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Tag: Centers for Medicare and Medicaid Services (CMS)

Wall Time Toolkit

Written by AAA Staff on . Posted in Patient Care, Professional Standards, Regulatory.

Extended ambulance patient offload times (APOT), or “wall times,” at hospitals are causing long waits for 911 and interfacility patients and exacerbating the EMS workforce shortage. Ambulance services across the country are continually trying to meet demand with fewer resources; when EMS providers are kept out of service for extended periods of time because they are unable to transfer patient care at the hospital, wait times for both 911 and inter-facility patients increase and both emergency and non-emergency calls pile up. 

We recognize that the issue of extended wall times is not new, but an existing problem exacerbated by the ongoing battle with COVID-19 across the country. Increased wall times are a symptom of a much larger problem for which there is no easy solution.

This toolkit will provide an overview of EMTALA, highlight the intersection between EMTALA and APOT, and address some frequently asked questions along with links to resources and examples of how services are addressing this issue across the country.

Download Sample Letter

Download EMTALA Memo

EMTALA – Emergency Medical Treatment and Labor Act
Summary of Major Provisions

  • The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law that was enacted as part of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (42 U.S.C. §1395dd).
  • EMTALA provides that when an individual comes to an emergency department, he/she/they must be stabilized and treated, regardless of their insurance status or ability to pay.
  • EMTALA is often referred to as the “anti-dumping” law and was designed to prevent hospitals from transferring uninsured or Medicaid patients to another hospital without, at a minimum, providing a medical screening examination to ensure they were stable for transfer.
  • EMTALA requires the hospital to provide a screening examination to determine if an emergency medical condition exists and, if so, provide stabilizing treatment to resolve the patient’s emergency medical condition.
  • EMTALA requires Medicare-participating hospitals with emergency departments to screen and treat the emergency medical conditions of patients in a non-discriminatory manner to anyone, regardless of their ability to pay, insurance status, national origin, race, creed, or color.

EMTALA & Ambulance Patient Offloading Times (APOT)

  • EMS agencies have been struggling with extended Emergency Department patient offload times. This has been exacerbated over the last few years of the COVID-19 pandemic.
  • This has impacted the ability of EMS agencies to provide services and respond to ambulance service requests. Additionally, it is impacting many public safety agencies that are responding to medical emergencies.
  • Centers for Medicare & Medicaid Services (CMS) issued a memorandum on extended ambulance patient offload times and EMTALA in July 2006.
    • In the memorandum, CMS noted “Many of the hospital staff engaged in such practice believe that unless the hospital “takes responsibility” for the patient, the hospital is not obligated to provide care or accommodate the patient”
    • CMS stated that this practice may result in a violation of the Emergency Medical Treatment and Labor Act (EMTALA) and “raises serious concerns for patient care and the provision of emergency services in a community.”
    • Additionally, CMS notes that this practice may also result in a violation of 42 CFR 482.55, the Conditions of Participation for Hospitals for Emergency Services, which requires that a hospital meet the emergency needs of patients in accordance with acceptable standards of practice.
    • EMTALA defines[1] when a patient “presents” at an emergency department in the following way:

(1) Has presented at a hospital’s dedicated emergency department, as defined in this section, and requests examination or treatment for a medical condition, or has such a request made on his or her behalf. In the absence of such a request by or on behalf of the individual, a request on behalf of the individual will be considered to exist if a prudent layperson observer would believe, based on the individual’s appearance or behavior, that the individual needs examination or treatment for a medical condition;

(2) Has presented on hospital property, as defined in this section, other than the dedicated emergency department, and requests examination or treatment for what may be an emergency medical condition, or has such a request made on his or her behalf. In the absence of such a request by or on behalf of the individual, a request on behalf of the individual will be considered to exist if a prudent layperson observer would believe, based on the individual’s appearance or behavior, that the individual needs emergency examination or treatment;

(3) Is in a ground or air ambulance owned and operated by the hospital for purposes of examination and treatment for a medical condition at a hospital’s dedicated emergency department, even if the ambulance is not on hospital grounds. However, an individual in an ambulance owned and operated by the hospital is not considered to have “come to the hospital’s emergency department” if –

(i) The ambulance is operated under communitywide emergency medical service (EMS) protocols that direct it to transport the individual to a hospital other than the hospital that owns the ambulance; for example, to the closest appropriate facility. In this case, the individual is considered to have come to the emergency department of the hospital to which the individual is transported, at the time the individual is brought onto hospital property;

(ii) The ambulance is operated at the direction of a physician who is not employed or otherwise affiliated with the hospital that owns the ambulance; or

(4) Is in a ground or air nonhospital-owned ambulance on hospital property for presentation for examination and treatment for a medical condition at a hospital’s dedicated emergency department. However, an individual in a nonhospital-owned ambulance off hospital property is not considered to have come to the hospital’s emergency department, even if a member of the ambulance staff contacts the hospital by telephone or telemetry communications and informs the hospital that they want to transport the individual to the hospital for examination and treatment. The hospital may direct the ambulance to another facility if it is in “diversionary status,” that is, it does not have the staff or facilities to accept any additional emergency patients. If, however, the ambulance staff disregards the hospital’s diversion instructions and transports the individual onto hospital property, the individual is considered to have come to the emergency department.

[1] 42 CFR § 489.24(b) – Special responsibilities of Medicare hospitals in emergency cases.

APOT Strategies

  • EMS agencies who are experiencing extended ambulance patient offload times should engage the hospital leadership to collaborate to identify possible solutions. Often, we assume that the hospital leadership is aware that the EMS crews are being held for extended periods of time. Also, the hospital may not understand how APOT is impacting your organization and the overall EMS and public safety response.  Emphasize that EMS is one piece of a larger EMS system.
  • EMS agencies should consider educating or reminding the hospital leadership about their obligations under EMTALA.
  • Consider placing a transfer coordinator or another member of your staff to stay with patients during the transition between EMS and ED care. The EMS agency is under no obligation to do this and could set a precedent or expectation by the hospital that extended APOT is the EMS agency’s responsibility.  However, it may serve to free up valuable EMS resources.

EMTALA & APOT Frequently Asked Questions

  1. Are EMS personnel required to remain with the patient until an emergency department personnel “accept” report or “takes over care” of the patient?

Answer: No, the EMS crew is not legally required to remain with the patient until the hospital personnel take a report or take over patient care.  As the EMTALA provisions above cite, the EMS crew may choose to remain with the patient but, as soon as that patient arrives on hospital property or enters the emergency department, the hospital is legally responsible for the patient.

  1. What if the patient’s condition requires constant attention and the patient cannot be left alone without causing the patient harm?

Answer:  If the patient’s condition dictates that the patient cannot be safely left alone, the crew would have an ethical obligation to continue to care for the patient until care can be safely transferred to the appropriate caregiver. The EMS crew should continue to provide patient care and should contact a supervisor or Officer in Charge (OIC) at their agency to inform them of the situation and request assistance with facilitating the transfer of care.

  1. What do I do if the emergency department staff fail/refuse to take a report or take over care of the patient?

Answer:  The EMS crew should attempt to provide a verbal report to an emergency department staff member if possible.  If no one is available, or the hospital staff will not make someone available to take a verbal report, the crew should tell an ED staff member that the EMS crew will be leaving the patient, where the patient was left and the patient’s general condition.  EMS providers should document how long they waited after arriving at the ED, where they left the patient, which ED staff member they notified, and the patient’s condition when they left in their patient care report.  EMS providers should be sure to leave a copy of their patient care report or an abbreviated patient care report with the hospital staff or with the patient.

In some states, extended APOT may be reportable to the state-level oversight agency, such as the state EMS Office or the Department of Public Health.

If hospitals are unresponsive to the initial conversation, you could also consider escalating the issue to your State Survey Agency, the agency primarily charged with taking EMTALA complaints.

We have created a draft letter for use in communicating with your State Survey Agency; be sure to update the draft letter to include specific examples and data that illustrate the particular issues your service is facing and the steps you’ve taken to try and resolve the issue so far.

  1. Can I be accused of patient abandonment if I leave a patient in the ED without a member of the ED staff taking over the care of the patient?

Answer:  Because the legally becomes the hospital’s responsibility upon arrival on hospital property or upon arrival in the ED, it is highly unlikely that a claim of abandonment could be sustained.  The most important thing EMS providers can do is to exercise reasonable care of the patient before, upon, and after arrival at the ED.  EMS providers who reasonably attempt to furnish a report to the ED staff or who ensure that the patient can be safely left at the ED with either an abbreviated or full patient care report will likely be protected from liability.

Additional Resources

Best Practices for Mitigating Ambulance ED Delays webinar

California Emergency Medical Services Authority Ambulance Patient Offload Time (APOT) webpage

CMS Regional Office Directory

Statewide Method of Measuring Ambulance Patient Offload Times

State Survey Agency Directory
This is the agency primarily charged with receiving EMTALA complaints.

Wall time Collaborative a partnership to reduce ambulance patient off-load delays
presentation from 2013

In the News:

EMS crews forced to wait hours to drop patients at overwhelmed hospitals

TODAY | CCIIO Open Door Forum No Surprises Act

Written by AAA Staff on . Posted in Finance, Legislative, Regulatory.

Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight

Special Open Door Forum: Provider Requirements under the No Surprises Act
Wednesday December 8, 2021 | 2:00-3:00 pm Eastern Time
Conference Call Only
Participant Dial-In Number: 1-888-455-1397
Conference ID #: 8604468

 

The Center for Consumer Information and Insurance Oversight (CCIIO) and the CMS Office of Communication will host an orientation to provider requirements under the No Surprises Act.

Starting January 1, 2022, consumers will have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. Through new rules aimed to protect consumers, excessive out-of-pocket costs will be restricted, and emergency services must continue to be covered without any prior authorization, and regardless of whether or not a provider or facility is in-network.

On July 1, 2021, the “Requirements Related to Surprise Billing; Part I,” interim final rule was issued to restrict surprise billing for patients in job-based and individual health plans who get emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers.

On September 30, 2021, a second interim final rule was issued and is open for public comment. The “Requirements Related to Surprise Billing; Part II” rule provides additional protections against surprise medical bills, including:

  • Establishing an independent dispute resolution process to determine out-of-network payment amounts between providers (including air ambulance providers) or facilities and health plans.
  • Requiring good-faith estimates of medical items or services for uninsured (or self-paying) individuals.
  • Establishing a patient-provider dispute resolution process for uninsured (or self-paying) individuals to determine payment amounts due to a provider or facility under certain circumstances.
  • Providing a way to appeal certain health plan decisions.

Together, these lay the groundwork to provide consumers with protection against surprise billing, starting in 2022. Learn more about how these rules help consumers.

Here is the link to our No Surprises page that has the slides: https://www.cms.gov/nosurprises/Policies-and-Resources/Provider-requirements-and-resources

We look forward to your participation.

Special Open Door Participation Instructions:

Participant Dial-In Number: 1-888-455-1397

Conference ID #: 8604468

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help. 

A transcript and audio recording of this Special ODF will be posted to the Podcast and Transcripts website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html for downloading.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.gov/OpenDoorForums/.

Thank you for your interest in CMS Open Door Forums.

CMS | Ambulance Open Door Forum Dec 9

Written by AAA Staff on . Posted in ET3, Regulatory.

The next CMS Ambulance Open Door Forum scheduled for:

Date:  Thursday, December 9, 2021

Start Time:  2:00pm-3:00pm PM Eastern Time (ET);

Please dial-in at least 15 minutes before call start time.

To participate by phone:

Dial: 1-888-455-1397 & Reference Conference Passcode: 8604468

Conference Leaders: Jill Darling, Maria Durham

**This Agenda is Subject to Change**

  1. Opening Remarks

Chair- Maria Durham, Director, Division of Data Analysis and Market Based Pricing

Moderator – Jill Darling (Office of Communications)

Announcements & Updates

  1. Emergency Triage, Treat, and Transport (ET3) Model Update
  2. Upcoming Implementation Dates of the Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model
  3. Ground Ambulance & Patient Billing Advisory Committee Member Nomination Period
  1. CY 2022 Ambulance Inflation Factor (AIF) Change Request 12488, Transmittal 11044
  2. Medicare Ground Ambulance Data Collection System CY 2022 Physician Fee Schedule Final Rule

III. Open Q&A

**DATE IS SUBJECT TO CHANGE**

Next Ambulance Open Door Forum: TBA

ODF email: AMBULANCEODF@cms.hhs.gov

———————————————————————

This Open Door Forum is open to everyone, but if you are a member of the Press, you may listen in but please refrain from asking questions during the Q & A portion of the call. If you have inquiries, please contact CMS at Press@cms.hhs.gov. Thank you.

Open Door Participation Instructions:

This call will be Conference Call Only.

To participate by phone:

Dial: 1-888-455-1397 & Reference Conference Passcode: 8604468

Persons participating by phone do not need to RSVP. TTY Communications Relay Services are available for the Hearing Impaired.  For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.

Instant Replay: 1-800-856-2271; Conference Passcode: No Passcode needed

Instant Replay is an audio recording of this call that can be accessed by dialing 1-800-856-2271 and entering the Conference Passcode beginning 1 hours after the call has ended. The recording is available until December 11, 2021, 11:59PM ET.

For ODF schedule updates and E-Mailing List registration, visit our website at http://www.cms.gov/OpenDoorForums/.

Were you unable to attend the recent Ambulance ODF call? We encourage you to visit our CMS Podcasts and Transcript webpage where you can listen and view the most recent Ambulance ODF call. Please allow up to three weeks to get both the audio and transcript posted to: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html.

CMS provides free auxiliary aids and services including information in accessible formats. Click here for more information. This will point partners to our CMS.gov version of the “Accessibility & Nondiscrimination notice” page. Thank you.

CCIIO Open Door Forum No Surprises Act

Written by AAA Staff on . Posted in Finance, Legislative, Regulatory.

From CMS on December 3, 2021

Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight

Special Open Door Forum: Provider Requirements under the No Surprises Act
Wednesday December 8, 2021 | 2:00-3:00 pm Eastern Time
Conference Call Only
Participant Dial-In Number: 1-888-455-1397
Conference ID #: 8604468

 

The Center for Consumer Information and Insurance Oversight (CCIIO) and the CMS Office of Communication will host an orientation to provider requirements under the No Surprises Act.

Starting January 1, 2022, consumers will have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. Through new rules aimed to protect consumers, excessive out-of-pocket costs will be restricted, and emergency services must continue to be covered without any prior authorization, and regardless of whether or not a provider or facility is in-network.

On July 1, 2021, the “Requirements Related to Surprise Billing; Part I,” interim final rule was issued to restrict surprise billing for patients in job-based and individual health plans who get emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers.

On September 30, 2021, a second interim final rule was issued and is open for public comment. The “Requirements Related to Surprise Billing; Part II” rule provides additional protections against surprise medical bills, including:

  • Establishing an independent dispute resolution process to determine out-of-network payment amounts between providers (including air ambulance providers) or facilities and health plans.
  • Requiring good-faith estimates of medical items or services for uninsured (or self-paying) individuals.
  • Establishing a patient-provider dispute resolution process for uninsured (or self-paying) individuals to determine payment amounts due to a provider or facility under certain circumstances.
  • Providing a way to appeal certain health plan decisions.

Together, these lay the groundwork to provide consumers with protection against surprise billing, starting in 2022. Learn more about how these rules help consumers.

Here is the link to our No Surprises page that has the slides: https://www.cms.gov/nosurprises/Policies-and-Resources/Provider-requirements-and-resources

We look forward to your participation.

Special Open Door Participation Instructions:

Participant Dial-In Number: 1-888-455-1397

Conference ID #: 8604468

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help. 

A transcript and audio recording of this Special ODF will be posted to the Podcast and Transcripts website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html for downloading.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.gov/OpenDoorForums/.

Thank you for your interest in CMS Open Door Forums.

Federal Court Enjoins the CMS Mandatory Vaccine Emergency Temporary Standard (ETS)

Written by Scott Moore on . Posted in Judicial, News, Regulatory.

On Monday, November 29, 2021, the United States District Court for the Eastern District of Missouri – Eastern Division has issued a preliminary injunction staying the Centers for Medicare and Medicaid Services (CMS) Mandatory Vaccination Emergency Temporary Standards (ETS) which were set to take effect on January 4, 2022. This preliminary injunction currently only applies to healthcare providers in the plaintiff states.

On November 10, 2021, the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire filed a nine (9) count complaint in the United States Court for the Eastern District of Missouri seeking relief from the CMS Emergency Temporary Standard (ETS) which requires certain certified healthcare facilities to mandate COVID-19 vaccination of all employees, contractors, and those performing services “under arrangement.”  The complaint alleged that the ETS violates numerous provisions of the Administrative Procedures Act (APA), the Social Security Act (SSA), that CMS failed to consult with the state agencies that would be charged with enforcing such a mandate, failure to perform an impact analysis of the new rules, and several other Constitutional violations.

In the ruling, U.S. District Judge Matthew T. Schelp, agreed with the plaintiffs that a preliminary injunction was warranted because it posed an irreparable harm and that the plaintiffs demonstrated a likelihood of success on the merits of their complaint. The thirty-two (32) page ruling cites that Congress did not give CMS the authority to enact the mandatory vaccination regulations, nor authorized CMS to issue regulations that pre-empt validly enacted state legislation that contradict these new rules. The court believed that the plaintiffs would likely be able to show that CMS violated numerous administrative and rulemaking procedures.

Throughout the ruling the court cited the likelihood of significant harm to state sovereignty and how the implementation of the rule’s requirements would cause substantial economic harm to both the states and the healthcare facilities. Not only through the cost of implementation but also through the impact to a healthcare facility’s ability to provide care due to employees who refuse to get vaccinated.

This ruling is only applicable to covered healthcare facilities in the states of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire. It is unknown if the stay will be expanded to other jurisdictions. Additionally, the OSHA Vaccination & Testing ETS is currently enjoined and OHSA has announced that they will halt implementation and enforcement associated with those rules. Despite these rulings, many EMS employers are subject to the mandatory vaccination requirements under the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors.

I advise employers to take the initial steps toward compliance while these cases proceed through the legal system. EMS employers are already required to have policies and procedures to determine and maintain a log of their employee’s vaccination status. Additionally, many EMS employers have already been contacted by their contracted healthcare facilities who have enacted a vaccine mandate, either prior to, or in response to the CMS ETS.  These facilities may still independently require your staff to be vaccinated.

I recognize that these are incredibly challenging times. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing hello@ambulance.org.

 

CMS | Data Collection Q&A December 14

Written by AAA Staff on . Posted in Advocacy Priorities, Cost Data Collection, Cost Survey, Regulatory.

From CMS
Medicare Ground Ambulance Data Collection System Webinar: Question and Answer (Q&A) Session  Tuesday, December 14, 2021 | 2:00 PM – 3:00 PM ET

To register for this CMS Zoom webinar:

https://cms.zoomgov.com/webinar/register/WN_Jy_wpLZLQnuNu5vv_5Dbyw

After registering, you will receive a confirmation email containing information about joining the webinar.

Do you have questions about the Medicare Ground Ambulance Data Collection System? We are holding a live Q&A session on December 14, 2021 at 2:00 pm.  Please send questions in advance to AmbulanceDataCollection@cms.hhs.gov  with “December 14 Q&A” in the subject line. We will answer your questions that you submitted in advance during the call or participants may also submit live questions using the “Q&A” button at the bottom of your Zoom screen.  In addition, we will update documents on our Ambulances Services Center webpage with answers to common questions from this session.

For more information, including the list of ground ambulance organizations selected to collect and report information starting in 2022, see the Ambulances Services Center webpage, the CY 2022 PFS Final Rule, the CY 2020 PFS final rule, and the Bipartisan Budget Act of 2018.

Notice on Ground Ambulance and Patient Billing Advisory Committee

Written by Tristan North on . Posted in Executive, Government Affairs, News, Regulatory.

The Centers for Medicare and Medicaid Services (CMS) has filed for publication in the Federal Register the Solicitation of Nominations Notice for the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The Notice is scheduled to be included in the Federal Register for tomorrow, Tuesday, November 23.

The Congress created the GAPB Advisory Committee as part of The No Surprises Act enacted last year and currently being implemented by the Departments of Health and Human Services, Labor and the Treasury. The American Ambulance Association, International Association of Fire Chiefs, International Association of Fire Fighters, National Association of Emergency Medical Technicians, and the National Volunteer Fire Council successfully advocated that the Congress take into consideration the unique characteristics of ground ambulance services when determining balance billing policy for our services. The Congress excluded ground ambulance services from the provisions of The No Surprises Act and created the GAPB Advisory Committee to address balance billing.

The AAA has identified candidates, including AAA President Baird, who we will be supporting for inclusion on the Advisory Committee who we believe are well-positioned to represent the AAA membership. Once formed, the Advisory Committee has 180 days in which to report its recommendations to the Congress. The directive of the Committee is to review options to “improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing.” We will be keeping the AAA membership continually informed of the actions and deliberations of the GAPB Advisory Committee.

Should you have any questions regarding the GAPB Advisory Committee, please contact AAA Senior Vice President of Government Affairs Tristan North. He can be reached at tnorth@ambulance.org.

Federal Government Releases COVID-19 Vaccination Requirement Rules: CMS and OSHA Outline Requirements for Certain Health Care Providers and Certain Employers

Written by Scott Moore on . Posted in Government Affairs, Regulatory.

by Scott Moore, J.D. & Kathy Lester, J.D. M.P.H.

Today, the Occupational Health and Safety Administration (OSHA) and Centers for Medicare & Medicaid Services (CMS), released the highly anticipated mandatory COVID-19 vaccination regulations for employers with 100 or more employees and new COVID-19 vaccination requirements in the Conditions of Participation (COPs)/Conditions for Coverage (CfCs).

OSHA COVID-19 Vaccination Regulations

A summary of the new rules can be found on the OSHA website.  Under this latest rule, OSHA stated that any employer who is subject to the Healthcare ETS released in June, 2021 is not subject to the Vaccination and Testing ETS.  This would include many EMS employers.  However, healthcare employers should refer to the Healthcare ETS to ensure that they are in compliance with those requirements.

It is important for EMS employers to note, where they have “healthcare support services”, as defined under §1910.502(vi) of the Healthcare ETS, that are not subject to the Healthcare ETS because these employees are segregated in non-healthcare settings (stand-alone administrative facilities), those employees will be subject to the requirements Vaccination and Testing ETS.

There was nothing in the latest ETS that prevents employers from instituting a mandatory vaccination requirement for its employees.  Many EMS employers are already required to mandate vaccination under a state or local law.  These employers may continue to require vaccinations for its employees.

CMS COVID-19 Health Staff Vaccination Rule

CMS also released an Interim Final Rule with Comment (IFC) governing health care staff vaccination requirements, as well as a Press Release, Fact Sheet, and Frequently Asked Questions.  While the IFC regulations do not directly apply to ground ambulance suppliers, the definition of staff that includes individuals contracted with or that have other arrangements with facilities directly regulated will be indirectly subject to the rules through their arrangements with the facilities.  For example, an EMS service that has no contract or arrangement with any of the directly covered health care facilities listed below should not be subject to the CMS requirements.  However, a ground ambulance service that has a contract with a nursing home to provide interfacility transports, for example, would be indirectly affected because of the requirement on the nursing home to ensure that contractors meet the vaccine requirements.  Additionally, there the regulations do not prevented a health care facility from creating their own requirements on vendors that do not have an existing contract with the facility.

The ICF amends the existing Conditions or Participation / Conditions for Coverage for the following facilities:

  • Ambulatory Surgery Centers;
  • Community Mental Health Centers;
  • Comprehensive Outpatient Rehabilitation Facilities;
  • Critical Access Hospitals;
  • End-Stage Renal Disease Facilities;
  • Home Health Agencies;
  • Home Infusion Therapy Suppliers;
  • Hospices;
  • Hospitals;
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services;
  • Psychiatric Residential Treatment Facilities (PRTFs);
  • Programs for All-Inclusive Care for the Elderly Organizations (PACE);
  • Rural Health Clinics/Federally Qualified Health Centers; and
  • Long Term Care facilities.

The IFC requires facilities to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19.  Exclusions from the requirement are permitted for staff (or contactors) who have pending requests for, or who have been granted, exceptions to the vaccine requirements or those staff for whom COVID-19 vaccinations must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

Staff is defined to include employees, as well as licensed practitioners, students, trainees, volunteers, and “[i]ndividuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.”

The IFC excludes (1) staff that exclusively provide telehealth/telemedicine services outside of the facility setting and that do not have direct contact with patients and (2) staff that provide support services exclusively outside of the facility setting and that do not have direct contact with patients.

The IFC defines an individual as fully vaccinated when 2 weeks or more has passed since the staff completed a primary vaccination series for COVID-19.  That can be either the administration of a single-dose vaccine or the administration of all required doses of a multi-dose vaccine.  It does not include booster shots.

Facilities directly regulated by the COPs/CfCs will have to have policies and procedures to implement the requirement.  Among these requirements is a process for ensuring the implementation of additional precautions, intended to mitigate transmission and spread of COVD-19, for all staff (and contractors) who are not fully vaccinated.  There are also contingency planning requirements and documentation and tracking requirements.

The IFC provides facilities 30 days to make sure that staff have received at least the first dose of a primary series or a single dose of COVID-19 vaccine prior the staff providing any care, treatment, or other services for the facility and/or its patients.  Within 60 days, the facility must ensure that staff have completed the primary vaccination services (except for those who have been granted an exemption or exclusion).

CMS will enforce the regulations through the existing onsite compliance review process with state survey agencies. Accreditation organizations will also be required to update their survey processes.  If a facility is not in compliance, the existing enforcement remedies related to the COPs/CfCs, which can include termination from the Medicare program, will apply.

The rule preempts state law under Article VI § 2 of the U.S. Constitution.

The rule takes effect November 5, but stakeholders have 60 days to provide comments with comments due by January 4, 2022.

 

             

 

CMS | Open Door Forum on Prior Authorization for RSNAT

Written by Amanda Riordan on . Posted in Regulatory.

From CMS on October 5, 2021

Centers for Medicare & Medicaid Services Center for Medicare and Medicaid Innovation

Special Open Door Forum:  Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model National Expansion

Thursday, October 28, 2021
2:00-3:30 pm Eastern Time
Conference Call Only

Participant Dial-In Number: 1-888-455-1397 | Conference ID #: 8604468

CMS will host a Special Open Door Forum (SODF) to allow ambulance suppliers, other Medicare providers, and additional interested parties to learn about the upcoming national expansion of the Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization Model in Medicare fee for service. CMS is implementing the national model in multiple phases beginning with Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas on December 1, 2021.  The RSNAT Prior Authorization Model is currently operating in New Jersey, Pennsylvania, and South Carolina since 2014 and in North Carolina, Virginia, West Virginia, Maryland, Delaware, and the District of Columbia since 2016. This Special ODF will include information on national expansion, the prior authorization process, and a Q&A period.

You can find more information on the model and slides for the ODF presentation by going to:

http://go.cms.gov/PAAmbulance

Questions on the model can be sent to: AmbulancePA@cms.hhs.gov

We look forward to your participation.

Special Open Door Participation Instructions:

Participant Dial-In Number: 1-888-455-1397

Conference ID #: 8604468

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.

A transcript and audio recording of this Special ODF will be posted to the Special Open Door Forum website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts for downloading.                  

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums

Thank you for your interest in CMS Open Door Forums.

CMS | Medicare Ground Ambulance Data Collection Webinars October 7 & 12

Written by AAA Staff on . Posted in Cost Data Collection, Cost Survey, Regulatory.

From CMS on October 4, 2021

Dear Ground Ambulance Providers and Suppliers,

Please attend our October 7 webinar and October 12 Q&A session to learn about the Medicare Ground Ambulance Data Collection System. Both events will use Zoom. Starting January 1, 2023, selected ground ambulance organizations are required to report cost, utilization, revenue, and other information to CMS. Organizations that fail to report may be subject to a 10% payment reduction.

Medicare Ground Ambulance Data Collection System Webinar: Labor Costs – October 7

Thursday, October 7 from 2­­­­­­­­­­-3pm ET

Register for this Zoom webinar.

During this webinar, CMS will walk through the Labor Cost section of the Medicare Ground Ambulance Data Collection Instrument (section 7). The presentation includes examples to help different types of ground ambulance organizations understand how to collect and report data for their paid and volunteer staff.

A Q&A session will follow this presentation. You may also send your questions in advance to AmbulanceDataCollection@cms.hhs.gov with “October 7 Labor Cost Webinar” in the subject line.

More information:

 

Medicare Ground Ambulance Data Collection System: Q&A Session – October 12

Tuesday, October 12 from 2-3pm ET

Register for the session.

Do you have questions about the Medicare Ground Ambulance Data Collection System? Join this live Q&A session. You may also send your questions in advance to AmbulanceDataCollection@cms.hhs.gov with “October 12 Q&A” in the subject line. We’ll update documents on our Ambulances Services Center webpage with answers to common questions from this session.

More Information:

CMS Will Pay for COVID-19 Booster Shots, Eligible Consumers Can Receive at No Cost

Written by AAA Staff on . Posted in Drugs & Pharma, Regulatory.

From CMS on September 24, 2021

CMS Will Pay for COVID-19 Booster Shots, Eligible Consumers Can Receive at No Cost

Coverage without cost-sharing available for eligible people with Medicare, Medicaid, CHIP, and Most Commercial Health Insurance Coverage

Following the Food and Drug Administration’s (FDA) recent action that authorized a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) will continue to provide coverage for this critical protection from the virus, including booster doses, without cost sharing.

Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible. In addition, thanks to the American Rescue Plan Act of 2021 (ARP), nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration, without cost-sharing. COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market. People can visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby.

“The Biden-Harris Administration has made the safe and effective COVID-19 vaccines accessible and free to people across the country. CMS is ensuring that cost is not a barrier to access, including for boosters,” said CMS Administrator Chiquita Brooks-LaSure. “CMS will pay Medicare vaccine providers who administer approved COVID-19 boosters, enabling people to access these vaccines at no cost.”

CMS continues to explore ways to ensure maximum access to COVID-19 vaccinations. More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html and through the CMS COVID-19 Provider Toolkit.

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CMS | National Stakeholder Call with the Administrator

Written by AAA Staff on . Posted in Regulatory.

You are invited to join the Administrator of the Centers for Medicare & Medicaid Services’ (CMS), Chiquita Brooks-LaSure, and her leadership team, to hear key updates from her first 100 days in office. The Administrator’s vision is for CMS to serve the public as a trusted partner and steward, dedicated to advancing health equity, expanding coverage, and improving health outcomes. We invite you to join us for this first national stakeholder call to learn more about how you can partner with us as we implement our vision.

When:   September 17, 2021 from 12:30 PM ET – 1:00 PM ET

Speakers:  

  • CMS Administrator, Chiquita Brooks-LaSure
  • CMS Leadership team

Who should attend: National and local stakeholders and partners

To Join the Call Click Here: https://cms.zoomgov.com/j/1605025285?pwd=VW5vb0RUbG1RMFFPWllxbGtRYlF5QT09

Questions:  We want to hear from you. Questions can be submitted in advance of the webinar by emailing Partnership@cms.hhs.gov

TODAY | CMS Cost Data Collection System Q&A Session

Written by AAA Staff on . Posted in Cost Data Collection, Cost Survey, Uncategorized.

CMS Medicare Ground Ambulance Data Collection Q&A Session

Tuesday, September 14 from 2-3 pm ET

CMS is hosting a Q&A session about the Medicare Ground Ambulance Data Collection System tomorrow at 2:00pm Eastern.

Do you have questions about the Medicare Ground Ambulance Data Collection System? Join this live Q&A session. You may also send questions in advance to AmbulanceDataCollection@cms.hhs.gov with “September 14 Q&A” in the subject line. We’ll update documents on our Ambulances Services Center webpage with answers to common questions from this session.

More Information:

Register for this session

 

Biden Issues Exec Orders Requiring COVID-19 Vaccinations

Written by Scott Moore on . Posted in Regulatory.

The Biden Administration Issues Several Executive Orders Requiring Mandatory COVID-19 Vaccination

On September 9, 2021, the Biden Administration issued several Executive Orders which impact more than 100 million workers in an effort to end the COVID-19 pandemic.  The two Executive Orders, Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees and Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors were highlighted during a Presidential press conference.

During his announcement, President Biden said that there are more than 80 million Americans, who are not vaccinated.  As a result he stated that “it is essential that Federal employees take all available steps to protect themselves and avoid spreading COVID-19 to their co-workers and members of the public.”  Additionally, the President stated he issued these orders “to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law.”

The orders will require that all Federal employees and employees of Federal Contractors mandate vaccination.  The President stated that if businesses and individuals want to work with the federal government, they must be vaccinated.  Under the order, The Safer Federal Workforce Task Force (Task Force), will issue guidance to all covered agencies consistent with these Orders within seven (7) days.

The President also announced that the U.S. Department of Labor (U.S. DOL) will be issuing emergency rules that will require employers of 100 or more employees to require vaccination or mandatory weekly COVID-19 testing for all workers.  Additionally, the President announced that he is expanding requirements for employers to provide paid leave to employees so that they can obtain the COVID-19 vaccinations.  He provided no details on how much the paid leave requirement will be expanded.

Lastly, the Centers for Medicare and Medicaid Services (CMS) announced that it will be expanding the vaccination requirements for healthcare facilities that bill Medicare.  Currently, the Biden Administration requires that all long-term care staff working for facilities that bill Medicare must be vaccinated against COVID-19.  In the latest announcement, CMS stated that it will be expanding the mandatory vaccination requirements to other Medicare-certified facilities, including hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, and others, as a condition for participating in the Medicare and Medicaid programs.  CMS is developing an Interim Final Rule with Comment Period that will be issued sometime in October.

The President’s expanded COVID-19 plan follows numerous states, such as Connecticut, Rhode Island, California, Massachusetts, and several others that have already enacted mandatory vaccination requirements for healthcare, county or municipal, and long-term care workers.  Many of states that have enacted mandatory vaccination requirements provided for no vaccination exceptions, or made provisions for medical exceptions to the vaccination requirements.

We will not know the specific vaccine mandate requirements under these new rules until the Task Force, the U.S. DOL, and CMS publishes these emergency rules.  It is important for employers to understand that they are still required to engage any employee seeking an accommodation from the mandatory vaccination requirements in the interactive process as required under the Americans with Disabilities Act (ADA) or Title VII of the Civil Rights Act.  We recommend employers follow a consistent documented process and seek legal advice when handling any accommodation requests.

We will continue to monitor developments with these new requirements.  Be sure to contact the AAA if you have questions about these Executive Orders or need assistance in ensuring you are in compliance.

CMS Webinar | Cost Collection Q&A

Written by AAA Staff on . Posted in Cost Data Collection, Cost Survey.

From CMS

Medicare Ground Ambulance Data Collection System: Question and Answer Session on September 14, 2021 2:00 PM – 3:00 PM ET.

To participate in the Q&A session, you must register for the session at: https://cms.zoomgov.com/webinar/register/WN_tuyiGdvORRiTXbmPaTQ1zg.

After registering, you will receive a confirmation email containing information about joining the webinar.

Do you have questions about the Medicare Ground Ambulance Data Collection System? We are holding a live Q&A session on September 14, 2021 at 2:00 pm.  Please send questions in advance to AmbulanceDataCollection@cms.hhs.gov with “September 14 Q&A” in the subject line. We will answer your questions that you submitted in advance during the call or participants may also submit live questions in the “chat” box.  In addition, we will update documents on our Ambulances Services Center webpage with answers to common questions from this session.  For more information, including the lists of ground ambulance organizations selected to collect and report information starting in 2022, see the Ambulances Services Center webpage, the CY 2022 Physician Fee Schedule (PFS) Proposed Rule: https://www.govinfo.gov/content/pkg/FR-2021-07-23/pdf/2021-14973.pdf, and the CY 2020 Physician Fee Schedule final rule.

CMS Announces Timeline for National Expansion of Prior Authorization for Repetitive, Scheduled Non-Emergency Ambulance Transportation

Written by Brian Werfel on . Posted in Government Affairs, Regulatory.

On August 26, 2021, the Centers for Medicare and Medicaid Services (CMS) announced its proposed timeline for the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports (RSNAT).  The formal notice appeared in the Federal Register on August 27, 2021.

Background

In December 2014, the Centers for Medicare and Medicaid Services (CMS) implemented a prior authorization model for payment of repetitive, scheduled non-emergent ambulance transportation.  Under this Model, ambulance suppliers are required to seek and obtain prior authorization for the transportation of repetitive patients beyond the third round-trip in a 30-day period.  Absent prior authorization, the Medicare Administrative Contractors (MACs) are required to subject further claims to prepayment review.

The Model was initially implemented in three states: New Jersey, Pennsylvania, and South Carolina.  These “Year 1” states were selected based on relatively high per-capita expenditures on RSNAT.  The Model was subsequently expanded in January 2016 to five additional states (Delaware, Maryland, North Carolina, Virginia, and West Virginia) and to District of Columbia.  These “Year 2” states were selected based on their inclusion in the same MAC Jurisdiction as one or more of the Year 1 states.

The purpose of the RSNAT Model was to test whether prior authorization would be effective in reducing Medicare expenditures on RSNAT, without adversely impacting beneficiary access to medically necessary services.  CMS engaged Mathematica, a public health care research firm, to study the impact of prior authorization on ambulance utilization in the demonstration states.  Mathematica issued several reports that concluded that the Model was effective in reducing Medicare expenditures without any measurable impact on the quality of care available to Medicare beneficiaries.

On November 23, 2020, CMS published a notice in the Federal Register indicating that it intended to expand the Prior Authorization Model to all remaining states and U.S. territories.  However, citing the current Public Health Emergency, CMS elected not to set a timeline for that national expansion.

The current notice announces that timeline for national expansion

Expansion Timeline

CMS has indicated that the RSNAT Model will be expanded into new states on the following timeline:

Expansion Date Affected States
December 1, 2021 Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas
Not earlier than

February 1, 2022

 Alabama, California, Georgia, Hawaii, Nevada, Tennessee, American Samoa, Guam, and the Northern Mariana Islands
Not earlier than

April 1, 2022

 Florida, Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, Wisconsin, Puerto Rico, and the U.S. Virgin Islands
Not earlier than

June 1, 2022

 Connecticut, Indiana, Maine, Massachusetts, Michigan, New Hampshire, New York, Rhode Island, and Vermont
Not earlier than

August 1, 2022

 Alaska, Arizona, Idaho, Kentucky, Montana, North Dakota, Ohio, Oregon, South Dakota, Utah, Washington, and Wyoming

 

An analysis of the proposed timeline suggests that CMS has elected to expand the RSNAT Model based on existing Medicare Administrative Contractor (MAC) Jurisdictions.  For example, each of the states slated to be included in the December 1, 2021 expansion fall within MAC Jurisdiction H.  This MAC Jurisdiction is administered by Novitas Solutions, Inc.  Novitas also administers MAC Jurisdiction L, which has been operating under the RSNAT Model since 2014.  Thus, CMS likely selected MAC Jurisdiction H for the first stage of the national expansion due to Novitas’ experience in administering the RSNAT Model.

The second stage of the national expansion will occur no earlier than February 1, 2022.  This stage will include all states and territories located in MAC Jurisdiction J and MAC Jurisdiction E.  MAC Jurisdiction J is administered by Palmetto GBA, LLC, which has been administering the RSNAT Model in MAC Jurisdiction M since 2014.  MAC Jurisdiction E is administered by Noridian Healthcare Solutions, LLC.  This will be Noridian’s first experience with the RSNAT Model.

The third stage of the national expansion will occur no earlier than April 1, 2022.  This stage will include all states and territories located in MAC Jurisdiction 5 (Wisconsin Physicians Service Government Health Administrators), MAC Jurisdiction 6 (National Government Services, Inc.), and MAC Jurisdiction N (First Coast Service Options, Inc.)

The fourth stage of the national expansion will occur no earlier than June 1, 2022.  This stage will include all states and territories located in MAC Jurisdiction 8 (Wisconsin Physicians Service Government Health Administrators) and MAC Jurisdiction K (National Government Services, Inc.).

The final stage of the will occur no earlier than August 1, 2022.  This stage will include all states and territories located in MAC Jurisdiction 15 (CGS Administrators, LLC) and MAC Jurisdiction F (Noridian Healthcare Solutions, LLC).

Outreach and Education

With the formal announcement of CMS’ timeline for the national expansion of the RSNAT Model, the American Ambulance Association will be increasing its educational efforts related to prior authorization.  This will include webinars and other educational materials on the technical elements of the prior authorization process, the importance of third-party documentation, as well as basic best practices related to the transportation of repetitive patients.  We encourage all members that may be impacted by the expansion of prior authorization to take advantage of these educational materials.

CMS Releases Medicare COVID-19 Vaccine Data Analysis and PUF

Written by AAA Staff on . Posted in Emergency Preparedness, Executive, Patient Care, Regulatory.

From CMS on August 25, 2021

Today, the Centers for Medicare & Medicaid Services (CMS) released two new resources with information on Medicare beneficiaries on whose behalf at least one fee-for-service (FFS) claim for the administration of the COVID-19 vaccine has been submitted to the Medicare program.

First, we released a paper titled Assessing the Completeness of Medicare Claims Data for Measuring COVID-19 Vaccine Administration. This paper presents preliminary findings on the count of individuals ages 65 and older with at least one COVID-19 vaccine administration claim in the Medicare data compared to the count of people 65+ with at least one COVID-19 vaccine dose in the data reported by the Centers for Disease Control and Prevention (CDC). Using data as of June 4th, 2021, we estimate that CMS received a claim for COVID-19 vaccine administration for roughly half of Medicare beneficiaries who have received at least one COVID-19 vaccine dose as compared to the estimated counts based on adjusted CDC figures (17.5 million out of 36.6 million). As a result, we recommend that the public apply significant caution when analyzing COVID-19 vaccine administration trends using Medicare claims data.

Second, we released the Medicare COVID-19 Vaccine Public Use File (PUF) which presents a high-level and preliminary overview of Medicare utilization and spending information from Medicare FFS claims for the administration of the COVID-19 vaccine. The PUF shows that between December 11, 2020 and June 30, 2021, Medicare payments for administration of the COVID-19 vaccine were over $1.1 billion.  The PUF is based on Medicare FFS claims CMS received by August 6, 2021.

[Note: The Medicare FFS program is paying for COVID-19 vaccine administration on behalf of MA beneficiaries as well as for FFS beneficiaries receiving COVID-19 vaccinations in 2020 and 2021.]

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