On July 31, 2025, the Assistant Secretary for Technology Policy (ASTP)  finalized the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing rule—also known as HTI-4. While not as buzzy as some recent policy headlines, this rule quietly packs a punch for developers, providers, and policymakers working to build a more transparent and connected prescription drug ecosystem.

At its core, HTI-4 is about making prescribing and medication access more real-time, transparent, and aligned with patient needs. It updates health IT certification criteria in three key areas: electronic prescribing, real-time prescription benefit (RTPB), and electronic prior authorization (ePA).

What’s in the HTI-4 Final Rule?

So, what exactly did ASTP finalize in HTI-4? While it builds on concepts introduced in earlier rules, specifically HTI2, and aligns with other federal initiatives such as CMS Interoperability and Prior Authorization Final Rule CMS-507-F, this rule zeroes in on health IT certification updates intended to improve transparency, efficiency, and interoperability in prescribing and prior authorization workflows. HTI4 focuses on enabling health IT developers to support real-time prescription information, modernized ePrescribing, and automated prior authorization—while reinforcing FHIR and NCPDP standards across the board. Taking a closer look at the rules, key provisions include:

1. Real-Time Prescription Benefit (RTPB):
   HTI-4 implements provisions from the Consolidated Appropriations Act (CAA) of 2021, which enables prescribers to access prescription benefit information at the point of care. It finalizes a new certification criterion requiring the use of the National Council of Prescription Drug Plans (NCPDP) Real-Time Prescription Benefit standard (version 13). This capability allows providers and patients to see medication cost information—including formulary coverage, out-of-pocket costs, and whether prior authorization is required—right at the point of prescribing. The goal is to help prescribers and patients compare drug prices and identify lower cost alternatives.

• • For Medicare Part D: This builds on CMS’s Part D requirements that already support RTPB, reinforcing the expectation that certified health IT systems should facilitate transparent prescribing decisions for beneficiaries.
  • For Providers: While the rule applies to Medicare only, there’s growing pressure for commercial health plans to follow suit. Providers don’t want to toggle between workflows depending on the patient’s insurance. Health plans may find themselves fielding questions from providers who expect the same functionality across all health plans for patients.
  • For Patients: Especially in Medicare, where drug costs are a common burden, giving beneficiaries visibility into their options is a step toward empowering more informed decisions. While adoption statistics are still catching up, the availability of these tools could help patients compare alternatives and potentially reduce their out-of-pocket costs.
  • For the Market: Broader adoption of RTPB tools—if implemented consistently/optimally—could drive overall system savings. A well-informed, value-conscious patient is a key piece in bending the cost curve.

2. Electronic Prescribing:
   The rule updates certification criteria to align with the latest version of the NCPDP SCRIPT standard (2023011), which supports better communication between prescribers and pharmacies. The improved script version was adopted in collaboration with CMS to support nationwide interoperability between prescriber systems and Part D sponsors. The rule also requires prescriber systems to support functionality for ePA of prescriptions. Health IT developers have until the end of 2027 to make the transition. After January 1, 2028, systems must be certified to the new standard.
   
   
3. Electronic Prior Authorization (ePA):
   HTI-4 also formalizes three certification criteria based on Fast Healthcare Interoperability Resources (FHIR®) implementation specifications for ePA. These criteria, leveraging standards from the HL7 Da Vinci Project, will enable providers using certified health IT to request coverage requirement information from health plans needed for a prior authorization request, submit the request directly from their certified system, and monitor the status. These standards enable providers to:

• • Request coverage information from payers
  • Assemble required documentation
  • Submit and check the status of prior authorization requests

This aligns with the broader push under CMS-0057 to reduce administrative burden and increase automation in the prior authorization process.

Who Must Comply with HTI‑4?

The HTI‑4 final rule establishes updated health IT certification criteria—which must be followed by health IT developers (for certification purposes)—and affects healthcare providers who use certified health IT within CMS’s programs (e.g., Medicare Promoting Interoperability, MIPS). It is not placing new mandates on Medicare Part D plans or commercial payers under this rule itself.

To clarify:

• Health IT developers must ensure their products, including EHRs, meet the updated criteria for electronic prescribing, real-time prescription benefit, and electronic prior authorization.
• Healthcare providers must use certified health IT that meets these criteria if they participate in relevant Medicare programs.
• The rule does not impose new requirements on Medicare plans or commercial payers—although there is logic for payers to adopt the functionality voluntarily to support interoperability goals.

Adoption of Standards for Patient, Provider, and Payer APIs

HTI4 also adopts a broader set of FHIR-based implementation specifications for APIs that support clinical and administrative data exchange—including formulary and provider directory information. These include:

• CRD: Coverage Requirements Discovery (HL7 FHIR Da Vinci IG v2.0.1 – STU 2)
• DTR: Documentation Templates and Rules (HL7 FHIR Da Vinci IG v2.0.1 – STU 2)
• PAS: Prior Authorization Support (HL7 FHIR Da Vinci IG v2.0.1 – STU 2) — all supporting the ePA criteria in the rule
• CARIN IG for Blue Button®: Consumer Directed Payer Data Exchange (v2.0.0 – STU 2 US)
• Da Vinci PDex: Payer Data Exchange (v2.1.0 – STU 2.1)
• Da Vinci PDex – US Drug Formulary (v2.0.1 – STU 2)
• Da Vinci PDex – Plan Net (v1.1.0 – STU 1.1 US)

These guide how payers, providers, and patients access and exchange structured data—like formulary information, provider directories, and prior authorization workflows—through standardized FHIR APIs. While CMS recommended these in related API rules, their inclusion in HTI‑4 signals growing alignment across ASTP certification and CMS interoperability initiatives.

Deadlines to Know:

• Real-Time Prescription Benefit and SCRIPT: January 1, 2028 – new standards go into effect for certification
• Electronic Prior Authorization Measure Reporting: Begins in 2027 for Medicare providers in relevant programs
• Transition Period: Through December 31, 2027, developers may continue using the previous SCRIPT standard (2017071)

What Happens if You Don’t Comply?

There’s no fine spelled out in HTI-4 itself. However, failure to meet the related CMS program requirements could reduce reimbursement for providers by up to a quarter of the annual payment update for hospitals, for example. For providers participating in the Medicare Interoperability Program (MIPS), noncompliance can result in reduced reimbursement. Since the primary audience for the rule is certified health IT developers, noncompliance could mean losing certification altogether. And let’s be real: in a highly competitive health IT market, losing compliance status or appearing behind on interoperability is a business risk you don’t want.

Final Thoughts

HTI-4 may not make big headlines, but it’s a meaningful move toward more consistent, real-time medication access and administrative simplification. It reinforces technical standards already in play, raises the bar for certified health IT, and signals where the policy winds are blowing toward more transparency, automation, and usability for both providers and patients.

The rule doesn’t require commercial plans to act, but it does set the stage for market competition. Health plans, vendors, and provider groups that want to stay ahead of expectations—or keep their stakeholders happy—should be looking beyond minimum compliance to smart, scalable implementation across their whole populations.

POCP has been involved in the development of these standards. If you are looking to check the box, of course, we're available to help. If you're looking to leverage your compliance work toward gaining a competitive advantage, we'd be delighted to brainstorm ways you could maximize the opportunity. Reach out to us to set up a time to chat.