CMS-9115-F
In effectInteroperability and Patient Access Final Rule
The foundational Patient Access & Provider Directory API standard that every upcoming CMS interoperability mandate builds on.
July 1, 2021
OmniCompli
The Unified Source of Compliance
OmniCompli is the unified compliance layer of Smile Omni designed to satisfy CMS-0057-F, and upcoming CMS regulations. It provides a standards-based rules framework that transforms fragmented regulatory interpretation into consistent, transparent, and auditable execution that is reusable as compliance needs grow.
OmniCompli replaces fragmented and disconnected compliance workflows with a single, shared rules foundation. The technical investment that Payers put into the standards and interoperability for one rule, carries forward to future rules. Regulatory and policy requirements are translated into computable, deterministic logic that executes consistently at enterprise scale, ensuring decisions are applied the same way across programs, systems, and partner ecosystems.
Building for The Regulatory Roadmap
One compliance Engine for CMS-0057-F and Upcoming CMS Rules
To manage fragmented projects, Payer compliance leaders have had to lead business-process changes with every new regulatory requirement. The industry is moving toward embedded interoperability, and managing today's regulatory roadmap demands deep technical and architecture-level fluency in interoperability, FHIR, and real-time data exchange.
Compliance leaders who are guiding their teams, the whole Payer organization and Provider networks through this regulatory roadmap require a unified compliance engine that does not recreate the historical fragmentation, burden, and cost of starting over for every mandate.
The technical and operational investment into CMS-9115-F and CMS-0057-F extends to CMS-4208-F2, CMS-0053-F, CMS-0062-P and other upcoming mandates.
As each CMS Rule is finalized, OmniCompli extends the existing foundation forward. Smile Digital Health will continue to share technical and operational specifics on new rules as the industry progresses along the regulatory roadmap.
The CMS Compliance Timeline
2021
2024
CMS-4205-F2
In effectMedicare Part D Health IT Standards Final Rule
The foundational e-prescribing standard for Medicare Part D. CMS-0062-P extends this same NCPDP framework to prior authorization for pharmacy-benefit drugs.
July 17, 2024
2026
CMS-9883-F
In effect2027 HHS Notice of Benefit and Payment Parameters
Sets 2027 ACA Marketplace standards, including new non-network plan transparency on provider payment acceptance.
July 20, 2026
CMS-9897-F
In effectFederal Independent Dispute Resolution (IDR) Operations Final Rule
Standardizes claim-coding transparency on EOBs, cuts IDR fees 85%, and expands dispute batching for out-of-network claims.
August 3, 2026
CMS-4208-F2
FinalMedicare Plan Finder Provider Directory Rule
Requires FHIR®/JSON provider directory APIs so CMS can publish accurate MA network data on Medicare Plan Finder.
October 1, 2026
CMS-4215-P
ProposedMedicare Drug Price Negotiation Program Proposed Rule
Applies to IPAY 2029. Codifies drug selection, negotiation, and Maximum Fair Price rules into permanent Part D regulation.
Fall 2026
2027
CMS-0057-F
FinalInteroperability and Prior Authorization Final Rule
Mandates five FHIR APIs, faster prior authorization decisions with public reporting for Payers.
January 1, 2027
CMS-2454-IFC
Interim finalMedicaid Community Engagement (Work) Requirement
Requires states to verify 80 hours per month of qualifying work activity as a condition of Medicaid eligibility, and verification requirements for enrollment and renewal to managed care plans.
January 1, 2027
CMS-9882-P
ProposedTransparency in Coverage Proposed Rule
Overhauls machine-readable price files into smaller, contextualized, quarterly in-network and out-of-network disclosures. Price transparency provision to members upon request, starting January 1, 2027.
January 1, 2027
CMS-4212-F
FinalCY 2027 Medicare Advantage and Part D Final Rule
Simplifies Medicare plan quality scoring, codifies Inflation Reduction Act drug cost protections, and sets new marketing and communications requirements for Medicare Advantage and Part D plans.
January 1, 2027
CMS-4205-F2
FinalMedicare Part D Health IT Standards — F&B/RTPB Compliance ("Script Sync")
Brings real-time drug cost and coverage transparency to the point of prescribing for Medicare Part D members and prescribers.
January 1, 2027
CMS-0062-P
ProposedPrescription Drug Prior Authorization Proposed Rule
Extends CMS-0057-F's electronic prior authorization framework to prescription drugs via FHIR and NCPDP standards.
October 1, 2027
2028
CMS-4205-F2
FinalMedicare Part D Health IT Standards — SCRIPT Full Enforcement
Completes the shift to a single, modern e-prescribing standard connecting prescribers, pharmacies, and Part D sponsors.
January 1, 2028
CMS-0053-F
FinalElectronic Claims Attachments & Signatures Rule
The first-ever HIPAA standard for electronic claims attachments. Replaces fax and mail with structured X12/HL7® exchange.
May 26, 2028
In effect
Final, upcoming
Proposed
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Meet Regulatory Requirements
Built for CMS-0057-F Requirements
Defensible Electronic Prior Authorization
The Electronic Prior Authorization (ePA) API applies CRD, DTR, and PAS logic so every request is adjudicated accurately, on time, and every decision is explainable.
Continuity
The Payer-to-Payer API automates secure, ID-matched data exchange between plans, providing continuity of care as a member's coverage changes.
Trusted Access for In-Network Providers
The Provider Access API shares member data with in-network providers with proper authorization and consent, closing gaps without friction.
Public Transparency
The Patient Access API keeps prior auth metrics and decisions public, report-ready, and audit-ready.
Discoverability
The Provider Directory API makes provider data publicly available and searchable for better care decisions.
Trusted by over 30 US Payers, OmniCompli touches 110M+ American Lives.
Collaborations with CDC, WHO and CMS on interoperability and regulatory projects.
Compliance and Beyond
Innovation Beyond the Mandates
OmniCompli is a unified rules layer built on a fully computable foundation. This single engine powers not only compliance to the upcoming CMS-0057-F mandates, but also real-time prior authorization automations, prospective care gaps management, and continuous quality measures including HEDIS® and MIPS and other downstream use-cases.
The OmniCompli Advantage
Computability removes ambiguity, so systems and teams evaluate information the same way across the enterprise. That same foundation extends to every regulation that follows.
With a unified, computable compliance foundation, organizations experience:
Consistent Interpretation
Rules execute the same way across every program, system, and reviewer, with one interpretation.
Built Once, Reused for Every Mandate
The rules engine configured for CMS-0057-F extends to new mandates, without significant rework or reinvestment.
Trust through Transparency
Decisions are transparent, defensible, explainable, and audit-ready.
Ecosystem and Delegate Consistency
In- and out-of-network providers, delegates, third-party administrators, UMs and PBMs get the same answer using the same policy, consistently.
Burden Reduction
Deterministic automations reduce manual efforts, and eases burdens on Payers, Providers, and members alike.
Unified Quality
Compliance, utilization management, quality, and operations align on one interpretation of policy.
OmniCompli powers not only compliance to the upcoming CMS mandates, but also real-time prior authorization automations, prospective care gaps management, and continuous quality measures including HEDIS®
and MIPS, and other downstream use-cases.
Smile Digital Health Reinforces Commitment to Simplify Prior Authorization for Millions of Americans
OmniCompli Solutions
Solutions for CMS-0057-F That Carry Forward
Each solution operationalizes regulatory and policy requirements using the same shared rules foundation, ensuring consistent execution across programs.
Whether you need an out-of-the-box solution to CMS-0057-F compliance, or a fully managed solution ahead of January 1, 2027, these solutions meet the deadline in front of you, and extend to meet what comes next.
OmniCompli
CMS Suite
The Core Regulatory Compliance Automation
CMS Suite translates CMS interoperability and compliance requirements into deterministic, executable logic. It operationalizes regulatory mandates using standards-based inputs and transparent rule execution, reducing variability caused by manual interpretation.
Includes: FHIR APIs for CDR, DTR, PAS, Payer-to-Payer, Provider Directory and Patient Access.
Who it’s for
Organizations required to meet CMS interoperability and compliance mandates.
Why it matters
It delivers predictable, auditable compliance outcomes aligned to regulatory expectations.
OmnCompli
CMS Suite+
Enterprise-scale Compliance Execution
Expand capabilities of CMS Suite to include enterprise-scale automations that require higher throughput, deeper operational alignment, and faster iteration as mandates evolve. CMS Suite+ supports consolidated rule governance across compliance, UMs and quality reporting teams, reducing duplication and overhead, across the organization and network (including in and out of network providers).
Includes: Real-time auditable and defensible Prior Auth Adjudication.
Who it’s for
Enterprises operating multiple, complex regulatory and operational compliance programs, across multi-site networks
Why it matters
Faster adoption and provider/ member satisfaction. In addition, as mandates evolve, significant architectural redesign is minimized.
OmnCompli
CMS Concierge
Deliver Managed CMS Compliance Implementation
Pair the CMS Suite solution with OmniConcierge for an operationally ready CMS compliant outcome. Smile experts execute the implementation, hosting, maintenance, and regulatory change management.
Who it’s for
Organizations that need speed, predictability, and operational confidence in meeting CMS mandates before Jan 1st 2027.
Why it matters
It is a cost-effective solution that reduces time to compliance, lowers operational burden, and provides a clear path from managed execution to self-managed capability as internal maturity grows
Why OmniCompli
Solve the Right Problem
Most organizations don't manage compliance through one system — they manage it through a combination of: narrative policy documents, hard-coded logic within clinical systems, hard-coding logic within claim systems, and UM vendor and/or delegated partner's own configuration or interpretation of the same regulation. Each new CMS mandate exposes that fragmentation again.
A unified compliance framework fixes the structural problem, not just the current rule. Centralizing interpretation and execution eliminates conflicting logic, reduces operational burden, and makes every decision transparent and defensible — infrastructure that adapts as mandates evolve, rather than rebuilt or re-configured for each one.
Your organization's compliance journey is unique. Whether you need an out-of-the-box product, targeted API integrations for your existing stack, or a strategic partner to take you beyond the mandates, OmniCompli meets you, your provider networks and delegates, at every step, turning your compliance investment into lasting operational insight. Share this page with your delegates, third-party administrators, UMs and PBMs so your whole network functions from consistent interpretation of the rule.
How OmniCompli Fits Within Smile Omni
Compliance Is Now an Operational Capability, Not a Check-list
OmniCompli operates on the trusted data foundation provided by OmniVera and works in concert with OmniConcierge to deliver compliance outcomes that are consistent, explainable, and scalable across the enterprise.
Speak with Our Team
See how OmniCompli powers your modernization strategy with clarity,
consistency, and confidence.
Deep Dive with OmniCompli
Use Case
Technology Behind Real-time Prior Auth
Use CaseTechnology Behind Real-time Prior Auth
Read our real-world use case.
Read the Use Case
Blog
Fixing Systemic Prior Auth Denials
BlogFixing Systemic Prior Auth Denials
How deterministic AI approach can resolve a systemic flaws.
Read the Article
Blog
The Ultimate CMS Compliance RFP Starter-kit for US Payers
BlogThe Ultimate CMS Compliance RFP Starter-kit for US Payers
Get the free downloadable kit to future-proof your compliance investment.
Read the Article
Video
Revolutionize Prior Auth with Proven Automations
VideoRevolutionize Prior Auth with Proven Automations
Tested proven PriorAuth solutions delivered.
Watch the VideoTOUCH
Blog
Does Your PriorAuth Solution Serve All Providers?
BlogDoes Your PriorAuth Solution Serve All Providers?
Compliance assumptions are risky and expensive.