CCSQ-393-2017-0081_SOW.docx

STATEMENT OF WORK (SOW)

Acquisition of Data from a Lung Cancer Screening Registry to Document Compliance with Eligibility Criteria in the Medicare National Coverage Determination (NCD) for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) 1/04/16

I. Background Medicare Part B covers lung cancer screening with low dose computed tomography (LDCT) for Medicare beneficiaries that meet specified criteria described in the Medicare National Coverage Determination (NCD). (See: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274). The primary purpose for requiring the submission of data to the registry is to document compliance with the coverage criteria in the NCD that are not evidenced on the health care claim. As a condition of coverage, the Centers for Medicare & Medicaid Services (CMS) requires that certain data elements be submitted to a CMS-approved registry.

A. Purpose

The purpose of this SOW is to collect and provide CMS the data it needs to determine whether lung cancer LDCT screenings performed are in compliance with the NCD coverage criteria described in the NCD (See: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274).

II. Requirements 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 requirements of this Statement of Work.

A. Requirements/Tasks to be Performed

1. The Contractor shall submit to CMS a set of data elements (see Table 1) for every Medicare patient receiving lung cancer screening with LDCT. The data shall be in a machine-readable format with one record containing the variables specified below per patient, per screening.

2. The contractor shall submit to CMS a description of data security measures and HIPAA compliance.

3. The contractor shall keep CMS apprised of changes in methods and any other issues that may affect acquisition of the data described in this SOW.

4. The contractor shall schedule a meeting or teleconference with the CMS Contracting Officer Representative (COR) at the start of the contract.

5. Every data submission from the contractor shall be accompanied by an explanatory email.

6. There shall be qualified scientific oversight. Individuals with appropriate clinical, scientific and technical expertise will oversee all aspects of the registry data collection.

7. The data collection shall be pre-tested, validated and checked for reliability.

8. All those involved in the data collection shall be trained commensurate with their roles. There shall be appropriate data auditing.

9. The data collection shall be designed to minimize burdens to providers and patients.

10. The hypotheses, methods, data sources, data elements, quality assurance, error rates and limitations shall be available to the public.

11. The information collected shall be in accordance with any and all applicable privacy and security policies and requirements.

Table 1: Data Elements Required for Payment for Lung Cancer Screening with Low Dose Computed Tomography (LDCT)

Eligible radiology imaging facilities are required to collect and submit the following data elements to a CMS-approved registry for each lung cancer screening with LDCT performed.

If former smoker, years since quitting.

Pack-years as reported by the ordering practitioner.

For current smokers, smoking cessation interventions available.

Initial screen or subsequent screen

B. Report Requirements

See attached Schedule of Deliverables.

C. Period of Performance The period of performance is based on the delivery of one year of lung cancer LDCT screening data. The start date for the contract is March 1, 2017. The period of performance is based on receiving data for lung cancer LDCT screenings on and after the dates of service beginning November 1, 2016. In order to clean and verify data, a 6-month lag time is required for accumulating each data set. Therefore, the first set data (November 1, 2016 through January 31, 2017) will be delivered by May 1, 2017.

Accordingly, the second data set (February 1, 2017 through October 31, 2017) will be delivered by February 15, 2018. Thus, the period of performance is from date of award through the last data delivery on February 15, 2018.

D. Government Property Not applicable E. Level of Effort or Key Personnel Requirements This contract is for purchase of data and not for payment for the service to collect the minimum set of data.

III. Quality Assurance The Contractor shall demonstrate the following qualifications to be considered a qualifying Lung Cancer prospective clinical study:

1. The contractor must meet the criteria for CMS-approved registries set forth in the NCD (see http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274).

2. The data elements provided by the contractor shall be consistent with the specifications in the NCD (see http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274) and CMS claims payment criteria.

3. The contractor shall demonstrate expertise in data accuracy, and maintenance.

IV. References Final National Coverage Determination for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274.

V. Contact Information

COR

Michelle Atkinson Centers for Medicare & Medicaid Services Center of Clinical Standards and Quality 7500 Security Blvd., Mailstop S3-02-01 Baltimore, MD 21244-1850 Phone: 410-786-2881 Fax: 410-786-9286 E-mail: michelle.atkinson@cms.hhs.gov

Data Officer Dan Babish Centers for Medicare & Medicaid Services Center of Clinical Standards and Quality 7500 Security Blvd., Mailstop S3-02-01 Baltimore, MD 21244-1850 Phone: 410-786-6607 Fax: 410-786-9286 E-mail: daniel.babish@cms.hhs.gov

GTL

Linda Gousis Centers for Medicare & Medicaid Services Center of Clinical Standards and Quality 7500 Security Blvd., Mailstop S3-02-01 Baltimore, MD 21244-1850 Phone: 410-786-8616 Fax: 410-786-9286 E-mail: linda.gousis@cms.hhs.gov

Contracting Officer Lucille Lee Centers for Medicare & Medicaid Services Office of Acquisitions and Grant Management 7500 Security Blvd., Mailstop C2-21-15 Baltimore, MD 21244-1850 Phone: 410-786-5447 E-mail: lucille.lee@cms.hhs.gov

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