CMS Final Rule Impacts Payers’ Approval and Denial Practices

CMS Interoperability and Prior Authorization Rule Significantly Impacts Payers’ Approval and Denial Practices

Overview


On January 17, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the CMS Interoperability and Prior Authorization final rule (Final Rule) (fact sheetCMS’ interoperability website), which aims to improve prior authorization processes and enhance patient, provider and payer access to interoperable patient data.

The Final Rule builds on the technological foundation implemented in CMS’ May 2020 CMS Interoperability and Patient Access rule and broadly applies to Medicare Advantage (MA) organizations, state Medicaid and the Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the federally facilitated exchanges (FFEs) (collectively referred to as Payers).[1]

The Final Rule requires Payers to, among other things, implement certain application programming interfaces (APIs) to improve electronic data exchanges, adds a new measure to the Merit-based Incentive Payment System (MIPS) to encourage the adoption of electronic processes, and streamlines prior authorization to reduce the burden on providers and facilitate patients’ timely access to care. This On the Subject focuses on key changes to Payers’ prior authorization practices.

In Depth


IMPLEMENTATION AND MAINTENANCE OF PRIOR AUTHORIZATION API

Beginning in 2027, Payers must implement Prior Authorization API to further “support and streamline” prior authorization decisions. The API must (i) be populated with the Payer’s list of covered items and services that require prior authorization, (ii) identify the documentation required to obtain approval of the item/service, (iii) support a Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant request and response, and (iv) communicate whether the Payer approves, denies or requires more information regarding the request. With respect to an approval, a Payer must communicate the date or circumstance under which an authorization ends. As for a denial, a Payer must communicate the specific reason for the denial (as discussed further below).

The implementation of a Prior Authorization API may require Payers to make substantial investments. CMS delayed the proposed implementation date of this requirement by one year to allow Payers additional time to develop, test and maintain their platforms, as well as to conduct outreach and education to providers. Providers are not required to use the Prior Authorization API; however, the Final Rule includes incentives to encourage certain providers to take up the platforms (e.g., by finalizing new electronic prior authorization measures for MIPS-eligible clinicians).

PROVIDING REASONS FOR DENIALS

When Payers deny prior authorization requests today, the information they provide often varies from one Payer to the next. Beginning in 2026, the Final Rule will require Payers to provide a specific reason for denying a prior authorization request, regardless of the method used to send the request (calls, email, standard transactions, etc.). A “specific reason” for denial may include referencing the plan provision on which the denial is based, citing to coverage criteria, providing a narrative explanation, or noting that the documentation submitted did not support the plan of care. In comments to the Final Rule, CMS indicates that a “specific reason” for the denial means a Payer must provide sufficient information in the denial response so that a provider understands what action they must take to obtain coverage, which may include an appeal, submission of additional information or identifying alternative treatment options.

Depending on the line of business, Payers may already be subject to certain denial notification standards (e.g., before an MA plan can issue a denial based on medical necessity, the decision must be reviewed by a healthcare professional with relevant expertise). Those standards remain intact and are not changed by the Final Rule.

PRIOR AUTHORIZATION DECISION AND NOTIFICATION TIMEFRAMES

The Final Rule meaningfully shortens Payers’ decision and notification timeframes for standard prior authorization requests (i.e., a non-expedited, non-urgent request), while establishing decision timeframes for expedited prior authorization requests (i.e., an urgent request) for Medicaid FFS and CHIP FFS, which are not currently specified in federal regulations. Generally, Payers must now respond as expeditiously as a patient’s health condition requires but no later than 72 hours after receiving an expedited request (unless a shorter timeframe is required by applicable state law)[2] and no later than seven calendar days after receiving a standard request. In some instances, the timeframe for responding to a standard request may be extended to up to 14 calendar days. The reduced timeframes do not apply to QHP issuers on the FFEs since those issuers are subject to unique claims and appeals, external review and pre-service claims processes.

The new standards will apply beginning in 2026.

Depending on the line of business, the timeframes for standard prior authorization requests are noticeably shorter than current standards. For example, for MA plans, existing regulations require organizations to notify a beneficiary of its determination for a standard prior authorization request within 14 calendar days after the organization receives the request. Under the Final Rule, this timeframe would be cut in half for standard requests.

Current vs. Finalized Prior Authorization Timeframes

Line of Business Current Standard Finalized Standard
Expedited Standard Expedited Standard
Medicare Advantage and Applicable Integrated Plans As expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receiving the request As expeditiously as the enrollee’s health condition requires, but no later than 14 calendar days after receiving the request As expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receiving the request As expeditiously as the enrollee’s health condition requires, but no later than 7 calendar days after receiving the request
Medicaid Managed Care As expeditiously as the beneficiary’s health condition requires, but no later than 72 hours after receiving the request As expeditiously as the beneficiary’s health condition requires and within state-established time frames that may not exceed 14 calendar days following receipt of the request As expeditiously as the enrollee’s health condition requires and no later than 72 hours after receipt of the request As expeditiously as the enrollee’s health condition requires and within State established timeframes that may not exceed 7 calendar days after receiving the request
CHIP Managed Care As expeditiously as the beneficiary’s health condition requires, but no later than 72 hours after receiving the request As expeditiously as the beneficiary’s condition requires and within state-established time frames that may not exceed 14 calendar days following receipt of the request As expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receipt of the request, unless a shorter minimum time frame is established under state law As expeditiously as the enrollee’s condition requires but no later than 7 calendar days after receiving the request, unless a shorter minimum time frame is established under state law
Medicaid FFS Not specified in federal regulation Not specified in federal regulation As expeditiously as a beneficiary’s health condition requires, but in no case later than 72 hours after receiving the request, unless a shorter minimum time frame is established under state law As expeditiously as a beneficiary’s health condition requires, but in no case later than 7 calendar days after receiving the request, unless a shorter minimum time frame is established under state law
CHIP FFS Not specified in federal regulation 14 calendar days following receipt of the request for items and services In accordance with the medical needs of the patient, but no later than 72 hours after receiving the request for an expedited determination In accordance with the medical needs of the patient, but no later than 7 calendar days after receiving the request
QHP Issuers on the FFEs As soon as possible, taking into account the medical exigencies, but not later than 72 hours after receipt of the claim Within a reasonable period of time appropriate to the medical circumstances, but not later than 15 days after receipt of the claim No change No change

Authors’ summary of CMS’ proposed rule (Table 4) and Final Rule (Table E1), with a few modifications to reflect more detail. Extensions of timeframes are not included in the chart.

PUBLIC REPORTING: APPROVALS, DENIALS AND APPEALS

Beginning in 2026, Payers must post on their websites prior authorization data, including:

  • A list of all items and services that require prior authorization
  • The percentage of standard prior authorization requests that were approved, denied and approved after appeal
  • The percentage of prior authorization requests for which the timeframe for review was extended
  • The percentage of expedited prior authorization requests that were approved and denied
  • The average and median time that elapsed between the submission of a request and a determination by the Payer for both standard and expedited requests.

MA plans will report at the contract level (a change from CMS’ proposed rule), Medicaid managed care plans and CHIP managed care entities will report at the plan level, QHP issuers on the FFEs will report at the issuer level, and state Medicaid and CHIP FFS programs will report at the state level.[3] Payers must post the initial set of metrics by March 31, 2026, and then provide updates annually thereafter. At this time, CMS will not collect the prior authorization data itself. However, the agency will continue to monitor complaints received by beneficiaries and providers for potential discrimination through prior authorization and utilization management programs and will take action, as necessary.

Note that none of the prior authorization policies included in the Final Rule apply to drugs.[4] CMS may consider options for improving the prior authorization processes for drugs in future rulemakings.

Endnotes


[1] Integrated plans must report items and services covered by MA organizations at the MA contract level and items and services covered by Medicaid managed care plans at the plan level.

[2] The policies do not apply to prescription drugs that may be self-administered, provider-administered, dispensed or administered in a pharmacy or hospital or over-the-counter drugs that may be covered by an applicable payer. Payers may voluntarily incorporate these policies into their business rules for prior authorizations for drugs

[3] Note that the policies do not apply to health insurance issuers or group health plans outside the FFEs (e.g., commercial payers generally and employer-sponsored plans), though such payers may voluntarily implement the provisions to the extent permitted under federal and state laws.

[4] CMS specifically authorizes states to set shorter timeframes for prior authorization decisions for state Medicaid programs, CHIP FFS programs, Medicaid managed care plans and CHIP managed care entities under 42 CFR 438.210 and 42 CFR 457.495(d)(2). CMS also notes that states may require an applicable integrated plan to adhere to a shorter timeframe through contract.