PricingDataAnalysisandCoding(PDAC)RequestforProposal.doc

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

TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1

DESCRIPTION OF SERVICES

B.2

TYPE OF CONTRACT

B.3

ESTABLISHED COST AND FIXED FEE

B.4

HHSAR 352.232-9 WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

B.5

TASK DIRECTIVES

B.6

TRAVEL

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1

STATEMENT OF WORK

SECTION D - PACKAGING AND MARKING

D.1

PACKAGING AND MARKING

SECTION E - INSPECTION AND ACCEPTANCE

E.1

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

E.2

APPROVALS BY THE PROJECT OFFICER

E.3

INSPECTION OF SERVICES – COST REIMBURSEMENT

SECTION F - DELIVERIES OR PERFORMANCE

F.1

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

F.2

PERIOD OF PERFORMANCE

F.3

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

F.4

DELIVERABLES

F.5

HHSAR 352.249-14 EXCUSABLE DELAYS (JAN 2006)

SECTION G - CONTRACT ADMINISTRATION DATA

G.1

ACCOUNTING AND APPROPRIATION DATA

G.2

PAYMENT, SELECTED ITEMS OF COST REIMBURSEMENT CONTRACTS

G.3

DISSEMINATION, PUBLICATION & DISTRIBUTION OF INFORMATION

G.4 SUBCONTRACTING REPORTING (Only for Large Business Contractors)

G.5

SUBCONTRACTING PROGRAM FOR SMALL AND SMALL DISADVANTAGED BUSINESSES

G.6

SMALL DISADVANTAGED BUSINESS PARTICIPATION

G.7

SUBCONTRACT CONSENT

G.8

SERVICE OF CONSULTANTS/ SUBCONTRACTORS

G.9

CONTRACTING OFFICER RESPONSIBILITY

G.10

CONTRACTOR PDAC PROGRAM DIRECTOR

G.11 PROJECT OFFICER tc "G.8 Project Officer " \l 2

G.12

TECHNICAL DIRECTION

G.13 DESIGNATION OF PROPERTY ADMINISTRATORtc "G.7 Designation of Property Administrator " \l 2

G.14

GOVERNMENT FURNISHED PROPERTY

G.15

CONTRACTOR FURNISHED PROPERTY

G.16

INVOICING AND PAYMENT

G.17

METHOD OF PAYMENT

G.18

CORRESPONDENCE PROCEDURES

G.19

DATA TO BE DELIVERED

G.20

WORKING PAPERS

G.21

INDIRECT COST RATES – PROVISIONAL AND FINAL

G.22

USE OF GOVERNMENT DATA (REPORTS/FILES/COMPUTER TAPES OR DISCS)

G.23

HHSAR 352.270-5 KEY PERSONNEL (JAN 2006)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 HHSAR 352.224-70 CONFIDENTIALITY OF INFORMATION (JAN 2006) tc "H.4 352.224-70 Confidentiality of information. (APR 1984) " \l 2

H.2

CONDITIONS OF PERFORMANCE

H.3

CONFLICT OF INTEREST

H.4

APPROVAL OF CONTRACT ACQUIRED INFORMATION TECHNOLOGY

H.5

HIPAA BUSINESS ASSOCIATE PROVISION II

H.6

SECTION 508 – ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

H.7

REHABILITATION ACT, SECTION 508 ACCESSIBILITY STANDARDS

H.8

HHSAR 352.270-7 PAPERWORK REDUCTION ACT (JAN 2006)

H.9

WAGE DETERMINATION

H.10

DISCLOSURE OF INFORMATION

H.11

PARTICIPATION IN DEMONSTRATIONS

H.12

RECORD RETENTION

H.13

REPORTABLE EVENTS

H.14

SYSTEMS OF RECORDS

H.15 SECURITY CLAUSE – BACKGROUND – INVESTIGATIONS FOR CONTRACTOR PERSONNEL / WORK PERFORMED OUTSIDE THE UNITED STATES AND ITS TERRITORIES

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I.1

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

I.2

DEPARTMENT OF HEALTH & HUMAN SERVICES ACQUISITION REGULATIONS (HHSAR)

I.3

52.215-19 NOTIFICATION OF OWNERSHIP CHANGES (OCT 1997)

I.4

52.222-2 PAYMENT FOR OVERTIME PREMIUMS (JUL 1990)

I.5 52.222-39 NOTIFICATION OF EMPLOYEE RIGHTS CONCERNING PAYMENT OF UNION DUES OR FEES (DEC 2004)

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

J-1

STATEMENT OF WORK

J-2

GOVERNMENT FURNISHED MATERIAL

J-3

DELIVERABLES LIST

J-4

RESERVED FOR INCORPORATION OF WAGE DETERMINATIONS

J-5

BILLING INSTRUCTIONS

J-6

CONSENT TO SUBCONTRACT CHECKLIST

J-7

SMALL BUSINESS SUBCONTRACTING PLAN

J-8 RESERVED FOR INCORPORATION OF CONTRACTORS ORGANIZATIONAL CONFLICT OF INTEREST CERTIFICATE

J-9

NON-DISCLOSURE STATEMENT

J-10

WORKLOAD DATA

J-11

DIRECTIONS TO CENTRAL OFFICE

J-12

BUSINESS PROPOSAL SPREADSHEET/TEMPLATE

SECTION K – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR QUOTERS K.1 TO BE COMPLETED BY THE OFFEROR [THE REPRESENTATIONS AND CERTIFICATIONS MUST BE EXECUTED BY AN INDIVIDUAL AUTHORIZED TO BIND THE OFFEROR]

K.2

52.204-7 CENTRAL CONTRACTOR REGISTRATION (CCR) (JUL 2006)

K.3

NATIONAL INSTITUTES OF HEALTH (NIH) DATABASE

K.4

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2006)

K.5

52.230-1 COST ACCOUNTING STANDARDS NOTICES AND CERTIFICATION (JUN 2000)

K.6

FINANCIAL INFORMATION

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR QUOTERS

L.1

PROCUREMENT TIMELINE

L.2

FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

L.3 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE AND SMALL BUSINESS STANDARD L.4

FAR 52.215-1 INSTRUCTIONS TO OFFERORS - COMPETITIVE ACQUISITION (JAN 2004)

L.5

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

L.6

FAR 52.233-2 SERVICE OF PROTEST (SEP 1996)

L.7

FEDERAL ACQUISITION REGULATION (FAR) CLAUSES - CONTRACT AWARD

L.8 SMALL, SMALL DISADVANTAGED BUSINESS, VETERAN-OWNED AND DISABLED VETERAN OWNED SMALL BUSINESS, HUBZONE SMALL BUSINESS, AND WOMEN OWNED SMALL BUSINESS SUBCONTRACTING PLAN (This Provision Does Not Apply to Small Business Concerns) L.9

COMMUNICATIONS PRIOR TO CONTRACT AWARD

L.10

GENERAL INSTRUCTIONS

L.11

PROPOSAL ORGANIZATION

L.12

TECHNICAL PROPOSAL INSTRUCTIONS (WRITTEN)

L.13

BUSINESS PROPOSAL INSTRUCTIONS

L.14

CONFLICT OF INTEREST AND COMPLIANCE PROGRAM INSTRUCTIONS

L.15

ORAL PRESENTATIONS

L.16 FAR 52.215-20 ALT I - REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION OTHER THAN COST OR PRICING DATA (OCT 1997)

SECTION M – EVALUATION FACTORS FOR AWARD

M.1

GENERAL PROCEDURES FOR AWARD OF CONTRACTS

M.2 TECHNICAL EVALUATION CRITERIA

M.3

EVALUATION OF BUSINESS PROPOSAL

M.4

FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1

DESCRIPTION OF SERVICES

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.

Due to the complexity of the contract effort called for in the 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. The SOW specifies additional requirements and challenges that the Contractor must meet.

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.

B.2

TYPE OF CONTRACT/PRICE/PAYMENT

CMS anticipates award of a Cost Plus Fixed Fee (CPFF) contract.

Note to Offerors: The identification of the CPFF amounts will be inserted upon award.

B.3

ESTABLISHED COST AND FIXED FEE

The estimated cost of this contract is $TBD. The fixed fee is $TBD. The total Cost Plus Fixed Fee is $TBD.

B.4

HHSAR 352.232-9 WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays’’ or ‘‘Default’’, as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

B.5

TASK DIRECTIVES

The Contracting Officer may use individual Task Directives with specifically defined scopes and schedules to direct the contractor to perform special projects. Task Directives may also be issued to request a special administrative or user support services project. This mechanism will be used on a project-by-project basis and will be incorporated into the contract through the Changes clause (FAR 52.243-2).

Task Directives issued under this contract may be fixed price or cost reimbursement. The contractor is required to establish separate cost accounts for each Task Directive issued and to segregate those costs on their vouchers.

Task Directives SLINS may be used for such things as travel, training, transition or other related costs. Before billing against this SLIN, the Contractor MUST have written approval from the Contracting Officer.

An estimate of $50,000 per year has been provided in the total CPFF column of B.3 ESTABLISHED COST AND FIXED FEE and also in the individual Task Directive SLINs within the Cost Template provided as Attachment J-12. This figure is assumed to include all applicable burdens and fee (please note that fixed fee will not be allowable on potential future travel costs included as part of the Task Directives).

B.6

TRAVEL

An estimated annual dollar amount for Travel has been included in the Cost Template provided as Attachment J-12 under the Summary tab. The figure is assumed to include all applicable burdens. Please note that fixed fee will not be allowable on travel costs. Offerors should determine the split between cost and indirects within their Business Proposal as well as between SLINs for the specific Period of Performance.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1

STATEMENT OF WORK

The Statement of Work is provided under Section J as Attachment J-1 and made a part of this contract.

SECTION D – PACKAGING AND MARKING

D.1

PACKAGING AND MARKING

All deliverables required under this contract must be shipped and marked in accordance with Section F.4. Deliverables and any other requirements are set forth herein.

SECTION E – INSPECTION AND ACCEPTANCE

E.1

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

www.arnet.gov/far/ Federal Acquisition Regulation (FAR) Clauses:

52.246-3

INSPECTION OF SUPPLIES – COST REIMBURSEMENT (MAY 2001)

52.246-5

INSPECTION OF SERVICES – COST REIMBURSEMENT (APR 1984)

E.2 APPROVALS BY THE PROJECT OFFICER tc "E.3 Approvals by the Project Officer " \l 2 All services or supplies to be delivered to the Project Officer will be deemed to have been accepted 60 calendar days after date of delivery, except as otherwise specified in this contract, if written approval or disapproval has not been given within such period. The Project Officer's approval or revision to the services or supplies delivered shall be within the general scope of work stated in this contract.

E.3

INSPECTION OF SERVICES – COST-REIMBURSEMENT

a.

All work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government.

b. The Government's Project Officer is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this contract.

c. Inspection and acceptance of the Contractor's performance shall be in accordance with FAR Clause 52.246-3, “Inspection of Supplies – Cost Reimbursement” and FAR Clause 52.246-5 "Inspection of Services-Cost Reimbursement."

SECTION F – DELIVERIES OR PERFORMANCE

F.1

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

www.arnet.gov/far/ Federal Acquisition Regulation (FAR) Clauses:

52.242-15

STOP WORK ORDER (AUG 1989) ALTERNATE I (APR 1984)

F.2 PERIOD OF PERFORMANCEtc "F.2 PERIOD OF PERFORMANCE (Base Period Only) " \l 2 The work and services hereunder shall be completed as follows:

The period of performance for completion of all work under this contract shall be from the effective date of contract award (assume 06/01/08 for pricing and planning purposes) as follows:

CLIN

DESCRIPTION

PERIOD OF PERFORMANCE

Base Period – Implementation 06/01/08 – 07/31/08

Base Period – Operations

08/01/08 – 05/31/09

Base Period – Task Directives 06/01/08 – 05/31/09

Option Period 1 – Operations

06/01/09 – 05/31/10

Option Period 1 – Task Directives 06/01/09 – 05/31/10

Option Period 2 – Operations

06/01/10 – 05/31/11

Option Period 2 – Task Directives 06/01/10 – 05/31/11

Option Period 3 – Operations

06/01/11 – 05/31/12

Option Period 3 – Task Directives 06/01/11 – 05/31/12

Option Period 4 – Operations

06/01/12 – 05/31/13

Option Period 4 – Task Directives 06/01/12 – 05/31/13

Option Period 4 – Closeout/Trans.

03/01/13 – 05/31/13

F.3

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

a. At the option of the Government, this contract may be extended by the Contracting Officer giving written notice of extension to the contractor prior to the expiration date of this contract; provided, that the Contracting Officer shall have given preliminary notice of the Government's intent to extend not later than 60 days prior to the last day of the term of this contract (such preliminary notice shall not be construed as an exercise of the option, and will not bind the Government to exercise the option). If the Government exercises this option, the contract, as extended, shall be deemed to include this option provision; provided, however, that the total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

b. In the event that the contract is extended, the contractor shall continue the effort described in Section C - Statement of Work during the period immediately following that set forth in Section F.2 entitled "Period of Performance."

PRIVATE

F.4

DELIVERABLES

a. A list of deliverables is provided under Section J, Attachment J-3, attached hereto and made part of this contract.

b. All deliverables required under this contract shall be packaged, marked and shipped in accordance with U.S. Government specifications. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.~f

c. The Contractor shall submit all required deliverables and reports in accordance with the attached schedule. Reports submitted under the contract shall reference and cite the contract number and identify CMS as the sponsoring agency.

d. Satisfactory performance under the contract shall be deemed to occur upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the schedule, Attachment J-3, (reports submitted under the contract shall reference and cite the contract number and identify CMS as the sponsoring agency):

Note: Additional deliverables may be assigned as part of the product planning process.

Individual products may be released on a flow basis, as necessary by the direction of the

Project Officer.

Addressees:

Project Officer:

Centers for Medicare & Medicaid Services

Attn: TBD

Contracting Officer:

Centers for Medicare & Medicaid Services

Office of Acquisition and Grants Management

Division of Medicare Contracts

Attn: TBD

Contract Specialist:

Centers for Medicare & Medicaid Services

Office of Acquisition and Grants Management

Division of Medicare Contracts

Attn: TBD

All electronic files shall be submitted in a format that is compatible with Microsoft Office PC-based software. As this requirement is subject to change, the contractor shall be able to adapt to any new CMS standard in order to submit deliverables. Unless specifically denoted as “workday(s),” all timeframes are in calendar days, calendar weeks, calendar months, etc. after the effective date of the contract.

F.5 HHSAR 352.249-14 EXCUSABLE DELAYS (JAN 2006)

(a) Except with respect to failures of subcontractors, the Contractor shall not be considered to have failed in performance of this contract if such failure arises out of causes beyond the control and without the fault or negligence of the Contractor.

(b) Such causes may include, but are not restricted to, acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Contractor. If the failure to perform is caused by the failure of a subcontractor to perform, and if such failure arises out of causes beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either of them, the Contractor shall not be deemed to have failed in performance of the contract, unless:

(1) The supplies or services to be furnished by the subcontractor were obtainable from other sources,

(2) the Contracting Officer ordered the Contractor in writing to procure such supplies or services from such other sources, and

(3) the Contractor failed to comply with such order.

Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of such failure and if the Contracting Officer determines that any failure to perform was caused by circumstances beyond the control and without the fault or negligence of the Contractor, the delivery schedule shall be revised accordingly, subject to the rights of the Government under the termination clause contained in this contract. (As used in this clause, the terms ‘‘subcontractor’’ and ‘‘subcontractors’’ mean subcontractor(s) at any tier.)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1

ACCOUNTING AND APPROPRIATION DATA

To be incorporated at time of award

G.2

PAYMENT, SELECTED ITEMS OF COST REIMBURSEMENT CONTRACTS

1. Travel Costs (Including Foreign Travel)

The Contractor shall be reimbursed for travel costs in accordance with FAR 31.205-46.

2. Per Diem

Expenses for subsistence and lodging shall be reimbursed to the Contractor only to the extent where overnight stay is necessary for performance under this contract. Incurred costs shall be considered to be reasonable and allowable only to the extent that they do not exceed, on a daily basis, the maximum per diem rates in effect at the time of travel as set forth in the Federal Travel Regulations. See FAR 31.205-46(2).

3. Cost of Materials

The cost of materials furnished or used under this contract shall be reimbursed in accordance with paragraph (b) of the clause entitled "Allowable Cost and Payment (FAR 52.216-7 DEC 2002)" for cost reimbursement contracts. Expendable material costs for items such as office supplies, report paper, etc., and tools of the trade shall be priced in accordance with the Contractor’s approved accounting practices or standards, as applicable. The Contractor shall be required to support all material costs claimed.

4. Relocation Costs

In accordance with FAR 31.205-35, relocation costs, either direct charged or included in the contractor's indirect cost pools, associated with an individual not completing a term of service equal to one year working under this contract shall be an unallowable cost under this contract.

ADVANCE \d12G.3

DISSEMINATION, PUBLICATION & DISTRIBUTION OF INFORMATION

(a) Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the contractor's right to use data or information obtained from a non-restrictive source. Any questions concerning "privileged information" shall be referred to the Contracting Officer.

(b) Some data or information may require special consideration with regard to the timing of its disclosure so that preliminary findings which could create erroneous conclusions are not stipulated. Also, some data or information, which relate to policy matters under consideration by the Government, may also require special consideration with regard to the timing of its disclosure so that the open and vigorous debate, within the government, of possible policy options is not damaged.

(c) Any questions about use or release of the data or information or handling of material under this contract shall be referred to the Contracting Officer who must render a written determination. The Contracting Officer's determinations will reflect the results of internal coordination with appropriate program and legal officials.

(d) Written advance notice of at least forty-five (45) days shall be provided to the Contracting Officer of the Contractor's desire to release findings of studies or research or data or information described above. If the Contractor disagrees with the Contracting Officer's determination, and if this disagreement cannot be settled by the Contractor and the Contracting Officer in a mutually satisfactory manner, then the issue will be settled pursuant to the "Disputes" clause.

(e) Any presentation of any report, statistical or analytical material based on information obtained from this contract shall be subject to review by the Project Officer before dissemination, publication, or distribution. Presentation includes, but is not limited to, papers, articles, professional publications, speeches, testimony or interviews with public print or broadcast media. This does not apply to information that is requested pursuant to the Federal Freedom of Information Act.

(f) The Project Officer review shall cover accuracy, content, manner of presentation of the information, and also the protection of the privacy of individuals. If the review finds that the Privacy Act is or may be violated, the release/use of the presentation shall be denied until the offending material is removed or until the Contracting Officer makes a formal determination, in writing, that the privacy of individuals is not being violated.

(g) If the review shows that the accuracy, content, or manner of presentation is not correct or is inappropriate in the light of the purpose of the project, the Project Officer shall immediately inform the Contractor, in writing, of the nature of the problem. If the Contractor disagrees, the Project Officer may insist that the presentation contain, in a manner of equal importance, materials, which show the government's problem with the presentation.

(h) The Contractor agrees to acknowledge support by CMS whenever reports of projects funded, in whole or in part, by this contract are published in any medium. The Contractor shall include in any publication resulting from work under this contract, an acknowledgment substantially, as follows:

"The analyses upon which this publication is based were performed under Contract Number _______________________, entitled, _______________________________,”

Sponsored by the Centers for Medicare & Medicaid Services, Department of Health & Human Services."

Any deviation from the above legend shall be approved, in writing, by the Contracting Officer.

G.4 SUBCONTRACTING REPORTING (Only for Large Business Contractors)

If applicable, the Contractor shall report all subcontract awards to small, small disadvantaged, women-owned, HUBZones, veteran-owned and service-disabled veteran-owned small business concerns. The reports shall be prepared using the electronic Subcontracting Reporting System (eSRS) via the internet at http://www.esrs.gov. The Individual Subcontracting Report (ISR), formerly SF294, shall be submitted semi-annually for the periods of October 1 through March 31 and April 1 through September 30. The Summary Subcontracting Report (SSR), formerly, SF 295 shall be submitted annually for the period of October 1 through September 30.

The report(s) shall be delivered not more than thirty (30) calendar days following the close of each period covered.

G.5 SUBCONTRACTING PROGRAM FOR SMALL AND SMALL DISADVANTAGED BUSINESSES (Only for Large Business)

If applicable, the contractor hereby agrees to implement the conditions of the subcontracting plan submitted and approved by the Contracting Officer for this contract. The Small Business and Small Disadvantaged Business Subcontracting Plan is hereby incorporated and made a part hereof as Attachment J-7 of this contract.

G.6

SMALL DISADVANTAGED BUSINESS PARTICIPATION

In accordance with FAR 19.1202-4, when using Small Disadvantaged Business (SDB) participation as a factor that considers the extent to which SDB concerns are specifically identified, the SDB concerns considered in the evaluation shall be listed in the contract. The contractor shall notify the Contracting Officer of any substitutions of these firms. The following small disadvantaged businesses have been identified:

TBD (to be filled in at contract award) G.7

SUBCONTRACT CONSENT

(a) To facilitate the review of a proposed subcontract by the Project Officer and the Contracting Officer, the Contractor shall submit the information required by the FAR Clause 52.244-2 (JUN 2007) entitled, "Subcontracts" to the Contracting Officer. The Contracting Officer shall review the request for subcontract approval and the Project Officer's recommendation and advise the Contractor of his/her decision to consent to or dissent from the proposed subcontract, in writing.

(b) Consent is hereby given to issue the following subcontract(s):

TBD

G.8

SERVICE OF CONSULTANTS/ SUBCONTRACTORS

a. For the purposes of this contract, consultants are considered subcontractors.

b. The Contractor shall follow the procedures established in the following Federal Acquisition Regulation (FAR) clauses when requesting Contracting Officer consent to subcontract for Consultants and/or other subcontracts:

Federal Acquisition Regulation (FAR) Clauses:

52.244-2

Subcontracts (JUN 2007)

52.244-5

Competition in Subcontracting (DEC 1996)

52.244-6

Subcontracts for Commercial Items and Commercial Components

(MAR 2007)

G.9

CONTRACTING OFFICER RESPONSIBILITY

In accordance with FAR 52.201-1 Definitions, the term ‘Contracting Officer’ means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the Contracting Officer acting within the limits of their authority delegated by the Contracting Officer.

Notwithstanding any of the other provisions of this Contract, the Contracting Officer shall be the ONLY individual authorized to:

a. Enter into and commit/bind the Government by contract for supplies or services;

b. Accept nonconforming work or waive any requirement of this Contract;

c. Authorize reimbursement to the Contractor for any costs incurred during the performance of the Contract, and

d. Modify any term or condition of this Contract, i.e., make any changes in the Statement of Work; modify/extend the period of performance; change the delivery schedule.

G.10

CONTRACTOR PDAC PROGRAM DIRECTOR

(TBD – to be supplied by contractor) will serve as PDAC Program Director. It will be his/her responsibility to obtain the staff necessary and to direct the work for the conduct of this project. The PDAC Program Director shall also keep the Government Project Officer up to date regarding all technical, cost and schedule-related issues. The Government reserves the right to approve any necessary successor to be designated as PDAC Program Director.

G.11 PROJECT OFFICER tc "G.8 Project Officer " \l 2

(a) The following Project Officer(s) will represent the Government for the purpose of this contract:

[Provided Upon Award]

(b) The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; (6) providing technical direction in accordance with Section G.12; and (7) reviewing of invoices/vouchers.

(c) The Project Officer does not have the authority to act as an agent of the Government under this contract. Only the Contracting Officer has the authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

(d) The Government may unilaterally change its Project Officer designation.

(e) The Project Officer may be assisted by Business Function Leads (BFL). The BFLs will not have the authority to provide technical direction in accordance with Section G.12, however, they may be responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6)reviewing of invoices/vouchers.

G.12

TECHNICAL DIRECTION

(a) Performance of the work under this contract shall be subject to the technical direction of the Project Officer. The term "technical direction" is defined to include, without limitation, the following:

(1) Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

(2) Provision of information to the Contractor, which assists in the interpretation of drawings, specifications, or technical portions of the work description.

(3) Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

(b) Technical direction must be within the general Scope of Work stated in the contract. The Project Officer does not have the authority to and may not issue any technical directions which:

(1) Constitutes an assignment of additional work outside the general Scope of Work of the contract.

(2) Constitutes a change as defined in the contract clause entitled "Changes - Cost Reimbursement."

(3) In any manner causes an increase or decrease in the total estimated contract cost, fixed-fee, or the time required for contract performance.

(4) Change any of the expressed terms, conditions, or specifications of the contract.

(c) All technical direction shall be issued in writing by the Project Officer or shall be confirmed by him/her in writing within five working days after issuance.

(d) The Contractor shall proceed promptly with the performance of technical direction duly issued by the Project Officer in the manner prescribed by this article and within his/her authority under the provisions of this article.

(e) If, in the opinion of the Contractor, any instruction or direction issued by the Project Officer is within one of the categories as defined in (l) through (4) above, the Contractor shall notify the Contracting Officer in accordance with FAR 52.243-7, Notification of Changes.

G.13 DESIGNATION OF PROPERTY ADMINISTRATOR tc "G.7 Designation of Property Administrator " \l 2 The CMS Property Administrator, Administrative Services Group, Office of Property and Space Management at (410) 786-6462, is hereby designated the property administration function for this contract. The Contractor agrees to furnish information regarding Government Property to the Property Administrator in the manner and to the extent required by the Property Administrator, his duly designated successors, and in accordance with FAR Part 45 and Department of Health & Human Services (DHHS) Manual entitled, Contractor's Guide for Control of Government Property, (1990). This manual may be accessed at http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm G.14

GOVERNMENT FURNISHED PROPERTY

Pursuant to FAR Part 45 – Government Property and FAR clause 52.245-1, Government Property (JUN 2007), of this contract, the Government will furnish for performance of the work required herein a list of property, which is provided under Section J, Attachment J-2, and is hereby made part of this contract.

G.15

CONTRACTOR FURNISHED PROPERTY

Offerors shall provide a list of Contractor Furnished Property they plan on using to complete the requirements of the contract.

G.16 INVOICING AND PAYMENT (See Attachment J-5 for Billing Instructions) The Contractor shall report data in accordance with the format described in the cost proposal instructions. Please also refer to Section J, Attachment J-12 – Business Proposal Spreadsheet/Template.

Submission of invoices for payment:

1. Once each month following the effective date of this contract, the Contractor may submit to the Government an invoice for payment, in accordance with FAR clause 52.216-7 “Allowable Cost & Payment.” The Government shall make provisional payments on all invoices pending the completion of a final audit of the Contractor’s cost records.

2. To expedite payment, invoices shall be prepared and submitted as follows:

--Original and four (4) copies shall be submitted to the address below:

Department of Health & Human Services

Centers for Medicare & Medicaid Services

OFM/Division of Accounting Operations

P.O. Box 7520

7500 Security Boulevard

Baltimore, MD 21207-0520

--For overnight delivery:

Department of Health & Human Services

OFM/Division of Accounting Operations

7500 Security Boulevard/Mailstop: C3-11-03

Baltimore, MD 21244-1850

--One (1) copy shall be sent to the Project Officer.

3. Content of invoice:

--Contractor’s name and invoice date;

--Contract number or other authorization for delivery of property and/or services;

--Description, CLIN, cost or price and quantity of property and/or services actually delivered or rendered, breakout of hours incurred by labor category;

--Shipping and payment terms;

--Other substantiating documentation or information as required by the contract;

--Name, title, phone number and complete mailing address of responsible official to whom payment is to be sent;

--Taxpayer Identification Number; and

--Period of performance or delivery date of goods or services provided.

4. Invoice payment

Reimbursement for invoices submitted under this contract shall be made not later than thirty (30) days after receipt of the original invoice from the Contractor in the copies requested at the paying office designated above.

Payment will be authorized after the Division of Accounting has received a certification of the invoice by the Project Officer and verification that the invoice amount is consistent with the schedule set forth under Section B of this contract. Any discrepancies determined as a result of the audit could delay the processing of the invoice and may result in the invoice being returned to the Contractor for corrections. Inquiries relating to payments should be directed to the Office of Financial Management/Accounting Management Group, ATTN: Janet Kahler on (410) 786-5427 or Suzanne Turgeon on (410) 786-1924.

5. Interest on overdue payment

The Prompt Payment Act, Public Law 97-177 (96 Stat.85.31 U.S.C. 1801) and FAR 52.232-25 Prompt Payment (OCT 2003), is applicable to payments under this contract and requires the payment of interest on payments made more than 30 days after receipt of an invoice by the Division of Accounting Operations, pursuant to FAR 32.907.

Determinations of interest due will be made in accordance with the provisions of the Prompt Payment Act and Office of Management and Budget Circular A-125.

tc \l1 "G.2

INVOICING AND PAYMENT

G.17 METHOD OF PAYMENT tc \l1 "G.3

METHOD OF PAYMENT

In accordance with FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration (OCT 2003),, the Centers for Medicare & Medicaid Services (CMS) shall only make an electronic reimbursement/payment.

In accordance with FAR 52.204-7, Central Contractor Registration (JUL 2006), the contractor must register in the Central Contractor Registration (CCR) database.

The contractor shall notify CMS’ Division of Accounting Operations of all EFT and address changes in CCR via the following email address: CCRChanges@cms.hhs.gov G.18

CORRESPONDENCE PROCEDURES

To promote timely and effective administration, correspondence (except for invoices), submitted under this contact shall be subject to the following procedures:

(a) Technical Correspondence - Technical correspondence (as used herein, this term excludes correspondence which proposes or otherwise involves waivers, deviations or modifications to the requirements, terms or conditions of this contract) shall be addressed to the Project Officer/Government Task Lead (GTL) with an informational copy of the basic correspondence to the Contracting Officer.

(b) Other Correspondence - All other correspondence shall be addressed to the Contracting Officer with an informational copy of the basic correspondence to the Project Officer/GTL.

(c) Subject Lines - All correspondence shall contain a subject line, commencing with the contract number and assigning consecutive numbers (serial numbers to permit accountability), as illustrated below:

EXAMPLE:

Contract No. - 500-00-XXXX

Sequence # - XX (YEAR) - XXXX

Subject - Request for Subcontract Consent

G.19

DATA TO BE DELIVERED

Any working papers, interim reports, data given by the Government or first produced by the Contractor under the contract or collected or otherwise obtained by the Contractor under the contract, or results obtained or developed by the Contractor (subcontractor or consultants) pursuant to the fulfillment of this contract are to be delivered, documented, and formatted as directed by the Contracting Officer.

In addition, information and/or data, which are held by the Contractor related to the operation of their business and/or institution and which are obtained without the use of Federal funds, shall be considered "PROPRIETARY DATA" and are not "subject data" to be delivered under this contract.

tc " SECTION G - CONTRACT ADMINISTRATION DATA " G.20 WORKING PAPERS tc \l1 "G.9

WORKING PAPERS

The Contractor shall provide, at the request of the Contracting Officer, all the working papers used by the participating officials and employees of the Contractor in connection with all work undertaken pursuant to the contract.

G.21

INDIRECT COST RATES – PROVISIONAL AND FINAL

a. Pursuant to the provisions of FAR 52.216-7 entitled "Allowable Cost & Payment (DEC 2002)," in Section I of this contract, the allowable Indirect Costs under this contract shall be obtained by applying the final rates or rates negotiated to the appropriate bases. The period or periods for which such rates will be established shall correspond to the Contractor's fiscal year(s). The final rate proposal is to be submitted to the Contracting Officer.

In the event that the final rate proposal is submitted to the cognizant audit agency, the Contractor shall advise the Contracting Officer in writing when and to whom it was submitted.

b. Pending establishment of final rates for any period, provisional reimbursement will be made on the basis of the provisional rates shown below. To prevent substantial over or under payment, and to apply either retroactively or prospectively, provisional rates may, at the request of either party, be revised by mutual agreement. The Government will execute a contract modification upon receipt of DCAA’s or the audit agency’s indirect rate audit to incorporate the negotiated indirect rates. In the event the final indirect cost rates are less than the provisional rates, retroactive adjustments to both the applicable costs and award fee shall be made at the time of contract modification. The Government shall not be obligated to pay any additional amount should the final indirect cost rates exceed the negotiated ceilings stated below. In the event the audit determined final indirect cost rates are less than the original negotiated ceiling rates, the negotiated rates will be reduced to conform to the lower rates.

Type

Cost Center Provisional Rate Ceiling Rate Base Period

Provisional

(a)

(b)

(c)

(d)

(Letters a through d will describe the contractor’s rate build up. We will populate this information prior to award):

(a) applies to total ;

(b) applies to total ;

(c) applies to total ;

(d) applies to total ;

* TBD at time of contract award (The above categories will be populated prior to award).

c. Reimbursement will be limited to the negotiated indirect cost ceilings established in the contract and the contractor’s final rates are hereby limited to the negotiated indirect cost ceiling(s) stated above. The Government has no obligation to pay any additional amount to the contractor should the final indirect cost rates exceed the negotiated ceilings as stated in the contract.

d. In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7(d)(2), Allowable Cost and Payment incorporated by reference in this contract in Part II, Section I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified below:

Director, Division of Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6100 Building, Room 6B05

6100 Executive Blvd. MSC-7540

Bethesda, MD. 20892-7540

The period or periods for which such rates will be established shall correspond to the contractor’s fiscal year(s). The final rate proposal shall also be submitted to the Contracting Officer at:

Office of Acquisition and Grants Management

Attn: Kathy Markman, M/S C2-21-15

7500 Security Boulevard

Baltimore, MD 21244-1850

G.22

USE OF GOVERNMENT DATA (REPORTS/FILES/COMPUTER TAPES OR DISCS)

Any data given to the contractor by the Government shall be used only for the performance of the contract unless the Contracting Officer specifically permits another use, in writing. Should the Contracting Officer permit the contractor the use of Government-supplied data for a purpose other than solely for performance of this contract and if such use could result in a commercially viable product, the Contracting Officer and the contractor must negotiate a financial benefit to the Government. This benefit should most often be in the form of a reduction in the price of the contract; however, the Contracting Officer may negotiate any other benefits he/she determines are adequate compensation for the use of these data.

Upon the request of the Contracting Officer or the expiration date of this contract, whichever shall come first, the contractor shall, upon instructions from the Contracting Officer, return or destroy all data given to the contractor by the Government. However, the Contracting Officer may direct that the data be retained by the contractor for a specific period of time, which period shall be subject to agreement by the contractor. Whether the data are returned, retained, or destroyed shall be the decision of the Contracting Officer with the exception that the contractor may refuse to retain the data. The contractor shall retain no data, copies of data, or parts thereof, in any form, when the Contracting Officer directs that the data be returned or destroyed. If the data are to be destroyed, the contractor shall directly furnish evidence of such destruction in a form the Contracting Officer shall determine is adequate. (See also Attachment J-1, Statement of Work, Section C.2).

G.23 HHSAR 352.270-5 KEY PERSONNEL (JAN 2006) tc "H.2 352.270-5 Key personnel. (APR 1984) " \l 2

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

All proposed substitutions must be submitted, in writing, to CMS at least thirty (30) days prior to the proposed substitution or as soon as reasonably known. Each request shall provide a detailed explanation of the circumstances necessitating the proposed substitution, a complete resume and any other information required by CMS. All proposed substitutions must have qualifications equal to or greater than the person(s) being replaced.

When key personnel positions are vacated due to unforeseen circumstances, a proposed replacement shall be submitted in writing for approval no later than 30 calendar days from the date the position was vacated. Interim replacements should be identified when a permanent replacement cannot be identified within this time frame. The Centers for Medicare & Medicaid Services (CMS) may consider a 60-day interim replacement until a permanent replacement is secured.

The following individuals are considered “key” under this contract:

TO BE COMPLETED AT TIME OF AWARD

PDAC Program Director

PDAC Medical Director

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 HHSAR 352.224-70 CONFIDENTIALITY OF INFORMATION (JAN 2006) tc "H.4 352.224-70 Confidentiality of information. (APR 1984) " \l 2

(a) Confidential information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the ‘‘Disputes’’ clause.

(c) If it is established elsewhere in this…