SAM_JA Exception to Fair Opportunity FFSDCS_Final.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

Acquisition Title: Fee For Service Data Collection System Bridge Contract (FFSDCS Bridge) – Extension Modification Agency: CMS Acquisition Year: 2025 Author: Gregory Snyder, Contract Specialist, and Charlie Brewer, Health Insurance Specialist

1. Description of Action:

A. Nature ☐ New Requirement ☐ Follow-On Order ☒ Modification of Existing Purchase Order / Contract Number: HHSM-500-2016-

00028I/75FCMC24F0223

B. Order Against

HHSM-500-2016-00028I Multiple Award IDIQ Contract Strategic Partners Acquisition Readiness Contract (SPARC)

C. Contract Type ☒ Firm-Fixed Price ☐ Time and Materials ☐ Cost Plus Fixed Fee (CPFF)

☐ Term ☐ Completion

☐ Cost Plus Award Fee (CPAF) ☐ Other:

D. Projected Cost / Price of contract (Base & All Options): CMS is requesting to increase the original/negotiated costs of $6,137,425 by $6,000,000 to a total of $12,137,425.

E. The total estimated value of the proposed sole source action (for modifications only):

$6,000,000

F. Funding Source (s): 003505: Fee For Service Data Collection System / 0511: Program Operations_Direct:Disc

G. Basis for Approval (Far 6.303-1(d)) ☒ Individual Basis

☐ Class Basis

This document contemplates award of a modification to a task order that was awarded using the “logical follow-on” exception to fair opportunity. The contractor is Data Computer Corporation of America (DCCA) and the current contract number is HHSM-500-2016-00028I/75FCMC24F0223. The current POP is:

Base Period 09/24/24-06/23/25 with a Transition Out 06/24/25-09/23/25. The total obligated amount for this contract is $6,137,425. Prior to the bridge contract, DCCA held the contract for this work. The contract number was HHSM-500-2016-00028I/75FCMC19F0001. The contract had a period of

Performance (PoP) of September 24, 2019-September 23, 2024. The total obligated amount for that contract was $20,205,598.44. The task order was competed amongst all Small Business SPARC contract holders at the time of solicitation.

2. Description of Supplies or Services:

This is a Task Order for one year (with three months of optional transition) of IT System Development and Support Services to create and maintain a large data collection system for several types of Medicare data.

The proposed modification will modify the POP to add one additional year. Known as the Fee for Service Data Collection System (FFSDCS), this system collects three types of data; Clinical laboratory data, Part B drug information, and survey data from Ambulance providers. Although each module is independent, they share a common backbone infrastructure. This data collection system currently collects private payer data from Medicare Part B applicable clinical laboratories that manufacture laboratory tests that are paid on the Clinical Laboratory Fee Schedule (CLFS) as required by The Protecting Access to Medicare Act (PAMA) of 2014 (HR4302). This system also currently collects quarterly data from drug manufacturers used to calculate the average sales price (ASP) as required by section 1847A of the Social Security Act needed pay for Medicare Part B drugs. This system collects cost, revenue, and other information from ambulance providers and suppliers as required by section 50203(b) of The Bipartisan Budget Act (BBA) of 2018. Finally, because of this proposed modification and being a high priority from the Administration, the FFSDCS will need to support the drug acquisition cost survey for hospitals paid under Hospital Outpatient Prospective Payment System (OPPS). This would create a new and imperative 4th module in the FFSDCS.

Currently, the FFSDCS delivers the following functionality:

▪ Fee for Service manufacturers to submit relevant data to CMS using an online system that allows CMS to receive accurate and timely data

▪ FFS market data to be submitted using a standardized format and the automated validation of the business requirements.

▪ Calculations of the submitted data (i.e. averages, weighted medians, etc) performed using data driven pricing models within the application.

▪ Automated Reporting throughout the system.

▪ Flexibility to reflect ongoing changes resulting policy updates or changes

▪ Integration with CMS shared services

▪ Provisions for helpdesk support

The Period of Performance (POP) is being revised:

FROM:

Base POP: 09/24/24-06/23/25 (Optional) Transition Out: 06/24/25-09/23/25

TO:

Base POP: 09/24/24-06/23/25 Option Period 1/Extension POP: 06/24/25-06/23/26 (Optional) Transition Out: 06/24/26-09/23/26

3. Authority and Rationale:

The Contracting Officer shall give every awardee a fair opportunity to be considered for a delivery/task order exceeding $3,500 unless one of the following statutory exceptions applies. FAR 16.505(b)(2). Mark the applicable exception:

☒ The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays [FAR 16.505(b)(2)(i)(A)];

☐ Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized [FAR 16.505(b)(2)(i)(B)];

☐ The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order [FAR 16.505(b)(2)(i)(C)]; or

The current task order under which FFSDCS System Development and Support Services are performed was awarded in 2024. Prior to that award, the contract was awarded in 2019 using fair opportunity under the CMS SPARC multiple-award IDIQ contract. Since the most recent award in 2024, new Presidential priorities have shifted the timelines and need for the collection of certain statutory data (see the Lowering Drug Prices By Once Again Putting Americans First executive order). Also, Section 1833(t)(14)(D) of the Social Security Act, which requires the Comptroller General of the United States to conduct a survey to determine the hospital acquisition cost for each specified covered outpatient drug (SCOD) and to furnish that data to the Secretary for use in setting the payment rates under subparagraph (A), has been revisited by the Administration. It has been years since a survey has been conducted and the Administration wants this survey and module set up in 2025. This conflicts with the timing of the existing task order given the one year POP is set to end in June 2025, followed by a three-month option period for phase-out transition. This will not allow enough time for the new 4th module of the hospital acquisition costs to be implemented and transitioned to a follow-on contract.

Introducing the possibility of a new contractor at this juncture would introduce undue risk of harm to the Government and jeopardize successful performance of the work. Because the reporting is statutory and requires significant support and onboarding a new contractor during that time introduces unacceptable risk of unsuccessful performance on behalf of the government. The FFSDCS has been tasked by the CMS Administrator’s office to create a 4th module of the FFSDCS for additional statutory data collection. We are not able to have a contract transition commence at this time when 1) we have been tasked to build a new module to collect statutory data that must launch by 1/1/26 and heavily uses data and infrastructure from 2 of the existing FFSDCS modules; 2) we are commencing lab reporting (that was delayed via Congressional action) 3) we will still have active ambulance submitters in the system and 4) the Average Sales Price (ASP) module which was recently modernized will not yet be stable. A new contractor would need time to become familiar with the existing system, manage help desks for ambulance, labs, and ASP, time that is not available for the existing requirements. There is not enough time to get familiar with the system and the user needs to build a new module for ~4000 new users by the end of 2025. This task order includes a help desk and there will be over 10,000 ambulance organizations reporting data in the system for the first time as it is a new requirement. The helpdesk supports over 6,000 labs, many of which will be reporting for the first time as well as ~700 manufacturers. The new module would include an additional ~4000 hospitals. We are therefore https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-putting-americans-first/ https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-putting-americans-first/ planning to modify the bridge contract to add one additional year to complete the work that was delayed or unknown by no fault of the contractor

☐ It is necessary to place the order to satisfy a minimum guarantee [FAR 16.505(b)(2)(i)(D)].

☐ A statute expressly authorizes or requires that the purchase be made from a specified source. [FAR 16.505(b)(2)(i)(E)].

4. Provide a statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made:

The circumstances which necessitate a contract modification regarding altered implementation deadlines as directed via congressional mandate negate the Government’s ability to provide a fair opportunity to other offerors at the present time. CMS does not anticipate the circumstances necessitating this extension to last beyond the stated period. As such, CMS intends to provide a fair opportunity with a future competition. The acquisition team has been working on the re-competition through acquisition planning and market research for a competitive procurement utilizing Fair Opportunity ordering procedures on the GSA Multiple Award Schedule. Market research one-on-one meetings with industry and other efforts have been ongoing since November 2024.The competitive acquisition contemplated herein is tentatively planned for an award date of June 2026 to allow adequate time for a potential supplier transition.

5. State any other facts supporting the justification:

The largest set of changes will be occurring in the next nine months. These involve Section 1833(t)(14)(D) of the Act, which required the Comptroller General of the United States to conduct a survey to determine the hospital acquisition cost for each specified covered outpatient drug (SCOD) and to furnish that data to the Secretary for use in setting the payment rates under subparagraph (A) for 2006. Section 1833(t)(14)(D)(ii) requires the Secretary to conduct periodic surveys of hospital acquisition costs for each specified covered outpatient drug for use in setting the payment rates under OPPS. Further, the General Accountability Office (GAO) conducted the required survey and, in reporting the results in 2006, recommended that the Secretary thereafter validate, “on an occasional basis— possibly every 5 or 10 years—ASP data that manufacturers report to CMS for developing drug payment rates.” In the ensuing years, CMS has not conducted a survey of the drug acquisition costs for all hospitals. Other statutorily mandated work that must continue involves the Part B ASP module in the system to support requirements in the Consolidated Appropriations Act (CAA) of 2021, Infrastructure Investment and Jobs Act (IIJA) of 2021, and the Inflation Reduction Act (IRA). On September 26, 2024, Section 221 of the Continuing Appropriations and Extensions Act, 2025 was passed and delayed data reporting requirements for clinical diagnostic laboratory tests (CDLTs) so they would be reporting for the first time since 2017. Ground Ambulance data collection mandated by the Balanced Budget Act of 2018 continues. Working with a new contractor would entail taking time to transfer all aspects of the existing database, ensuring that all existing components continue to run, all help desks are functional and would render Administrator-directed timelines impossible to meet.

Approvals:

1. Program Office Certification. This is to certify that portions of this justification have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for Exceptions to Fair Opportunity, which form the basis for this justification.

Contracting Officer Representative (COR) / Date

Program/Project Manager (P/PM) / Date

2. Contracting Officer Certification and Best Value Determination:

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief, the information and/or data provided to support the rationale and recommendation for approval, is accurate and complete.

By my signature below, after review of the relevant documents, I have determined that the order subject to this Justification represents the best value for the Government as set forth in FAR 16.505(b)(2)(ii)(B)(5), and constitutes a fair and reasonable price. The basis for my determination is as follows:

Contracting Officer / Date

3. CMS Competition Advocate Approval I have reviewed this Exception to Fair Opportunity and find that it adequately supports other than full and open competition.

Name / Date

4. Head of Contracting Activity (HCA) Approval I hereby confirm that the circumstances described above apply and approve this Justification for Exception to Fair Opportunity.

___N/A_______________________________________________ HCA Name / Date

5. Office of Small and Disadvantaged Business Utilization

____N/A_______________________________________________

6. OGC Legal Review

_____N/A______________________________________________

7. HHS Competition Advocate Approval

_____N/A______________________________________________

8. Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby confirm the circumstances described above apply and approve the Justification for Exceptions to Fair Opportunity.

_____N/A____________________________________________ SPE Name / Date

_____N/A____________________________________________