RHSES-102: Operational Requirements

DOCUMENT REF: RHSES-102

TITLE: Operational Requirements: Purchasing, Resilience, and Equity

Status: Normative

1.0 The Purchasing & Revenue Backbone (PRB)

1.1 Cooperative Structure and Safe Harbor Compliance

The Entity must establish or contract with a purchasing mechanism that strictly adheres to 42 CFR § 1001.952(j) (Group Purchasing Organizations).

  • 1.1.1 Written Agreement: The Entity must possess a written agreement with each vendor and member that specifies the fee structure.
  • 1.1.2 Fee Cap and Disclosure: The PRB shall typically limit administrative fees to 3% of the purchase price. If fees exceed 3%, the PRB must disclose the amount to the member annually and to the Secretary of HHS upon request.
  • 1.1.3 Audit Trail of Fees: The Certified Technology Partner must maintain a real-time ledger of all administrative fees collected, categorizing them by Vendor, Member, and Contract ID to facilitate instant reconciliation.
  • 1.2 Price-Resilience Framework

    To mitigate supply chain volatility, the PRB must implement a "Must-Stock" and "Value-Tier" protocol.

  • 1.2.1 Value-Tier Mandate: For every SKU classified as "High-Spend" (top 20% of spend volume), the PRB must identify and contractually secure at least one "Value-Tier" alternative (e.g., A-rated generic, therapeutic equivalent).
  • 1.2.2 Dynamic Substitution Logic: The procurement platform must utilize an algorithmic trigger. IF < THEN. This logic must be documented in the Algorithm Change Protocol (ACP).
  • 1.2.3 Rural Protection Circuit Breaker: Prior to the execution of any physician compensation reduction, the Governance Board must review a "Supply Chain Optimization Report." If the report indicates that "Value-Tier" utilization is below 80%, compensation reductions are prohibited until supply chain efficiencies are maximized.
  • 2.0 Health Equity Fund (HEF) Construction

    2.1 Restricted Fund Accounting

    The HEF shall not be treated as general operating cash. It must be established as a "Net Asset with Donor Restrictions" (or contractual restrictions) in accordance with FASB ASU 2016-14.

  • 2.1.1 Automated Allocator: The Certified Technology Partner must implement a "Split-Payment" architecture (e.g., smart contract or automated clearing house rule) that diverts the mandated percentage (e.g., 20%) of all Administrative Fees directly to the HEF depository account at the moment of settlement.
  • 2.1.2 Permissible Use Taxonomy: Expenditures from the HEF must map to specific "Social Determinants of Health (SDOH)" codes or "Infrastructure Improvement" categories. General administrative overhead is a prohibited expense class for HEF funds.
  • 3.0 AI Compliance Layer (ACL)

    3.1 ISO 42001 Alignment

    The Entity must manage its AI/ML tools (used for billing, substitution, or care gaps) in accordance with ISO/IEC 42001.

  • 3.1.1 AI Impact Assessment: An annual assessment must be conducted to evaluate the potential for algorithmic bias in the "Value-Tier" substitution recommendations (e.g., ensuring lower-cost items are not disproportionately recommended to protected demographic groups).
  • 3.1.2 Data Provenance: The system must maintain an immutable log of the training data and decision logic used for any "Clinical Decision Support" output, complying with FDA SaMD guidance for "Good Machine Learning Practice (GMLP)."