DME MACs, ZPICs, and UPICs where Orthotic/Prosthetic advice and guidance is needed.

8. Provides guidance and Orthotic/Prosthetic expertise regarding orthotic and prosthetic items to Contractor personnel, CMS, and to external Contractor staff limited to the DME MACs, ZPICs, and UPICs.

9. May attend and participate in DME Coordination Meetings (DCMs).

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

1. Minimum Work Experience The O/P shall possess three or more years of experience as a certified Orthotist and certified Prosthetist. The O/P shall possess three or more years of experience 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 knowledge of the Medicare program, preferably as it relates to coverage and/or coding policies and guidelines. Experience involving development of coverage and coding policies and guidelines under a Medicare program contract is preferred. Public relations experience, such as working with professional associations (i.e. medical, DME, physicians, etc.) is preferred.

2. Minimum Educational Requirements The O/P shall possess certification as a certified Orthotist and certified 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 shall maintain an active and current certification as an Orthotist/Prosthetist.

B.6 Biomedical Engineer (Key Personnel)

The Biomedical Engineer shall be fully dedicated to the Contractor. The Biomedical Engineer is directly responsible and accountable for assessing new DMEPOS products and technology compared to other DMEPOS products and technology to facilitate pricing, coding and classification of DMEPOS items and services. The Biomedical Engineer shall perform and/or participate in the following roles and functions:

1. Conducts technology assessments of the design, purpose, function, effectiveness, and cost of medical devices and supplies. Drafts reports related to these assessments for use in pricing, coding and classification of DMEPOS items and services.

2. Assesses the comparability and relative costs of the new DMEPOS items and/or technology in relation to other DMEPOS items and technology for the purpose of establishing Medicare payment amounts for new DMEPOS items and technology.

3. Initiates comprehensive technology assessments for up to ten products per year. Makes recommendations regarding additional resources needed to complete each assessment in no later than nine months. Coordinates efforts of additional staff and/or subcontractors whenever they are brought in as resources for conducting a technology assessment.

4. Reviews submitted HCPCS applications and participates in all CMS HCPCS Workgroup meetings, either in person or via conference call.

5. Coordinates with law enforcement on requests for assessments of DMEPOS technologies, testimony and other assistance during the course of investigations and/or trials.

6. Participates in HCPCS conference calls with DMDs, HCPCS staff, and other relevant participants.

7. Participates in conferences calls with CMS, DME MACs, ZPICs, and UPICs where Orthotic/Prosthetic advice and guidance is needed.

8. Provides guidance regarding assessments of DMEPOS technologies to Contractor personnel, CMS, and to external Contractor staff limited to the DME MACs and ZPICs.

9. May attend and participate in DME Coordination Meetings (DCMs).

The Biomedical Engineer is a full time position and shall meet the following qualifications:

1. Minimum Work Experience The Biomedical Engineer shall possess three or more years of experience in a bioengineering or biomedical engineering position. The Biomedical Engineer shall possess a thorough knowledge of the theory, design characteristics, operation and functions of various types of medical equipment, instrumentation, and devices. The Biomedical Engineer shall possess three or more years of experience in conducting technology assessments, including assessing the cost of medical devices and products.

2. Minimum Educations Requirements The Biomedical Engineer shall possess a Bachelor’s degree or higher in Bioengineering or Biomedical Engineering.

B.7 Other Required Contractor Personnel

While the following personnel will not be subject to the Key Personnel requirement that applies to the Program Director, Medical Director, Special Projects Coordinator, Orthotist/Prosthetist, Biomedical Engineer and HCPCS Coding Specialist, the Contractor shall also provide for the following employees:

B.7.1 Manager of Reports and Analysis

The Manager of Reports and Analysis shall be fully dedicated to the Contractor. The Manager of Reports and Analysis is accountable for assuring the Statistical Analysis functions as described in Section E.4 of this SOW are met. The Manager of Reports and Analysis shall perform and/or participate in the following roles and functions:

1. Oversee the development of all standard and ad-hoc reports, and assure the validity and clarity of the data output.

2. Participates in conference calls with CMS, DME MACs, ZPICs, UPICs, and the NSC for special analytic reports or projects, as needed.

3. May attend and participate in DME Coordination Meetings (DCMs).

The Manager of Reports and Analysis shall meet the following qualifications:

1. Minimum Work Experience The Manager of 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 as it relates to statistical analyses of Medicare claims data is required. The Manager of Reports and Analysis shall have a minimum of three years management or related experience. Management experience under a Medicare program contract is preferred.

2. Minimum Educational Requirements The Manager of Reports and Analysis shall have, at a minimum, a bachelor’s degree in mathematics or statistics from an accredited institution.

B.7.2 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 Project 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 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.7.3 Other Personnel

The Contractor shall provide for certain officer functions specified in this SOW, including:

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

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

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

These personnel need not be dedicated solely to the contract, 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 shall 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 shall provide a particular certification. For required certifications where this SOW does not specify the certifying official, the Contractor will certify based on the direction of the CMS Contracting Officer’s Representative (COR)].

In addition, the Contractor shall hire and train (or otherwise provide directly or through subcontract) sufficient personnel 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 TRANSITION-OUT REQUIREMENTS

In keeping with C.1 below, the Contractor shall efficiently and effectively implement its operational responsibilities, as 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 transition-out this PDAC contract.

C.1 Contractor 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 PDAC contractor as well as others involved in the project such as the outgoing PDAC contractor, data center, etc.). The term “implementation” shall be used for those activities normally associated with just the incoming PDAC contractor. However, in general usage, the term “transition” often will be applied to the incoming PDAC 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 PDAC contractor to the incoming PDAC contractor.

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

CMS will…