HIT Perspectives – January 2023
2023 Brings Unprecedented Opportunities to Shape the Future of Interoperability via Policy Making
By Kim Boyd, Regulatory Resource Center Lead & Senior Consultant
- The health IT policy landscape has been busy
- Several critical NPRMs and numerous RFI have been released in recent months
- Whether proposed rules on real-time pharmacy benefit, improving prior authorization & interoperability and digital identity, there is a lot to unpack
- This article provides an overview of key NPRMs
Looking back on 2022, we saw a sharp increase in policy activity with numerous requests for information (RFIs) and notices of proposed rulemaking (NPRMs). The driving force behind this race to finalize and publish new regulations is the increasing need for improved data fluidity and interoperability. To that end, many of the RFIs and NPRMs involve solving the complex issue of interoperability in health care with requirements that include use of new implementation guides (IGs), application programming interface (API) standards, attachments, as well as the standards development and guidance work happening in HL7 Fast Healthcare Interoperability Resources (FHIR) accelerators.
RFIs can be issued by such government entities as the Centers for Medicare & Medicaid Services (CMS) or by private-sector organizations, including FHIR accelerators, professional societies, and nonprofits. RFIs are used to gather ideas, feedback and concerns from a diverse range of health care stakeholders, including patients, providers, payers and health information technology (health IT) developers, to aid in planning and developing new policies or modifying existing ones.
An NPRM is a public notice that is issued by law when an independent agency of the government wishes to add, remove or change a rule or regulation as part of the federal rulemaking process. NPRMs are published in the Federal Register and typically allow 60 days for public comment from any interested party and an additional 30 days for reply comments.
Point-of-Care Partners (POCP) recently submitted responses to CMS RFIs regarding advanced explanation of benefits (AEOBs) and good faith estimates (GFEs) for covered individuals and the development of a national directory of health care providers (HCPs). A summary of these initiatives and our recommendations can be found in our RFI blog post. You can read our complete response to the RFI and the AEOBs and GFEs for covered individuals here, as well as our complete response to the RFI regarding the national directory of HCPs and services here.
Several NPRMs pertaining to data exchange and interoperability were also released. Our experts in federal and state policy, along with our health IT capabilities experts, have been analyzing these notices. To help health care stakeholders understand what is being proposed, we have listed recent NPRMs in order of their comment submission due dates, provided a summary of the rules’ intents and offered some recommendations for you and your organization to consider.
As you dig more deeply into the proposed rules below, keep in mind that you and your organization have the opportunity to shape federal policy in ways that benefit patients and beneficiaries, providers, payers and health IT developers, ultimately giving engaged health care stakeholders competitive data exchange advantages. The only roadblock to becoming engaged in rulemaking commentary is the dragging of one’s feet. The newness of the year may be waning, but resolutions to be proactive, forward-thinking, information-sharing stakeholders should still stick!
CY2024 Policy and Technical Changes Proposed Rule
This proposed rule revises Medicare Advantage (Part C), Medicare prescription drug benefit (Part D), Medicare cost plans, and Program of All-inclusive Care for the Elderly (PACE) regulations. The proposed changes are related to Star ratings, electronic prior authorization (ePA) and real-time prescription benefit (RTPB) standards, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization (PA), passive enrollment, network adequacy, identification of overpayments, formulary changes and other programmatic areas.
Without mention of ePA or RTPB in the name, health IT stakeholders may not recognize the significance this rule could have for their prescribing and billing processes as well as patient data and cost transparency at the point of care. As a member of the National Council for Prescription Drug Programs (NCPDP), POCP has helped lead the creation and implementation of standards for prescription benefit claims (telecommunication), electronic prescribing (ePrescribing) and ePA (SCRIPT) and the RTPB standard.
Via this NPRM and future final rulemaking, there are two standards that CMS proposes to adopt and subsequently incorporate into the Code of Federal Regulation: • NCPDP SCRIPT Standard Implementation Guide, version 2022011, January 2022 (Approval Date for ANSI: December 2, 2021).
• NCPDP Real-Time Prescription Benefit Standard, Implementation Guide, version 12, October 2021 (Approval Date for ANSI: September 27, 2021).
We support adoption of NCPDP SCRIPT, version 2022011, but believe the 18-month transition period during which time either the NCPDP SCRIPT standard version 2017071 or 2022011 can be used, should be extended to 24 months before requiring exclusive use of standard version 2022011. We are encouraged to see that CMS is looking to update Part D to the newer standards in a more accelerated time frame. Similarly, we support adoption of the RTPB standard, but believe the January 1, 2025 deadline to require certification to this standard should be extended to midyear or January 2026. Additionally, there is an updated version of the RTPB standard, version 13, with new features and elements. CMS should consider adoption of version 13 as opposed to version 12.
This rule also proposes requiring updated standards for ePAs, version 2022011. It suggests that once a PA has been approved, it is valid for the duration of the patient’s approved course of treatment and plans must provide a minimum 90-day transition period when Medicare Advantage enrollees currently undergoing treatment may switch plans.
We are assessing Office of the National Coordinator for Health IT standards certification updates regarding patient population designations to improve health equity, care coordination and provider directories that include more specific information regarding language capabilities as well as controlled substance prescribing capabilities.
The deadline for submitting comments for the calendar year 2024 Policy and Technical Changes proposed rule is February 13, 2023.
Advancing Interoperability and Improving PAs
The intent of this proposed rule is to improve patient and provider access to health information and streamline processes for PA of medical items and services. Part of the Biden administration’s commitment to modernizing the nation’s health care system with improved health data exchange and interoperability, it addresses industry feedback received on the CMS December 2020 proposed rule to improve PA processes using technology to improve access to necessary health records.
The new proposed rule adds requirements for use of industry-standard FHIR APIs that will improve a patient’s ability to request their personal health information using a health app. The use of FHIR-based APIs for provider-to-payer data exchange is also a proposed requirement for improving patient care coordination across multiple networks, particularly to facilitate PA decisions. This newly released proposed rule demonstrates a continued commitment to patient-centered care by improving access to information at the point of care. You can find more details about this NPRM in our recent blog post, which summarizes our assessment of it. The deadline for submitting comments for the Advancing Interoperability and Improving Prior Authorizations proposed rule is March 13, 2023.
Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard
This proposed rule requires adoption of standards for attachment transactions to support both medical claims and PA transactions that require documentation or health information that cannot be inserted in ePA request fields or claims transaction forms. It also includes a standard for electronic signatures to be used to consent to health information attachment transactions. The rule implements requirements set out in the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 enacted on March 30, 2010 and collectively known as the Affordable Care Act. This proposed rule will require adoption of an HL7 standard clinical document architecture (CDA). HL7 produces a consolidated CDA implementation guide that specifies document types.
The National Committee on Vital and Health Statistics, an advisory committee that makes recommendations to the Department of Health and Human Services (HHS) , has held numerous hearings regarding claims attachment standards. The Workgroup for Electronic Data Exchange, which also advises HHS, hosted a meeting in December to discuss how attachment requirements and consolidated CDA implementation will converge with FHIR standards. Additional meetings are planned to discuss updating to the X12 standard in a phased approach. The deadline for submitting comments to the Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard is March 21, 2023.
NIST Digital Identity Guidelines
The National Institute of Standards and Technology (NIST) is working to ensure that standards for information exchange protect digital identities and patient privacy. In the fourth draft revision to its digital identity guidelines, technical requirements and recommended processes for meeting digital identity management assurance levels are provided. These include identity proofing, authentication, and federation, as well as security and considerations for equity. More information about these guidelines can be found here. The deadline for submitting comments to NIST about the digital identity guidelines is March 24, 2023.