/ en Fri, 25 Apr 2025 21:19:23 -0500 Mon, 04 Nov 24 15:20:37 -0600 <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) Nov. 1 released its calendar year (CY) 2025 outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) <a href="https://www.federalregister.gov/public-inspection/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical" target="_blank">final rule</a>. The rule increases OPPS rates by a net 2.9% in CY 2025 compared to CY 2024.</p><p>The policies and payment rates in the rule will generally take effect on Jan. 1, 2025.</p><div class="panel module-typeC"><div class="panel-heading"><h3 class="panel-title">Key Highlights</h3></div><div class="panel-body"><p>CMS’ final rule will:</p><ul><li>Increase Medicare hospital OPPS rates by a net 2.9% in CY 2025.</li><li>Pay separately for diagnostic radiopharmaceuticals with per-day costs above $630.</li><li>Exclude qualifying cell and gene therapies from comprehensive ambulatory payment classification (C-APC) packaging.</li><li>As required by law, implement temporary additional payments for certain non-opioid treatments for pain relief dispensed in the hospital outpatient department (HOPD) and ASC settings.</li><li>Adopt three measures related to health equity for the Outpatient, ASC and Rural Emergency Hospital (REH) Quality Reporting Programs (QRP) and extend voluntary data reporting for two hybrid measures in the Inpatient Quality Reporting Program.</li><li>Establish a new Condition of Participation (CoP) for hospitals and critical access hospitals (CAHs) offering obstetrical services, and update quality assessment performance improvement (QAPI), emergency services and discharge planning CoPs.</li><li>Cover and pay for HIV Pre-Exposure Prophylaxis (PrEP) drugs and related services in HOPDs as additional preventive services under the OPPS.</li></ul></div></div><h2>AHA Take</h2><p>According to a statement by AHA Senior Vice President of Public Policy Analysis and Development Ashley Thompson, “Medicare's sustained and substantial underpayment of hospitals has stretched for almost two decades, and today's final outpatient rule only worsens this chronic problem. The agency's final increase of less than 3% for outpatient hospital services will make the provision of care, investments in the health care workforce, and addressing new challenges, such as cybersecurity threats, more difficult. These inadequate payments will have a negative impact on patient access to care, especially in rural and underserved communities nationwide.</p><p>“The AHA fully shares CMS’ goals of improving maternal health outcomes and reducing inequities in maternal care,” said Thompson. “While we appreciate that the final rule provides hospitals with additional implementation time and greater flexibility in how they meet certain requirements, we remain concerned about CMS’ excessive use of Conditions of Participation to drive its policy agenda and the potential risk for these requirements to inadvertently reduce access to maternal care. We believe a less punitive and more collaborative approach would be more effective given that the key drivers of maternal health outcomes are highly complex and involve multiple stakeholders. The AHA remains committed to working with the Administration and other stakeholders to advance a full range of solutions to improve maternal outcomes.”</p><p>Highlights of the CY 2025 OPPS/ASC final rule follow.</p><h2>CY 2025 OPPS Final Rule Changes</h2><h3>Payment Update</h3><p>CMS updates OPPS rates by a net 2.9% for CY 2025. This includes a market-basket update of 3.4% and a statutorily required productivity cut of 0.5 percentage points. These payment adjustments, in addition to other changes in the rule, are estimated to result in a net increase in OPPS payments of 3.2% in CY 2025 compared to CY 2024. For hospitals that do not publicly report quality measure data, CMS will continue to impose the statutory 2.0 percentage point additional reduction in payment, resulting in a 0.9% OPPS update.</p><p>CMS estimates that the total increase in Federal Government expenditures under the OPPS for CY 2025, compared to CY 2024, due to the changes to the OPPS in the final rule, will be approximately $1.98 billion. Taking into account estimated changes in enrollment, utilization and case mix for CY 2025, CMS estimates that OPPS expenditures for CY 2025, including beneficiary cost-sharing, would be approximately $87.7 billion, which is approximately $4.7 billion higher than estimated OPPS expenditures in CY 2024.</p><p>CMS increases the conversion factor to $89.169 in CY 2025 compared to $87.382 in CY 2024. This update reflects several factors: the 2.9% OPPS payment update, the wage index budget neutrality adjustment, the 5% annual cap for individual hospital wage index reductions budget neutrality adjustment, the cancer hospital payment budget neutrality adjustment and an increase of 0.10 percentage points for the difference in pass-through spending. CMS will use a reduced conversion factor of $87.439 in the payment calculation for hospitals that fail to meet the Hospital Outpatient QRP.</p><h3>Data Used in CY 2024 OPPS/ASC Rate Setting</h3><p>CMS used the CY 2023 claims data and the most updated cost report extract from the Healthcare Cost Report Information System, which primarily includes cost reports from CY 2022, to set OPPS and ASC payment rates.</p><h3>Packaging Policy for “Threshold-packaged” and “Policy-packaged” Drugs, Biologicals and Radiopharmaceuticals</h3><p>CMS pays for drugs, biologicals and radiopharmaceuticals that do not have pass-through status in one of two ways: packaged payment or separate payment (individual Ambulatory Payment Classifications (APCs)). For CY 2025, CMS maintains the packaging threshold for “threshold-packaged” drugs, including non-implantable biologicals and therapeutic radiopharmaceuticals, of $140 per day. This means that such products with a per-day cost of $140 or less will have their cost packaged in the procedure with which they are billed.</p><p>There are exceptions to this threshold-based packaging policy for certain “policy-packaged” drugs, biologicals and contrast agents. CMS will continue to package the costs of all anesthesia drugs; drugs, biologicals, and contrast agents and other drugs that function as supplies when used in a diagnostic test or procedure; and drugs and biologicals that function as supplies when used in a surgical procedure (e.g., skin substitutes), regardless of whether they meet the $140 per day threshold.</p><h4>Diagnostic Radiopharmaceuticals Separate Payment</h4><p>CMS finalizes its proposal to pay separately for diagnostic radiopharmaceuticals with per-day costs above $630 —approximately two times the volume-weighted average cost amount currently associated with diagnostic radiopharmaceuticals in the Nuclear Medicine APCs. It will update the $630 threshold in CY 2026 and subsequent years by the Producer Price Index for Pharmaceutical Preparations. Finally, CMS will pay for separately payable diagnostic radiopharmaceuticals based on their mean unit cost derived from OPPS claims for CY 2025.</p><h4>Exclusion of Cell and Gene Therapies from C-APC Packaging</h4><p>CMS finalizes its proposal to exclude qualifying cell and gene therapies from C-APC packaging.</p><h4>Add-on Payment for Radiopharmaceutical Technetium-99m (Tc-99m)</h4><p>For CY 2025, CMS will continue its current policy to apply an add-on payment to radiopharmaceuticals that use Tc-99m produced without the use of highly enriched uranium. However, for CY 2026, CMS finalizes its proposal to replace this add-on payment with an add-on payment for radiopharmaceuticals that use Tc-99m derived from domestically produced Mo-99.</p><h4>Payment for HIV PrEP in HOPDs</h4><p>CMS finalizes its proposal to cover and pay for HIV PrEP drugs and related services as additional preventive services under the OPPS, as described by CMS through a National Coverage Determination issued and effective Sept. 30, 2024.<a href="#fn1"><sup>1</sup></a> Covered services include the HIV PrEP drugs, drug administration, HIV and hepatitis B screening, and individual counseling performed by physicians or certain other health care practitioners.</p><h3>Intensive Outpatient and Partial Hospitalization Programs</h3><p>CMS will maintain the existing rate structures for Intensive Outpatient Program (IOP) and Partial Hospitalization Program (PHP) services as established in the previous rulemaking. The agency will calculate cost information using CY 2023 claims data and the OPPS data set to identify services eligible for payment under the IOP and PHP benefits.</p><h3>Cancer Hospital Payment Adjustment</h3><p>CMS will continue providing additional payments to cancer hospitals so that a cancer hospital’s payment-to-cost ratio (PCR) after the additional payments is equal to the weighted average PCR for the other OPPS hospitals using the most recently submitted or settled cost report data. Current law also requires this weighted average PCR to be reduced by 1.0 percentage points. Therefore, for CY 2025, CMS will use a target PCR of 0.87 to determine the CY 2025 cancer hospital payment adjustment to be paid at cost report settlement. That is, the payment adjustments will be the additional payments needed to result in a PCR equal to 0.87 for each cancer hospital.</p><h3>Quality Reporting Programs</h3><p>For the Inpatient QRP, CMS will continue voluntary reporting of certain data elements for the Hybrid Hospital-wide Mortality and Readmissions measures that will impact the fiscal year (FY) 2026 payment determination as proposed and already communicated to hospitals outside of the rulemaking process; in response to public comment, the agency finalizes an additional year of voluntary reporting of these data elements so that data reporting also will not affect FY 2027 payment.</p><p>For the Hospital Outpatient QRP, CMS finalizes its proposal to adopt a patient-reported outcome measure of the patient’s understanding of information related to recovery after outpatient surgery beginning with voluntary reporting in CY 2025 and mandatory reporting beginning CY 2026. The agency will also remove two measures found to have little to no effect on patient outcomes.</p><p>CMS makes programmatic updates to the ASC QRP and the REH QRP regarding data reporting requirements upon conversion to REH status and the reporting period for one existing quality measure in the program.</p><p>For the Outpatient, ASC and REH QRPs, CMS finalizes the adoption of three measures related to health equity as proposed; these measures have already been adopted in the Inpatient QRP. These include the Hospital Commitment to Health Equity measure, with mandatory reporting beginning CY 2025, Screening for Social Drivers of Health measure and Screen Positive Rate for Social Drivers of Health, with voluntary reporting in CY 2025 and mandatory reporting beginning CY 2026.</p><h3>Remote Outpatient Therapy, Diabetes Self-management Training and Medical Nutrition Therapy</h3><p>Barring congressional action, providers can no longer bill for remote outpatient therapy, diabetes self-management training and medical nutrition therapy beginning Jan. 1, 2025. CMS reiterates that extensions of statutory waivers expanding the list of telehealth-eligible providers are necessary for CMS to update these billing policies.</p><h3>Periodic In-person Visits for Mental Health Services Furnished Remotely by Hospital Staff to Beneficiaries in their Homes</h3><p>In previous rulemaking, CMS finalized a requirement that payment for remote mental health services may only be made if the beneficiary receives an in-person service within six months prior to the provision of remote service and then annually. CMS reiterates that these in-person visit requirements are currently set to take effect for services furnished on or after Jan. 1, 2025. Congress would need to extend previous statutory waivers to continue to waive the in-person visit requirements beyond Jan. 1, 2025.</p><h3>Changes to the Inpatient-only List</h3><p>For CY 2025, CMS finalizes the addition of three liver allograft services to the inpatient-only list. The American Medical Association CPT Editorial Panel for CY 2025 created the CPT codes for these three services. Additionally, CMS finalizes removing a pelvic fixation code from the inpatient-only list for CY 2025.</p><h3>Access to Non-opioid Treatments for Pain Relief</h3><p>As directed by the Consolidated Appropriations Act of 2023, CMS implements temporary additional payments for specific non-opioid treatments for pain relief dispensed in the HOPD and ASC settings from Jan. 1, 2025, through Dec. 31, 2027. CMS finalizes a calculation methodology to determine the payment limitation as required by statute. The agency finalizes six drugs and five devices that qualify for these payments, which will be paid separately.</p><p>The qualifying drugs have FDA-approved indications to reduce post-operative pain or produce postsurgical analgesia, and the qualifying medical devices have demonstrated through evidence that they reduce opioid usage when used in the postoperative setting.</p><h3>Changes to the Review Timeframes for the HOPD Prior Authorization Process</h3><p>CMS reduces the permissible review timeframe for prior authorization requests for relevant covered outpatient department services from 10 business days to seven calendar days for standard reviews.</p><h2>CY 2025 ASC Final Rule Changes</h2><h3>ASC Payment Update</h3><p>For CYs 2019 through 2023, CMS adopted a policy to update ASC payment rates using the hospital market basket. In light of the impact of the COVID-19 public health emergency on health care utilization, the agency extends this policy through CYs 2024 and 2025. As such, it will increase payment rates by 2.9% for ASCs that meet the quality reporting requirements under the ASC QRP.</p><h3>Changes to the List of ASC-covered Surgical Procedures</h3><p>CMS evaluates the ASC-covered procedures list (CPL) each year to determine whether procedures should be added to or removed from the list. For CY 2025, the agency finalized, with modification, the addition of 21 medical and dental procedures to the ASC CPL based on its existing regulatory criteria.</p><h2>other Final Rule Policies</h2><h3>Health and Safety Standards for Obstetrical and Other Services in Hospitals and CAHs</h3><p>CMS finalizes a new obstetrical services CoP for hospitals and CAHs as part of its efforts to improve maternal health outcomes. This new CoP encompasses organization and supervision of services, delivery of care and staff training. CMS also finalized updates to the QAPI and emergency services CoPs. In addition, the final rule includes an update to the hospital discharge planning CoP.</p><h3>Obstetrical Services</h3><h4>Organization, Supervision of Services and Delivery of Care</h4><p>Beginning Jan. 1, 2026, hospitals and CAHs offering obstetrical services must offer such services in a “well-organized” fashion and per “nationally recognized standards of practice” for both physical health and behavioral health (including mental health and substance use disorders). The final CoP also requires that hospitals delineate obstetrical privileges for all practitioners per the competencies of each practitioner and requires all units providing obstetrical services to be supervised by an experienced, trained professional.</p><p>In a departure from the proposed rule, hospitals and CAHs with obstetrical care units must keep certain supplies readily available instead of maintaining equipment for each patient care room. In addition to a call-in system, cardiac monitor, and fetal doppler or monitor, hospitals and CAHs must maintain and keep readily available protocols and provisions, including equipment, supplies and medications necessary to treat obstetric emergencies.</p><h4>Staff Training</h4><p>Beginning Jan. 1, 2027, hospitals and CAHs offering obstetrical services must train relevant staff on selected topics that reflect the services’ scope and complexity, including facility-identified evidenced-based protocols to improve care delivery in the hospital or CAH.</p><h4>QAPI</h4><p>Under the final rule, hospitals and CAHs offering obstetrical services must regularly assess and work to improve maternal health disparities and outcomes among patients. Effective Jan. 1, 2027, hospitals and CAHs must track and analyze maternal health data, quality indicators and outcomes as part of their QAPI plans and use these findings to inform and update the staff training required under the obstetrical services CoP. CMS also requires the leadership of hospital obstetrical services to engage in QAPI activities, including data collection and monitoring. Finally, hospitals and CAHs must conduct at least one QAPI project focused on improving maternal health outcomes and disparities each year. Hospitals and CAHs in state, tribal or local jurisdictions with a maternal mortality review committee must also maintain a process to incorporate publicly available data into the hospital or CAH’s QAPI program.</p><h4>Emergency Services Readiness</h4><p>CMS has also finalized updates to the existing emergency services CoP for all hospitals and CAHs that offer emergency services, regardless of whether such hospital or CAH offers obstetrical services. Effective July 1, 2025, hospitals and CAHs must maintain adequate provisions and protocols to meet the emergency needs of patients per the offered emergency services’ complexity and scope, including but not limited to obstetrical emergencies. For hospitals, these provisions must include readily available equipment, supplies and medication necessary for treating emergency cases and a call-in system for each patient; no changes were made to existing requirements for equipment, supplies and medications for CAHs. For both hospitals and CAHs, applicable staff must be trained on these protocols and provisions annually, and findings from the hospital or CAH’s QAPI program should inform training topics and updates or other revisions to the training program.</p><h4>Transfer Protocols</h4><p>Beginning July 1, 2025, CMS will require hospitals to develop and maintain policies for transferring patients to the appropriate level of care, including among units within a facility and transfers to other hospitals. Relevant staff must receive annual training on these protocols. CMS did not change discharge planning requirements for CAHs.</p><h3>Changes to Medicaid Clinic Services Four Walls Exceptions</h3><p>CMS finalizes its proposal to add three exceptions to the four walls requirements for Medicaid clinic services: a mandatory exception for Indian Health Service (IHS) and Tribal clinics and optional exceptions for behavioral health clinics and clinics located in rural areas. Medicaid clinic services are distinct and separate from services provided in a Federally-Qualified Health Center (FQHC) or FQHC look-alike. In finalizing provisions related to clinics in rural areas, CMS allows states to adopt a definition of rural in use by certain federal agencies or a state’s rural policy-making agency and requires the state to attest that the definition best captures the rural population.</p><h3>IHS and Tribal Hospitals All-inclusive Rate</h3><p>Currently, IHS and tribal outpatient departments are excluded from the Medicare OPPS and are paid the Medicare outpatient hospital all-inclusive rate (AIR). IHS determines the AIR from cost reports and updates these rates annually. IHS and tribal hospitals have increasingly provided higher-cost drugs along with more complex and expensive services, such as cancer-related services. CMS believes that the AIR may no longer be adequate for these hospitals’ costs to provide these complex services and finalizes its proposals to pay an add-on to the AIR for certain high-cost drugs for people with Medicare who receive care at IHS or tribal hospitals.</p><h2>Further Questions</h2><p>The policies and payment rates in the final rule will take effect Jan. 1, 2025. Watch for a more detailed analysis of the final rule in the coming weeks.</p><p>If you have further questions, contact Roslyne Schulman, AHA’s director of outpatient payment policy, at <a href="mailto:rschulman@aha.org?subject=RE: Special Bulletin: CMS Outpatient PPS and ASC Final Rule for CY 2025 ">rschulman@aha.org</a>.</p><hr><ol><li id="fn1">The final National Coverage Determination can be found at <a href="https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310&fromTracking=Y&" target="_blank">NCA - Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection (CAG-00464N) - Decision Memo</a>.</li></ol></div><div class="col-md-4"><p><a href="/system/files/media/file/2024/11/Special-Bulletin-CMS-Issues-Hospital-Outpatient-Ambulatory-Surgical-Center-Final-Rule-for-CY-2025.pdf" target="_blank" title="Click here to download the Special Bulletin: CMS Outpatient PPS and ASC Final Rule for CY 2025 PDF."><img src="/sites/default/files/inline-images/Page-1-Special-Bulletin-CMS-Issues-Hospital-Outpatient-Ambulatory-Surgical-Center-Final-Rule-for-CY-2025.png" data-entity-uuid="350cb966-8e0d-481d-b427-38503d8bfd7f" data-entity-type="file" alt="Special Bulletin: CMS Issues Hospital Outpatient, Ambulatory Surgical Center Final Rule for CY 2025 page 1." width="696" height="900"></a></p></div></div></div> Mon, 04 Nov 2024 15:20:37 -0600 Ambulatory Surgical Center (ASC) /lettercomment/2024-09-09-aha-comments-cms-outpatient-ambulatory-surgery-center-cy-2025-proposed-payment-rule <div class="container"><div class="row"><div class="col-md-8"><p>September 9, 2024</p><p>The Honorable Chiquita Brooks-LaSure<br>Administrator<br>Centers for Medicare & Medicaid Services<br>Hubert H. Humphrey Building<br>200 Independence Avenue, S.W., Room 445-G<br>Washington, DC 20201</p></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2024/09/AHA-Comments-on-CMS-Outpatient-Ambulatory-Surgery-Center-CY-2025-Proposed-Payment-Rule.pdf" target="_blank" title="Click here to download the AHA Comments on CMS Outpatient, Ambulatory Surgery Center CY 2025 Proposed Payment Rule letter PDF.">Download the Full Letter PDF</a></div></div></div><div class="row"><div class="col-md-8"><p><em><strong>Re: CMS–1809–P: Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities (Vol. 89, No. 140), July 22, 2024.</strong></em></p><p>Dear Administrator Brooks-LaSure:</p><p>On behalf of our 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, the ���������� Association (AHA) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system proposed rule for calendar year (CY) 2025.</p><p>We support many of the OPPS proposed rule provisions, including unpackaging and paying separately for certain high-cost diagnostic radiopharmaceuticals, unpackaging from the comprehensive ambulatory payment classifications (C-APCs) and paying separately for certain cell and gene therapy products, and establishing new add-on payment for hospitals that use Technetium-99m (Tc-99m) derived from domestically produced Molybdenum-99 (Mo-99). We also appreciate that in response to comments from AHA and its members, the agency is considering reducing the reporting burden of its policy that helps offset the marginal costs that hospitals face in procuring domestically made surgical N95 respirators.</p><p>At the same time, the AHA continues to have strong concerns about the shortcomings in the annual payment update for hospital outpatient departments (HOPDs), in particular the market basket forecast and update. This is especially concerning considering past underwhelming market basket increases, specifically from CYs 2022 through 2024. Indeed, the forecasts on which CMS relies have consistently under-predicted cost growth, and the actual market basket increases are falling well short of inflation. <strong>Therefore, AHA urges CMS to consider whether adjustments are necessary in its approach to annual market basket updates to ensure that beneficiaries continue to have access to high-quality outpatient care. We also urge CMS to eliminate the productivity cut for CY 2025, as detailed below.</strong></p><p><strong>Further, the AHA shares CMS’ commitment to improving maternal health outcomes. However, we are concerned that CMS’ proposed CoPs fail to address the root causes behind poor maternal outcomes and may further reduce access to safe, high-quality obstetric care.</strong> Any potential solution to this crisis must consider the entire maternal health continuum and should prioritize the needs of pregnant and postpartum women. Instead of issuing duplicative and unnecessary regulations, the AHA urges CMS to partner with patients and the hospitals and health systems that serve them to address maternal morbidity and mortality causes. We believe a collaborative approach focused on patients not facilities will lead to meaningful patient outcome improvements while preserving access to safe, high-quality maternal health care.</p><p>We appreciate your consideration of these issues. Our detailed comments are attached. Please contact me if you have questions or feel free to have a member of your team contact Roslyne Schulman, AHA’s director for policy, at <a href="mailto:rschulman@aha.org?subject=RE: AHA Comments on CMS Outpatient, Ambulatory Surgery Center CY 2025 Proposed Payment Rule">rschulman@aha.org</a>.</p><p>Sincerely,</p><p>/s/</p><p>Ashley B. Thompson<br>Senior Vice President<br>Public Policy Analysis and Development</p><p><a href="/system/files/media/file/2024/09/AHA-Comments-on-CMS-Outpatient-Ambulatory-Surgery-Center-CY-2025-Proposed-Payment-Rule.pdf" target="_blank" title="Click here to download the AHA Comments on CMS Outpatient, Ambulatory Surgery Center CY 2025 Proposed Payment Rule letter PDF.">Download the complete letter PDF.</a></p></div><div class="col-md-4"><div class="external-link spacer"><a href="/system/files/media/file/2024/09/AHA-Comments-on-CMS-Outpatient-Ambulatory-Surgery-Center-CY-2025-Proposed-Payment-Rule.pdf" target="_blank" title="Click here to download the AHA Comments on CMS Outpatient, Ambulatory Surgery Center CY 2025 Proposed Payment Rule letter PDF."><img src="/sites/default/files/inline-images/Page-1-AHA-Comments-on-CMS-Outpatient-Ambulatory-Surgery-Center-CY-2025-Proposed-Payment-Rule.png" data-entity-uuid="3db1f84b-c317-425e-aa5a-f5e73a1f41b2" data-entity-type="file" alt="AHA Comments on CMS Outpatient, Ambulatory Surgery Center CY 2025 Proposed Payment Rule letter page 1." width="761" height="900"></a></div></div></div></div> Mon, 09 Sep 2024 15:07:48 -0500 Ambulatory Surgical Center (ASC) Thu, 29 Aug 2024 15:16:09 -0500 Ambulatory Surgical Center (ASC) <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) July 10 released its calendar year (CY) 2025 outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) <a href="https://public-inspection.federalregister.gov/2024-15087.pdf">proposed rule</a>. The rule would increase OPPS rates by a net 2.6% in CY 2025 compared to CY 2024. </p><p>CMS will accept comments on the proposed rule through Sept. 9.</p><div class="panel module-typeC"><div class="panel-heading"><h2>KEY HIGHLIGHTS</h2><p>CMS’ proposed policies would:</p><ul><li>Increase Medicare hospital OPPS rates by a net 2.6% in CY 2025.</li><li>Pay separately for diagnostic radiopharmaceuticals with per-day costs above a threshold of $630.</li><li>Exclude qualifying cell and gene therapies from comprehensive ambulatory payment classification (C-APC) packaging.</li><li>As required by law, implement temporary additional payments for certain non-opioid treatments for pain relief dispensed in the hospital outpatient department (HOPD) and ASC settings.</li><li>Adopt three measures related to health equity for the Outpatient, ASC and rural emergency hospital (REH) Quality Reporting Programs, and extend voluntary data reporting for two hybrid measures in the Inpatient Quality Reporting Program.</li><li>Establish new conditions of participation (CoPs) for hospitals and critical access hospitals (CAHs) focused on obstetrical services and maternal care.</li></ul></div></div><h2>AHA TAKE</h2><p>According to a statement by AHA Senior Vice President of Public Policy Analysis and Development Ashley Thompson, “CMS has yet again proposed an inadequate update to hospital payments. This proposed increase for outpatient hospital services of only 2.6% comes despite the fact that many hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, and we urge CMS to provide additional support in the final rule.” </p><p>“The AHA fully shares CMS’ goals of improving maternal health outcomes and reducing inequities in maternal care. However, we are deeply concerned by CMS’ continued and excessive use of Conditions of Participation to drive its policy agenda. We believe a less punitive and more collaborative and flexible approach is far superior. We will carefully review CMS’ proposals to determine whether they are feasible, sufficiently flexible for the wide variety of hospitals to which they would apply and do not inadvertently exacerbate maternal care access challenges.”</p><p>Highlights of the CY 2025 OPPS/ASC proposed rule follow.</p><h2>CY 2025 OPPS Proposed Rule Changes</h2><h3>Proposed Payment Update</h3><p>CMS proposes to update OPPS rates by a net 2.6% for CY 2025. This includes a proposed market-basket update of 3.0% and a statutorily required productivity cut of 0.4 percentage points. These payment adjustments, in addition to other proposed changes in the rule, are estimated to result in a net increase in OPPS payments to hospitals of 2.4% compared to CY 2024 payments.<strong> </strong>For hospitals that do not publicly report quality measure data, CMS would continue to impose the statutory 2.0 percentage point additional reduction in payment, resulting in a 0.6% OPPS update. CMS estimates that total payments to hospitals (including enrollment, utilization, case-mix and beneficiary cost sharing) would increase by approximately $5.2 billion in CY 2025 compared to CY 2024.</p><p>CMS proposes to increase the conversion factor to $89.379 in CY 2025, as compared to $87.382 in CY 2024. This update reflects several proposed factors: the 2.6% OPPS payment update, the wage index budget neutrality adjustment of 1.0026, the 5% annual cap for individual hospital wage index reductions adjustment of 0.9982, the cancer hospital payment adjustment of 1.0006 and a decrease of 0.44 percentage point for the difference in pass-through spending. CMS proposes to use a reduced conversion factor of $87.636 in the calculation of payments for hospitals that fail to meet the Hospital Outpatient Quality Reporting (OQR) Program.</p><h3>Data Proposed for Use in CY 2024 OPPS/ASC Ratesetting</h3><p>To set proposed OPPS and ASC payment rates, CMS would use the most updated cost reports and claims data available. Therefore, the agency proposes to use the CY 2023 claims data and the most updated cost report extract available from the Healthcare Cost Report Information System. This extract primarily includes cost reports with cost reporting periods from CY 2022.</p><h3>Proposed Packaging Policy for “Threshold-packaged” and “Policy-packaged” Drugs, Biologicals and Radiopharmaceuticals</h3><p>CMS pays for drugs, biologicals and radiopharmaceuticals that do not have pass-through status in one of two ways: packaged payment or separate payment (individual Ambulatory Payment Classifications (APCs)). For CY 2025, CMS proposes to maintain the packaging threshold for “threshold-packaged” drugs, including non-implantable biologicals and therapeutic radiopharmaceuticals, of $140 per day. This means that such products with a per-day cost of $140 or less would have their cost packaged in the procedure with which they are billed.</p><p>There are exceptions to this threshold-based packaging policy for certain “policy-packaged” drugs, biologicals and contrast agents. CMS proposes to continue to package the costs of all anesthesia drugs; drugs, biologicals, and contrast agents and other drugs that function as supplies when used in a diagnostic test or procedure; and drugs and biologicals that function as supplies when used in a surgical procedure (e.g., skin substitutes), regardless of whether they meet the $140 per day threshold.</p><p><u>Diagnostic Radiopharmaceuticals Separate Payment.</u> CMS proposes to pay separately for diagnostic radiopharmaceuticals with per-day costs above a threshold of $630 — which is approximately two times the volume-weighted average cost amount currently associated with diagnostic radiopharmaceuticals. It also proposes to update the $630 threshold in CY 2026 and subsequent years by the Producer Price Index for Pharmaceutical Preparations. Finally, CMS proposes to pay for separately payable diagnostic radiopharmaceuticals based on their Mean Unit Cost derived from OPPS claims.</p><p><u>Exclusion of Cell and Gene Therapies from Comprehensive APCs (C-APC) Packaging.</u> CMS proposes to exclude qualifying cell and gene therapies from C-APC packaging.</p><p><u>Add-on Payment for Radiopharmaceutical Technetium-99m (Tc-99m).</u> For CY 2025, there is an add-on payment that applies to radiopharmaceuticals that use Tc-99m produced without use of highly enriched uranium (HEU). CMS proposes that for CY 2026 it would replace the add-on payment for radiopharmaceuticals produced without the use of Tc-99m derived from non-HEU sources with an add-on payment for radiopharmaceuticals that use Tc-99m derived from domestically produced Mo-99.</p><p><u>Payment for HIV Pre-Exposure Prophylaxis (PrEP) in HOPDs.</u> For CY 2025, CMS proposes to cover and pay for HIV PrEP drugs and related services under the OPPS, if covered by CMS through a National Coverage Determination.<sup>1</sup> This proposed coverage would include coverage for the HIV PrEP drugs, drug administration, HIV and hepatitis B screening, and individual counseling performed by physicians or certain other health care practitioners.</p><h3>Intensive Outpatient and Partial Hospitalization Programs</h3><p>CMS proposes to maintain the existing rate structures for Intensive Outpatient Program (IOP) and Partial Hospitalization Program (PHP) services as established in previous rulemaking. To calculate cost information, the agency would use CY 2023 claims data and the OPPS data set to identify services eligible for payment under the IOP and PHP benefits.</p><h3>Proposed Cancer Hospital Payment Adjustment</h3><p>CMS proposes to continue providing additional payments to cancer hospitals so that a cancer hospital’s payment-to-cost ratio (PCR) after the additional payments is equal to the weighted average PCR for the other OPPS hospitals using the most recently submitted or settled cost report data. Current law also requires that this weighted average PCR be reduced by 1.0 percentage point. Therefore, for CY 2025, CMS proposes to use a target PCR of 0.87 to determine the CY 2025 cancer hospital payment adjustment to be paid at cost report settlement. That is, the payment adjustments will be the additional payments needed to result in a PCR equal to 0.87 for each cancer hospital.</p><h3>Quality Reporting Programs</h3><p>For the Inpatient Quality Reporting Program (IQR), CMS proposes to continue voluntary reporting of certain data elements for two hybrid quality measures that would impact the FY 2026 payment <a>determination</a><a href="#_msocom_1" id="_anchor_1" language="JavaScript">[TA1]</a> .</p><p>For the OQR, CMS proposes to adopt a patient-reported outcome measure of the patient’s understanding of information related to recovery after outpatient surgery beginning with voluntary reporting in CY 2025 and mandatory beginning CY 2026. The agency also proposes to remove two measures that were found to have little to no effect on patient outcomes.</p><p>CMS proposes to make programmatic updates to the ASC Quality Reporting Program (ASCQR) and seeks comment on a request for information regarding a new framework for ASC quality data reporting.</p><p>The agency also proposes certain programmatic updates for the Rural Emergency Hospital Quality Reporting Program (REHQR) regarding data reporting requirements upon conversion to REH status and the reporting period for one existing quality measure in the program.</p><p>For the OQR, ASCQR and REHQR, CMS proposes to adopt three measures related to health equity that have already been adopted in the IQR. These include the Hospital Commitment to Health Equity measure, with mandatory reporting beginning CY 2025, and Screening for Social Drivers of Health measure and Screen Positive Rate for Social Drivers of Health, with voluntary reporting in CY 2025 and mandatory reporting beginning CY 2026.</p><p>Finally, CMS seeks feedback on several aspects of the Overall Hospital Quality Star Rating methodology but does not propose to change the methodology.</p><h3>Remote Outpatient Therapy, Diabetes Self-management Training and Medical Nutrition Therapy</h3><p>CMS states that extensions of statutory waivers expanding the list of telehealth-eligible providers will be necessary for providers to continue billing for remote therapy services (including physical therapy, occupational therapy and speech language pathology), Diabetes Self-Management Training (DMST) and Medical Nutrition Therapy (MNT) when administered via telehealth. Barring Congressional action, providers will no longer be able to bill for remote outpatient therapy, DMST and MNT beginning Jan. 1, 2025.</p><h3>Periodic In-person Visits for Mental Health Services Furnished Remotely by Hospital Staff to Beneficiaries in their Homes</h3><p>CMS states that extensions of statutory waivers will be necessary to continue the in-person visit requirements waiver for mental health services. In-person visit requirements are currently set to take effect for services furnished on or after Jan. 1, 2025, unless Congress extends these waivers.</p><h3>Proposed Changes to the Inpatient-only List</h3><p>For CY 2025, CMS proposes to add three services (for which codes were newly created by the AMA CPT Editorial Panel for CY 2025) to the IPO list. </p><h3>Access to Non-opioid Treatments for Pain Relief</h3><p>As directed by the Consolidated Appropriations Act of 2023, CMS proposes to implement temporary additional payments for specific non-opioid treatments for pain relief dispensed in the HOPD and ASC settings from Jan. 1, 2025, through Dec. 31, 2027. CMS proposes a calculation methodology to determine the payment limitation as required by statute. The agency proposes seven drugs and one device that would qualify for these payments, which would be paid separately.</p><h3>Proposed Changes to the Review Timeframes for the HOPD Prior Authorization Process</h3><p>CMS proposes to change the current review timeframe for prior authorization requests for HOPD services from 10 business days to seven calendar days for standard reviews.</p><h2>CY 2025 ASC PROPOSED RULE CHANGES</h2><h3>ASC Payment Update</h3><p>For CYs 2019 through 2023, CMS adopted a policy to update the ASC payment system using the hospital market basket update. In light of the impact of the COVID-19 public health emergency on health care utilization, the agency extended this policy through CYs 2024 and 2025. As such, it proposes to increase payment rates by 2.6% for ASCs that meet the quality reporting requirements under the ASC Quality Reporting (ASCQR) Program.</p><h3>Proposed Changes to the List of ASC-covered Surgical Procedures</h3><p>CMS evaluates the ASC-covered procedures list (CPL) each year to determine whether procedures should be added to or removed from the list. For CY 2025, the agency proposes to add 20 medical and dental procedures to the ASC CPL based on its existing regulatory criteria.</p><h2>OTHER PROPOSALS</h2><h3>Proposed Health and Safety Standards for Obstetrical Services in Hospitals and CAHs</h3><p>CMS proposes new and updated CoPs for hospitals and CAHs as part of its efforts to improve maternal health outcomes. The new and updated CoPs encompass organization, staffing and delivery of care; staff training; quality assessment and performance improvement (QAPI); emergency services readiness; and transfer protocols.</p><p><u>Organization, staffing and delivery of care.</u> For hospitals and CAHs offering obstetrical services, CMS’ proposed CoP would require such services to be well organized and provided per nationally recognized standards of practice for both physical health and behavioral health (including mental health and substance use disorders). Hospitals and CAHs would be required to maintain a roster of all practitioners providing obstetrical care specifying the competencies of each practitioner. CMS also would require all units providing obstetrical services to be supervised by an experienced, trained professional. The agency also would require obstetrical care units to maintain certain supplies for obstetrical emergencies, complications, immediate post-delivery needs and other health and safety events.</p><p><u>Staff training.</u> Hospitals and CAHs offering obstetrical services would be required to train on selected topics that reflect the scope and complexity of the services offered.</p><p><u>QAPI.</u> Hospitals and CAHs offering obstetrical services would be required to include analyses of maternal health data, quality indicators and outcomes in their QAPI plans. CMS also would require hospitals to use the findings of the analyses to assess and improve maternal health outcomes, reduce disparities and inform staff training. Lastly, CMS would require the leadership of hospital obstetrical services to engage in QAPI activities.</p><p><u>Emergency services readiness.</u> CMS proposes an update to the existing emergency services CoP which would apply to all hospitals and CAHs that offer emergency services, regardless of whether such hospital or CAH offers obstetrical services. This update would require facilities to maintain protocols to meet emergency needs per the complexity and scope of emergency services offered at a hospital or CAH. Such protocols would include mandatory annual training for certain staff and maintenance of certain emergency medications and supplies.</p><p><u>Transfer protocols.</u> CMS proposes to require hospitals and CAHs to develop and maintain policies for transfers among units within a facility as well as transfers to other hospitals. Staff would be required to be trained on these protocols.</p><h3>Proposed Changes to Medicaid Clinic Services Four Walls Exceptions</h3><p>CMS proposes to add three exceptions to the four walls requirements for Medicaid clinic services: a mandatory exception for Indian Health Service/Tribal clinics and optional exceptions for behavioral health clinics and clinics located in rural areas. CMS is seeking input on defining rural areas, including whether to defer to states to define what areas are considered rural.</p><h3>Indian Health Service (IHS) and Tribal Hospitals All-Inclusive Rate (AIR)</h3><p>Currently, IHS and tribal outpatient departments are excluded from the Medicare OPPS and are paid the Medicare outpatient hospital AIR. IHS determines the AIR from cost reports and updates these rates annually. However, IHS and tribal hospitals have increasingly provided higher-cost drugs along with more complex and expensive services, such as cancer-related services. Therefore, CMS believes that the AIR may no longer be adequate to cover these hospitals’ costs of providing these complex services and is proposing to pay an add-on to the AIR for certain high-cost drugs for people with Medicare who receive care at IHS or tribal hospitals.</p><p>Additionally, CMS is seeking comments from stakeholders related to making all IHS and tribal hospitals eligible for payment at the IHS Medicare outpatient AIR. Specifically, the agency is requesting information on the types of clinics and costs of services in these provider settings. It notes that this is a similar request for information in the CY 2022 physician fee schedule proposed rule.</p><h2>FURTHER QUESTIONS</h2><p>CMS will accept comments on the proposed rule through Sept. 9. The final rule will be published around Nov.1, and the policies and payment rates will take effect Jan. 1, 2025. Watch for a more detailed analysis of the proposed rule in the coming weeks.</p><p>If you have further questions, contact Roslyne Schulman, AHA’s director of outpatient payment policy, at <a href="mailto:rschulman@aha.org">rschulman@aha.org</a>.</p><p>__________</p><p><small class="sm"><sup>1</sup> The final National Coverage Determination has not been issued as of the issuance of this proposed rule.</small><br> </p></div><div class="col-md-4"><a href><img src="/sites/default/files/inline-images/cover-image-cms-issues-hospital-outpatient-ambulatory-surgical-center-proposed-rule-for-cy-2025-bulletin-7-10-24.png" data-entity-uuid="60e00226-1568-41d2-a7d3-a47c07089157" data-entity-type="file" alt="Special Bulletin Cover Page" width="643" height="830"></a></div></div></div> Wed, 10 Jul 2024 17:19:23 -0500 Ambulatory Surgical Center (ASC)