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HomePublicationsOncology Issues

CMS Proposal Expands Prior Authorization Protections for Prescription Drugs Across Health Plans

June 15, 2026
Oncology Issues
June 2026
Volume 41
Issue 3

Author(s):

Nicole Tapay, JD

BY NICOLE TAPAY, JD

CMS Proposal Expands Prior Authorization Protections for Prescription Drugs Across Health Plans
Download Issue PDFDownload PDF

The Centers for Medicare & Medicaid Services (CMS) proposed a new rule on April 10, 2026, building upon an earlier regulation that set forth important prior authorization (PA) requirements for many health plans. The existing rule went into effect at the beginning of 2026 and applied to Medicare Advantage (MA) organizations, State Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs and managed care plans, and certain Affordable Care Act (ACA) plans. However, the rule had a significant limitation: It focused on PA for non-drug items and services and did not include standards for decisions relating to prescription drugs.

CMS now proposes to address this gap by requiring impacted payers to notify enrollees and providers of PA decisions related to drugs within set time frames and increase transparency for the PA of drugs through reporting requirements. The proposal also requires plans to support electronic PA for drugs covered under a medical benefit. The time frames for PA decision notifications and the requirements for electronic PA would be effective as of October 1, 2027.1

Some types of plans were already subject to requirements relating to PA decisions for drugs. However, this proposal would improve upon past requirements by requiring more plans to notify providers of PA decisions relating to drugs within specific time frames.2 This is especially important since PA is often required for chemotherapies as well as prescription drugs for ongoing illnesses.3

CMS is also soliciting input on whether additional types of drugs should be subject to similar PA requirements, as well as on possible streamlining or shortening of certain standards to improve consistency across plan types.

Medicare Advantage

MA plans are already subject to time frames for PA for Part B drugs. Current regulations require MA organizations to notify the enrollee (and the prescribing physician or other prescriber, as appropriate) of their decision on a request for a Part B drug as expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receiving a request and no later than 24 hours after receiving an expedited request. If a request for a Part B drug is denied, MA organizations must provide specific reasons for the denial along with additional information, such as how to request an appeal. Medicare Part D prescription drug plans are subject to similar rules. Given these existing requirements, the proposal did not propose changes to the PA notification standards for MA plans.4

The proposal includes new reporting requirements for MA plans (which offer Medicare Part B drugs). It would be mandatory to incorporate a list of Part B drugs requiring PA into the electronic application programming interface by October 1, 2027, and annually and publicly report specified PA metrics for Part B drugs no later than March 31, 2028.5

Furthermore, CMS is soliciting comments on whether there are any Part A (inpatient) drugs that are not included as part of a larger bundle of inpatient services, to which time frame requirements for PA decisions should apply for MA organizations. If so, the agency indicates it would consider finalizing a policy to ensure that all drugs requiring PA have “appropriate decision time frames.”6

Health Plans on the Federal Affordable Care Act Exchanges

Under the proposal, qualified health plan insurers (QHPs) on the federal ACA exchanges must notify the requesting provider about decisions on PA requests for drugs as expeditiously as required by the enrollee’s health condition, but no later than 72 hours after receiving a standard PA request and no later than 24 hours after receiving an expedited PA request.7

The proposal also requires QHPs to provide notice to the requesting provider of prior authorization decisions for non-drug items and services as expeditiously as the enrollee’s health condition requires, but no later than 7 calendar days after receiving a standard prior authorization request, and no later than 72 hours after receiving an expedited request for non-drug items and services.7 This notice requirement for expedited requests is consistent with current requirements for notifying enrollees of such decisions.7 Under the proposal, the time frames for PA requests for drugs and non-drugs would go into effect on October 1, 2027.7

The agency is soliciting comments on whether it should shorten the timelines for QHPs’ decisions on drugs to 24 hours for both standard and expedited requests, to align with existing standards for State Medicaid FFS programs, Medicaid managed care plans, and CHIP managed care entities, and on its proposal for State CHIP FFS programs, described below.

The proposal would allow QHP issuers to extend the time frames to notify the requesting provider of a PA decision by up to 14 calendar days under certain circumstances, and requires the QHPs to notify the requesting provider in writing of the reasons for the delay and inform the provider of the right to file an expedited grievance if the provider disagrees.8 Additionally, the proposed rule requires QHPs to provide a specific reason for the denial when denying PA requests for drugs, effective October 1, 2027.9 The proposed regulation also includes proposed reporting requirements relating to PA by QHPs for covered drugs.10

State Medicaid and CHIP FFS Programs and Medicaid and CHIP Managed Care Plans

State Medicaid FFS programs, Medicaid managed care plans, and CHIP managed care entities already have required time frames for PA decisions for covered outpatient drugs. They must respond to these PA requests within 24 hours and dispense at least a 72-hour supply of the drug in the case of emergencies. However, a different timeline applies to State CHIP FFS programs. As of January 1, 2026, State CHIP FFS programs must respond within 7 days to standard PA requests for drugs and 72 hours for expedited requests.6 CMS is proposing to align the required timeline for CHIP FFS programs to respond to PA requests for drugs with the requirements that apply to Medicaid FFS programs, managed care plans, and CHIP managed care plans.6

Additionally, CMS is asking if there are gaps in PA time frame requirements for some drugs and, if so, proposes to apply the PA decision time frames for non-drug items and services outlined in the PA rule already in effect to any subset of drugs without already-established PA time frames. This would apply to both State Medicaid FFS programs and managed care plans.6

Similar to QHPs, the proposed rule would require State Medicaid and CHIP FFS programs and managed care plans to communicate to providers the specific reason for denying a PA request for drugs, effective October 1, 2027.11 It also includes proposed reporting requirements relating to PA for covered drugs by Medicaid and CHIP FFS programs and managed care plans.12

Public Comment Period

CMS is accepting comments on the proposed rule until June 15, 2026. ACCC intends to submit comments and will continue to provide updates on its development.

Nicole Tapay, JD, is the director of cancer care delivery and health policy for the Association of Cancer Care Centers in Rockville, Maryland.

References

1. Centers for Medicare & Medicaid Services. 2026 CMS interoperability standards and prior authorization for drugs proposed rule. cms.gov. April 10, 2026. Accessed April 29, 2026. https:// www.cms.gov/newsroom/ fact-sheets/2026-cms-interoperability-standardsprior-authorization-drugs-proposed-rule

2. Centers for Medicare & Medicaid Services. Summary of proposed provisions in the 2026 CMS interoperability standards and prior authorization for drugs proposed rule (CMS0062-P). cms.gov. Accessed April 29, 2026. https://www.cms.gov/files/ document/summary-changes-provisions-rule10apr26-final-508-compliant.pdf

3. Henry TA. Fixing prior auth: nearly 40 prior authorizations a week is way too many. American Medical Association Newswire. April 24, 2025. Accessed April 29, 2026. https://www.ama-assn. org/practice-management/prior-authorization/ fixing-prior-auth-nearly-40-prior-authorizationsweek-way

4. Federal Register. Vol 91, No 71, p. 19933. April 14, 2026. Accessed April 29, 2026. https://www.govinfo. gov/content/pkg/FR-2026-04-14/pdf/2026-07205. pdf (Hereafter, referred to as “Fed. Reg.”)

5. Fed. Reg. p. 20049.

6. Fed. Reg. p. 19935

7. Fed. Reg. p. 19894.

8. Fed. Reg. pp. 19936-19937 and pp. 20060-20061.

9. Fed. Reg. p. 19893 and p. 20059.

10. Fed. Reg. pp. 19941-19945.

11. Fed. Reg. 19893.

12. Fed. Reg. pp. 19941-19945.

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