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Author: Kathy Lester

Member Advisory: MedPac to Discuss Ground Ambulance Data

Written by Kathy Lester on . Posted in Cost Data Collection, Member Advisories, News.

On Thursday, March 6, the Medicare Payment Advisory Committee (MedPAC) will hold the first of several Commission discussions related to the statutorily mandated report to review ground ambulance payment policy in light of the Ground Ambulance Data Collection System. The AAA has already met with MedPAC staff and will also provide a summary of the meeting. Given that CMS will likely publish the second data collection period report at the end of 2025, we anticipate that the MedPAC report will be published in its June 2026 report.
The MedPAC process involves a series of public meetings during which staff present materials to Commissioners. The Commissioners often ask questions and express opinions during this process. It is important to recognize that the Chair of MedPAC seeks to ensure consensus as much as possible in the final report. Thus, many of the comments made during public meetings are not included in final reports.
The AAA will continue its work with MedPAC as it works to develop the report.

CMS Proposed Expansion of ALS-2 to include Low-Tier O+ Whole Blood Transfusions Fails to Include Additional Funding for the Services

Written by Kathy Lester on . Posted in Medicare, Member Advisories, News, Patient Care, Reimbursement.

The Centers for Medicare & Medicaid Services (CMS) has released the Calendar Year (CY) 2025 proposed rule that proposes changes to the CY 2025 definitions of ALS-2 services to include one type of whole blood product. The rule does not propose any other changes to the Medicare ambulance fee schedule for 2025.

CMS proposes expanding the list ALS-2 to include low-tier O+ whole blood transfusions. However, there is no new money added to support the provision of the additional services. Specifically, CMS states that most transports involving whole blood are already reimbursed as ALS-2 and no additional payment will be added.  For the few instances when whole blood is used and not in connection with another ALS-2 service, the transport would now be reimbursed under ALS-2.  If a ground ambulance uses a blood product other than low-tier O+ whole blood, there would be no opportunity for reimbursement unless the transport qualified for ALS-2 through another service.

CMS states:

“We believe that many ground ambulance transports providing WBT already qualify for ALS2 payment, since patients requiring such transfusions are generally critically injured or ill and often suffering from cardio-respiratory failure and/or shock, and therefore are likely to receive one or more procedures currently listed as ALS procedures in the definition of ALS2, with endotracheal intubation, chest decompression, and/or placement of a central venous line or an intraosseous line the most probable to be seen in these circumstances. Patients requiring WBT are typically suffering from hemorrhagic shock, for which the usual course of treatment includes airway stabilization, control of the hemorrhagic source, and stabilization of blood pressure using crystalloid infusion and the provision of WBT or other blood product treatments when available, but not necessarily the administration of advanced cardiac life support medications. Consequently, we do not believe it is likely that most patients who may require WBT would trigger the other pathway to qualify as ALS2, the administration of at least three medications by intravenous push/bolus or by continuous infusion, excluding crystalloid, hypotonic, isotonic, and hypertonic solutions (Dextrose, Normal Saline, Ringer’s Lactate).”

“However, not all ground ambulance transports providing WBT may already qualify for ALS2 payment. An ambulance transport would not qualify for ALS2 payment where a patient received only WBT during a ground ambulance transport, and not one or more other services that, either by themselves or in combination, presently qualify as ALS2. We believe WBT should independently qualify as an ALS2 procedure because the administration of WBT and handling of low titer O+ whole blood require a complex level of care beyond ALS1 for which EMS providers and suppliers at the EMT-Intermediate or paramedic level require additional training. In addition, WBT requires specialized equipment such as a blood warmer and rapid infuser. While there is no established national training protocol, many systems follow the guidelines of the Association for the Advancement of Blood and Biotherapies (AABB), which requires additional training that is 4 hours in length for paramedics and 6 hours in length for EMS supervisory staff. Medicare’s requirements for ambulance staffing at 42 CFR 410.41(b) include compliance with state and local laws, which here would establish appropriate training requirements with respect to WBT administration.”

“Therefore, we believe it is appropriate to modify the definition of ALS2 to account for the instances where patients are administered WBT but do not otherwise qualify for ALS2 payment. Of note, we do not have the authority to provide an additional payment, such as an add-on payment for the administration of WBT under the AFS.”[1]

CMS proposes this changed based on data showing that about 1.2 percent of ground ambulance providers/suppliers use some time of blood product, with the majority (60 percent of those carrying the low-tier O+ whole blood). CMS does not discuss the ongoing discussions of the blood community and medical profession about the appropriateness of this treatment versus other types of whole blood or blood components. Nor does it discuss the cost of providing these services. Moreover, it does not address how this proposal may affect the current blood shortage in the United States.

The AAA is working with our members, other EMS organizations, and the blood community to assess the clinical aspects of this proposal, but has identified the failure to address the cost of providing blood and blood products to ground ambulance services that are already woefully underfunded.

The AAA will prepare a comment letter to submit before the September 9 deadline. We also plan to work with members who would also like to provide comments on the proposed rule.

 

[1]CMS. “CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments.” Display Copy pages 1165-66.

CMS Update-CY 2023 Final Ambulance Fee Schedule

Written by Kathy Lester on . Posted in Cost Data Collection, Medicare, Member Advisories, News.

Member Advisory:  CMS Issues CY 2023 Final Ambulance Fee Schedule Rule Updated Data Ground Ambulance Data Collection System

by Kathy Lester, JD, MPH

CMS has released the “CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicare and Medicaid Provider Enrollment Policies, Including for Skilled Nursing Facilities; Conditions of Payment for Suppliers of Durable Medicaid Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts” (Final Rule).  The Final Rule includes proposals affecting ground ambulance services in terms of medical necessity requirements and documentation requirements, as well as to the ground ambulance cost collecting tool.

I.           Medical Necessity and Documentation Requirements for Nonemergency, Scheduled, Repetitive Ambulance Services

              CMS finalizes the modifications to the documentation requirements codified in regulation pertaining to the medical necessity and documentation requirements for nonemergency, scheduled, repetitive ambulance services, such as those to/from dialysis facilities.  The Final Rule clarifies that the Physician Certification Statement (PCS), and additional documentation from the beneficiary’s medical record, may be used to support a claim that transportation by ground ambulance is medically necessary.  It also notes that the PCS and additional documentation must provide detailed explanations that: (1) are consistent with the beneficiary’s current medical condition; and (2) explain the beneficiary’s need for transport by an ambulance.  Coverage includes observation or other services rendered by qualified ambulance personnel.  It maintains the following requirements:

  • In all cases, the provider or supplier must keep appropriate documentation on file and, upon request, present it to CMS;
  • The ambulance service must meet all program coverage criteria including vehicle and staffing requirements; and
  • A signed PCS does not alone demonstrate that transportation by ground ambulance was medically necessary.

             CMS declines to “confine this regulatory clarification to the RSNAT prior authorization program, as there may be non-emergent, scheduled, repetitive ambulance transport services outside of that program that would be affected.” (Display Copy 1756)  CMS also does not provide further clarification about what it means by the term “additional documentation” because it believes that “the data elements needed will vary depending upon the beneficiary’s specific conditions and needs.” (Id.)  CMS also states that “[t]his proposal does not establish new obligations for documentation; rather, it merely clarifies existing requirements.” (Id. at 1757).  In response to a comment, CMS also writes, “In addition, our pre-proposal language and proposed regulatory language both reflect that the presence of a PCS alone is not sufficient to demonstrate medical necessity, and, therefore, must be supported by medical documentation.” (Id.)  CMS also declined to extend authorization to nurse practitioners and physicians’ assistants, stating that to do so would be outside of the scope of the rule.

II.         Ground Ambulance Data Collection Instrument

            CMS finalizes the proposed changes to the ground ambulance data collection instrument and instructions with a few additional modifications in response to comments.  They fall within four areas:  (1) editorial changes for clarity and consistency; (2) updates to reflect the web-based system; (3)  clarifications responding to feedback from questions from interested parties and testing; and (4) typos and technical corrections.  The updated instrument that includes all of the CY 2023 proposed changes to review and provide comments on is posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Medicare-Ground-Ambulance-Data-Collection-System-Instrument.pdf.

            One of these modification is to Section 5, Question 3c, which now reads: Does your organization respond to calls with another non- transporting agency such as a local fire department that is not part of your organization? After the question, the following instructions will be provided: This includes joint responses with other ground ambulance organizations as well as cases where a fire, police, or other public safety department responses to calls for service with your organization. Only consider cases where your ground ambulance does or would have transported the patient, if necessary.

            The Final Rule notes that the system already includes an “autosave” feature that saves responses as they are entered. The system also allows the same user to enter information at different times, and/or multiple users to enter information at different times. The system also already includes many validation and error checking steps that are automatically applied as respondents enter information. CMS also noted that it has no plans to adopt additional import functionality prior to the launch of the system, but that it will continue to explore the option of an API.  CMS also indicates that the final written tool and web-based platform will align before the system goes live.  A print function will also be available for the online submissions.

            CMS indicates that the data from the collection system will be made available to the public through posting on the CMS website at least every 2 years.  Summary results will be posted by the last quarter.  The data collected under the ground ambulance data collection system will be publicly available beginning in 2024.

            CMS also indicates that it will not require a ground ambulance organization to fill the data entry submitter and data certifier roles with different individuals.

            CMS has also provided additional guidance, including FAQs available at:  https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AmbulanceFeeSchedule/Downloads/Medicare-Ground-Ambulance-FAQs.pdf.

            CMS also finalizes its proposal for an automated process for submitting a hardship exemption request and informal review request.

III.        Origin and Destination Requirements Under the Ambulance Fee Schedule

            In the Final Rule, CMS also responds to comments it received on the Interim Final Rule that expanded the origin and destination requirements.  It finalizes the interim final policy that the expanded list of covered destinations for ground ambulance transports including, but are not limited to, any location that is an alternative site determined to be part of a hospital, CAH or SNF, community mental health centers, FQHCs, RHCs, physician offices, urgent care facilities, ASCs, any location furnishing dialysis services outside of an ESRD facility when an ESRD facility is not available, and the beneficiary’s home.  The policy will be In effect for the duration of the PHE for the COVID-19 only.

CMS End of PHE Roadmap

Written by Kathy Lester on . Posted in Emergency Preparedness, Medicaid, Medicare, Member Advisories, News.

CMS Prepares Providers and Suppliers for the End of the Public Health Emergency:

CMS Issues Updates on the End of Emergency Waivers and Flexibilities Issued during the PHE

By Kathy Lester, J.D., M.P.H.

 

Even though it appears that the Biden-Harris Administration will extend the COVID-19 Public Health Emergency (PHE) for at least another 90 days, CMS has begun the process of preparing for the termination of waivers and flexibilities that have been in effect during the pandemic.  During the PHE, the American Ambulance Association has worked closely with CMS and Congress to make sure that ground ambulance services were prioritized and provided with waivers and flexibilities to support their integral role as a front-line medical response during the pandemic.

 

CMS announced its roadmap for the end of the PHE on August 18.  The roadmap includes a summary of the policies that will terminate at the end of the PHE, but also notes that CMS intends to keep some policies in place even after the PHE ends. Examples of policies that will continue after the PHE is allowed to expire include certain morbidity and mortality reporting requirements on long-term care facilities and certain telehealth services expanded by Congress.

 

In its announcement, CMS indicated particular concern about patient safety.  “As mentioned by Lee A. Fleisher, M.D.; Michelle Schreiber, M.D.; Denise Cardo, M.D.; and Arjun Srinivasan, M.D., in February 17, 2022, New England Journal of Medicine Perspective, ‘Safety has also worsened for patients receiving post-acute care, according to data submitted to the Centers for Medicare and Medicaid Services (CMS) Quality Reporting Programs…’”

 

As part of this announcement, CMS released a fact sheet detailing the current status of the Medicare waivers and flexibilities for ambulance providers and suppliers.  Some of the policies highlighted in this fact sheet include:

 

  • Vaccine Reimbursement Rates: CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in outpatient settings for Medicare beneficiaries through the end of the calendar year that the COVID-19 PHE ends.  Effective January 1 of the year following the year that the COVID-19 PHE ends, CMS will set the payment rate for administering COVID-19 vaccines to align with the payment rate for administering other Part B preventive vaccines.  CMS plans to continue to pay a total payment of approximately $75 per dose to administer COVID-19 vaccines in the home for certain Medicare patients through the end of the calendar year that the COVID-19 PHE ends.

 

  • Alternative Destination: CMS indicates that it will include this issue in future rulemaking.

 

  • Treat in Place: CMS indicates that the waiver will end with the end of the PHE.

 

  • Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization: CMS notes that it has already returned to the full model operations including post-payment reviews of claims submitted during the PHE.

 

  • Signature Requirements: Absent indications of potential fraud and abuse, CMS will not review claims for dates of service during the COVID-19 PHE for compliance with the signature requirements.

 

  • Appeal Flexibilities: CMS will allow some of the flexibilities related to the timing of appears to continue consistent with existing authority for appeals once the PHE ends.

 

The AAA will continue to monitor the PHE and any changes in the waivers and flexibilities specific to ground ambulance services.  We encourage members to reach out to our team if concerns or questions arise as CMS winds down the PHE.

HHS Provides More Details on Phase 4 and Rural Provider Relief Fund Distribution

Written by Kathy Lester on . Posted in Government Affairs.

As previously reported by the AAA, the Department of Health and Human Services (HHS) has announced that it will open on September 29, Phase 4 of the Provider Relief Fund (PRF) to allocate $17 billion dollars for COVID-19 relief. In addition, it will provide $8.5 billion specifically for rural providers. On September 15, HHS held a stakeholder call on the PRF in which the agency provided more details on the distribution.

The application process will remain open for 4 weeks. Providers will be able to use the funding through December 31, 2022.  The Administration’s goal is to release the rural funds before Thanksgiving and the Phase four funds by mid-December 2021. The agency indicated it has additional funding it is holding back to reimburse for the uncompensated care fund for which providers and suppliers can still apply.

The AAA has been advocating relentlessly for the Administration to open a fourth phase of funding and support rural providers and suppliers.  As described below, these phases of funding will rely upon data from Medicare, Medicaid, and the State Children’s Health Insurance Program (CHIP).  It is important that all AAA members who qualify not only submit applications, but also make sure that you have appropriately submitted claims to these programs, including when allowed, claims under the ground ambulance treatment in place waiver. We strongly recommend that all AAA members apply for funding.

Phase 4 Funding

The Phase 4 PRF methodology and application will primarily follow the same rules set forth for Phase 3.  It will apply for Q2 2020 through Q1 2021.  The funding will be available for the same broad set of providers and suppliers that were eligible under Phase 3.

Phase 4 will have two components.  The Acting Administrator of HRSA has explained that 75 percent of the funding for Phase 4 will be determined based on a provider’s lost revenues and expenses that the provider submits through the application process.  HRSA will calculate the amount awarded based on the number of applications received.  However, it will establish a base for all providers and then adjust that base up for medium and small providers who have lower volumes over which to spread their costs.  The determination of provider size will be based on patient revenues.

The second component of Phase 4 funding will allocate 25 percent for bonus payments to providers serving Medicare, Medicaid, and CHIP patients.  The final amounts awarded will be determined based on the volume of services provided to these patient populations.

The Acting Administrator also noted that once again providers who have higher values compared to their peer group will be flagged and may have the amount they receive capped or may not receive any funding.  There will be a reconsideration process for these providers as well.

Rural Funding

In addition to Phase 4, HRSA will provide rural-specific relief to providers and suppliers serving rural patients.  The determination of whether a provider qualifies will be based on the patient’s location, not that of the providers.  HRSA will use Medicare, Medicaid, and CHIP data to calculate the payment, so the application process will be simplified and providers required to submit less information.  The amounts will be determine based on the number of patients served and the number of applicants.

Additional Relief

The Acting Administrator also indicated that HRSA will provide a 60-day grace period for those providers who received funds already and are required to report if they cannot meet the current reporting deadline.  She also noted that HRSA is establishing a reconsideration process for Phase 3 as well.  Details will be available on the HRSA website.

Additional Information

HRSA will be posting information on its website.  It will also host two webinars on September 30 and October 5 to provide more information about how providers can apply to these programs.

EMS Provider Comments Needed on the “Surprise Billing” Interim Final Rule

Written by Kathy Lester on . Posted in Advocacy Priorities, Regulatory.

The Department of Health and Human Services, Department of Labor, and the U.S. Treasury Department (Departments) have issued an Interim Final Rule (IFR) on “surprise billing” that will take effect September 13, 2021.  However, the Departments are taking comments on the IFR.  While the Congress expressly excluded ground ambulance organizations from the statute that the IFR seeks to implement, the Departments have included a prohibition on balance billing for nonemergency ground ambulance transports that occur after a patient has been stabilized in a facility.

The Congress established an Advisory Committee to consider the best way to address balance billing in the context of ground ambulance services, and the Departments should wait to be advised by that group before subjecting nonemergency ground ambulance transports to the broader balancing billing prohibition.

It is important that the Departments hear from as many stakeholders as possible opposing this expansion of the law.  To help you develop a comment letter, we provided the following template that we ask you to tailor to your experience and organization.  Tailored letters will be of greater value to the Department as they consider the rules.  At a minimum, please customize the templated language to insert information about who you are and where you operate.

The must be submitted by September 7, 2021.

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