CMS-0057-F
42 CFR Parts 422, 431, 438, 457
ONC Cures Act
45 CFR Part 170 & USCDI v3
HIPAA
45 CFR 164 Security Rule
Information Blocking
45 CFR Part 171 Compliance
HL7 Standards
FHIR R4, US Core 6.1.0, Terminology 5.5.0
CMS Interoperability and Prior Authorization Final Rule
CMS-0057-F | Federal Register 89 FR 8758 | Published February 8, 2024
The CMS Interoperability and Prior Authorization Final Rule requires impacted payers to implement FHIR-based APIs for patient access, provider access, prior authorization, and payer-to-payer data exchange. Compliance deadline: January 1, 2027.
Applicable CFR Citations
| CFR Citation | Requirement | InteropSuite Support |
|---|---|---|
| 42 CFR 438.242(b)(5) | Patient Access API - FHIR R4 with US Core profiles | FHIR bundle generation |
| 42 CFR 438.242(b)(6) | Provider Access API - Clinical and claims data exchange | FHIR bundle generation |
| 42 CFR 438.242(b)(7) | Prior Authorization API - Da Vinci PAS profiles | FHIR bundle generation |
| 42 CFR 438.242(b)(8) | Payer-to-Payer API - PDex profiles | Provenance source tracking |
| 42 CFR 438.210(d) | Prior authorization decision timeframes (7 days standard) | API requirement |
| 42 CFR Part 422 | Medicare Advantage Organizations | FHIR bundle generation |
| 42 CFR Part 431 | State Medicaid Agencies | FHIR bundle generation |
| 42 CFR Part 457 | CHIP Managed Care Entities | FHIR bundle generation |
| 45 CFR Part 156 | QHP Issuers on Federally-Facilitated Exchanges | FHIR bundle generation |
InteropSuite is a transformation library that generates CMS-compliant FHIR bundles. You are responsible for implementing the FHIR server APIs and ensuring end-to-end compliance.
ONC 21st Century Cures Act & HTI-1 Final Rule
85 FR 25642 | 89 FR 1192 (HTI-1) | 45 CFR Part 170
The ONC Cures Act Final Rule and HTI-1 update establish standards for health IT certification, including FHIR-based APIs, USCDI v3 data classes, and US Core 6.1.0 as the baseline standard effective January 1, 2026.
HTI-1 Key Requirements (89 FR 1192)
| Requirement | Effective Date | InteropSuite Support |
|---|---|---|
| USCDI v3 as baseline standard | January 1, 2026 | Full support |
| US Core IG 6.1.0 adoption | January 1, 2026 | All profiles |
| SMART App Launch 2.0.0 | January 1, 2026 | Server implementation |
Applicable CFR Citations
| CFR Citation | Requirement | InteropSuite Support |
|---|---|---|
| 45 CFR 170.213 | United States Core Data for Interoperability (USCDI) | USCDI v3 compliant |
| 45 CFR 170.215(a)(1) | HL7 FHIR Release 4.0.1 | Full support |
| 45 CFR 170.215(b)(1)(ii) | US Core Implementation Guide STU 6.1.0 | All profiles |
| 45 CFR 170.215(c)(2) | SMART App Launch IG Release 2.0.0 | Server implementation |
| 45 CFR 170.315(g)(10) | Standardized API for Patient and Population Services | Data transformation |
Information Blocking
45 CFR Part 171 | 21st Century Cures Act Section 4004
The Information Blocking Rule prohibits healthcare providers, health IT developers, and health information networks from practices that interfere with access, exchange, or use of electronic health information (EHI). InteropSuite enables compliant data sharing by transforming legacy formats to standardized FHIR.
How InteropSuite Helps Avoid Information Blocking
| Information Blocking Practice | How InteropSuite Helps |
|---|---|
| Technical barriers to access | Transforms HL7 v2.x, X12, C-CDA to standardized FHIR R4 |
| Non-standard data formats | Outputs US Core 6.1.0 compliant resources |
| Inability to respond to data requests | Enables real-time transformation for API responses |
| Limiting data to proprietary formats | Converts to open FHIR standard |
Applicable Exceptions (45 CFR 171 Subpart B)
| CFR Citation | Exception | Relevance |
|---|---|---|
| 45 CFR 171.201 | Preventing Harm Exception | Clinical decision - not affected by transformation |
| 45 CFR 171.202 | Privacy Exception | InteropSuite processes locally, no PHI exposure |
| 45 CFR 171.203 | Security Exception | AES-256-GCM encryption, audit logging |
| 45 CFR 171.204 | Infeasibility Exception | InteropSuite makes FHIR transformation feasible |
| 45 CFR 171.205 | Health IT Performance Exception | High-performance transformation engine |
| 45 CFR 171.301 | Content and Manner Exception | Outputs in standard FHIR format |
Enable Data Sharing, Avoid Information Blocking
By transforming legacy HL7 v2.x, X12, and C-CDA data to standardized FHIR R4 with US Core profiles, InteropSuite helps organizations meet their data sharing obligations and avoid information blocking violations.
HIPAA Security Rule
45 CFR Part 164 Subpart C | Security Standards for ePHI
The HIPAA Security Rule establishes national standards to protect electronic protected health information (ePHI) through administrative, physical, and technical safeguards.
Technical Safeguards (45 CFR 164.312)
| CFR Citation | Safeguard | InteropSuite Architecture |
|---|---|---|
| 45 CFR 164.312(a)(1) | Access Control - Unique user identification | Per-developer licensing |
| 45 CFR 164.312(a)(2)(iv) | Encryption and Decryption | AES-256-GCM quarantine |
| 45 CFR 164.312(b) | Audit Controls | Comprehensive audit logging |
| 45 CFR 164.312(c)(1) | Integrity - Protect ePHI from alteration | Tamper detection |
| 45 CFR 164.312(d) | Person or Entity Authentication | License key validation |
| 45 CFR 164.312(e)(1) | Transmission Security | 100% offline processing |
100% Offline - PHI Never Leaves Your Infrastructure
InteropSuite processes all data locally within your environment. No PHI is transmitted to external services, validation servers, or cloud endpoints. All profile specifications are embedded in the library.
HL7 Standards & Implementation Guides
Industry Standards for Healthcare Interoperability
Embedded Specifications
Input Format Standards
| Standard | Version | Coverage |
|---|---|---|
| HL7 v2.x | 2.3 - 2.8 | 30 message types (ADT, ORU, ORM, SIU, MDM, VXU, RDS, RDE, DFT) |
| X12 5010 | 005010X | 15 transaction types (837P/I/D, 835, 270, 271, 276, 277, 278, 834, 820, 275) |
| C-CDA | R2.1 | 11 document types, 33 section mappers |