J-and-A-Other-Than-Full-and-Open.pdf

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Attached to
NCQA Technical Assistance Federal contract opportunity
Solicitation number
230601
Issued by
Department of Health and Human Services Centers for Medicare and Medicaid Services

About this file

This document is a justification and approval for other than full and open competition. It details a proposed sole source contract award to the National Committee for Quality Assurance to provide technical assistance services to ensure appropriate use of non-electronic clinical quality measures in Center for Medicare and Medicaid Innovation models. The proposed five-year, firm-fixed price contract would support up to 100 quality measures annually being used to assess quality of care and evaluation activities in various Innovation Center models. As the owner and steward of the Healthcare Effectiveness Data and Information Set measures, NCQA is the only organization authorized to approve use and adjustments of its measures, provide technical specifications, and respond to inquiries regarding submission and calculation of the measures. The Department of Health and Human Services Centers for Medicare and Medicaid Services proposes this sole source award under the authority of FAR 6.302-1(b)(2) based on NCQA's exclusive licensing rights to the measures.

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JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-11#FAR_11_105 https://www.acquisition.gov/far/part-6#FAR_6_302_2 https://www.acquisition.gov/far/part-6#FAR_6_302_5

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

Modificationto Existing Purchase OrderContract Number:
Other: Firmed Fixed Price per deliverable 5-year, non-severable
Other Funds:
Name: Chautae Williamson
Position Title: Contracting Officer Representative
Email address: Chautae.Williamson@cms.hhs.gov
Phone: 410-786-2735
Name_2: Susannah Bernheim
Position Title_2: Physician/Chief Quality Officer
Email address_2: susannah.bernheim@cms.hhs.gov
Date: 4/13/2023
Phone_2: 410-786-4170
Date_2: 05/18/2023
Phone_3: 410-786-4170
Date_3: 05/18/2023
Name_3: Donald H. Knode, Jr.
Phone_4: 443-938-3812
Date_4: 5/25/2023
Name_4:
Phone_5:
Date_5:
Name_5:
Phone_6:
Date_6:
Name_6:
Phone_7:
Date_7:
Name_7:
Phone_8:
Date_8:
Text51: NCQA Technical Assistance
Text52: Chautae Williamson, COR
Text53: FY2023
Dropdown54: [CMS]
Check Box55: Yes
Check Box56: Off
Check Box57: Off
Check Box58: Yes
Check Box59: Off
Check Box60: Off
Check Box61: Off
Check Box62: Off
Text63: The National Committee for Quality Assurance (NCQA)
Text64: 1100 13th St., Third Floor
Text65: Washington, DC 20005
Check Box66: Yes
Check Box67: Off
Text68: 2,824,098
Text69: The purpose of this proposed contract action is to acquire technical assistance to ensure the appropriate use of non-Electronic Clinical Data Set (ECDS) quality measures from the National Committee for Quality Assurance (NCQA) in the Center for Medicare and Medicaid Innovation (Innovation Center) models. The Innovation Center models use quality measures to assess quality of care and support monitoring and evaluation activities. The quality measures may be used as specified by the measure owner, or re-specified to fit the specifics of a model within NCQA’s rules for appropriate use . For each quality measure, model-specific measure specifications must be created and posted online (publicly) for model participants, Innovation Center staff, and support Contractors. Under this contract, technical assistance shall be provided to ensure the appropriate use of NCQA measures on a per measure basis in new and existing models in each performance year. It is estimated that 80 measures will be in use on average annually and up to 100 measures at any one time. If a non-ECDS measure is converted to an ECDS measure, then CMMI shall continue to use the non-ECDS measure under the terms of this SOW for any such converted measure for the life of every CMMI model using the measure that has been converted. This is a firm fixed price per deliverable, 5-year period of performance, non-severable contract award.
Text70:

NCQA owns the proprietary rights to the system that collects HEDIS® data, and exclusive licensing rights, and is the only organization authorized to add measurement specifications and to provide technical assistance to health plans and auditors to ensure the appropriate use of NCQA measures. Since NCQA develops the measures and makes all of the updates to HEDIS®, it is the only qualified entity capable of and authorized to provide the needed technical assistance to organizations that use HEDIS and NCQA measures. This does not mean CMS or CMMI is required to use quality measures stewarded by NCQA. Before a model is approved in CMMI, extensive research and review is done, which could include selection of quality measures as part of the model’s quality strategy. Quality measures, regardless of the measure steward, are evaluated based on appropriateness and how they will impact the quality improvement and goals of the model. If the model determines a NCQA quality measure should be selected as part of the quality strategy, then NCQA is the only source that can provide permission to use and the required services.

As the organization that maintains and evolves HEDIS®, NCQA is the only source for this activity. In 1993, NCQA released HEDIS 2.0 that has become the “industry standard” performance measurement set. Originally designed for private employers' needs as purchasers of healthcare, HEDIS® has been adapted for use by public purchasers, government compliance monitors, and managed care consumers. HEDIS data submission tools and detailed technical specifications are developed and maintained by NCQA.

Please note, that while NCQA will be adding ECDS reporting standard to existing HEDIS measures, the Innovation Center will be speaking with NCQA about whether or not the use of non-ECDS measures used in Models may continue to be used even when/if a non-ECDS measure is converted to ECDS. If NCQA determines that the ECDS measure has to be used, the use of that measure will be covered under the enterprise ECDS Measure Access and Technical Support sole source contract to be awarded by CCSQ.

NCQA is adding the ECDS reporting standard to existing HEDIS® measures for voluntary reporting alongside their traditional counterparts. This allows health plans to assess their ECDS reporting capabilities using familiar measures. Based on reporting results to date and stakeholder feedback, NCQA is moving forward with transitioning the Breast Cancer Screening (BCS) and Colorectal Cancer Screening (COL) measures to ECDS only reporting. BCS will be transitioned for Measurement Year 2023 and COL will be transitioned for Measurement Year 2024. The Innovation Center currently uses both of these measures in their Models.

Text71:
Check Box72: Yes
Check Box73: Off
Check Box74: Off
Check Box75: Off
Text76:
Text77:
Text78:
Text79: Market research determined that NCQA is the sole source for HEDIS® measures based on the proprietary nature for these quality measures that CMMI needs for models. It was confirmed there are no other alternatives through market research, though CMMI can choose to engage in the costly and time-consuming process of developing quality measures on its own or use measures from other stewards, which also requires permission and licensing agreements from those entities.
Text80: N/A
Text81: This action will not be competed. FAR 6.302-1(b)(2) authorizes application of a contract to one sole source based on the existence of limited rights in data, so CMS has determined that, for the reasons previously cited, only NCQA has licensing rights and necessary capabilities to successfully perform this work.
Check Box82: Off
Check Box83: Yes
Text84: This action will not be competed. FAR 6.302-1(b)(2) authorizes application of a contract to one sole source based on the existence of limited rights in data, so CMS has determined that, for the reasons previously cited, only NCQA has the licensing rights and necessary capabilities to successfully perform this work. In other words, because this acquisition is a sole-source to an organization that owns the intellectual property associated with the quality measures the Innovation Center seeks to use, market research with other sources is not applicable.
Text85: None
Text86: FAR 6.302-1 (b)(2) authorizes application of a contract to one sole source based on the existence of limited rights in data, so it was

determined by CMS that only NCQA has the necessary capability to successfully perform this work.

Text87: NCQA has developed, continually updated, and annually collected the HEDIS® performance measurement set for CMS for 17 years. Since 1997, NCQA has been collecting Medicare, Medicaid and commercial HEDIS® results annually from health plans on a nationwide basis. The acronym “HEDIS®” is a registered trademark of NCQA, and is a brand name for a set of quality performance measures widely used in managed care. It is essential for the Innovation Center to award this contract non-competitively to NCQA for the continued use of their measures in current and future model tests. As the industry leader in quality assessment and reporting for managed care organizations and the only organization with licensing rights to its measures, NCQA is uniquely situated to provide this continued service to CMS.

HEDIS® Measures Development & Technical Specifications Since NCQA possesses the HEDIS® trademark, only NCQA can approve the addition, deletion, or modification of their measure specifications.

NCQA is the only organization that can ensure that new measures and annual updates to the HEDIS® specifications are accurately and consistently incorporated into the HEDIS® data collection process.

HEDIS® Calculation For managed care performance data to be officially considered and legally called “HEDIS®,” the data must be:

1) Collected using HEDIS® Volume 2 technical specifications;

2) Annually audited by an NCQA certified HEDIS® auditor according to uniform criteria; and

3) Submitted according to schedule to NCQA for centralized calculation.

NCQA only uses official HEDIS® data in its accreditation scoring and in its information products. NCQA occupies a unique position regarding the development and collection of performance measures for health care organizations.

Technical Support Integration The successful collection of HEDIS® data requires a coordinated effort between NCQA units responsible for measure development, measure and technical specification maintenance, and the data collection process. As the organization that owns, maintains and updates HEDIS® measures, NCQA is the only organization to have successfully developed and implemented health plan performance measures on a As the stewards of HEDIS®, only NCQA is able to develop new HEDIS® measures and replace outdated measures, and address technical inquiries about the HEDIS® specifications. Moreover, NCQA is the only organization in a position to ensure that new measures and annual updates to the HEDIS® specifications are accurately and consistently incorporated into the HEDIS® data collection process.

Technical Support As the Innovation Center will be using NCQA's HEDIS measures in their Model tests as appropriate, Innovation Center Model teams may adjust their measure specifications within or outside NCQA's allowable adjustments. As part of NCQA's support, based on the adjustment(s) a CMMI model team may wish to make a measure specification, NCQA's approval is required. Once a measure is approved for use in a model, it will likely need to be used for the life of a model (usually a minimum of 5 years in length). Additionally, as part of NCQA's support, they will provide and post online measure specifications for use by model participants, other model support contractors and Innovation Center staff/model teams. At a minimum, NCQA will provide measure specifications annually. Under this contract, NCQA will also provide their annual HEDIS Manual.

NCQA will also provide support on technical inquiries from the model teams, and model support contractors, and submitted by model participants to model teams. This support is interdependent because questions about HEDIS® technical specifications and technical specifications as applicable to measures modified for use in Innovation Center models submission activities. This interdependence is crucial for collecting HEDIS® accurately Real and Perceived Data Validity and Legitimacy The Innovation Center uses this data in publicly reported information products and therefore discrepancies are unacceptable as they would result in widespread confusion among health care organizations and beneficiaries. Because of the publication of model data associated with the use of the NCQA measures, NCQA support and approval of the use of a measure, in the manner specified that the Innovation Center requires to use the measure, is required.

2023-04-13T10:11:16-0400
Susannah Bernheim
Text89: Richard Asher
Text90: Richard Asher
2023-05-18T08:40:36-0400
Richard B. Asher Jr -S
2023-05-18T08:41:24-0400
Richard B. Asher Jr -S
Text93:
2023-05-25T07:45:20-0400
Donald Knode -S
Check Box96: Off
Check Box97: Off
Check Box98: Off
Check Box99: Off
Text102:
Text103:
Text105:
Text1:

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