Subject Matter Expert – Clinical Laboratory Fee Schedule (CLFS)

Job Description This is a remote position. Program: CMS Fee-for-Service Data Collection System (FFSDCS) Customer: Centers for Medicare & Medicaid Services (CMS), Center for Medicare / Hospital & Ambulatory Policy Group (HAPG) Location: Remote, with periodic travel to CMS (Woodlawn, MD) Clearance: Ability to obtain CMS Public Trust (Moderate) Citizenship: U.S. Citizen or Legal Permanent Resident (per CMS contracting requirements) Position Summary We are seeking a senior Subject Matter Expert to serve as the authoritative voice on Clinical Laboratory Fee Schedule (CLFS) policy and operations for the FFSDCS contract. The CLFS module of FFSDCS collects private payor rate data from applicable clinical laboratories — as required by Section 216 of the Protecting Access to Medicare Act (PAMA) of 2014 — and uses that data to calculate Medicare Part B payment rates for clinical diagnostic laboratory tests (CDLTs). You will translate statute, regulation, and CMS sub-regulatory guidance into system requirements, data validation logic, test scenarios, training content, and stakeholder communications, and will function as the policy-to-engineering bridge for every CLFS release. Key Responsibilities • Serve as the contract's authoritative interpreter of PAMA Section 216, 42 CFR Part 414 Subpart G, and CMS sub-regulatory guidance governing CLFS private payor rate reporting, applicable laboratory determination, applicable information, and the weighted median rate-setting methodology. • Translate CMS policy decisions and rulemaking outcomes into validated business requirements, requirements traceability matrices, and acceptance criteria for development teams working under the CMS Expedited Life Cycle (XLC) framework. • Author and maintain data validation rule sets for the CLFS submission process, including TIN-level submission integrity, HCPCS code applicability, private payor rate plausibility, volume edits, and reporting-entity-to-applicable-laboratory mappings. • Support the CLFS data reporting cycle end-to-end: pre-reporting outreach, submission (file upload and manual entry), CFO/President certification via OTP, validation, calculation of weighted medians, publication of rates, and post-publication corrections. • Define and review test cases covering submitter and certifier role workflows, data ingestion, edit checks, calculation outputs, and publication files; participate in code walkthroughs and validation testing. • Provide Tier 3 escalation support for help desk inquiries from reporting entities, applicable laboratories, certifying officials, and CMS staff on complex policy and business-process questions. • Develop and maintain CLFS sections of the User Manual, Operator Manual, training plan, and training materials, ensuring Section 508 conformance. • Support Authority to Operate (ATO) activities, annual Security Controls Assessments, and CFACTS documentation from a business-owner perspective. • Brief CMS leadership on data trends, submission compliance, and impacts of proposed policy changes; provide analytical support to inform Physician Fee Schedule rulemaking and other CMS proposals affecting CLFS. • Coordinate with Medicare Administrative Contractors (MACs), CMS Shared Services (CMS Enterprise Portal, IDM/EIDM), and other stakeholders as CLFS data is consumed by downstream payment systems. Requirements Required Qualifications • Bachelor's degree in health policy, health administration, public health, life sciences, economics, or a related field. • Minimum 7 years of progressive experience in Medicare Part B payment policy or clinical laboratory reimbursement, including at least 3 years working directly with CLFS, PAMA private payor rate reporting, or clinical lab billing operations. • Working knowledge of HCPCS Level I (CPT) and Level II laboratory codes, the CLFS rate-setting methodology (weighted median of private payor rates), and the distinction between CDLTs and Advanced Diagnostic Laboratory Tests (ADLTs). • Understanding of CLIA certification, the statutory “applicable laboratory” and “applicable information” definitions, the majority-of-Medicare-revenues threshold, and low-expenditure thresholds. • Demonstrated ability to translate statute and regulation into discrete, testable system requirements. • Experience supporting CMS or other federal contracts operating under a formal SDLC (XLC, EPLC, or equivalent). • Familiarity with CMS Enterprise Portal, IDM (formerly EIDM), CFACTS, and CMS Acceptable Risk Safeguards (ARS). • Strong written communication skills; able to produce policy memoranda, user-facing instructions, and engineering-grade requirements with equal clarity. Preferred Qualifications • Master's degree (MHA, MPH, MPP, or equivalent). • Prior experience as a contractor or federal employee on a CMS payment system (CLFS, ASP, PFS, OPPS, or AFS). • Direct experience inside a clinical laboratory's reimbursement, compliance, or finance function. • Familiarity with the CY Physician Fee Schedule (PFS) rulemaking cycle and how CLFS provisions move through proposed/final rules. • Working knowledge of Section 508 / 36 CFR Part 1194 accessibility requirements. • Experience with statistical or actuarial review of payment rate calculations. • Familiarity with Agile/Scrum delivery within an XLC-governed program. Work Environment • Remote-first; occasional on-site presence at CMS in Woodlawn, MD for stakeholder meetings, demos, ATO activities, and reporting-period readiness reviews. • Surge support required during CLFS data reporting periods (historically the January–March collection window in reporting years, plus quarterly correction windows). • Standard CMS business hours (Eastern Time); on-call availability during active reporting periods. Benefits Standard Employee Benefits. 50% Health Insurance Paid by Innosoft, Paid Vacation, 401K Match, STD LTD and AD&D paid by Innosoft.