/ en Wed, 30 Jul 2025 08:41:08 -0500 Fri, 18 Jul 25 11:40:52 -0500 /advisory/2025-07-18-home-health-prospective-payment-system-proposed-rule-cy-2026 <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) June 30 issued its <a href="https://www.federalregister.gov/documents/2025/07/02/2025-12347/medicare-and-medicaid-programs-calendar-year-2026-home-health-prospective-payment-system-hh-pps-rate" target="_blank">proposed rule</a> for the calendar year (CY) 2026 home health (HH) prospective payment system (PPS). Comments are due Sept. 2, and a final rule is expected around Nov. 1. New policies would generally be effective Jan. 1, 2026.</p><div><h2>Key Highlights</h2><p>The proposed rule would:</p><ul><li>Reduce net HH payments by an estimated 6.4%, or $1.135 billion, compared to CY 2025 payments. This reduction includes:<ul><li>A 3.2% market basket update, reduced by a 0.8% productivity adjustment.</li><li>A permanent behavioral adjustment (applied to the 30-day episode payment rate only) that is expected to reduce payments by 3.7%.</li><li>A temporary behavioral adjustment (applied to the 30-day episode payment rate only) that is expected to reduce payments by 4.6%.</li><li>An estimated 0.5% decrease in payments due to changes in outlier payments.</li></ul></li><li>Allow the face-to-face visit to be performed by any physician or non-physician practitioner, regardless of which practitioner certifies the need for HH services.</li><li>Remove a measure on patient COVID-19 vaccination and four patient assessment data elements related to social drivers of health.</li><li>Adopt a revised HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey and related measures.</li><li>Adopt one claims-based and three Outcome and Assessment Information Set (OASIS) based measures to the HH value-based payment (VBP) program.</li><li>Make several updates to the Medicare provider enrollment and accreditation regulations for durable medical equipment providers and suppliers.</li></ul></div><h2>AHA Take</h2><p>The AHA is concerned with CMS’ substantial proposed cuts to the HH PPS. Hospitals and other providers rely on both hospital-based and freestanding HH agencies to care for patients following discharge. Reimbursement cuts of this magnitude would reduce capacity and place a burden and strain back on hospitals, as well as patients who may be unable to access safe, effective and appropriate post-hospital care. The AHA will urge CMS to reconsider its approach to these payment reductions to ensure access for those in need of continued recovery at home.</p><h2>What You Can Do</h2><ul><li>Share this advisory with your senior management team to examine the impact these payment changes would have on your organization in CY 2026.</li><li>Submit a comment letter on the proposed rule to CMS by Sept. 2 explaining the rule’s impact on your patients, staff, facility and local health care partners.</li></ul><h2>Proposed CY 2026 Payment Updates</h2><p>The rule proposes a decrease in payments of 6.4%, or $1.135 billion, in CY 2026 as compared to CY 2025. This includes a proposed market basket update of 3.2%, reduced by a statutorily required 0.8% productivity factor. Further, CMS proposes a cut of 4.059% as a permanent behavioral adjustment (discussed further below); this would reduce payments by 3.7% overall, or $655 million. The agency also proposes a cut of 5.0% as a temporary adjustment (also discussed further below); this would reduce payments by 4.6% or $815 million. In addition, CMS estimates there would be a 0.5% decrease in payments because of an updated fixed-dollar loss ratio for outlier payments.</p><p>CMS also provides an estimate of impact by type of HH agency. It estimates that freestanding HH agencies would see a 6.3% decrease in payments, and facility-based HH agencies would receive a 5.7% decrease. In addition, HH agencies located in rural areas would receive a 6.1% decrease, while those in urban areas would see a 6.5% decrease.</p><h3>Proposed 30-day Episode Rates</h3><p>Applying the net market basket increase, behavioral adjustments, as well as budget neutrality factors for updated case-mix weights and wage indexes, CMS proposes an updated 30-day payment amount of $1,933.61. This is the standardized amount that is multiplied by case-mix weight and other factors to determine the final payment. This amount is 6.4% lower than the current 30-day payment rate of $2,057.35. Table 26 in the proposed rule (copied below) provides a breakdown of these changes. These proposed factors are subject to change due to updated data that become available prior to the publication of the final rule. Providers who fail to submit quality data would receive a 2-percentage-point reduction in their 30-day payment rate.</p><img src="/sites/default/files/inline-images/Table-26-CY-2026-National-Standardized-30-Day-Period-Payment-Amount.jpg" data-entity-uuid="97af0294-541a-486d-a76b-a8e841fdfc00" data-entity-type="file" alt="Table 26: CY 2026 National, Standardized 30-Day Period Payment Amount" width="854" height="258" class="align-center"><h3>Proposed Low Utilization Payment Adjustment (LUPA) Threshold and Rates</h3><p>Under the Patient-driven Groupings Model (PDGM), claims that do not meet a certain threshold of total visits are paid under the LUPA methodology, which is a per-visit rate. The LUPA methodology sets a visit threshold for each payment group at the 10th percentile of visits or two visits, whichever is higher. If the LUPA threshold is met, the case is paid the full 30-day period payment; if not, the LUPA per-visit rates apply. The proposed rule would update the LUPA thresholds using CY 2024 HH claims. These thresholds are listed in Table 25 of the proposed rule, which also includes the proposed recalibrated weights and other factors for payment groups.</p><p>CMS also updates the per-visit payment amount for each visit type using the payment update factors. As mentioned previously, the behavioral adjustments do not apply to these rates and only apply to the 30-day episode payment rate. Below are the proposed updated LUPA visit amounts from Table 28 of the proposed rule. Agencies that do not submit required quality data would have LUPA payments reduced by 2 percentage points.</p><img src="/sites/default/files/inline-images/Table-28-CY-2026-National-Per-Visit-Payment-Amounts.jpg" data-entity-uuid="a51f90ad-4cf7-4d3b-8d08-2b42ccbe6389" data-entity-type="file" alt="Table 28: CY 2026 National Per-Visit Payment Amounts" width="870" height="255" class="align-center"><h3>Case-mix Weights</h3><p>PDGM categorizes patients into one of 432 payment units, known as HH resource groups, using patient assessment data collected with the OASIS tool and other data. CMS annually recalibrates the HH case-mix weights based on the most recent, complete year of claims and patient assessment data. To recalibrate the CY 2026 weights, CMS proposes to use CY 2024 data to weight 30-day episodes under PDGM. This is the same methodology CMS used for CY 2025. The proposed 2026 case-mix weights are provided in Table 25 in the proposed rule and are available for download from CMS’ <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/home-health/home-health-prospective-payment-system-regulations-and-notices/cms-1828-p" target="_blank">HH PPS webpage</a>. These proposed weights are subject to change due to updated data that becomes available prior to the publication of the final rule.</p><p>CMS also applies a budget neutrality factor to the 30-day payment rate to ensure that case-mix weight changes do not increase or decrease overall payments. This year, CMS is proposing a budget neutrality factor of 1.0051, or 0.51% to account for proposed case-mix weight changes.</p><h3>Functional Impairment Levels</h3><p>Under PDGM, the functional impairment-related case-mix adjustment is determined by responses to certain OASIS items associated with activities of daily living and risk of hospitalization. A HH period of care receives points based on responses from these functional OASIS items. The sum of all these points is used to group HH periods into low, medium and high functional impairment levels, designed so that about one-third of HH periods fall within each level. For CY 2026, CMS proposes to use the CY 2024 claims data to update the functional points and functional impairment levels by clinical group and the same methodology used for CY 2025. The proposed OASIS functional points and the functional impairment thresholds by clinical group for CY 2026 are listed in the rule’s Tables 20 and 21, respectively.</p><h3>Comorbidity Groups</h3><p>Thirty-day episodes of care receive a comorbidity adjustment based on the presence of certain secondary diagnoses reported on HH claims. These diagnoses are based on a list of clinically and statistically significant secondary diagnoses subgroups with similar resource use. A “low-comorbidity adjustment” would be applied if one secondary diagnosis is present that is associated with higher resource use, and a “high-comorbidity” adjustment would be applied if two or more qualifying secondary diagnoses are present. For CY 2026, CMS proposes to continue using the same methodology, in combination with CY 2024 data. This would result in 20 low-comorbidity adjustment subgroups and 100 high-comorbidity adjustment subgroups. These subgroups are listed in Tables 22 and 23 of the proposed rule.</p><h3>High-cost Outliers</h3><p>HH PPS outlier payments are applied to 30-day episodes with estimated costs that exceed the outlier threshold, which is the sum of the payment amount and a wage-adjusted fixed-dollar loss (FDL) amount. The FDL amount is calculated by multiplying the FDL ratio by the payment amount for that claim. The payment made to providers for qualifying outlier claims is a percentage (referred to as the loss-sharing ratio) of the costs that surpass the threshold. For the HH PPS, the statute requires that the FDL amount and the loss-sharing ratio be set to target total outlier payments at 2.5% of aggregate payments. For CY 2026, CMS proposes no change to the existing 0.80 (80%) loss-sharing ratio. However, it proposes to increase the FDL ratio from 0.35 to 0.46, which it says would decrease overall payments by 0.5%, or $90 million, relative to CY 2025.</p><h2>Proposed Behavioral Adjustments Related to PDGM Implementation</h2><p>In 2018, Congress mandated that CMS implement the PDGM, which transitioned on Jan. 1, 2020, the HH PPS from a 60-day payment episode to a 30-day payment episode. The PDGM case-mix system bases payments on the clinical characteristics of a patient, abandoning the prior methodology of relying on therapy volume to determine payment. The clinical characteristics used to determine payment amounts include admission source and timing, principal diagnosis, functional impairment level and comorbidities. Under the PDGM, each 30-day episode is assigned to one of 432 HH resource groups.</p><p>CMS was required to set the initial PDGM 30-day episode payment amount at a budget-neutral level. To accomplish budget neutrality, CMS made several assumptions regarding providers’ expected behavioral changes. Specifically, CMS assumed that HH agencies would alter their coding of primary and secondary diagnoses on which payments are based. In addition, CMS assumed that the number of LUPA cases would decrease. After estimating the impact of these assumed behavioral changes, CMS finalized a behavioral offset of 4.36% to the 30-day payment rate in the CY 2020 final rule.</p><p>Congress also required that CMS maintain budget neutrality relative to the former payment system through CY 2026. The agency says it must apply two types of adjustments to maintain budget neutrality. The first is permanent adjustments to the 30-day payment rate to ensure that <em>future</em> spending neither increases nor decreases relative to what would have been paid. The second is temporary adjustments to recoup or repay <em>past</em> over- or underspending. Accordingly, the agency calculated and applied additional <em>permanent</em> budget neutrality adjustments in CYs 2023, 2024 and 2025 once data became available for payments post-implementation of the PDGM. CMS did not apply any <em>temporary</em> adjustments in these years, but it did provide estimates of the expected temporary recoupments needed to meet its statutory obligations for these years.</p><p>In the CY 2023 final rule, CMS determined that 30-day payments in CYs 2020 and 2021 were approximately 7.85% higher than they would have been under the legacy payment model. Therefore, it would need to prospectively reduce the 30-day payment rate permanently to ensure budget neutrality. However, for CY 2023, CMS only applied half of the needed permanent adjustment (-3.925%) and said it would apply the remainder in future years. For CY 2024, CMS determined that an additional adjustment of 5.78% was necessary to ensure budget neutrality based on claims through CY 2022. However, in response to concerns from providers, CMS decided to implement only half of this amount again, or -2.89%. In the CY 2025 rulemaking, CMS found that a -3.95% cut was necessary to achieve budget neutrality based upon claims through CY 2023. Again, CMS only implemented half that amount, or -1.975% in CY 2025.</p><p>CMS has now determined that, based upon claims analysis through CY 2024 claims, the 30-day payment rate is 4.059% higher than it would have been had CMS maintained budget neutrality. This includes both prior years’ adjustments that were not fully implemented and newly calculated adjustments based upon a review of CY 2024 claims. Therefore, CMS is proposing to implement the full permanent adjustment of -4.059% to the 30-day payment rate for CY 2026. CMS says this would reduce payments by approximately $655 million. The table below from the proposed rule shows both the overpayments calculated by CMS as well as the permanent adjustments that have been or are proposed to be implemented to date.</p><img src="/sites/default/files/inline-images/Table-18-Summary-of-Permanent-Adjustments-for-CYs-2020-2026.jpg" data-entity-uuid="8e2f44a4-a53f-4adc-af4b-1261ee35e293" data-entity-type="file" alt="Table 18: Summary of Permanent Adjustments for CYs 2020-2026" width="936" height="447" class="align-center"><p>As mentioned, in addition to permanent adjustments to prospectively ensure budget neutrality, CMS also says it is obligated to apply temporary adjustments to the 30-day payment rate to recoup past overpayments. Prior to this rulemaking, CMS had not yet proposed any of these temporary adjustments, although it did provide estimates for amounts needed to be recouped. In this rulemaking, CMS is proposing to begin implementing temporary adjustments to recoup what it says were overpayments from CY 2020 through CY 2024. To date, CMS says overpayments have totaled $5.3 billion. To recoup this all in CY 2026, CMS says it would need to apply an approximately 34% reduction to the 30-day payment rate. However, it also says that such a big reduction would place a hardship on providers, and instead proposes to implement a 5% temporary reduction to the base payment rate for CY 2026 to begin recouping overpayments. CMS says this would result in recouping about 14.8% of the overpayments to date in CY 2026, or approximately $786 million. Table 19 from the proposed rule below shows the overpayments CMS says must be recouped by CY.</p><img src="/sites/default/files/inline-images/Table-19-Summary-of-Temporary-Adjustments-Dollar-Amounts-for-CYs-2020-2026.jpg" data-entity-uuid="ead53bfe-f6d5-4498-86d2-7e71cd12ca8a" data-entity-type="file" alt="Table 19: Summary of Temporary Adjustments Dollar Amounts for CYs 2020-2026" width="936" height="490" class="align-center"><p>The permanent and temporary adjustments apply to the 30-day payment rate. They do not apply to other payments, such as LUPAs. Therefore, the permanent adjustment of -4.059% would reduce total payments by approximately 3.7%, and the temporary adjustment of 5.0% would reduce overall payments by approximately 4.6%. In addition, the temporary adjustment would not be factored in when determining future rates, so CMS would base its updated 30-day payment rates in future rulemakings on rates without the 5.0% reduction included. Finally, CMS says that all CY 2024 claims data was not available at the time of the proposed rule. Therefore, as it has done in prior rulemakings, it would update its proposed behavioral adjustments in the final rule using updated data.</p><h2>Proposed Change to Face-to-Face Encounter Requirement</h2><p>A HH beneficiary is required to have a face-to-face visit with either a physician or a non-physician practitioner (NPP). Currently, if the visit is performed by a physician, it must be the physician who also provides the certification for the need for home health services.<a href="#fn1"><sup>1</sup></a> However, if the visit is performed by an NPP, a different physician or NPP may certify the need for home health services. However, to provide additional flexibility and simplification, CMS is proposing to allow the visit to be performed by any physician or NPP regardless of which practitioner certifies the need for home health services. In this proposal, CMS also clarifies that the face-to-face visit documentation must still be related to the primary reason the patient requires home health services.</p><h2>HH Quality Reporting Program</h2><p>As mandated by the Social Security Act, HH agencies receiving Medicare payments have been required to collect and submit patient assessment data using the OASIS since 1999 and to participate in the HH Quality Reporting Program (QRP) since 2007. The Improving Medicare Post-Acute Care Transformation (IMPACT) Act required that, starting CY 2020, providers must report standardized patient assessment data elements (SPADEs) as part of the HH QRP. Failure to comply with these requirements results in a 2-percentage-point reduction to the HH agency’s annual market-basket update. In this rule, CMS proposes to remove one quality measure and four SPADEs beginning with the CY 2026 HH QRP. For FY 2025, the HH QRP comprises 19 measures (as the HHCAHPS Survey is reported as a single measure informed by multiple sub-items) based on updates to the QRP in previous rulemaking.</p><h3>Table 1: Previously Finalized Measures for the HH QRP, CY 2024-CY 2026</h3><table><thead><tr><th>Data Source</th><th>Measure</th><th>CY 25</th><th>CY 26</th><th>CY 27</th></tr></thead><tbody><tr><td rowspan="18">OASIS</td><td>Application of Percent of residents experiencing one or more falls with major injury (Long stay)</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Discharge Function Score</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Percent of Patients/Residents who are Up to Date with COVID-19 Vaccination</td><td>X</td><td>Y</td><td>Y</td></tr><tr><td>Improvement in Ambulation/Locomotion</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Improvement in Bathing</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Improvement in Bed Transferring</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Improvement in Dyspnea</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Influenza Immunization Received for Current Flu Season</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Improvement in Management of Oral Medications</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Timely Initiation of Care</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Drug regimen review conducted with follow-up for identified issues</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Transfer of Health Information to Provider</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Transfer of Health Information to Patient</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Total Estimated Medicare Spending per Beneficiary (MSPB)</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Potentially Preventable 30-day Post-Discharge Readmissions</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Home Health Within Stay Potentially Preventable Hospitalization</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Discharge to Community</td><td>X</td><td>X</td><td>X</td></tr><tr><td rowspan="5">HHCAHPS Survey</td><td>Care of Patients</td><td>X</td><td>X</td><td>Y</td></tr><tr><td>Communications between Providers and Patients</td><td>X</td><td>X</td><td>Y</td></tr><tr><td>Specific Care Issues</td><td>X</td><td>X</td><td>Y</td></tr><tr><td>Overall Rating</td><td>X</td><td>X</td><td>Y</td></tr><tr><td>Willingness to Recommend</td><td>X</td><td>X</td><td>Y</td></tr></tbody></table><p>X=Measure required for reporting as previously finalized</p><p>Y=Measure proposed for removal or modification in this rule</p><hr><h3>Proposed Removal of COVID-19 Vaccine: Percent of Patients Who Are Up-to-Date Measure</h3><p>CMS proposes to remove this measure from the HH QRP beginning with the CY 2026 program. The measure was originally adopted in the CY 2024 HH PPS final rule. Citing declining numbers of COVID-19 cases and deaths as well as the continued costs and burden to providers of reporting this measure, CMS estimates that cost savings from the measure’s removal as 47,168 hours annually across 11,904 HH agencies — a total of $4,326,249.</p><p>CMS proposes that, if finalized, data from the OASIS item O0350 would no longer be used to calculate the measure effective with the publication of the final CY 2026 HH PPS rule; the agency would formally remove the measure and associated OASIS beginning April 1, 2026. This means that, upon finalization of the proposal later this year and until the item can be removed from OASIS, HH agencies could enter any response (0, 1 or a dash) for the item with no effect on measure calculation (uncompleted responses would not meet submission requirements).</p><h3>Proposed Removal of Four Recently Adopted SPADEs</h3><p>Beginning with patients discharged on or after April 1, 2026, CMS proposes to remove four SPADEs under the social determinants of health category from all post-acute care patient assessment tools, including OASIS. CMS cites the “undue burden” that the collection of this information places upon providers and estimates that removing the items will save 158,835 hours of labor across all 11,904 HH agencies and $13,484,033 annually (or $1,132 per HH agency).</p><p>These items were finalized for adoption in the CY 2025 HH PPS final rule and slated to begin reporting with patients discharged in CY 2027; they include:</p><ul><li>Living Situation (R0310): What is your living situation today?</li><li>Food (R0320A): Within the past 12 months, you worried that your food would run out before you got money to buy more.</li><li>Food (R0320B): Within the past 12 months, the food you bought just didn’t last, and you didn’t have money to get more.</li></ul><p>Utilities (R0330): In the past 12 months, has the electric, gas, oil, or water company threatened to shut off services in your home?</p><h3>Proposed Revisions to HHCAHPS Survey and Measures</h3><p>CMS proposes to implement a revised (and shortened) version of the HHCAHPS survey and accompanying measures beginning with the April 2026 sample month.</p><p>The revisions were made based on an experiment that CMS conducted with 100 HH agencies in 2022 and include the addition of three new questions (which CMS calls “items”) to assess new topics of importance to patients and the removal of several questions on topics of less importance or not currently used in public reporting composites. CMS also made minor text changes to selected existing questions to help clarify the question or response options. The revised survey and measures were reviewed as part of the 2025 Pre-Rulemaking Measure Review process and recommended for adoption by the Post-Acute Care/Long-Term Care Committee. The table below provides a summary of the proposed changes, and Table 31 in the CY 2026 HH PPS proposed rule provides a comprehensive comparison of the current and proposed survey items.</p><h3>Table 2. Summary of Proposed HHCAHPS Measure Revisions</h3><table><thead><tr><th>Current Measures (Number of Items)</th><th>Proposed Measures (Number of Items)</th></tr></thead><tbody><tr><td>Care of Patients (4 items)</td><td>Care of Patients (5 items)</td></tr><tr><td>Communications between Providers and Patients (6 items)</td><td>Communications between Providers and Patients (5 items)</td></tr><tr><td rowspan="3">Specific Care Issues (7 items)</td><td>Talk About Home Safety (standalone item)</td></tr><tr><td>Review Medicines (standalone item)</td></tr><tr><td>Talk About Medicine Side Effects (standalone item)</td></tr><tr><td>Overall Rating (1 item)</td><td>Overall Rating (1 item)</td></tr><tr><td>Willingness to Recommend (1 item)</td><td>Willingness to Recommend (1 item)</td></tr><tr><td><strong>Total: 19 items</strong></td><td><strong>Total: 15 items</strong></td></tr></tbody></table><hr><p>If the revised survey and associated measures are finalized for adoption as proposed, CMS would adjust the methodology for the Summary Star Rating to account for these updates. Specifically, the Summary Rating would be based on the Overall Rating of Care; the new composite Care of Patients and Communications between Providers and Patients measures at a weight of one each; and the three new standalone measures at a weight of 1/3 each. The rest of the scoring methodology and public reporting policy would not change. Because the Summary Star Rating is calculated using four rolling quarters of data, scores on the new measures would not be publicly reported until October 2027 (based on data from the second quarter of 2026 through the first quarter of 2027); providers would be able to view their interim scores on their confidential Provider Preview reports after two full quarters of data are submitted.</p><p>CMS also proposes one change to the case-mix adjustment to survey scores. These adjustments refer to characteristics of the patient that are not under control of the HH agency that may affect reports of experience and include patient age, patient education, self-reported overall health, self-reported mental health, diagnosis of schizophrenia or dementia, whether the patient lives alone, whether the patient or a proxy answered the survey, and the language in which the survey was completed. Based on the same 2022 experiment, CMS found that the diagnosis adjustments were no longer significant and thus proposes to drop this adjustment from the scoring methodology.</p><p>Also based on findings from the 2022 experiment, CMS proposes to add a mode adjustment to the scoring methodology to account for differences in overall rating by telephone-only respondents. The agency notes that this is because telephone-only respondents were more negative in their evaluations of care relative to mail-only respondents across all measures, but the adjustments were generally small (most around 2 percentage points).</p><h3>Proposed Updates to Reconsideration Process</h3><p>Most CMS quality reporting and value programs — including the HH QRP — include a reconsideration process permitting providers to appeal a CMS initial determination of noncompliance with reporting or other programmatic requirements. In this rule, CMS proposes to specify the deadline for an HH agency to request an extension for a reconsideration request as 30 days from the date of the written notice of noncompliance. In addition, the agency proposes to grant requests for reconsiderations and reverse initial findings of noncompliance if the agency determines that the HH agency was in full compliance with the QRP requirements for the applicable program year, including established policies for extraordinary circumstances exceptions.</p><h3>Regulatory Text Updates to Account for All-Payer OASIS Data Reporting</h3><p>As finalized in the CY 2023 HH PPS final rule, CMS will require HH agencies to submit all-payer OASIS data for purposes of the HH QRP, beginning with voluntary data submission between Jan. 1, 2025, and June 30, 2025, and mandatory data submission beginning July 1, 2025, for the CY 2027 program year. In this proposed rule, CMS proposes updates to the regulatory text to reflect this previously finalized change. Specifically, CMS would change language in the HH Conditions of Participation regarding transmission of OASIS assessments to refer to “patients” instead of “beneficiaries,” as assessment data must now be submitted for all patients, including those who are not beneficiaries of Medicare or Medicaid. This does not change any other policy for assessment data reporting, including any exemptions for the OASIS.</p><h3>Request for Information (RFI): Shortening Data Submission Timelines</h3><p>CMS seeks input on decreasing the amount of time that HH agencies must submit quarterly quality measures and SPADE data to CMS. The agency notes that it is concerned that the time between data collection and measure reporting is too long, at nine months. The agency believes that the primary driver of this lag is the four and a half months after a quarter closes that HH agencies must submit data to CMS. CMS seeks input on potentially requiring that quality and SPADE data be submitted 45 days after the close of a quarter instead. The agency believes this would result in more timely publicly-reported data on HH agency performance. CMS found that, in 2022, only 1.3% of all OASIS assessments were submitted after 60 days, and only 0.9% were submitted between 60 days and the 4.5-month deadline.</p><h3>RFI: Digital Quality Measurement</h3><p>CMS seeks input on how to advance the uptake of digital quality measures in the HH QRP. CMS is particularly interested in the extent to which HH agencies are using application programming interfaces based on the Fast Healthcare Interoperability Resource standard to support any data reporting or exchange functions.</p><h3>RFI: Measure Concepts Under Consideration for Future Years</h3><p>CMS seeks public comment on the importance, relevance, appropriateness and applicability of certain quality measure concepts for future use in the HH QRP. These concepts include:</p><ul><li>Interoperability.</li><li>Cognitive function.</li><li>Nutrition.</li><li>Patient well-being.</li></ul><h2>HH Value-Based Purchasing Program</h2><p>The HH VBP model was adopted as a demonstration in the CY 2016 HH PPS final rule. In the CY 2022 HH PPS final rule, CMS finalized the expansion of the model nationwide beginning Jan. 1, 2022; read about the program methodology in AHA’s <a href="/advisory/2021-11-22-home-health-pps-final-cy-2022-rule">Regulatory Advisory</a> on that rule. In this proposed rule, CMS proposes to adopt one claims-based measure and three OASIS-based measures into the program’s measure set and to adjust the measure set and scoring based on changes proposed herein. The agency reasons that adopting more measures will increase the number of HH agencies that meet minimum HH VBP payment adjustment requirements.</p><h3>Proposed Adoption of Medicare Spending Per Beneficiary Post-Acute Care (MSPB-PAC) Measure</h3><p>CMS proposes to add this claims-based measure to the HHVBP measure set starting in CY 2026. MSPB-PAC assesses Medicare spending for Part A and B services clinically related to HH services during an episode of care relative to the Medicare spending for other HH agencies and is based on two years of data. The measure was added to the HH QRP in 2017 and is used across all post-acute care settings; if finalized as proposed, CMS would likely report scoring thresholds for this measure in the HH VBP program in the October 2025 Interim Performance Reports.</p><h3>Proposed Adoption of OASIS-based Function Measures</h3><p>CMS proposes to add three measures informed by OASIS assessment data to the HH VBP measure set starting in CY 2026. They include Improvement in Bathing (M1830), Improvement in Upper Body Dressing (M1810), and Improvement in Lower Body Dressing (M1820). The Improvement in Bathing measure is used in the HH QRP. CMS explains that it decided against including in the HH VBP measure set the Discharge Function Score measure that was recently adopted into all four post-acute care QRPs, as that measure does not consider bathing and dressing abilities critically important for HH AGENCY patients specifically.</p><h3>Proposed Removal of Three HHCAHPS Survey-based Measures</h3><p>Elsewhere in this proposed rule, CMS proposes to revise the HHCAHPS Survey and associated measures, which would influence the inclusion of these measures in the HH VBP program. Given these changes, CMS proposes to remove the three revised HHCAHPS items as they would not be able to be calculated according to the measure specifications as they appear in the HH VBP program. The measures include Care of Patients, Communications between Providers and Patients, and Specific Care Issues. The agency notes that it may propose to adopt new versions of these measures in future rulemaking.</p><h3>Proposed Weighting Changes</h3><p>If measures are finalized for adoption into the HH VBP measure set as proposed, CMS will need to update the weights of the individual measures and categories, as they contribute to the overall score. The table below lists the current and proposed weights across the larger-volume and smaller-volume cohorts.</p><img src="/sites/default/files/inline-images/Table-34-CY-2025-and-Proposed-Individual-Measure-Weights-and-Category-Weights-for-the-Expanded-HHVBP-Model.png" data-entity-uuid="a4d4ebc0-9ca6-4b0e-ab9f-80f87209ad5d" data-entity-type="file" alt="Table 34: CY 2025 and Proposed Individual Measure Weights and Category Weights for the Expanded HHVBP Model" width="624" height="340" class="align-center"><h3>RFI: Future Performance Measure Concepts</h3><p>CMS seeks feedback on certain performance measurement concepts used in the HH VBP. Specifically, the agency solicits comments on:</p><ul><li>Adopting measures on falls with major injury, well-being, nutrition and interoperability as considered for the HH QRP.</li><li>Calculating the HHCAHPS measure score based solely on achievement versus a benchmark rather than both achievement and improvement over the previous score.</li><li>Adding three HHCAHPS survey items to the HH VBP program from the Specific Care Issues category, which are proposed in this rule to become standalone measures.</li></ul><h2>Durable Medical Equipment, Prosthetics, Orthotics and Supplies Policies</h2><p>CMS has established processes and policies for enrollment of providers and suppliers into the Medicare program, which are designed to confirm that those seeking to bill Medicare for services and items furnished to beneficiaries meet all applicable federal and state requirements. In line with previous attempts to strengthen these processes and policies to guard against fraudulent or abusive behavior by providers and suppliers, CMS proposes several changes in this proposed rule that would update regulations for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) provider enrollment and accreditation. These include:</p><ul><li>Revocation and denial of enrollment policies.</li><li>DMEPOS accreditation and accrediting organization requirements.</li><li>Prior authorization for certain DMEPOS items.</li><li>The DMEPOS competitive bidding process.</li></ul><h2>RFI: Executive Order 14192 “Unleashing Prosperity Through Deregulation”</h2><p>On Jan. 31, 2025, President Trump issued Executive Order (EO) 14192, "Unleashing Prosperity Through Deregulation," which states the administration’s policy to significantly reduce the private expenditures required to comply with federal regulations. Accordingly, CMS is soliciting public input on approaches and opportunities to streamline regulations and reduce administrative burdens on providers, suppliers, beneficiaries and other interested parties participating in the Medicare program. CMS is collecting responses at <a href="https://www.cms.gov/medicare-regulatory-relief-rfi" target="_blank">https://www.cms.gov/medicare-regulatory-relief-rfi</a> and requests stakeholders submit comments through the provided web link.</p><h2>Next Steps</h2><p>The AHA urges all HH agencies to submit comments to CMS by Sept. 2. Comments may be submitted electronically at <a href="http://www.regulations.gov/" target="_blank">www.regulations.gov</a>.</p><h2>Further Questions</h2><p>For questions about payment provisions, contact Jonathan Gold, AHA’s senior associate director of payment policy, at <a href="mailto:jgold@aha.org">jgold@aha.org</a>; for quality-related questions, contact Caitlin Gillooley, AHA’s director of policy, at <a href="mailto:cgillooley@aha.org">cgillooley@aha.org</a>.</p><hr><ol><li id="fn1">The regulations also permit the visit to have been performed by a physician other than the certifying physician if the physician performing the visit cared for the patient in an acute or post-acute facility from which the patient was directly admitted to home health.</li></ol></div><div class="col-md-4"><a href="/system/files/media/file/2025/07/Regulatory-Advisory-Home-Health-Prospective-Payment-System-Proposed-Rule-for-CY-2026.pdf" target="_blank" title="Click here to download the Regulatory Advisory: Home Health Prospective Payment System Proposed Rule for CY 2026 PDF."><img src="/sites/default/files/inline-images/Page-1-Regulatory-Advisory-Home-Health-Prospective-Payment-System-Proposed-Rule-for-CY-2026.png" data-entity-uuid="641e1533-3576-451a-b608-e88a7450fddc" data-entity-type="file" alt="Regulatory Advisory: Home Health Prospective Payment System Proposed Rule for CY 2026 page 1." width="695" height="900"></a></div></div></div> table, th, td { border: 1px solid; } tr:nth-child(even) { background-color: #b9d9eb33; } th { background-color: #002855; color: white; } Fri, 18 Jul 2025 11:40:52 -0500 Regulations and Regulatory Advocacy /news/headline/2025-07-15-cms-proposes-increasing-medicare-hospital-outpatient-department-payment-rates-24-cy-2026 <p>The Centers for Medicare & Medicaid Services July 15 issued a <a href="https://www.federalregister.gov/public-inspection/2025-13360/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical" target="_blank">proposed rule</a> that would increase Medicare hospital outpatient prospective payment system rates by a net 2.4% in calendar year 2026 compared to 2025. This includes a proposed 3.2% market basket update, offset by a 0.8 percentage point cut for productivity.</p><p>In a statement shared with the <a href="/press-releases/2025-07-15-aha-statement-cy-2026-opps-proposed-rule" target="_blank">media</a>, Ashley Thompson, AHA senior vice president of public policy analysis and development, said the AHA was disappointed with the “inadequate” payment update “as many hospitals — especially those in rural and underserved communities — operate under challenging financial pressures.”</p><p><strong>SITE-NEUTRAL AND INPATIENT ONLY LIST PROPOSALS</strong></p><p>CMS <a href="https://www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-and-ambulatory-surgical" target="_blank">proposes</a> to pay for drug administration services furnished in grandfathered off-campus hospital outpatient departments at the site-neutral rate of 40% of the OPPS rate. The agency estimates this policy would cut OPPS spending by $280 million in CY 2026. It also requests comments on whether it should expand site-neutral payment to clinic visit services provided in on-campus HOPDs.</p><p>The agency also proposes phasing out the inpatient only (IPO) list over a 3-year period, beginning with removing 285 mostly musculoskeletal procedures for CY 2026. The IPO list details procedures that Medicare deems safe only in an inpatient setting.</p><p>“We oppose the proposal to expand ‘site-neutral’ cuts and eliminate the inpatient-only list, as both policies fail to account for the real and crucial differences between hospital outpatient departments and other sites of care,” Thompson said. “Studies show hospital outpatient departments are more likely to serve Medicare patients who are sicker, more clinically complex, and more likely to be disabled or living in poorer, rural communities than patients treated in independent physician offices.”</p><p><strong>EXPEDITED TIMELINE FOR REPAYMENT FOR NON-DRUG SERVICES AND NEW DRUG ACQUISITON COST SURVEY</strong></p><p>CMS is reconsidering the timeline for which all OPPS hospitals must repay the government for the $7.8 billion in increased payments they received for non-drug services between CYs 2018-2022 as a result of the agency’s budget-neutral policy to cut payments to 340B hospitals that was unanimously struck down by the Supreme Court. In prior rules, the agency had finalized repayments through an annual 0.5% reduction to the OPPS conversion factor starting in CY 2026 until the full $7.8 billion was repaid, which the agency had estimated would take 14 years. The agency now proposes to shorten the timeline so that the $7.8 billion is repaid by CY 2031 through a 2% annual reduction to OPPS conversion factor.</p><p>“We are also concerned with CMS’ proposal to claw back billions of dollars from hospitals at a far faster rate than originally promised,” Thompson said. “It is important to remember that this clawback punishes 340B hospitals for the agency’s own mistake in implementing a policy that a unanimous Supreme Court held to be unlawful. Doubling down on that unlawfulness, the proposed recoupment is both illegal and unwise, and it should not be finalized.”</p><p>In a related proposal, CMS also announces a new drug acquisition cost survey beginning in late CY 2025 into early CY 2026 for all hospitals paid under the OPPS for separately payable drugs. The results of the survey would be compiled and used to set payment rates for separately payable drugs in CY 2027 rulemaking.</p><p>Thompson said AHA was “concerned about the proposal to pursue a burdensome acquisition cost survey, especially if the agency’s goal is to drastically reduce Medicare payments to hospitals that serve the nation’s most vulnerable communities.”</p><p><strong>OTHER PROPOSALS</strong></p><p>CMS proposes to weaken the criteria for excluding services from coverage in ambulatory surgical centers. It also proposes making several changes to the hospital price transparency requirements including negotiated rate calculations, accuracy and completeness attestation, and enforcement processes.</p><p>CMS proposes several changes to the Outpatient, Rural Emergency Hospital, and ASC Quality Reporting Programs, including the removal of four measures related to COVID-19 vaccination of health care personnel and health equity. For the Outpatient and REH programs, the agency proposes adopting a new e-measure on timeliness of care in the emergency department. CMS also proposes establishing requirements for REHs to report e-measures. For the ASC program, CMS proposes adopting one patient-reported outcome measure. CMS also <a href="https://www.cms.gov/newsroom/press-releases/cms-proposes-bold-reforms-modernize-hospital-payments-strengthen-transparency-and-put-patients-back" target="_blank">proposes</a> updates to the methodology used to calculate the Overall Hospital Star Ratings to emphasize the Safety of Care measure group.</p><p>CMS will accept comments on the proposed rule for 60 days following publication in the Federal Register.</p><p>“We look forward to reviewing these proposals in more detail and participating in the comment process with the agency,” Thompson said.</p> Tue, 15 Jul 2025 19:13:21 -0500 Regulations and Regulatory Advocacy /lettercomment/2025-07-14-aha-comments-hhs-rfi-maha-initiative <p>July 14, 2025</p><p>Laina Bush<br>Acting Assistant Secretary for Planning and Evaluation<br>U.S. Department of Health and Human Services <br>200 Independence Avenue, S.W.<br>Washington, DC 20201</p><p>Jennifer Burnszynski<br>Associate Deputy Assistant Secretary, Office of Human Services Policy<br>U.S. Department of Health and Human Services <br>200 Independence Avenue, S.W.<br>Washington, DC 20201</p><p><em>Submitted Electronically</em></p><p><em><strong>RE: AHRQ 2025-001 Request for Information; Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again</strong></em></p><p>Dear Ms. Bush and Ms. Burnszynski,</p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the ���������� Association (AHA) appreciates the opportunity to provide comments on the request for information (RFI) to ensure lawful regulation and unleash innovation to promote better health.</p><p>The AHA agrees that reducing unnecessary administrative burden can foster improved health for the American people. The rescission of certain regulations will not only support reduced health care costs but also will increase access and quality of care as providers can focus more on direct patient care and less on burdensome paperwork. </p><p>This is essential to address, as more than a quarter of all health care spending goes to administrative tasks — totaling more than $1 trillion annually.<sup>1</sup></p><p>As the AHA shared in recent responses to RFIs on deregulation from the <a href="/system/files/media/file/2025/05/aha-response-to-omb-deregulation-rfi-letter-5-12-2025.pdf">Office of Management and Budget</a>, <a href="/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf">Federal Trade Commission</a> and <a href="/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf">Department of Justice</a>, there are a variety of actions the administration could take to reduce the burden on hospitals and health systems to improve access, reduce costs and foster competition.<sup>2,3,4</sup> Many of our recommendations included in those responses are relevant to the questions posed in this RFI and can be accessed by the hyperlinks above. In addition, we shared a more comprehensive list of 100 ways to free hospitals from burdensome administrative requirements, an updated version of which is attached. Given our prior responses, we focus these comments on the issue in this RFI that we have not previously addressed directly: regulatory changes to help reverse chronic disease.</p><p>We applaud the administration’s focus on reducing chronic disease, particularly among children. Compared to other developed countries, the U.S. has higher rates of chronic disease and the lowest life expectancy.<sup>5,6</sup>  The rate of premature death in the U.S. is twice that of other developed nations, mainly driven by cardiovascular disease, chronic respiratory illness and chronic kidney disease.<sup>7</sup> The growing prevalence of chronic disease in America has contributed to increased utilization of hospital services and higher case-mix indices, which contribute to higher health care costs.</p><p>There are clear areas of alignment between the administration’s interest in addressing chronic disease and hospitals’ work. Hospitals are a primary source of diagnosis and treatment for individuals with chronic illnesses. Many hospitals also are “moving upstream” and helping to address the root causes of chronic illness before they take hold. Some examples of hospitals’ work in this space include:</p><ul><li><strong>Prioritizing food and nutrition.</strong> Three out of four hospitals offer nutrition programs to help their community build healthier lives by tackling food and diet-related health challenges. Also, many hospitals have developed “Food Is Medicine” programs, or food prescription programs, to provide fresh fruits and vegetables for patients experiencing food insecurity or to treat chronic conditions.</li><li><strong>Preventing and managing chronic illnesses.</strong> Most hospitals offer free health screenings, giving patients the opportunity to catch health issues early and prevent the development of complex or long-term conditions when possible.</li><li><strong>Promoting wellness.</strong> Hospitals provide health education and other tools to help people make healthy lifestyle choices to reduce risk for conditions such as stroke, diabetes, heart disease, certain cancers and depression.</li></ul><p>The AHA has compiled a <a href="/system/files/media/file/2025/05/2025-AHA-MAHA-Report.pdf">report</a> and list of programs across all 50 states to demonstrate the critical work hospitals do every day to combat chronic illness. There are countless other examples, including hospitals offering transportation programs to help patients get to and from appointments, partnering to build safe housing options, and providing community resources to reduce isolation.</p><p>The AHA recently met with several hundred hospital leaders to discuss further efforts to address chronic disease in America. Several key themes emerged:</p><ul><li>Addressing both the causes and the treatment of chronic disease must be done in partnership with community organizations, especially in rural and underserved areas. No single organization has the expertise, resources or capacity to comprehensively address chronic disease alone.</li><li>Chronic disease is not limited to physical ailments. Behavioral and mental health conditions also can be chronic diseases and are frequent co-morbidities alongside physical illness.</li><li>In addition to addressing environmental and systemic issues contributing to chronic disease, patients must also adopt healthy behaviors.</li><li>Hospitals are not reimbursed for interventions that are not directly related to the services they provide. Hospitals and health systems will have limited capacity to take on additional responsibilities without financial support.</li><li>Health care coverage is critical to ensuring access to the care needed to help diagnose, treat and manage chronic diseases.    </li></ul><p><strong>Recommendations</strong></p><p>The AHA offers the following initial recommendations on deregulation opportunities to address chronic disease in the context of this RFI. We look forward to an ongoing dialogue with the administration about how hospitals can support our shared objective of reducing the incidence and burden of chronic disease in this country.</p><p><strong>Reduce administrative and coverage barriers to care. </strong>Patients often face difficulties accessing health care services due to coverage-related issues. For example, health plans’ prior authorization requests reached nearly 50 million in 2023 for Medicare Advantage beneficiaries alone, an increase from 42 million in 2022.<sup>8</sup> Uncertainty about costs — most often a function of understanding health plan cost-sharing obligations — can also create a barrier to care. To help patients access the care they need to prevent, diagnose and manage chronic illness, we encourage the Administration to:</p><ul><li>Fully operationalize the Interoperability and Prior Authorization Final Rule to establish standard electronic prior authorization processes in Medicare Advantage, the Health Insurance Marketplaces and Medicaid. This will help expedite patients’ access to medically necessary services.</li><li>Support patients in accessing pricing information by streamlining the various provider and insurer price transparency requirements and eliminating redundancies in reporting. Reducing complexity could help patients better understand their health care costs, potentially reducing a barrier to accessing care.</li></ul><p><strong>Advance the sustainable adoption of technology and innovation.</strong> Telehealth and other technologies show considerable promise in helping individuals manage their health, including chronic illness. However, as technology and consumer preferences have evolved, many regulations have not kept pace with innovation, potentially impeding patients’ access to services that could help them manage their chronic conditions. The AHA encourages the Administration (and Congress where appropriate) to:</p><ul><li>Remove telehealth originating site restrictions within the Medicare program to enable patients to receive telehealth in their homes.</li><li>Remove telehealth geographic site restrictions to enable beneficiaries in non-rural areas to have the same access to virtual care as those in rural areas.</li><li>Remove the in-person visit requirements for behavioral health telehealth.</li><li>Eliminate the telehealth physician home address reporting requirement, which compromises workforce safety.</li></ul><p><strong>Facilitate whole-person care. </strong>Chronic disease is rarely caused by a single factor, nor is it successfully treated in isolation. There are several ways in which existing regulations stymie providers’ ability to provide whole-person care. To address these issues, we encourage the administration to:</p><ul><li>Eliminate 42 CFR Part 2 requirements that protect patient privacy under HIPAA but hinder care team access to important health information, specifically, separation of records pertaining to substance use disorder information. As previously stated, there is a strong link between physical and behavioral health, especially with respect to chronic disease. In order to provide the best care possible, providers must have access to their patients’ full medical records.</li><li>Modernize the Stark Law and Anti-Kickback Statute regulations to better protect arrangements that promote value-based care. Whole-person care also entails care coordination and continuity, particularly for patients with chronic disease. Historically, these laws have had the effect of impeding value-based arrangements involving care coordination and/or collaborative electronic platforms by making many of them difficult to undertake without running afoul of either or both laws. Critical steps were taken by the first Trump administration to promote care coordination through value-based safe harbors under those laws, and we continue to support these safe harbors and recommend that they be maintained in their current form. To further address this challenge, we would encourage the adoption of a broad Anti-Kickback Statute safe harbor akin to the “access to care/low risk of harm” exception to the Civil Monetary Penalties Law, which would immunize arrangements that promote access to health care items or services and present a low risk of harm to patients and federal health care programs. This would more effectively protect (and therefore promote) beneficial arrangements that clearly improve patient access to health care items or services. </li></ul><p><strong>Sustain the health care workforce.</strong> The health care system relies on doctors, nurses and other clinicians to diagnose, treat and manage chronic disease. Unfortunately, our health care workforce is increasingly burning out and leaving the profession, often citing excessive administrative burdens that pull them away from patient care. This can lead to delays in patients accessing the care they need to manage their chronic conditions. In order to support the workforce, the AHA encourages the Administration to:</p><ul><li>Streamline care plan documentation requirements to eliminate<strong> </strong>duplicate paperwork by removing the requirement for distinct nursing care plans when an interdisciplinary team is caring for the patient and maintains an interdisciplinary care plan.</li><li>Support expanding care capacity by removing Medicare restrictions on nurse practitioners and other advanced practice providers that are often more restrictive than under state licensure.</li><li>Permanently remove the requirements for outpatient physical therapy plans of care to be signed and dated every 90 days.</li></ul><p>We look forward to opportunities to work with the administration on these and further recommendations to reduce unnecessary, unfounded or redundant regulations with a particular focus on how we can support individuals to live their healthiest lives. Please contact me if you have questions, or feel free to have a member of your team contact Jennifer Holloman, AHA’s director of policy, at <a href="mailto:jholloman@aha.org" title="Email address">jholloman@aha.org</a>.</p><p>Sincerely,</p><p>/s/</p><p>Ashley Thompson<br>Senior Vice President<br>Public Policy Analysis and Development</p><div><hr><div id="ftn1"><p><small class="sm"><sup>1</sup> “Active steps to reduce administrative spending associated with financial transactions in US health care,” Sahni, N., et. al., Health Affairs Scholar, Volume 1, Issue 5, November 2023, qxad053, </small><a href="https://doi.org/10.1093/haschl/qxad053"><small class="sm">https://doi.org/10.1093/haschl/qxad053</small></a><small class="sm">.</small></p></div><div id="ftn2"><p><small class="sm"><sup>2</sup></small><a href="/system/files/media/file/2025/05/aha-response-to-omb-deregulation-rfi-letter-5-12-2025.pdf"><small class="sm">/system/files/media/file/2025/05/aha-response-to-omb-deregulation-rfi-letter-5-12-2025.pdf</small></a><small class="sm">.</small></p></div><div id="ftn3"><p><small class="sm"> <sup>3</sup></small><a href="/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf"><small class="sm">/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf</small></a><small class="sm">.</small></p></div><div id="ftn4"><p><small class="sm"><sup>4</sup></small><a href="/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf"><small class="sm">/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf</small></a><small class="sm">.</small></p></div><div id="ftn5"><p><small class="sm"><sup>5 </sup></small><a href="https://www.healthsystemtracker.org/chart-collection/how-has-the-burden-of-chronic-diseases-in-the-u-s-and-peer-nations-changed-over-time/#:~:text=Broadly%2C%20a%20larger%20share%20of,of%20depression%20(1.3%20times)"><small class="sm">https://www.healthsystemtracker.org/chart-collection/how-has-the-burden-of-chronic-diseases-in-the-u-s-and-peer-nations-changed-over-time/#:~:text=Broadly%2C%20a%20larger%20share%20of,of%20depression%20(1.3%20times)</small></a><small class="sm">.</small></p></div><div id="ftn6"><p><small class="sm"><sup>6</sup> </small><a href="https://www.healthsystemtracker.org/chart-collection/u-s-life-expectancy-compare-countries/#Life%20expectancy%20at%20birth%20by%20sex,%20in%20years,%202023"><small class="sm">https://www.healthsystemtracker.org/chart-collection/u-s-life-expectancy-compare-countries/#Life%20expectancy%20at%20birth%20by%20sex,%20in%20years,%202023</small></a><small class="sm">.</small></p></div><div id="ftn7"><p><small class="sm"><sup>7</sup> </small><a class="ck-anchor" href="https://www.healthsystemtracker.org/chart-collection/what-drives-differences-in-life-expectancy-between-the-u-s-and-comparable-countries/" id="https://www.healthsystemtracker.org/chart-collection/what-drives-differences-in-life-expectancy-between-the-u-s-and-comparable-countries/."><small class="sm">https://www.healthsystemtracker.org/chart-collection/what-drives-differences-in-life-expectancy-between-the-u-s-and-comparable-countries/</small></a><a class="ck-anchor" id="https://www.healthsystemtracker.org/chart-collection/what-drives-differences-in-life-expectancy-between-the-u-s-and-comparable-countries/."><small class="sm">.</small></a></p><div><div id="ftn1"><p><small class="sm"><sup>8</sup> </small><a href="https://www.kff.org/medicare/issue-brief/nearly-50-million-prior-authorization-requests-were-sent-to-medicare-advantage-insurers-in-2023/"><small class="sm">https://www.kff.org/medicare/issue-brief/nearly-50-million-prior-authorization-requests-were-sent-to-medicare-advantage-insurers-in-2023/</small></a><small class="sm">.</small></p><hr><h4 class="text-align-center">Attachment</h4><h4 class="text-align-center">100 Ways to Free Hospitals from Wasteful and Burdensome Administrative Requirements to Provide the Highest Quality, Most Efficient Care to Patients </h4><h2>BILLING, PAYMENT AND OTHER ADMINISTRATIVE REQUIREMENTS </h2><p>Research estimates that between 25% and 35% of all health care spending is on administrative tasks, with billing and collections, which include coverage and eligibility verification, being one of the costliest areas. The following changes could dramatically lower administrative costs; many would also improve patient access to care. </p><h3>Interactions with Health Plans</h3><ol><li>Eliminate duplicative and costly billing infrastructure within hospitals, health systems and other providers by shifting cost-sharing collection responsibilities to insurers — the entities that set co-pay, deductible and co-insurance amounts.</li><li>Reduce variation in prior authorization processes by enforcing the interoperability and prior authorization final rule, which will streamline electronic prior authorization processes across many payers.</li><li>Eliminate billions in excess health care system costs, resulting from providers chasing payment from insurers, by establishing prompt pay requirements in all forms of health care coverage, including Medicare Advantage.</li><li>Implement a standardized claims attachment to allow plans to request and providers to transmit necessary medical records via a safe electronic transmission standard.</li><li>Reduce the time providers waste tracking down the unique criteria that each Medicare Advantage plan uses to adjudicate claims by establishing a single clinical standard for both Traditional Medicare and Medicare Advantage.</li><li>Reduce the time patients spend waiting for post-acute care placements by disallowing plans from implementing prior authorization requirements for these services in certain circumstances.</li><li>Eliminate duplication and data collection burdens on providers by establishing a single national provider directory and requiring plans to exclusively use the national database rather than create their own.</li><li>Remove requirements for payers and plans to have separate credentialing processes and allow for payers to instead recognize hospital credentialing.</li><li>Adopt a standard process for providers to appeal a Medicare Advantage plan denial of a prior authorization request or claim.</li><li>Minimize the burden of managing pharmaceutical supplies while improving patient safety by prohibiting insurers from unilaterally adopting policies that force providers to use pharmaceuticals provided by the insurer’s affiliated pharmacy benefit manager rather than using their own supply (also known as “white bagging”).</li><li>Establish and enforce network adequacy requirements for post-acute care on Medicare Advantage plans to enable patients to begin necessary post-acute care as timely as possible while freeing up inpatient capacity.</li><li>Improve the flawed and cumbersome No Surprises Act Independent Dispute Resolution process while retaining the patient protections against surprise billing to allow insurers and out-of-network hospitals and health systems to work together more efficiently to determine appropriate reimbursement.</li><li>Remove the prior authorization requirement for non-emergent Veterans Affairs community care network services, which requires providers to submit a form that takes at least three days to process, therefore unnecessarily delaying care.</li><li>Expand access to alternative coverage options for employees, such as through Individual Reimbursement Arrangements, which would reduce the administrative burden on employers.</li></ol><h3>Information Technology and Coding</h3><ol start="15"><li>Repeal the excessive and confusing “information blocking” rule that would impose unjustified penalties on providers.</li><li>Modify the HIPAA cybersecurity rule of December 2024 to make the requirements voluntary.</li><li>Modify the HIPAA Breach Notification Rule to remove the requirement to report breaches affecting fewer than 500 individuals.</li><li>Eliminate billing and coding requirements for psychiatric care at 42 CFR 483.102as they are overly stringent and not based on medical criteria.</li><li>Streamline the Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) code sets to standardize reporting across all payors.</li><li>Eliminate unique HCPCS codes for generic drugs, which adds burden by complicating the billing process. </li></ol><h3>Administrative and Regulatory Barriers to Care</h3><ol start="21"><li>Repeal the Food and Drug Administration Laboratory Developed Tests final rule that will hamper hospital labs’ ability to continue developing high-quality in-vitro tests that have increased access to care and reduced costs.</li><li>Repeal the Institutions for Mental Disease exclusion within the Medicaid program so that hospitals and other providers can ensure Medicaid patients who need inpatient behavioral health care can get the most effective care efficiently.</li><li>Similarly, repeal the 180-day lifetime limit on inpatient psychiatric facility services under Medicare.</li><li>Allow inpatient rehabilitation facilities (IRFs) to care for more than just inpatient rehabilitation patients when capacity is an issue (such as during a pandemic), which could reduce patient wait times for care.</li><li>Eliminate the observation hours “carve-out” policy for diagnostic or therapeutic services.</li><li>Simplify the detailed and complex reporting process of the Medicare Cost Reports.</li><li>Modernize the Stark Law and Anti-kickback Statute regulations to better protect arrangements that promote value-based care.</li><li>Repeal the requirement that Critical Access Hospital (CAH) based ambulance services only receive cost-based reimbursement if they are the sole ambulance provider within 35 miles. Instead, all CAH-based ambulance providers should receive cost-based reimbursement.</li><li>Modify Environmental Protection Agency project building timelines that significantly delay the construction of new sites of care.</li><li>Expand hospitals’ ability to utilize swing beds.</li><li>Improve the timeliness and efficiency of 340B child site registration by re-adopting the prior policy of allowing hospitals to register child sites under the 340B program even if they are not included on their most recently filed cost report.</li></ol><h3>Medicare Payment and Processes</h3><ol start="32"><li>Repeal the IRF Review Choice Demonstration under which IRFs will have 100% of their traditional Medicare claims subject to either pre- or post-claim review for at least six months.</li><li>Repeal the Center for Medicare and Medicaid Innovation’s (CMMI) Increasing Organ Transplant Access mandatory kidney transplant model that purports to better align payment with quality but over-focuses on quantity over quality.</li><li>Make voluntary all CMMI models with particular focus on the recently announced Transforming Episode Accountability Model, which will mandate that some of the most vulnerable hospitals transition to bundled payments for five types of surgical episodes.</li><li>Eliminate the skilled nursing facility three-day length of stay requirement that often delays patients from transitioning to the most appropriate site of care.</li><li>Simplify and expedite discharge processes by removing the requirement that hospitals provide patients with a list of post-acute care (PAC) providers from which to select when hospitals already work with patients and PAC providers for appropriate placement.</li><li>Eliminate the CAH 96-hour rule as a condition of participation (CoP) which requires an annual average length of stay of 96 hours or less and eliminate the 96-hour condition of payment rule that requires physicians in CAHs to certify upon admission that an inpatient can be reasonably expected to be discharged or transferred to another hospital within 96-hours.</li><li>Eliminate the requirement that a hospital operate for at least six months under the prospective payment system before converting to CAH status.</li><li>Eliminate the “must-bill” policy for dual eligible beneficiaries, which requires providers to bill both Medicare and Medicaid even though no Medicaid payment may be expected.</li><li>Allow for exceptions to the requirement that Medicare overpayments are returned in 180 days, given that providers may need additional time to complete investigations.</li><li>Allow Medicare bad debts to be written off as contractual allowances, which is consistent with standard accounting practices and was permitted under prior policies.</li><li>Eliminate the policy that to receive Medicare bad debt reimbursement for dual eligible beneficiaries, providers must bill the state Medicaid program AND receive/submit the remittance advice listing any Medicaid payment, which is burdensome and not always possible.</li><li>Standardize coverage, coding and billing criteria among Medicare Administrative Contractors (MACs).</li><li>Remove the restriction that disallows hospitals from choosing a different MAC.</li><li>Streamline the Medicare appeals process to allow uploading of medical records at the time of claim filing.</li><li>Streamline Medicare mandatory notices to patients, including eliminating where applicable rules require providers to give notice both in-person and via paper notices. Examples of such notices include the Important Message from Medicare, Advance Beneficiary Notice of Non-coverage, and Medicare Outpatient Observation Notice, the Notice of Medicare Non-Coverage and Medicare Change of Status Notice.</li><li>Rescind Centers for Medicare and Medicaid Services (CMS) regulations requiring hospitals to report detailed information about drug invoices on their cost reports beginning in 2026. Manufacturers should be required to report the additional pricing information necessary for CMS to create average sales prices.</li><li>Revise Medicare drug price negotiation guidance to prohibit drug manufacturers from implementing retrospective rebate models in the 340B Drug Pricing Program, which would add considerable administrative costs to hospitals serving the most vulnerable communities.</li><li>Strengthen Medicare-dependent and Sole Community Hospitals by allowing participating hospitals to choose from an additional base year when calculating payments. </li></ol><h3>Price Transparency </h3><ol start="50"><li>Eliminate the convening provider requirement as part of good faith price estimates given to patients, because there is no technical solution to operationalize it.</li><li>Create a more streamlined and accurate process for patients to access pricing information by having insurers serve as the “source of truth” by publishing the negotiated rates and requiring hospitals to post cash price and chargemaster rates. </li></ol><h2>QUALITY AND PATIENT SAFETY </h2><p>High-quality, safe care is the core of hospitals’ missions. While many regulations originated out of an interest to improve care quality or patient safety, those same regulations, over time, have often become obsolete or redundant. However, in many cases, they remain required despite having outlived their usefulness. The following changes would support hospitals’ efforts to adapt to continue offering the highest quality, safest care. </p><h3>Quality Reporting </h3><ol start="52"><li>Repeal the onerous and now outdated CoP that requires hospitals to report data on acute respiratory illnesses, including influenza, COVID-19 and RSV, once per week, with more frequent and extensive data reporting required during a public health emergency.</li><li>Reduce administrative burden by eliminating the outdated requirement for post-acute care providers to report COVID-19 and influenza vaccine rates for patients/residents and staff.</li><li>Similarly, remove the outdated requirement for hospitals to report staff vaccination rates.</li><li>Remove the sepsis bundle measure, which evidence shows has not led to better outcomes but entails an enormous administrative burden, from all hospital quality reporting and value programs, replacing it with a measure of sepsis outcomes.</li><li>Eliminate (or at minimum streamline) the Meaningful Use (now Promoting Interoperability) program as it has outlived its usefulness.</li><li>Eliminate (or, at a minimum, significantly streamline) the onerous Hospital Consumer Assessment of Healthcare Providers and Systems (patient satisfaction) survey of hospitals, as the quality of the instrument and use of the results have degraded due to low response rates.</li><li>Support quality and patient safety while reducing burdens by reducing the required reporting of electronic clinical quality measures to a more targeted set of core measures.</li><li>Remove the requirement for hospitals to report reflecting screening for social determinants of health measures that are not linked to better outcomes.</li><li>Eliminate the mandatory requirement for Accountable Care Organizations to report quality data electronically, versus allowing reporting via a web interface.</li><li>Eliminate the Hospital Readmission Reduction Program, as performance has topped out.</li><li>Suspend the Medicare hospital star ratings program as the methodology is inadequate, including distorted comparisons of hospital performance and a significant time lag.</li><li>Remove quality measures from the inpatient psychiatric quality reporting program that are not directly relevant to inpatient psychiatric care, such as whether the facility offers smoking cessation services.</li><li>Remove all structural measures from hospital quality reporting programs that have little evidence tying their use to better care or outcomes, including the Patient Safety Structural Measure, Health Equity Structural Measure and Age-Friendly Hospital measure.</li><li>Remove (or, at a minimum, make voluntary) the reporting of hybrid hospital readmissions/mortality measures and hip/knee arthroplasty patient-reported outcome measures due to significant feasibility issues.</li></ol><h3>Surveys and Accreditation</h3><ol start="66"><li>Minimize in-person hospital surveys for low-risk complaints and resume them virtually.</li><li>Permanently adopt concurrent validation surveys for CMS accrediting organizations, eliminating duplicative “lookback” surveys that require a full resurvey of hospital compliance with CoPs.</li><li>Allow hospitals time to ensure adequate staffing and resources during surveys without compromising the integrity of those surveys by eliminating the prohibition on accrediting organizations providing same-day notification of a survey.</li><li>Eliminate punitive removals of “deemed status” when a hospital has one or more condition-level citations on a validation survey, which is unnecessary for adequate oversight. </li></ol><h3>Other</h3><ol start="70"><li>Repeal the nursing home staffing rule that would not improve quality or safety and would require nearly 80% of all nursing homes — including those with five stars — to increase staffing.</li><li>Revise the obstetrical care CoP by removing requirements that are not directly relevant to improving obstetrical care and redundant with existing requirements, such as requirements focused on non-obstetrical emergencies, supplies and training.</li><li>Reduce unnecessary burden while ensuring adequate emergency response preparation by reducing the number of required hospital emergency preparedness drills to once a year.</li><li>Remove the requirement that hospitals provide translation services for patients in 15 different languages and instead allow hospitals to ensure adequate translation for the populations they serve.</li><li>Enable inpatient psychiatric facilities (IPFs) to provide appropriate monitoring of patients at risk of suicide without overburdening the workforce or adding unnecessary costs by eliminating the requirement that IPFs have one-to-one monitoring of patients at risk of suicide.</li><li>Eliminate 42 CFR Part 2 requirements providing special privacy protections for behavioral health patients and protect their privacy under HIPAA.</li><li>Eliminate the Occupational Safety and Health Administration (OSHA) “walkaround rule” that allows union representatives to accompany OSHA inspectors.</li><li>Enable hospitals to reduce costs by limiting the requirement to purchase supplies through CMS-approved vendors to only medical devices and other aspects of direct patient care and exempting non-clinical items such as office furniture and supplies.</li><li>Support providers’ access to cheaper drugs by enforcing rules to prevent gaming of patents and other policies that stifle pharmaceutical competition. </li></ol><h2>TELEHEALTH </h2><p>As technology and consumer preferences have evolved, more care can safely be delivered via telehealth. However, numerous regulations restrict the use of virtual care. Addressing the following areas would not only reduce unnecessary burdens on the health care system but also improve clinician capacity, increasing access to care. </p><ol start="79"><li>Remove telehealth originating site restrictions to enable patients to receive telehealth in their homes.</li><li>Remove telehealth geographic site restrictions to enable beneficiaries in non-rural areas to have the same access to virtual care as those in rural areas.</li><li>Remove restrictions on telehealth modalities to enable a wider range of services (e.g., audio only) to be safely delivered via telehealth.</li><li>Similarly, remove restrictions on the provider types eligible to perform telehealth.</li><li>Remove restrictions on the types of distant sites eligible to perform telehealth services.</li><li>Allow hospital outpatient departments to bill for telehealth services when patients are in their homes (assuming statutes are updated to allow for telehealth to patients' homes permanently).</li><li>Remove the in-person visit requirements for behavioral health telehealth.</li><li>Remove restrictions to allow new patients to receive remote physiologic monitoring.</li><li>Remove case-by-case approval of new telehealth services; instead, include all Medicare-covered services as eligible telehealth services and remove them on a case-by-case basis.</li><li>Remove in-person visit requirements prior to prescribing controlled substances by establishing a special registration process for virtual prescribers.</li><li>Remove requirements for hospice recertification to be completed in person to allow for telehealth-based recertification.</li></ol><h2>WORKFORCE</h2><p>The health care system’s greatest asset is our workforce. Unfortunately, doctors, nurses, technicians and others are increasingly burned out and leaving the profession, often citing excessive administrative burden that pulls them away from patient care. The following regulatory relief ideas would support our workforce.</p><ol start="90"><li>Eliminate the telehealth physician home address reporting requirement, which compromises workforce safety.</li><li>Remove requirements for outpatient physical therapy plans of care to be signed off by a physician or nurse practitioner every 90 days.</li><li>Reform nursing and allied health education payments to relax the CMS interpretation of "director control.”</li><li>Eliminate or raise the tax-free limit of $5,250 on employer-provided funds spent to train employees in high-demand services like radiology.</li><li>Repeal the Federal Trade Commission's Non-Compete Clause Rule.</li><li>Reform rules related to “fair market value” to ensure that hospitals can obtain access to necessary specialist services.</li><li>Eliminate nurse practitioner practice limitations that are more restrictive under CMS rules than under state licensure.</li><li>Promote medical licensure reciprocity to allow practitioners to work across state lines.</li><li>Do not promulgate Occupational Safety and Health Administration federal workplace violence regulations that would be duplicative of the rigorous accreditation requirements hospitals already face and add an administrative burden.</li><li>Reduce unnecessary costs in the system by pursuing medical liability reform by eliminating joint and several liability.</li><li>Similarly, cap non-economic and punitive damages as part of medical liability. </li></ol></div></div></div></div> Mon, 14 Jul 2025 14:09:16 -0500 Regulations and Regulatory Advocacy /lettercomment/2025-05-23-aha-comments-ftc-anticompetitive-deregulations-rfi <div class="container"><div class="row"><div class="col-md-8"><p>May 23, 2025</p><p>The Honorable Andrew N. Ferguson<br>Chairman<br>Federal Trade Commission<br>600 Pennsylvania Ave. NW<br>Washington, DC 20580</p><p><em><strong>Re: Request for Public Comment Regarding Reducing Anti-Competitive Regulatory Barriers (Dkt. ID FTC-2025-0028-0001)</strong></em></p><p>Dear Chairman Ferguson:</p><p>On behalf of the ���������� Association’s (AHA) nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, we appreciate your invitation to submit comments identifying regulations that make health care markets less competitive.</p><p>The AHA shares the Trump administration’s belief that the “ever-expanding morass of complicated Federal regulation imposes massive costs on the lives of millions of Americans, creates a substantial restraint on our economic growth and ability to build and innovate, and hampers our global competitiveness.”<a href="#fn1"><sup>1</sup></a> And we share the Federal Trade Commission’s (FTC) belief that “[r]egulations that reduce competition, entrepreneurship, and innovation can hamper the American economy.”<a href="#fn2"><sup>2</sup></a> We therefore welcome the opportunity to comment on the laws and regulations that make it harder for hospitals and health systems to compete fairly in the health care.</p><p>As we submit these comments, we are mindful that this is, in many ways, well-trodden ground. In 2018, the first Trump administration issued a report entitled <em>Reforming America’s Healthcare System Through Choice and Competition</em> (2018 Report), which correctly observed that “many government laws, regulations, guidance, requirements and policies… resulted in healthcare markets that lack the benefits of vigorous competition. Increasing competition and innovation in the healthcare sector will reduce costs and increase quality of care—improving the lives of Americans.”<a href="#fn3"><sup>3</sup></a> Seven years later, the AHA starts from that exact premise. Many of the issues identified in that 2018 Report remain or have worsened, and many new challenges have emerged. Then, as now, the U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country.</p><p>In this letter, we provide an overview of the key statutes and regulations that have impeded competition in the health care market and offer a series of recommendations to remedy these obstacles. We first outline the key areas of regulation that have permitted commercial insurers to limit market competition, narrow consumer choice and undermine access to health care for Americans — all while avoiding true accountability under the nation’s antitrust laws. We then describe other categories of regulations that limit the ability of hospitals and health systems to compete in the market, including those that impose undue administrative burdens, inhibit the expansion of telehealth, limit growth within the health care workforce and generally inflict large costs on the health care industry without corresponding benefits.<a href="#fn4"><sup>4</sup></a></p><p><a href="/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf"><span><em><strong>Download the full letter.</strong></em></span></a></p><hr><ol><li id="fn1">Executive Order 14192, Unleashing Prosperity Through Deregulation (Jan. 31, 2025).</li><li id="fn2">Press Release, Request for Public Comment Regarding Reducing Anti-Competitive Regulatory Barriers (April 13, 2025).</li><li id="fn3">U.S. Departments of Health and Human Services, Treasury, and Labor, Reforming America’s Healthcare System Through Choice and Competition (2018) at 16-17.</li><li id="fn4">AHA separately submitted comments incorporating many of these suggestions to HHS, CMS, and OMB as part of the parallel effort to reduce burdensome regulations. May 12, 2025, Letter from AHA to Secretary Kennedy, Administrator Oz, and Director Vought re Request for Information: Deregulation (FR Doc. 2025-06316) <a href="/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi">/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi</a></li></ol></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf" target="_blank" title="Click here to download the AHA Comments on FTC Anticompetitive Deregulations RFI letter PDF.">Download the Letter PDF</a></div></div></div></div> Fri, 23 May 2025 11:50:55 -0500 Regulations and Regulatory Advocacy /news/headline/2025-05-23-aha-responds-doj-ftc-anticompetitive-regulation-rfis <p>AHA May 23 submitted recommendations to the <a href="/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf">Department of Justice</a> and <a href="/system/files/media/file/2025/05/AHA-Comments-on-FTC-Anticompetitive-Deregulations-RFI.pdf">Federal Trade Commission</a> in response to the agencies’ requests for information on unnecessary or burdensome anticompetitive regulations. “[T]he U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country,” AHA Deputy General Counsel Julie Rapoport Schenker wrote in the letters to the agencies. The AHA’s recommendations included addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among others. <br><br>The RFIs follow a similar request from the Office of Management and Budget regarding deregulation, to which the AHA <a href="/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi">responded</a> May 13. </p> Fri, 23 May 2025 10:44:03 -0500 Regulations and Regulatory Advocacy /lettercomment/2025-05-23-aha-comments-doj-anticompetitive-deregulations-rfi <div class="container"><div class="row"><div class="col-md-8"><p>May 23, 2025</p><p>The Honorable Abigail Slater<br>Assistant Attorney General<br>Anticompetitive Regulations Task Force<br>Antitrust Division<br>U.S. Department of Justice<br>950 Pennsylvania Ave. NW<br>Washington, DC 20530</p><p><em><strong>Re: Anticompetitive Regulations Task Force Press Release (Dkt. ID ATR-2025-0001-0002)</strong></em></p><p>Dear Assistant Attorney General Slater and Task Force Members:</p><p>On behalf of the ���������� Association’s (AHA) nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, we appreciate your invitation to submit comments identifying regulations that make health care markets less competitive.</p><p>The AHA shares the Trump administration’s belief that the “ever-expanding morass of complicated Federal regulation imposes massive costs on the lives of millions of Americans, creates a substantial restraint on our economic growth and ability to build and innovate, and hampers our global competitiveness.”<a href="#fn1"><sup>1</sup></a> And we share the Department of Justice’s (DOJ) belief that “unnecessary anticompetitive regulations put affordable healthcare out of reach for millions of American families.”<a href="#fn2"><sup>2</sup></a> We therefore welcome the opportunity to comment on the laws and regulations that make it harder for hospitals and health systems to compete fairly in the health care marketplace — which DOJ rightly identifies as one of the “markets that ha[s] the greatest impact on American households.”</p><p>As we submit these comments, we are mindful that this is, in many ways, well-trodden ground. In 2018, the first Trump administration issued a report entitled Reforming America’s Healthcare System Through Choice and Competition (2018 Report), which correctly observed that “many government laws, regulations, guidance, requirements and policies… resulted in healthcare markets that lack the benefits of vigorous competition. Increasing competition and innovation in the healthcare sector will reduce costs and increase quality of care—improving the lives of Americans.”<a href="#fn3"><sup>3</sup></a> Seven years later, the AHA starts from that exact premise. Many of the issues identified in that 2018 Report remain or have worsened, and many new challenges have emerged. Then, as now, the U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country.</p><p>In this letter, we provide an overview of the key statutes and regulations that have impeded competition in the health care market and offer a series of recommendations to remedy these obstacles. We first outline the key areas of regulation that have permitted commercial insurers to limit market competition, narrow consumer choice and undermine access to health care for Americans — all while avoiding true accountability under the nation’s antitrust laws. We then describe other categories of regulations that limit the ability of hospitals and health systems to compete in the market, including those that impose undue administrative burdens, inhibit the expansion of telehealth, limit growth within the health care workforce and generally inflict large costs on the health care industry without corresponding benefits.<a href="#fn4"><sup>4</sup></a></p><p><a href="/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf"><span><em><strong>Download the full letter.</strong></em></span></a></p><hr><ol><li id="fn1">Executive Order 14192, Unleashing Prosperity Through Deregulation (Jan. 31, 2025).</li><li id="fn2">Press Release, Justice Department Launches Anticompetitive Regulations Task Force (March 27, 2025).</li><li id="fn3">U.S. Departments of Health and Human Services, Treasury, and Labor, Reforming America’s Healthcare System Through Choice and Competition (2018) at 16-17.</li><li id="fn4">AHA separately submitted comments incorporating many of these suggestions to HHS, CMS, and OMB as part of the parallel effort to reduce burdensome regulations. May 12, 2025, Letter from AHA to Secretary Kennedy, Administrator Oz, and Director Vought re Request for Information: Deregulation (FR Doc. 2025-06316) <a href="/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi">/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi</a></li></ol></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/05/AHA-Comments-on-DOJ-Anticompetitive-Deregulations-RFI.pdf" target="_blank" title="Click here to download the AHA Comments on DOJ Anticompetitive Deregulations RFI letter PDF.">Download the Letter PDF</a></div></div></div></div> Fri, 23 May 2025 10:10:08 -0500 Regulations and Regulatory Advocacy /news/headline/2025-05-13-public-comment-period-opens-deregulation-rfi-hhs <p>The Department of Health and Human Services May 13 <a href="https://www.hhs.gov/press-room/fda-10-to-1-deregulatory-plan-to-lower-costs-empower-patients.html" target="_blank">announced</a> a 60-day public comment period opened for stakeholders regarding its <a href="https://www.federalregister.gov/public-inspection/2025-08384/request-for-information-ensuring-lawful-regulation-and-unleashing-innovation-to-make-american" target="_blank">request for information</a> to remove outdated or unnecessary regulations. The request stems from an <a href="https://www.whitehouse.gov/presidential-actions/2025/01/unleashing-prosperity-through-deregulation/" target="_blank">executive order</a> issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at <a href="https://www.regulations.gov/deregulation" target="_blank">regulations.gov/deregulation</a>.</p><p>The RFI follows a similar request from the Office of Management and Budget regarding <a href="https://www.federalregister.gov/documents/2025/04/11/2025-06316/request-for-information-deregulation" target="_blank">deregulation</a>, to which the AHA <a href="/lettercomment/2025-05-12-aha-response-omb-deregulation-rfi" target="_blank">responded</a> May 12. The AHA’s recommendations fell under four categories: billing, payment and other administrative requirements; quality and patient safety; telehealth; and workforce. The fiscal year 2026 inpatient prospective payment system, skilled nursing facility, inpatient rehabilitation facility, inpatient psychiatric facility and long-term care hospital payment rules also have similar regulatory relief requests for information that are due June 10.</p> Tue, 13 May 2025 17:14:55 -0500 Regulations and Regulatory Advocacy /executive-orders-and-federal-actions/2025-05-29-regulatory-relief-promote-domestic-production-critical-medicines <div class="container"><div class="row"><div class="col-md-8"><p>Directs the Commissioner of the Food and Drug Administration to review and eliminate any duplicative or unnecessary requirements in regulations and guidance pertaining to the development of domestic pharmaceutical manufacturing within 180 days. Further directs the commissioner to streamline and accelerate the development of domestic pharmaceutical manufacturing, and requires the commissioner to review regulations and guidance regarding the inspection and approval of manufacturing capabilities and emerging technologies that enable the manufacturing of pharmaceutical products and ingredients. Directs the commissioner to review the current risk-based approach to prior approval of licensure inspections and further directs the commissioner to undertake measures to improve enforcement of data reporting and to issue guidance on production, compliance, and related issues. Requires the commissioner to develop and advance improvements to the inspection regime within 90 days and make public disclosures regarding the annual number of inspections conducted by the FDA on foreign facilities.</p><p>Directs the Administrator of the Environmental Protection Agency to update regulations and guidance with respect to the inspection and approval of pharmaceutical manufacturing capacity and eliminate duplicative or unnecessary requirements within 180 days. Establishes the EPA as the lead agency for the permitting of pharmaceutical manufacturing facilities that require preparation of an Environmental Impact Statement and directs the EPA to work with the Office of Management and Budget and other agencies to expedite the review and approval of relevant permits. Further directs the Secretary of the Army, within 180 days, to review permits issued pursuant to certain environmental laws and determine whether additional permits are necessary to facilitate the efficient permitting of pharmaceutical manufacturing facilities.</p></div></div></div> Mon, 05 May 2025 08:06:32 -0500 Regulations and Regulatory Advocacy /news/headline/2025-04-15-cms-update-spa-template-medication-assisted-treatment-benefit <p>The Centers for Medicare & Medicaid Services today released a <a href="https://www.federalregister.gov/public-inspection/2025-06400/agency-information-collection-activities-proposals-submissions-and-approvals-medicaid-and-childrens" title="CMS notice">notice</a> seeking public comment on the collection of information request regarding the State Plan Amendment template for medication-assisted treatment. SPA templates are provided by CMS to assist states with Medicaid application submissions as well as reducing administrative burden and increasing efficiency. States are required to cover MATs for opioid use disorder under their state Medicaid programs. CMS said it is planning to update the SPA template for MAT to align with statutory updates. The comment period will be open for 14 days following publication in the April 16 Federal Register.</p> Tue, 15 Apr 2025 14:47:55 -0500 Regulations and Regulatory Advocacy /news/headline/2025-04-10-trump-administration-issues-executive-orders-reducing-anti-competitive-barriers-repealing-unlawful <p>The Trump administration yesterday released executive orders on reducing anti-competitive regulatory <a href="https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-barriers/" title="EO on barriers">barriers</a> and repealing certain <a href="https://www.whitehouse.gov/presidential-actions/2025/04/directing-the-repeal-of-unlawful-regulations/" title="EC on regs">regulations</a> deemed unlawful.  </p><p>  </p><p>The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   </p><p>  </p><p>The order on repealing unlawful regulations is linked to a Feb. 25 <a href="https://www.federalregister.gov/documents/2025/02/25/2025-03138/ensuring-lawful-governance-and-implementing-the-presidents-department-of-government-efficiency" title="Feb 5 EO">executive order</a> that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.</p> Thu, 10 Apr 2025 15:26:14 -0500 Regulations and Regulatory Advocacy