Provider Compliance Group-Fast Healthcare Interoperability Resources

• Significant System Management Change
• PIA Validation (PIA Refresh/Annual Review)

• Addition of AIPC to the PCG-FHIR system authorization boundary.
• iQIES interconnection - Assessment data from iQIES, which includes OASIS and MDS data. The Outcome and Assessment Information Set (OASIS) includes home health data.  The Minimum Data Set (MDS) includes skilled nursing facilities data.
• PCG FHIR will provide direct connectivity to the Review Contractors (RCs). This enhancement introduces new APIs and connectivity to support the secure exchange of review requests, supporting documentation, review responses, and associated metadata between PCG-FHIR and Review Contractors.

The Provider Compliance Group (PCG) - Fast Healthcare Interoperability Resources (FHIR) system establishes a FHIR based communication channel between Providers and CMS. PCG-FHIR provides the following capabilities:

1. The Fast Healthcare Interoperability Resources (FHIR) solution is capable of receiving and processing FHIR-based documentation submissions and FHIR-based Prior Authorization (PA) requests and responses.

   PCG-FHIR provides direct connectivity to Review Contractors (RCs) to support the secure exchange of review requests, supporting documentation, review responses, and associated metadata between PCG-FHIR and Review Contractors. Responses received from RCs are converted into FHIR resources and made available for Providers to retrieve. PCG-FHIR also provides the capability for Review Contractors (RCs) to send documentation requests in FHIR format to providers.

   PCG-FHIR also exchanges information with CMS Electronic Submission of Medical Documentation (esMD), an existing CMS solution utilizing approved connectivity. Responses received through esMD are converted into FHIR resources and made available for Providers to retrieve.

   1. Users (pProviders) are able to submit transactions, retrieve correspondence, and query the status of submissions.
   2. PCG-FHIR supports FHIR-based communication workflows between providers, CMS, and Review Contractors (RCs)

2. The Electronic Clinical Templates API (ECTA) module supports the transformation of Medicare FFS coverage rules from paper-based (including PDF version) into a machine-processable representation in a standard-based FHIR format interoperable across systems. ECTA exposes the digitized rules library through API services. These APIs are also exposed through the PCG-FHIR server.

   Users are able to determine if Prior Authorization is required for a specific service or item and if any coverage requirements exist. Users can also access the specific documentation requirements that exist.
   FHIR and ECTA employ shared system components.

3. PCG-FHIR additionally is implementing support of interoperability capabilities for the retrieval and exchange of Post-Acute Care (PAC) assessment-related healthcare data using standards-based FHIR APIs. The PCG-FHIR solution translates the incoming FHIR request and exchanges information with CMS with the Internet Quality Improvement and Evaluation System (iQIES) through existing CMS-approved APIs and connectivity mechanisms to support retrieval of authorized assessment data and resources for Medicare Administrative Contractor (MAC) users.

   Supported PAC assessment data types include Outcome and Assessment Information Set (OASIS) and Minimum Data Set (MDS) resources.

   1. Assessment-related data is exchanged using approved CMS interoperability interfaces and standards-based FHIR APIs.
   2. PCG-FHIR does not serve as the system of record for PAC assessment data and retrieves information from authorized CMS data sources and interfaces.
4. The Artificial Intelligence Supported Effort for Provider Compliance (AIPC) module enhances documentation quality prior to claims submission by leveraging a CMS-approved large language model (LLM) for automated compliance validation. AIPC performs real-time compliance checks and provides feedback to users, helping reduce provider burden and minimize improper claim payments. AIPC is currently focused on supporting Hospice documentation compliance workflows
   1. Submitted documents are processed to support compliance readiness and are temporarily stored within the system.
   2. Results are displayed to users through a dedicated graphical user interface (GUI) and are only accessible to authorized users and CMS operational support personnel as required for system operations and support activities.
   3. AIPC employs dedicated system components and services, including a dedicated virtual private cloud (VPC), separate from the shared PCG-FHIR and ECTA infrastructure.

The PCG-FHIR system processes and stores both Personally Identifiable Information (PII) and Protected Health Information (PHI) in support of its operational functions.

The PCG-FHIR system does not collect, share or access information directly from individuals. The PCG-FHIR system accepts information in FHIR format and converts that information to data acceptable for esMD. PCG-FHIR could receive all or a subset of the following information in the FHIR bundle, parses it and puts it an XDR file for esMD, but PCG-FHIR does not store any of this information. The information that is transported through the PCG-FHIR system may contain the following elements: Subscriber/Member Number or Unique Patient Identifier (UPI) (this is referring to Beneficiary MBI – Medicare Beneficiary Identifier from a CMS standpoint), Subscriber Full Name, Subscriber Address, Subscriber City, State, and Zip code; Subscriber Birth Date, Driver's License, E-mail Address, Practitioner National Provider Identifier (NPI), Practitioner Name, Practitioner Address, Practitioner City, State, and Zip code; Organization Contact Name, Organization Contact Email Address, Organization Contact Telephone and Organization Contact Fax. Medical Documents in the form of attachments, such as: Care Plan, Consultation Note, Continuity of Care Document (CCD), Diagnostic Imaging Report (DIR), Discharge Summary, History and Physical, Operative Note, Procedure Note, Progress Note, Referral Note, and Transfer Summary. Personally Identifiable Information (PII) information on the medical documents relate to the subscriber/beneficiary and include Member Number, Full Name, Mailing Address, Birth Date, claims submitted and medical records.

Data transmitted with the MACs are temporarily stored by the PCG-FHIR for up to 90 days.

PCG-FHIR also supports the retrieval of Post-Acute Care (PAC) assessment-related healthcare data from iQIES using standards-based FHIR APIs. Supported PAC assessment data types include Outcome and Assessment Information Set (OASIS) and Minimum Data Set (MDS) resources. OASIS data includes home health related data. MDS data includes skilled nursing facilities data.

PAC data is not stored on PCG-FHIR. PAC data is simply converted from the source-data format to FHIR standards and is transferred through PCG-FHIR.

PCG-FHIR does not collect, share or access information directly from individuals. It acts as a conduit system and establishes a FHIR based communication channel between Providers systems and CMS systems. It receives specific information from Subscribers (Patients/Beneficiaries) and Providers, in the form of a FHIR bundle, analyzes this information, and puts it in the XDR file for the esMD system, but it does not store any of this information.

For Patients (Subscribers/Beneficiaries) PCG-FHIR parses the following information from the FHIR Bundle and transmits to Review Contractors but does not store this information: Subscriber/Member Number or Unique Patient Identifier (UPI)/MBI, Subscriber Full Name, Subscriber Address, and Subscriber Birth Date.

For Providers, PCG-FHIR parses the following information from the FHIR Bundle and transmits to Review Contractor, but does not store this information: Practitioner National Provider Identifier (NPI), Practitioner Name, Practitioner Address, Organization Contact Name, Organization Contact Address, Organization Contact Telephone and Organization Contact Fax. 

When RCs send documentation requests to the Providers, the RC requests for additional documents pertaining to a particular claim. These documentation requests will need to be stored temporarily in the PCG-FHIR solution until the Provider retrieves the request. Such requests would include Beneficiary information, such as last name, first name, beneficiary ID, details about procedures performed, etc. The requests may also include Provider related information such as name, address, NPI, etc.

• Data transmitted with the MACs are temporarily stored by the PCG-FHIR for up to 90 days.

PCG-FHIR also supports the retrieval of Post-Acute Care (PAC) assessment-related healthcare data from iQIES using standards-based FHIR APIs.  Supported PAC assessment data types include Outcome and Assessment Information Set (OASIS) and Minimum Data Set (MDS) resources. OASIS data includes home health related data. MDS data includes skilled nursing facilities data.

For the iQIES integration, the data being transmitted is primarily patient assessment and clinical data from the post-acute care assessment instruments.

Outcome and Assessment Information Set (OASIS) and Minimum Data Set (MDS) data can include:

• Patient demographics
• Diagnoses and clinical conditions
• Functional status (mobility, self-care, activities of daily living)
• Cognitive and behavioral assessments
• Medication and treatment information
• Wound and skin assessments
• Outcomes and quality measures
• Therapy utilization
• Care planning information

PAC data is not stored on PCG-FHIR.  PAC data is simply converted from the source-data format to FHIR standards and is transferred through PCG-FHIR.

AIPC supports hospice documentation review and compliance assistance workflows. Authorized users may submit hospice-related documentation for automated analysis and review. Information processed by AIPC may include beneficiary information, hospice election statements, Certifications of Terminal Illness (CTIs), physician narratives, and associated metadata.

Hospice-related documentation and associated processing results are temporarily stored within AIPC for up to 3 months to support automated analysis, manual review workflows, auditing, troubleshooting, and operational support activities.

The PCG-FHIR system is not a system of record. Information is not collected, shared or accessed by the PCG-FHIR system. System Administrators and Developers of the PCG-FHIR system are direct Contractors with CMS. The PCG-FHIR system does not collect or maintain end-user identification or authentication information.

• Driver's License Number
• Name
• Date of Birth
• E-Mail Address
• Mailing Address
• Phone Numbers
• Medical Records Number
• Medical Notes
• Therapy records
• Other - Unique Patient Identifier (UPI)/MBI. National Provider Identifier (NPI). Fax number. Hospice records.

• Patients
• Other - Providers

Each year, the Centers for Medicare & Medicaid Services' (CMS) Medicare Fee-For-Service (FFS) program makes billions of dollars in estimated improper payments. CMS employs several types of Review Contractors (RC) to measure, prevent, identify, and correct these improper payments. The RCs identify improper payments by requesting medical documentation for a small sample of claims. Also, CMS runs several Prior Authorization programs to safeguard beneficiaries’ access to medically necessary items and services while reducing improper Medicare billing and payments. The PCG-FHIR project is creating a CMS end point where Providers can submit medical documentation and Prior Authorization requests in a FHIR format. These FHIR requests may contain PII or Protected Health Information (PHI). To simplify the solution implementation, the FHIR request is converted to an XDR format and sent to RCs through the existing esMD system. Given this, the PCG-FHIR system is ONLY processing the FHIR request to pass it on to the RC. The PCG-FHIR system does not collect, share or access information directly from individuals. It acts as a conduit system and establishes a FHIR based communication channel between Providers systems and CMS systems. It receives specific information from Subscribers (Patients/Beneficiaries) and Providers, but it does not store any of this information. PII received by PCG-FHIR is not functionally processed but transferred to esMD. PCG-FHIR only parses the PII from the FHIR Bundle, formats into an XDR format and sends it to esMD. PCG-FHIR does not disclose or share the PII with any other application or entity.

PCG-FHIR stores the above-mentioned information. The primary usage of the information from Providers to RCs does not change. The purpose of the documentation request is to notify providers of what information/documentation needs to be sent back to the RCs to complete processing of a given claim.

PCG-FHIR also supports the retrieval of Post-Acute Care (PAC) assessment-related healthcare data from iQIES using standards-based FHIR APIs.  Supported PAC assessment data types include Outcome and Assessment Information Set (OASIS) and Minimum Data Set (MDS) resources. OASIS data includes home health related data. MDS data includes skilled nursing facilities data.  

AIPC supports hospice documentation review and compliance assistance workflows. Authorized users may submit hospice-related documentation for automated analysis and review. Information processed by AIPC may include beneficiary information, hospice election statements, Certifications of Terminal Illness (CTIs), physician narratives, and associated metadata.

Submitted documents are analyzed to identify potential documentation deficiencies, compliance concerns, and opportunities for correction prior to submission through existing CMS business processes. AIPC is a decision-support tool and does not submit information to Medicare Administrative Contractors (MACs), make coverage determinations, or serve as the authoritative system of record.

• Other - Not Applicable.

• Other - Not Applicable.

• Other - The PCG-FHIR system does not collect, share or access information directly from individuals. Providers collect information directly from individuals and send the information to the PCG-FHIR system in FHIR structure to be transferred in a compatible form to esMD.  This information includes PII.

• Users: FHIR Users
  Providers and MAC users: may access PII/PHI contained within documentation requests, prior authorization transactions, attachments, and supporting clinical documentation associated with their authorized workloads. Access is limited to records necessary to perform medical review, documentation exchange, claims processing, and related business functions. Users may only access information within their authorized scope.

  iQIES Users
  Authorized Medicare Administrative Contractor (MAC) users: may access beneficiary PII/PHI contained within OASIS and MDS assessment records made available through iQIES integration. Information may include beneficiary demographic data, assessment responses, diagnoses, clinical observations, functional status, and other post-acute care assessment information. Access is required to support medical review activities, documentation validation, coverage determinations, and other CMS-authorized program integrity and operational functions. Access is restricted based on user roles and business need.

  AIPC Users
  Authorized MAC users: may access beneficiary and provider information contained within hospice documentation submitted to AIPC, including Hospice Election Statements, Certifications of Terminal Illness (CTIs), physician narratives, and associated metadata. Access is required to perform hospice documentation review, compliance assistance, and operational support activities. Users are limited to information necessary to perform their assigned responsibilities

• Administrators: System Administrators are only accessing the system for management and maintenance of the PCG-FHIR platform. Administrators cannot access the PII that is electronically transported through the PCG-FHIR system.

  Administrators will not have access to any PII.

• Developers: System Developers are only accessing the system for management and maintenance of the PCG-FHIR platform. Developers cannot access the PII that is electronically transported through the PCG-FHIR system.

  Developers will not be able to access any PII.

• Contractors: System Administrators and Developers are CMS direct contractors that only access the system for management and maintenance of the PCG-FHIR platform. System Administrators and Developers do not access the electronically transported medical records sent through the PCG-FHIR system.

  Contractors will not be able to access any PII

• Others: Others - PCG-FHIR parses the PII data from the FHIR bundle input file and transmits the transaction in an encrypted format to RCs. Users of the system (providers and vendors representing them) will have access to PII data pertaining only to their end-users. This access is required to conduct general business regardless of PCG-FHIR.

  PCG-FHIR parses the PII data from the FHIR bundle input file, converts it into an XDR transaction format, and transmits the transaction in an encrypted format to esMD. (Individuals within the PCG-FHIR boundary will not have access to PII that is transferred through the system.)

The principle of least privilege is utilized for all access to the PCG-FHIR system. Access control lists are used to silo access and control access based on an individual’s privileges.

System Administrators and Developers cannot access the PII that is electronically transported through the PCG-FHIR system. System Administrators and Developers are CMS direct contractors that only access the system for management and maintenance of the PCG-FHIR platform.

The PCG-FHIR system does not collect, share or access information directly from individuals. 

Administrative: Administrative controls that are in place to secure PII include only assigning needed privileges to user accounts that access the PCG-FHIR environment. Annual account reviews are performed to ensure that those user accounts have the needed access and automated actions to disable inactive user accounts. 

Technical: Technical controls that are in place to secure PII include Web Application Firewalls that protect and control network traffic that goes in and out of the PCG-FHIR system. Vulnerabilities and exploits are scanned for within the PCG-FHIR system by a Continuous Monitoring program.

Physical: From a physical controls standpoint, PCG-FHIR resides in the CMS Amazon Web Services (AWS) environment. Physical and environmental security controls are inherited from a central level from the Cloud Support team.