HHS finalizes rule for prescription drug cost transparency

The health IT arm of the Department of Health and Human Services finalized a rule this week that federal leaders say will remove red tape and enable faster prior authorization and real-time prescription benefit checks.

The policy changes also will improve electronic prescribing standards, the agency said.

The final rule, called the Health Data, Technology, and Interoperability: Electronic Prescribing, Real – Time Prescription Benefit and Electronic Prior Authorization rule, or HTI-4, was included as a portion of the Centers for Medicaid and Medicaid Services’ (CMS) Inpatient Prospective Payment System (IPPS) rule, a 2,000-page rule that dropped on Thursday.

ASTP offers a fact sheet outlining the major updates in the rule. The unpublished version of the CMS IPPS rule can be found here.

The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) leads the federal government’s health IT efforts and establishes criteria for certified heath IT tech, such as electronic health records (EHRs).

ASTP has released a series of “Health Data, Technology, and Interoperability” (HTI) regulations over the last two years. The HTI-1 final rule was issued in December 2023 to move the needle on interoperability and established first-of-its-kind nationwide requirements for transparency around AI and algorithms used in health IT.

Six months later, in July 2024, ASTP proposed another major policy update with its HTI-2 rule, a hefty draft rule that clocked in at 1,067 pages with implications for public health and payer health IT. But HHS ultimately finalized a pared-down version of HTI-2 in December aimed at advancing health data interoperability and implementing provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA).

HTI-2 did not include certification for public health and payer health IT, nor was it included in this latest rule.

Also in December, ASTP pushed through the HTI-3 final rule with proposals related to reproductive health data and information blocking regulations.

Many industry experts speculated that ASTP/ONC broke up the sweeping HTI-2 proposed rule in order to finalize as much as it could before the new administration took office this past January.

The provisions in this latest rule, HTI-4, were all pulled from the HTI-2 proposed rule released a year ago and also align with CMS priorities. The rule aims to support technical requirements included in CMS’ Interoperability and Prior Authorization regulation unveiled in January 2024 that aims to shift payers to electronic prior authorization.

The HTI-4 final rule will enable “the use of certified EHRs to submit prior authorizations, select drugs consistent with a patient’s insurance coverage, and exchange electronic prescription information with pharmacies and insurance plans,” according to a blog post authored by Thomas Keane, M.D., Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology and Steve Posnack, Principal Deputy Assistant Secretary for Technology Policy and Principal Deputy National Coordinator for Health Information Technology.

With the updated criterion, certified EHRs will now help providers speed up care and reduce admin burden, according to ASTP.

Patients and prescribers can use the tools that are being added to health IT certification to compare drug prices and identify lower cost alternatives. ASTP is adding a new certification criterion enabling prescriber access to prescription benefit information at the point of care, Keane and Posnack wrote.

“Through ongoing collaboration and coordination with CMS, we are committed to advancing interoperability for patients, health care providers, and payers to ease administrative burdens. This final rule is a critical step in these efforts,” the ASTP leaders wrote.

Brendan Keeler, a health IT thought leader and interoperability practice lead at HTD Health, noted in a LinkedIn post that ASTP’s move to finalize the HTI-4 rule “is not a massive revamping of the certification program but fairly tactical updates to support CMS programs short term.”

And the fact that ASTP published the health IT policy inside a larger CMS rule could signal a new pattern — “ASTP is subordinate and in service of the CMS. Worth tracking,” Keeler noted.

According to ASTP, the updates in this latest health IT regulation enable improvements to workflow automation, reduce the manual effort required to conduct prior authorizations, improve operational workflow and support more timely and transparent clinical decision-making.

“We estimate these efficiencies will save millions of hours of clinician time annually, totaling $19 billion in labor cost savings over 10 years. In turn, that time savings can be used to spend more time with patients and less time on paperwork,” ASTP wrote in the fact sheet.

Key dates to keep in mind:

Developers certifying a health IT module to the electronic prescribing criterion may use either the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 or 2023011 during a transition period ending December 31, 2027.

After January 1, 2028, certified health IT developers certifying a health IT module to the electronic prescribing criterion may only be certified to the updated version of the criterion using NCPDP SCRIPT standard version 2023011.

Here are top takeaways from the rule:

Electronic prescribing

ASTP is updating the baseline standard for electronic prescribing for the first time in half a decade.

The HTI-4 final rule updates the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3), which supports the availability of certified health IT to enable the exchange of prescription information among prescribers, pharmacies, intermediaries and payers.

The electronic prescribing certification criterion now incorporates an improved version of the NCPDP SCRIPT standard. ASTP/ONC adopted the standard last year in collaboration with CMS to support nationwide interoperability between prescriber systems and Medicare Part D sponsors. ASTP now requires that prescriber systems support functionality for electronic prior authorization of prescriptions, which until now was optional in the program.

The updated criterion is based on the NCPDP SCRIPT standard version 2023011.

Previously optional electronic prior authorization transactions are now required for the certification criterion, while additional optional transactions have been removed in order to simplify the criterion. ASTP points to section XI.B.4.b.(3) in the HTI-4 final rule for more details.

Real-time prescription benefit

The HTI-4 final rule adopts a new real-time prescription benefit certification criterion to enable access to prescription drug information that providers and their patients can use to compare the cost of a drug of a suitable alternative. The finalized certification criterion is based on the NCPDP Real-Time Prescription Benefit standard version 13. This certification criterion will be included in the Base EHR definition in 45 CFR 170.102 beginning on January 1, 2028.

Any health IT module presented for certification to the electronic prescribing criterion must also be certified to the real-time prescription benefit criterion, ASTP said.

Electronic prior authorization

The final rule also adopts three new certification criteria to support more efficient management of electronic prior authorization tasks and reduce administrative burden for providers. These criteria are based on Fast Healthcare Interoperability Resources (FHIR) implementation specifications developed by the HL7 Da Vinci project.

The criteria enable providers using certified health IT to: request information from payers about coverage requirements; navigate and assemble the information needed to support a prior authorization request; submit that request directly from their certified health IT system; and, monitor the status of a request, Keane and Posnack wrote in the blog post.

“This all drives towards Da Vinci Prior Authorization, now broken into three criteria. It’s required rather than recommended like it is for payers, but it’s not yet included in Base EHR definition by a specific date,” Keeler wrote in his LinkedIn post breaking down the final rule.

The three new certification criteria are:

Provider prior authorization API – coverage requirements discovery, which enables a healthcare provider to request information from payers about coverage requirements.

Provider prior authorization API – documentation templates and rules, which provides a mechanism for clinicians and other EHR users to navigate and quickly assemble the information needed to support a prior authorization request according to a payer’s requirements.

Provider prior authorization API support to allow submission of prior authorization requests from health IT systems as well as checking the status of a previously submitted request.

These new health IT certifications align with prior authorization API requirements CMS established for impacted payers in the 2024 CMS Interoperability and Prior Authorization Final Rule.

These criteria will also support healthcare providers participating in the Medicare Promoting Interoperability program and the MIPS Promoting Interoperability performance category, who will be required to report on an electronic prior authorization measure beginning in 2027, ASTP said.

Modular API criteria

HHS also adopted two additional health IT certification criteria for API functionality that are referenced in the criteria for electronic prior authorization included in HTI-4.

A new criteria for workflow triggers for decision support interventions for clients will enable clinical decision support tasks through an API, allowing decision support results to be integrated into a provider’s EHR workflow.

And, a subscriptions criteria will let a user or system to be notified by a server of a particular event or data update of interest.

Adoption of standards for patient, provider and payer APIs

The HTI-4 final rule also pushes forward implementation specifications related to the exchange of clinical and administrative data with payers as well as the sharing of formulary and provider directory information.

Three of these specifications (CRD, DTR, PAS) support the criteria finalized for electronic prior authorization. The other specifications were recommended by CMS for use by payers implementing the APIs established in the Interoperability and Prior Authorization Final Rule.