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:
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 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:
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.
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.
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.
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.
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.
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.
Webinar July 7, 2021 | 13:00–13:30 ET | Free to AAA Members
Speakers: Kathy Lester, Esq. & Asbel Montes
On July 1, CMS issued a proposed rule on Surprise Billing which applies to those providers and physicians identified in the No Surprises Act. This statute subjected ground ambulance suppliers to an HHS Advisory Committee process prior to any rulemaking addressing these services.
The consultants and staff of the American Ambulance Association are doing a deep dive into the 400+ page rule and evaluating its nuances. We continue to understand from our conversations that ground ambulances are not included and instead are subjected to the Advisory Committee.
The American Ambulance Association will soon provide a summary to members, and will address any confusion with the Administration. Join AAA for a quick take live webinar on July 7 at 13:00 ET to learn more!
Also Adds Dollars to the Provider Relief Fund to Support Rural Providers and Suppliers
March 10, 2021
Moments ago, the House of Representatives joined the Senate in passing “The American Rescue Plan.” Among the many provisions, this legislation includes waiver authority to allow the Medicare program to reimburse for ground ambulance services provided during the COVID-19 public health emergency when the beneficiary has not been transported under certain circumstances. It also increases the Provider Relief Fund by $8.5 billion, targeting the money to rural providers and suppliers, including ground ambulance services.
The American Ambulance Association (AAA) worked diligently with Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) to reimburse ground ambulance services when they provide health care services to a beneficiary, but because of the pandemic the beneficiary was not transported. CMS concluded and communicated in a Frequently Asked Question (FAQ) that the Social Security Act requires the beneficiary to be transported in order for Medicare to reimburse the ground ambulance provider or supplier for the care provided.
To address this problem during the pandemic, Sens. Catherine Cortez Masto (D-NV) and Bill Cassidy (R-LA) introduced S. 149 that would allow CMS to waive the statutory provision creating the barrier to reimbursement during the pandemic. More specifically, it would allow CMS to reimburse ground ambulance services responding to a 9-1-1 or equivalent emergency call even when the beneficiary is not transported when a community-wide EMS protocol prohibiting the transport is in place. Reps. Cindy Axne (D-IA), John Larson (D-CT), and Bruce Westerman (R-AR) introduced the companion bill, H.R. 1609, in the House.
The Senate included S. 149 in “The American Rescue Plan Act of 2021,” which passed the Senate 50-49 on March 6. This amended version passed the House along party lines earlier today and the President is expected to sign the bill into law before March 14.
CMS must exercise its authority under the waiver for the provision to be implemented. The AAA has already begun working with CMS to urge it to act as quickly as possible and we are coordinating this effort with the International Association of Fire Chiefs, International Association of Fire Fighters, National Association of EMTs, National Volunteer Fire Council and the Congressional Fire Services Institute.
In addition to the waiver allowing for reimbursement for treatment in place, the final bill includes $8.5 billion additional dollars for the Provider Relief Fund directed to rural health care providers and suppliers. The funds can be used for health care related expenses and lost revenues that are attributable to COVID–19. To be eligible for a payment, an eligible rural health care provider or supplier must be enrolled Medicare or Medicaid and submit to the Secretary an application that includes a justification statement, documentation of the expenses or losses, the tax identification number, assurance required by the Secretary, and any other information the Secretary requires. The expenses and losses cannot have been reimbursed from another source or another source cannot already be obligated to reimburse.
“The American Rescue Act” marks an important step forward for ground ambulance organizations who have been on the front line of the pandemic and offers important relief recognizing the unique and essential role these organizations play in community response to the pandemic.
For more information on the provisions of the bill that impact ground ambulance services, please sign up for the webinar on “The American Rescue Plan and EMS” scheduled for this Friday, March 12, at 2:00 pm (eastern).
It appears that members of Congress on the House Ways & Means, Energy & Commerce, and Education & Labor Committees along with the Senate Health, Education, Labor, & Pensions Committee have reached a compromise agreement that will allow “surprise” billing legislation to be considered for passage before the end of the year. While the details of the legislation have yet to be unveiled, the American Ambulance Association has learned that it is likely to include provisions related to ground ambulance service and air ambulance service providers and suppliers.
Earlier legislation moved forward by the House Education & Labor Committee included a requirement for the Administration to create a Federal Advisory Committee to review ways to increase transparency around fees and charges for ground ambulance services and to better inform consumers about their treatment options. We believe that this language will be included in the compromise, but that there may be an opportunity to suggest modifications to make it more balanced and fairer in terms of the charge of the Committee and the types of individuals and organizations who will be selected to participate on it. The AAA is recommending that the Advisory Committee have at least a year to study and report on issues related to balance billing by ground ambulance service providers and suppliers, including the role of local and state governments in EMS systems amongst other considerations. It is also important that the Committee members include representatives from all types, sizes, and geographical areas of ground ambulance service providers and suppliers, as well as state EMS officials, and paramedics and EMTs.
It is likely that if the congressional leadership agree to move this legislation forward, it would be attached to the end of the year packages that may also include COVID-19 relief, Medicare extenders, and the annual spending bills.
As reported in various media outlets, on December 1 the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted 13-1 to recommend that health care providers, expressly including EMS personnel, be prioritized to receive the COVID-19 vaccines during Phase 1a of the vaccine distribution plan. The complicating factor is that State and local governments have the final say in whether these recommendations are incorporated into their own distribution plans. Thus, we encourage all AAA members to engage actively with their State and local governments to urge the adoption of the CDC recommendation. The AAA has developed a toolkit for members to use in reaching out to their state and local government officials.
View and Download Toolkit Here►
The AAA has been engaging with ACIP and other federal policy makers to urge them to prioritize EMS in the vaccine distribution plan. On November 19, the AAA submitted a comment letter to the ACIP advocating that the advisory committee specifically include EMS personnel in their recommendation of groups in the first phase of receiving the vaccination. Even though States and local governments will create their own list, having EMS listed in Phase 1a CDC recommendations is a critically important step toward influencing the State and local process.
During its second emergency meeting in less than a month, ACIP met to develop recommendations on the prioritization of vaccines, given that it will be impossible to provide access to everyone in the United States immediately after the vaccines are approved. In both virtual meetings, Committee members noted the importance of EMS personnel having access to the vaccine in the very top tier for prioritization. Other health care personnel on this list are defined as hospitals, long-term care facilities, outpatient clinics, home health care, pharmacies, and public health. The Phase 1a tier also includes residents of nursing homes, assisted living facilities, and other residential care settings, given that approximately 40 percent of all COVID-19 deaths have occurred in these settings. The final recommendation approved states:
When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel§ and 2) residents of long-term care facilities.
Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.
Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.
The CDC plans to publish this recommendation in the Morbidity Mortality Weekly Report as well.
The only controversial issue related to whether long-term care facility residents should receive the vaccine given the limited information available about its effectiveness and safety in these populations.
Because President Trump has indicated that State and local governments do not have to follow the CDC recommendations, it is critically important that AAA members work closely with their State and local governments to ensure that the CDC recommendations with regard to EMS are adopted by them as well. The AAA has posted a tool kit on our website to help our members provide the necessary information to their State and local governments as they are making these decision.
ACIP will continue to evaluate the distribution prioritization for Phase 1b, which will likely be non-health care essential workers, and Phase 1c, which will include adults with high-risk medical conditions and adults 65 years or older.
by Kathy Lester, J.D., M.P.H.
As the American Ambulance Association (AAA) reported yesterday, President Trump issued an Executive Order (EO) “An America-First Healthcare Plan.” The EO includes several provisions, including related to drug importation generally and for insulin specifically. It also includes statements that indicate if the Congress does not act before the end of the year, the President will have the Department of Health and Human Services (HHS) “take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.” It does not mention ground ambulances.
In addition to suggesting action if the Congress does not pass legislation, the EO also states that within 180 days, the Secretary will update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including:
The narrative related to balance billing (surprise coverage) reads as follows:
My Administration is transforming the black-box hospital and insurance pricing systems to be transparent about price and quality. Regardless of health-insurance coverage, two‑thirds of adults in America still worry about the threat of unexpected medical bills. This fear is the result of a system under which individuals and employers are unable to see how insurance companies, pharmacy benefit managers, insurance brokers, and providers are or will be paid. One major culprit is the practice of “surprise billing,” in which a patient receives unexpected bills at highly inflated prices from providers who are not part of the patient’s insurance network, even if the patient was treated at a hospital that was part of the patient’s network. Patients can receive these bills despite having no opportunity to select around an out-of-network provider in advance.
On May 9, 2019, I announced four principles to guide congressional efforts to prohibit exorbitant bills resulting from patients’ accidentally or unknowingly receiving services from out-of-network physicians. Unfortunately, the Congress has failed to act, and patients remain vulnerable to surprise billing.
In the absence of congressional action, my Administration has already taken strong and decisive action to make healthcare prices more transparent. On June 24, 2019, I signed Executive Order 13877 (Improving Price and Quality Transparency in American Healthcare to Put Patients First), directing certain agencies — for the first time ever — to make sure patients have access to meaningful price and quality information prior to the delivery of care. Beginning January 1, 2021, hospitals will be required to publish their real price for every service, and publicly display in a consumer-friendly, easy-to-understand format the prices of at least 300 different common services that are able to be shopped for in advance.
We have also taken some concrete steps to eliminate surprise out‑of-network bills. For example, on April 10, 2020, my Administration required providers to certify, as a condition of receiving supplemental COVID-19 funding, that they would not seek to collect out-of-pocket expenses from a patient for treatment related to COVID-19 in an amount greater than what the patient would have otherwise been required to pay for care by an in-network provider. These initiatives have made important progress, although additional efforts are necessary.
Not all hospitals allow for surprise bills. But many do. Unfortunately, surprise billing has become sufficiently pervasive that the fear of receiving a surprise bill may dissuade patients from seeking appropriate care. And research suggests a correlation between hospitals that frequently allow surprise billing and increases in hospital admissions and imaging procedures, putting patients at risk of receiving unnecessary services, which can lead to physical harm and threatens the long-term financial sustainability of Medicare.
Efforts to limit surprise billing and increase the number of providers participating in the same insurance network as the hospital in which they work would correspondingly streamline the ability of patients to receive care and reduce time spent on billing disputes.
The AAA will continue to advocate for the resources necessary to sustain life-saving mobile healthcare.