Comments to Administrator Oz on the CMS proposed rule on interoperability standards and prior authorization for drugs
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, Maryland 21244
Dear Administrator Oz:
The HIV+Hepatitis Policy Institute is a national organization promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. We submit these comments on the Centers for Medicare & Medicaid Services’ proposed rule on Interoperability Standards and Prior Authorization for Drugs (CMS-0062-P).
We believe that prior authorizations (PAs) are overused, frequently inappropriate, and impose serious burdens on patients, caregivers, and providers. A 2024 survey by the American Medical Association found that 93% of physicians report that PAs cause patient care delays, 82% say they can lead to treatment abandonment, and 29% reported that PA caused a serious adverse event in a patient’s care.[1] A 2025 IQVIA analysis substantiated these findings, showing that approximately 27% of all written prescriptions in the U.S. go unfilled due to insurance rejections, high costs, and PA issues.[2]
For individuals managing serious chronic conditions like HIV and hepatitis, PA delays and denials lead to dangerous treatment gaps, heightened risks of drug resistance, and irreversible health consequences. Evidence shows that utilization management techniques (UMTs), including PA, severely disrupt HIV care. Specifically, one provider-based study reported that 72% of clinicians found that UMTs and restrictive formularies directly impede their ability to prescribe optimal HIV treatment and pre-exposure prophylaxis (PrEP).[3]
Given the clinical urgency of managing and preventing HIV, CMS should establish a baseline policy that prior authorization is entirely prohibited for antiretrovirals across all programs under its oversight. Medicare and many state-regulated markets have already successfully established this standard, reflecting a broad consensus that access delays for these lifesaving medications are clinically unacceptable. We expand on this position in our detailed recommendations below.
We commend CMS for taking on prior authorization for prescription drugs. CMS established interoperability and prior authorization requirements for medical items and services in its 2024 final rule but did not include prescription drugs. Extending these protections to drugs is long overdue and critically important to patients. We urge CMS to use this rulemaking not simply to standardize the PA process, but to meaningfully reduce its use and overall burden. Our comments address decision timeframes, metrics reporting, step therapy protections, laboratory test access, and the need for meaningful enforcement.
Electronic Prior Authorization and Interoperability APIs
Sec. II.A: Interoperability Standards for APIs; Sec. II.B: Electronic Prior Authorization for Drugs; Sec. II.B.3: Medical Benefit Drugs in PA API
We support CMS’s proposals to improve FHIR-based interoperability APIs so that providers can access real-time coverage and formulary information and complete PA requests more efficiently. Streamlining this process matters most for patients with chronic conditions who depend on consistent access to medications. We offer two recommendations to strengthen these provisions.
Recommendation
We recommend CMS require PA APIs for medical-benefit drugs to enable real-time, patient-specific coverage checks, analogous to the existing pharmacy-benefit PA APIs. This is especially important for HIV long-acting injectable medications used for both treatment and prevention, where coverage pathways vary significantly by payer and clinical setting. Importantly, while federal guidance has prohibited PAs for PrEP since 2024, plans frequently exploit the complexities of medical-benefit billing for newer long-acting formulations to circumvent these protections. Real-world implementation science data on novel long-acting injectable PrEP illustrates this barrier acutely, demonstrating that the median time from a written prescription to the first injection is 27 days, with PA requirements alone responsible for an average delay of 11.6 days.[4] Without patient-specific, real-time coverage information at the point of care, providers face delays before a PA request is even submitted.
Recommendation
We recommend CMS require plan APIs to clearly flag when a state law prohibits a PA on a particular drug or requires a shorter decision timeframe than what the plan proposes. For example, multiple states prohibit the use of PAs or step therapy for PrEP, post-exposure prophylaxis (PEP), or HIV treatments. CMS should clarify that the federal timeframes in this rule are a floor, not a ceiling, and do not preempt stronger state-level protections. Surfacing this information directly in the API response by requiring APIs to dynamically recognize state-level prohibitions and instantly return a ‘No Prior Authorization Required’ status would reduce errors, prevent unnecessary PA submissions, and protect patients in states that have enacted stronger PA protections.
Finally, because these drug-benefit requirements build on the same FHIR-based API platform that impacted payers have already implemented for medical items and services, this rule represents an addition to existing infrastructure rather than an entirely new build. Consequently, payers face no technical justification for delaying implementation, and we urge CMS to hold firm to its proposed compliance dates.
Expanding Scope: State-Based Exchanges and Employer Plans
Sec. II.D: Small Group Market QHPs on FF-SHOP Exchanges; CMS RFC on future rulemaking for SBEs
CMS explicitly requests comment on whether to extend these requirements to qualified health plans on state-based exchanges, and we strongly support that extension. We also urge the Administration to close a second gap: the millions of patients with employer-sponsored coverage who face the same prior authorization barriers without equivalent federal protection.
Recommendation
In response to CMS’s explicit request for comment, we strongly support future rulemaking to require QHP issuers on state-based exchanges (SBEs) to comply with these requirements. Patients enrolled in SBE plans face identical PA barriers as those on FFE plans, and many states have already enacted PA laws that align with or exceed the standards proposed here. Excluding SBE plans creates an inequitable patchwork of patient protections that depends solely on which state a patient resides in.
Recommendation
We urge the Administration, including the Departments of Labor, Health and Human Services, and Treasury, to pursue future rulemaking extending these requirements to employer-sponsored (ERISA) plans. The patient access and transparency goals of this rule apply equally to the millions of people with employer-sponsored coverage. Employer-sponsored insurance is the largest source of health coverage for Americans under 65, covering 154 million people,[5] and the PA barriers this rule addresses are just as prevalent in that market. Coordinated interagency rulemaking is the appropriate vehicle to extend these protections.
Prior Authorization Decision Timeframes
Sec. II.C.3: Prior Authorization Decision Timeframes; Sec. II.C.3.b (QHPs); Sec. II.C.3.c (Medicaid/CHIP); CMS RFC on drug timeframe gaps
We support CMS’s proposals to establish and enforce expedited PA decision timeframes across QHPs, Medicaid, and CHIP. A 2026 study in JAMA Health Forum found that of branded medication prescriptions initially rejected by PA, 65% experienced multi-day delays with a median processing time of six days, and Medicaid patients faced 8% lower approval rates than other market segments.[6] For people living with HIV and hepatitis, delays in PA decisions can mean dangerous gaps in treatment, increased risk of drug resistance, and irreversible health consequences. We offer four recommendations.
Recommendation
We recommend that CMS explicitly prohibit the use of prior authorization for antiretrovirals used for the treatment and prevention of HIV under any insurance program subject to CMS oversight. Prior authorization should not be permitted for these critical therapies. Medicare has already established this standard, with prior authorization prohibited for antiretrovirals in Part D (including HIV treatments and emergency post-exposure prophylaxis), as well as for PrEP in Part B. Furthermore, many states have enacted similar protections for state-regulated insurance markets, and prior authorization for PrEP is also mostly prohibited in private insurance. This reflects a broad policy and clinical consensus that access delays for antiretrovirals carry profound public health risks and are not clinically acceptable. If CMS does not implement a blanket prohibition, it must, at minimum, adopt our alternative recommendation below to make these therapeutic areas expedited by default.
Recommendation
CMS explicitly requests comment on whether to require 24 hours for all QHP drug PA requests, not just expedited requests. We strongly support this approach and urge CMS to finalize it. The proposed 72-hour standard window creates meaningful clinical risk for patients who depend on daily access to antiretroviral therapy, hepatitis C treatment, or PrEP and cannot safely wait three days for a coverage decision. We would note that people prescribed post-exposure prophylaxis (PEP) must initiate treatment as soon as possible and no more than 72 hours after an exposure to HIV. We further recommend CMS apply this same 24-hour standard to QHP issuers on state-based exchanges in future rulemaking, since patients on SBE plans face identical clinical needs and should not face longer PA timelines simply because of which exchange they enrolled through.
Recommendation
Separately, we recommend CMS pursue future rulemaking to require Medicare Advantage organizations to respond to all PA requests for drugs no later than 24 hours. Unlike the impacted payers covered by this rule, MA organizations are not subject to new drug PA decision timeframes in this rulemaking. There is no clinical or administrative justification for a longer response window for this population than what is already required by Medicaid and CHIP. More than 111,000 Medicare beneficiaries are currently living with HIV, a number expected to roughly double over the next decade as people living with HIV age into Medicare.[7]
Recommendation
We recommend that if CMS does not align standard PA timeframes to a 24-hour maximum across all impacted markets or prohibit PAs on HIV prevention drugs or treatments, CMS should clarify in the final rule that requests involving high-priority therapeutic areas, such as HIV treatment, chronic hepatitis B and C treatments, PrEP, and especially PEP, qualify for expedited review by default. Under current regulations, providers must separately request and justify an expedited review by proving that a standard delay would seriously jeopardize a patient’s life or health. For therapies where treatment interruption or delays in initiation carry serious clinical consequences, such as irreversible liver damage in hepatitis or viral rebound and drug resistance in HIV, administrative delay inherently carries this risk. Removing the subjective, plan-by-plan interpretation and establishing an automatic, expedited-by-default designation for these specific therapies would guarantee that critical prescriptions are processed within 24 hours across all lines of business, preventing dangerous treatment disruptions and protecting patient health.
PA Transparency: Upfront Disclosure and Denial Justifications
Sec. II.C.2: Specific Reason for Denial in Response to Prior Authorization Requests for All Drugs
We support CMS’s proposal to require Medicaid and CHIP FFS programs, Medicaid managed care plans, CHIP managed care entities, and QHP issuers on the FFEs to provide a detailed, specific reason when denying a PA request for any drug. Vague denial reasons are inadequate for conditions like HIV and hepatitis where treatment choices are clinically individualized and delays can be irreversible. We note that Medicare Advantage already has this requirement from the 2024 final rule; this proposal appropriately extends the same protection to the remaining impacted payers.
Recommendation
We recommend CMS also require plans to clearly disclose, in advance, the PA requirements for all covered drugs, including which drugs require PA, the specific clinical criteria that must be satisfied, and the documentation required to support a request. Providers and patients should be able to access this information before submitting a PA request. Prospective transparency is as essential as the denial reason requirement: patients and providers should not learn what was required only after a request has already been denied. A 2025 survey of 1,000 patients found that more than half reported needing to take additional steps such as phone calls or repeating tests to obtain medications through the PA process, and one third reported that PA delays led to worse health outcomes.[8] Nebraska, Arkansas, and North Dakota require insurers to publicly post PA policies, clinical criteria, and documentation requirements in a clear and accessible format for patients.[9]
RECOMMENDATION
We recommend CMS require that all patients be clearly informed of their right to appeal a prior authorization denial and that appeals be decided within a defined timeframe. The appeal timeframe should reflect the urgency of the underlying request, so that an expedited drug request receives an expedited appeal decision. Patients facing a denial of a medically necessary therapy should never be left without a binding deadline for a decision on their appeal, particularly for HIV and hepatitis treatments where delays carry irreversible clinical consequences.
Prior Authorization Metrics Reporting
Sec. II.C.7: Publicly Report PA Metrics for Drugs; Sec. II.C.5-6: Reporting for Non-Drug Items
While we support CMS’s proposal to require public reporting of drug PA metrics, we urge CMS to strengthen the reporting framework so the data are standardized, plan-specific, searchable, and disaggregated by drug or therapeutic category. The proposed data reporting at the aggregate level would obscure the very disparities this reporting is intended to surface. High denial rates for HIV antiretrovirals or hepatitis C treatments could be invisible within broad aggregate figures, and patients selecting plans during open enrollment would have no way to identify which plans systematically deny the drugs they need. Meaningful transparency requires plan-level data.
Recommendation
We recommend CMS require granular, standardized public reporting of PA metrics disaggregated by: (1) therapeutic area or drug category; (2) reason for denial; (3) brand vs. generic drug; (4) type of utilization management applied (PA vs. step therapy); (5) average length of delay created by PA; (6) rate of treatment abandonment; and (7) whether the patient ultimately received the initially prescribed therapy or a payer-directed alternative. CMS should also monitor reported denial rates alongside timeframe compliance to ensure that faster PA requirements do not simply produce faster denials. This data should be available on plan comparison and shopping tools so patients can evaluate plans based on PA performance before enrollment.
Recommendation
We recommend CMS extend our suggested public reporting requirements to Medicare Part D plans. In Section II.C.7 of the proposed rule, CMS explicitly excludes covered Part D drugs for Medicare Advantage-Prescription Drug (MA-PD) plans from the new public reporting requirements, citing the avoidance of duplicative reporting. Part D sponsors currently submit PA metrics to CMS, but this data is not made publicly available. This recommendation applies to both standalone prescription drug plans (PDPs) and MA-PD plans: CMS should require Part D sponsors to publicly report the same standardized metrics proposed here for other impacted payers. There is no justification for withholding this information from patients, researchers, and policymakers.
Step Therapy and Continuity of Prior Approvals
Sec. III.D: Request for Information: Step Therapy
We respond to CMS’s request for information on step therapy with three recommendations. For people living with HIV and hepatitis, step therapy and PA restart requirements can force treatment interruptions and non-medical switching that directly jeopardize health outcomes.
Recommendation
We recommend CMS prohibit step therapy requirements for HIV antiretrovirals across all markets under its authority. IAS-USA clinical guidelines published in JAMA establish that antiretroviral regimen selection is individualized based on each patient’s efficacy history, tolerability, adverse effects, resistance patterns, comorbidities, and preferences; regimens may need to change for virologic failure or adverse effects, but not for payer-directed cost reasons.[10] Research on stable HIV patients who underwent a first-line regimen switch found that switchers experienced significantly higher subsequent healthcare costs and ambulatory utilization compared to non-switchers,[11] and a systematic review of non-medical switching found a negative impact on medication adherence in 75% of analyzed cases.[12] For all other drugs where step therapy remains in place, CMS should at minimum require plans to honor prior step therapy when a patient changes plans and is stable on their current treatment.
Recommendation
We recommend CMS require that step therapy be clearly disclosed to patients and providers and not disguised as or conflated with PA. When a plan requires a patient to fail on an alternative therapy before accessing the prescribed drug, that requirement must be transparently labeled as step therapy so patients and providers understand what is being required and what appeal rights apply. All step therapy programs should include a transparent, efficient exceptions process with defined timeframes and clear criteria for clinical exceptions.
Recommendation
We recommend CMS require plans to honor active PA approvals from a patient’s prior plan for a mandatory transition period of at least 30 to 60 days when a patient changes coverage. During this period, the new plan may conduct its own PA review but may not interrupt the patient’s access to their current treatment. At least 10 states passed PA reform legislation in 2024 and at least 18 more took legislative action in 2025, many including provisions requiring plans to honor PAs during coverage transitions, confirming that mandatory continuity protections are practically achievable.[13] If the new plan’s PA criteria are substantially similar to those under which the original approval was granted, the prior approval should transfer permanently. We further recommend CMS require that plans be prohibited from retroactively denying coverage or billing patients for drugs dispensed during the transition period.
Laboratory Tests and Prior Authorization
Sec. III.E: Request for Information: Laboratory Tests and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
We respond to CMS’s request for information on laboratory tests by urging CMS to extend prior authorization interoperability and transparency requirements to cover laboratory tests in future rulemaking. For people living with HIV and hepatitis, and for people accessing PrEP for HIV prevention, PA barriers on laboratory tests can delay or prevent care just as consequentially as PA barriers on drugs themselves.
Recommendation
We recommend CMS extend PA interoperability and transparency requirements to laboratory tests in a future rulemaking, encompassing both HIV and hepatitis treatment monitoring labs and PrEP-related labs. IAS-USA clinical guidelines recommend CD4 and viral load monitoring every three to six months for patients newly initiated on antiretroviral therapy, and at least annually once virologically stable,10 meaning a person living with HIV requires repeated laboratory testing throughout their lifetime of care, and any PA delay on these tests can delay the clinical decisions that protect their health. CDC PrEP clinical guidelines require baseline HIV testing, STI screening, and kidney function testing prior to PrEP initiation, with repeat testing at least every three months thereafter;[14] PA delays on any of these tests create a direct obstacle to PrEP initiation and ongoing access. Extending the PA API and related interoperability standards to lab tests would bring the same transparency and workflow improvements to this category of services that this rule proposes for drugs.
Enforcement and Compliance
General; not separately addressed in this rule
We are concerned that the critical patient protections proposed in CMS-0062-P will be undermined without a robust, centralized federal enforcement framework. While we strongly support the newly mandated decision timelines and reporting requirements, operational standards alone do not guarantee plan compliance. Without explicit federal penalties or mandatory corrective actions for payers that routinely exceed maximum response windows, the rule risks creating a system of transparency without accountability. We urge CMS to establish clear enforcement thresholds and act on the recommendations below to ensure these vital rules are actively and uniformly enforced.
Recommendation
We recommend CMS take active steps to monitor and enforce compliance with CMS FAQ Part 68, which directed applicable issuers not to use utilization management to steer patients toward one form of recommended PrEP over another. A cohort study published in JAMA Network Open found that among individuals seeking PrEP, up to a week’s delay beyond same-day dispensing was associated with 29% higher odds of HIV-1 acquisition compared with those who received same-day PrEP,[15] underscoring the clinical urgency of compliance. The availability of electronic PA data under this rule should make monitoring considerably more feasible.
Recommendation
We recommend CMS enforce parity between Medicaid fee-for-service (FFS) and Medicaid managed care utilization management. Medicaid managed care organizations sometimes impose considerably more prior authorization and step therapy than the state’s own FFS program for the same drugs. Because MCOs administer the same Medicaid benefit under contract with the state, their utilization management should be no more restrictive than the state’s FFS program, and CMS should monitor for and enforce this parity.
Recommendation
We recommend CMS require that when an impacted payer misses a federally mandated PA decision deadline for a drug, the request is automatically approved or, at minimum, the patient receives an emergency supply sufficient to bridge the gap until a decision is made. This protection matters because the current enforcement framework has significant gaps. A federal automatic approval or emergency supply standard should apply to all impacted payers and eliminate the current state-by-state patchwork of protections.
Recommendation
We recommend that when a plan’s publicly reported PA metrics fall outside defined thresholds, for example denial rates for a therapeutic area that are statistical outliers relative to peer plans or documented patterns of missed decision timeframes, CMS or the relevant state should be required, not merely permitted, to initiate a corrective action plan. The CAP should be publicly disclosed and progress should be reported on a defined schedule. Transparency without a mandatory enforcement trigger converts public reporting into an accountability exercise in name only.
Conclusion
The HIV+Hepatitis Policy Institute appreciates the opportunity to provide feedback on these proposed standards. We emphasize that technical optimization must not serve to validate or expand the current overuse of utilization management. The true measure of successful regulatory reform is a meaningful reduction in the overall volume of PAs and restrictive step therapy protocols that patients and providers face daily. We urge the administration to enforce these reduction goals firmly and to pursue swift, coordinated interagency rulemaking to expand these electronic API, timeline, and transparency protections to the millions of individuals enrolled in health plans currently excluded from this rule.
If you have any questions or need additional information, please do not hesitate to reach out to our Government Affairs Manager, Zach Lynkiewicz, at zlynkiewicz@hivhep.org.
Sincerely,
Carl E. Schmid II
Executive Director
[1] American Medical Association. 2024 Prior Authorization Physician Survey. December 2024. Available at: ama-assn.org.
[2] IQVIA Institute for Human Data Science, Understanding the Use of Medicines in the U.S. 2025 (IQVIA, 2025), iqvia.com.
[3] Prajapati G, Fleming SP, Badowski ME, Koren DE, Clanton OR, Patel H, Perez-Kempner L, Jain A, Sharma S. P-302. Real-world Utilization Management of Antiretrovirals for HIV Treatment and Pre-exposure Prophylaxis: A Systematic Literature Review. Open Forum Infect Dis. 2026 Jan 11;13(Suppl 1):ofaf695.522. doi: 10.1093/ofid/ofaf695.522. PMCID: PMC12791998.
[4] Aniruddha Hazra, Philip A Chan, Meredith Clement, Christopher J Kaperak, Hussein Safa, Joshua P Havens, Sandra A Springer, Jill Blumenthal, Matthew Spinelli, Susanne Doblecki-Lewis, Ami Multani, June Gipson, Joesph Cherabie, Rona Vail, Stephen Sukumaran, Chase A Cannon, Rebecca Lillis, Isolde Butler, Christian Turner, Ellen Taraschi, Gilianne Narcisse-Cempini, Leah Kunzmann, Romini Smith, Drew Halbur, Rupa R Patel, Multi-Center Real-World Implementation Outcomes of Lenacapavir for HIV Pre-Exposure Prophylaxis, Clinical Infectious Diseases, 2026;, ciag316, https://doi.org/10.1093/cid/ciag316.
[5] Kaiser Family Foundation. Employer-Sponsored Health Insurance 101. April 2026. Available at: kff.org.
[6] Wang Y, Levy JF, Mattingly TJ II, Anderson G. Prior Authorization and Associated Delays and Denials of Branded Medication Dispensation. JAMA Health Forum. 2026;7(4):e260760. doi:10.1001/jamahealthforum.2026.0760.
[7] Hyle EP, Ang L, Luu G, et al. Costs associated with increasing numbers of Medicare beneficiaries with HIV aged 65 years and older from 2026 to 2035. medRxiv. December 27, 2025. doi:10.64898/2025.12.19.25342703.
[8] DrFirst. 2025 Prior Authorization Patient Survey. Survey of 1,000 U.S. patients. Available at: drfirst.com (January 2026).
[9] CHIR Faculty, Prior Authorization Reform Heats Up, Ctr. on Health Ins. Reforms, Georgetown Univ. (Dec. 17, 2025), https://chir.georgetown.edu/prior-authorization-reform-heats-up/.
[10] Gandhi RT, Landovitz RJ, Sax PE, et al. Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2025;333(7):609-628. doi:10.1001/jama.2024.24543.
[11] Ward MG, Bhavan K, Bhatt NR, et al. Economic Outcomes of First-Line Regimen Switching Among Stable Patients with HIV. J Manag Care Spec Pharm. 2017. doi:10.18553/jmcp.2017.16403.
[12] Vanderpoel J, Ford JH. The impact of non-medical switching among ambulatory patients: an updated systematic literature review. J Mark Access Health Policy. 2019;7(1):1700166. doi:10.1080/20016689.2019.1700166.
[13] American Medical Association / Georgetown Center on Health Insurance Reforms. Prior authorization state legislation tracker, 2024-2025. Available at: ama-assn.org and chir.georgetown.edu.
[14] Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States, 2021 Update. Clinical Practice Guideline. Available at: cdc.gov.
[15] Yang J et al. Preexposure Prophylaxis Prescription Dispensation Status and HIV-1 Acquisition. JAMA Network Open. December 2025. doi:10.1001/jamanetworkopen.2025.42308.