Regulation

The CMS Interoperability and Prior Authorization Rule (CMS-0057-F)

Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program (CMS-0057-F), 89 FR 8758

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Regulator

Centers for Medicare and Medicaid Services

Who it applies to

  • Medicare Advantage organisations
  • State Medicaid fee for service programs and state CHIP fee for service programs
  • Medicaid managed care plans and CHIP managed care entities
  • Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, excluding issuers offering only stand-alone dental plans and, under the final rule, issuers offering only QHPs on the Federally-facilitated Small Business Health Options Program Exchanges. QHP issuers on State-based Exchanges on the Federal Platform are not subject to the rule
  • Not Medicare fee for service, not commercial employer sponsored plans, and not plans sold through State-based Exchanges operating their own platforms
  • Not prior authorisation for drugs, which CMS excluded from this rule and addressed separately in the CMS-0062-P proposed rule of April 2026
  • MIPS eligible clinicians, eligible hospitals and critical access hospitals, only for the new Electronic Prior Authorization measure in the Promoting Interoperability programs

Penalties

CMS-0057-F does not create a standalone penalty scheme. Compliance is enforced through the existing authorities that govern each payer type: Medicare Advantage contract oversight and compliance actions for MA organisations, state and federal oversight of Medicaid and CHIP managed care contracts, and Exchange oversight for QHP issuers on the Federally-facilitated Exchanges. CMS finalised an exceptions process for QHP issuers on the FFEs from the API requirements, conditioned on annual approval of a narrative justification. For provider organisations there is no penalty at all under this rule, because it does not regulate them. The provider facing consequence sits in the Promoting Interoperability programs, where the Electronic Prior Authorization measure begins with the calendar year 2027 performance period.

Deadlines

Dates that already bind, and dates still ahead.

DateWhat happens
Final rule published in the Federal Register at 89 FR 8758.
Effective date of the final rule. The substantive obligations phase in later.
Prior authorisation process policies apply: decision timeframes, specific denial reasons, and the requirement to publish metrics. This is the date for MA organisations and state Medicaid and CHIP fee for service programs. Medicaid and CHIP managed care follow from the rating period beginning on or after this date, and QHP issuers on the FFEs from plan years beginning on or after it. Annual reporting of Patient Access API metrics to CMS also begins.
First deadline for impacted payers to post the previous calendar year's prior authorisation metrics publicly on their websites, and to report calendar year 2025 Patient Access API metrics to CMS.
Four FHIR APIs due: Patient Access with prior authorisation information, Provider Access, Payer-to-Payer, and Prior Authorization. Same phasing by payer type as the 2026 dates.
Electronic Prior Authorization measure begins under the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, with the calendar year 2027 performance period and 2029 MIPS payment year.

What changed in 2026

Movement by year, newest first. Where nothing in the text moved, that is recorded too.

  • 2026

    This is the year the rule started to bite. From January 1, 2026 impacted payers have had to meet the shortened decision timeframes, give a specific reason when they deny, and prepare the public metrics that were first due on their websites by March 31, 2026. Those metrics are the first genuinely comparable public dataset on prior authorisation behaviour by plan, and they are worth pulling for every payer you contract with.

    CMS also proposed to go further. CMS-0062-P was published on April 14, 2026 at 91 FR 19890, with comments closing June 15, 2026. It proposes to extend electronic prior authorisation to drugs, to require several HL7 FHIR implementation guides that CMS-0057-F only recommended, to require payers to report their API endpoints to CMS, to collect API usage metrics, and to bring small group market QHP issuers on the FF-SHOP Exchanges into scope. HHS also proposed to adopt FHIR based HIPAA standards for referral certification and authorisation transactions. As of early August 2026 it remains a proposal, so do not build a plan on it, but do read it as a clear signal of direction.

  • 2025

    Nothing in CMS-0057-F itself came due in 2025, but the provider side of the equation moved. The HTI-4 final rule, published inside the FY2026 CMS IPPS final rule and effective October 1, 2025, established the first federal certification criteria for electronic prior authorisation in certified health IT. That is what makes it reasonable to ask an EHR vendor when their electronic prior authorisation capability will be certified rather than merely announced. CMS also ran a Health Technology Ecosystem request for information, published May 16, 2025 at 90 FR 21034, seeking input on the wider interoperability landscape.

  • 2024

    The final rule was published on February 8, 2024 and took effect on April 8, 2024, with the operational requirements deferred to 2026 and the API requirements to 2027. CMS deliberately separated the two so that payers could deliver the process changes without waiting for the technology.

What does CMS-0057-F actually require?

The rule has two halves with different deadlines, and confusing them is the most common mistake in vendor conversations.

The process half, in force since January 1, 2026. Impacted payers must respond to prior authorisation requests for items and services within fixed timeframes, must send notices to providers when they make a decision including a specific reason when they deny, and must publish aggregated metrics about their prior authorisation processes on their own websites each year by March 31. These apply regardless of whether the request arrived through an API, which is the detail that makes them useful immediately.

The technology half, due January 1, 2027. Impacted payers must implement and maintain four FHIR based APIs: an expanded Patient Access API that includes prior authorisation information, a Provider Access API, a Payer-to-Payer API, and a Prior Authorization API.

Both halves phase in the same way by payer type. The stated date applies directly to Medicare Advantage organisations and state Medicaid and CHIP fee for service programs. Medicaid and CHIP managed care plans comply from the rating period beginning on or after that date, and QHP issuers on the Federally-facilitated Exchanges from plan years beginning on or after it. In practice that means a managed care plan with a July rating period is on a different clock to a Medicare Advantage plan, which matters when you are chasing a specific payer.

Which payers are covered, and which are not?

Scope is where most provider organisations lose time, because the rule covers a large share of government funded volume and almost none of the commercial book.

Payer typeIn scope?Decision timeframes apply?Four APIs due
Medicare Advantage organisationsYesYes, from January 1, 2026January 1, 2027
State Medicaid and CHIP fee for serviceYesYes, from January 1, 2026January 1, 2027
Medicaid and CHIP managed careYesYes, from the rating period beginning on or after January 1, 2026Rating period beginning on or after January 1, 2027
QHP issuers on the Federally-facilitated ExchangesYes, with an exceptions process for the API requirementsNo. CMS did not change their timeframes, which remain 15 days for standard and 72 hours for expedited decisions under 45 CFR 147.136Plan years beginning on or after January 1, 2027
Stand-alone dental plan issuers and FF-SHOP only issuersNo, excluded from this final ruleNoNot applicable
QHP issuers on State-based Exchanges on the Federal PlatformNoNoNot applicable
Medicare fee for serviceNoNoNot applicable
Commercial and employer sponsored plansNoNoNot applicable

Two implications follow. First, if your payer mix is heavily commercial, this rule will not fix your prior authorisation problem and you should not size a business case as though it will. Second, for the government funded share it creates a hard, dated obligation you can hold a payer to by name, which is a considerably stronger position than the one providers had in 2023.

How fast do payers now have to decide?

For covered items and services, excluding drugs, the timeframes finalised in CMS-0057-F are:

  • 72 hours for expedited requests, unless a shorter minimum timeframe is established under applicable state law.
  • 7 calendar days for standard requests, with the possibility of an extension of up to 14 days in certain circumstances.

For Medicare Advantage this is a meaningful compression of the standard timeframe. For Medicaid managed care, extensions of up to 14 calendar days remain available under existing rules in defined circumstances. QHP issuers on the Federally-facilitated Exchanges were deliberately left out of the timeframe changes: commenters objected, and CMS declined, pointing to the existing internal claims and appeals standards at 45 CFR 147.136 that already require notification within 15 days for standard determinations and 72 hours for expedited requests.

Alongside the clock, payers must send a notice to the provider on every decision and include a specific reason when they deny. That single requirement is quietly the most useful part of the rule for anyone running denial management, because a specific reason is machine readable in a way that a generic denial code is not, and it is the raw material an appeals workflow needs.

Note what the rule does not do. It does not tell payers what to require prior authorisation for, and it does not constrain how they decide. Constraints on using algorithms in utilisation review are coming from state law rather than from CMS, which is why the California statutes on AI in utilisation review are worth reading next to this one.

What are the four APIs, and what will they let you do?

All four are due by January 1, 2027 on the phasing described above, and all four are FHIR based, building on the technical standards CMS finalised in the 2020 CMS Interoperability and Patient Access final rule.

APIWhat it carriesWhat it changes operationally
Patient Access API, expandedExisting claims, encounter and clinical data, plus information about certain prior authorisationsPatients can see prior authorisation status in an app of their choice, which shifts some status chasing away from your front desk
Provider Access APICurrent patient data from the payer including adjudicated claims and encounter data, excluding remittances and cost sharing, USCDI data classes, and prior authorisation informationYou can pull a payer held longitudinal view for patients attributed to you, useful for care coordination and gap closure
Payer-to-Payer APIThe same data set, exchanged when a patient moves between impacted payersReduces the reauthorisation churn that follows a plan change, subject to patient opt in
Prior Authorization APIWhether prior authorisation is required, what documentation is needed, and submission and status of the request itselfThe one that makes genuine prior authorisation automation possible rather than a screen scraping exercise

A caution on implementation guides. CMS-0057-F requires FHIR based APIs but stopped short of mandating every associated HL7 implementation guide, recommending several instead. That flexibility is why two compliant payers can still be awkward to integrate with in different ways. The CMS-0062-P proposed rule of April 2026 would require certain implementation guides that are currently only recommended, which if finalised would materially improve interoperability in practice. Until then, assume per payer integration work and budget for it.

What should a provider organisation demand from payers and vendors?

You have no obligations under this rule, which means your entire leverage is in what you ask for and when. Six requests are worth making now.

From each impacted payer. One, the URL of the published prior authorisation metrics, which were first due March 31, 2026. Two, their Prior Authorization API roadmap with a named date inside the 2027 window and a sandbox availability date. Three, written confirmation of which implementation guides they will support, since the rule leaves several as recommendations. Four, the format of the specific denial reason they now send, so your revenue cycle automation can parse it rather than route it to a human.

From your EHR or automation vendor. Five, whether their electronic prior authorisation capability is certified to the HTI-4 criteria that took effect October 1, 2025, and if not, when. Six, how the product behaves when a payer is not yet live on the Prior Authorization API, because through 2026 and much of 2027 that will be the normal case and a product that only works against a compliant payer solves nothing this year.

Ask these in writing, in vendor selection rather than after signature, and expect uneven answers. The published metrics in particular tend to surprise people: comparing approval rates and appeal overturn rates across the plans you contract with is now possible with public data, and it changes which contracts you argue about.

Does the rule cover prescription drugs?

No, and this is the single most common misreading. CMS explicitly excluded drugs from the Prior Authorization API and from the process requirements in CMS-0057-F. The timeframes, the specific denial reason requirement and the published metrics all apply to medical items and services excluding drugs covered under the relevant benefit.

CMS proposed to close that gap on April 14, 2026 in CMS-0062-P, published at 91 FR 19890, with comments closing June 15, 2026. The proposal would require impacted payers to make electronic prior authorisation available for drugs and would extend many of the existing interoperability requirements for non-drug items and services to cover drugs. It would also require payers to report API endpoints for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer and Prior Authorization APIs to CMS, collect API usage metrics, bring small group market QHP issuers on the FF-SHOPs into scope, and require several HL7 FHIR implementation guides that are currently only recommended.

As of early August 2026 none of that is law. Plan your drug prior authorisation workflows on the assumption that the current manual and NCPDP based routes persist through 2026, and treat the proposal as a reason to ask vendors whether their architecture could absorb a drug pathway rather than a reason to wait.

What does this rule not do?

Being clear about the limits saves a great deal of misplaced optimism.

  • It does not reduce what requires prior authorisation. Payers still set their own lists. The rule requires that the list be published, not that it shrink.
  • It does not require providers to use the APIs. There is no mandate on your side. The nearest thing is the Electronic Prior Authorization measure in the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, beginning with the calendar year 2027 performance period and the 2029 MIPS payment year.
  • It does not touch commercial plans. For most hospitals and practices, a large share of prior authorisation volume sits outside the rule entirely.
  • It does not regulate how payers decide. Nothing here constrains the use of algorithms in utilisation review, which is being addressed at state level instead.
  • It does not cover drugs. See the section above.

What it does give you is dated, enforceable behaviour from a defined set of payers, and a public dataset to hold them to. That is enough to make a real difference to a prior authorisation automation business case, provided the case is built on your actual payer mix rather than on the rule's headline.

What should you do, and by when?

A sequenced plan for the rest of 2026 and 2027.

  1. Now: segment your prior authorisation volume by payer type. How much sits with Medicare Advantage, Medicaid and CHIP managed care, and QHPs on the Federally-facilitated Exchanges, and how much is commercial or Medicare fee for service and therefore untouched. Everything downstream depends on this number, and the prior authorisation cost calculator is a quick way to put a figure on the addressable share.
  2. Now: pull the published metrics for every in-scope payer you contract with. They were due on payer websites by March 31, 2026. Compare approval, denial and appeal overturn rates and take the outliers into contract discussions.
  3. Now: capture the specific denial reasons payers have been required to send since January 2026, and check whether your intake process is storing them in a structured field rather than a scanned letter.
  4. Q4 2026: get written API roadmaps from your top payers with sandbox dates, and confirm which implementation guides each will support.
  5. Q4 2026: confirm your EHR's HTI-4 electronic prior authorisation certification status and decide whether you integrate natively or through a separate automation layer.
  6. 2027: plan for the Electronic Prior Authorization Promoting Interoperability measure from the calendar year 2027 performance period, and for staged payer go lives rather than a single switch.

The organisations that get value from this rule are the ones that treat 2026 as the year to prepare data and contracts rather than the year to buy software. If you want that sequencing done against your own payer mix, with the build or buy decision made on evidence, that is the work in our deployment roadmap.

Official sources

Primary documents from the issuing authority. Where a summary and the source disagree, the source is right.

Questions we get asked

Does the CMS prior authorization rule apply to commercial insurance?

No. CMS-0057-F applies to Medicare Advantage organisations, state Medicaid and CHIP fee for service programs, Medicaid and CHIP managed care plans, and QHP issuers on the Federally-facilitated Exchanges. Commercial and employer sponsored plans, Medicare fee for service, and QHPs sold through State-based Exchanges operating their own platforms are all outside it.

When do payers have to answer prior authorization requests in 7 days?

Since January 1, 2026 for Medicare Advantage organisations and state Medicaid and CHIP fee for service programs, and from the rating period beginning on or after that date for Medicaid and CHIP managed care. The limits are 7 calendar days for standard requests, with an extension of up to 14 days in certain circumstances, and 72 hours for expedited requests unless state law sets a shorter minimum. QHP issuers on the FFEs are excluded and keep their existing 15 day standard.

Do providers have to use the Prior Authorization API?

No. The rule places no obligation on providers. The closest thing is the Electronic Prior Authorization measure in the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, which begins with the calendar year 2027 performance period and the 2029 MIPS payment year for clinicians, and the calendar year 2027 EHR reporting period for hospitals and critical access hospitals.

Does CMS-0057-F cover prior authorization for drugs?

No. CMS excluded drugs from both the Prior Authorization API and the process requirements. In April 2026 CMS proposed a separate rule, CMS-0062-P at 91 FR 19890, to extend electronic prior authorisation to drugs. Comments closed June 15, 2026 and it was still a proposal as of early August 2026.

Where can I find a payer's prior authorization approval and denial rates?

On the payer's own website. Impacted payers have had to publish aggregated annual metrics since March 31, 2026, covering the list of items and services that require prior authorisation and the percentages approved, denied, approved after appeal, extended and then approved, and the equivalent figures for expedited requests. Ask your payer contact for the exact URL rather than searching for it.

Will this rule make prior authorization automation worth building?

For the government funded share of your volume, it substantially improves the case, because a Prior Authorization API and a structured denial reason are what automation needs. For a commercial heavy payer mix it changes very little. Size the business case on your actual payer segmentation before committing to a platform, and assume payer by payer integration work through 2027.