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CMS Relaxes Physician Certification Statement Signature Requirements During Public Health Emergency for COVID-19

CMS Relaxes Physician Certification Statement Signature Requirements During Public Health Emergency for COVID-19

 By Kathy Lester, J.D., M.P.H.

  The Centers for Medicare & Medicaid Services (CMS) has released guidance that recognizes the difficulty ambulance service providers and suppliers may have during the COVID-19 Public Health Emergency (PHE) in obtaining a physician certification statement (PCS) signed by a physician or other authorized professional. The question and answer below indicates that CMS (and its contractors by extension) will not deny claims during a future medical audit even if there is no signature for non-emergency ambulance transports, absent an indication of fraud or abuse. Ambulance service providers and suppliers should indicate in the documentation that a signature was not able to be obtained because of COVID-19. The AAA advises completing the PCS form and then indicating if a physician, or other appropriate personnel, has not signed it by writing “COVID-19 Public Health Emergency” on the signature line. CMS also reminds providers and suppliers that medical necessity still needs to be met.

The American Ambulance Association has been advocating for CMS to ease its restrictions on signature requirements during the COVID-19 PHE. The FAQ posted by CMS is consistent with our recommendations.

The specific Q&A is below:

Q. For ambulance services that require a physician, or, in lieu of that, certain non-physician personnel, to sign and certify that a non-emergency ambulance transport is medically necessary, are these signature requirements not required during the COVID-19 PHE? 

A. We understand that in certain situations during the COVID-19 PHE it may not be feasible to obtain the practitioner signature. Therefore, for claims with dates of service during the COVID- 19 PHE (January 27, 2020 until expiration), CMS will not review for compliance with appropriate signature requirements for non-emergency ambulance transports during medical review, absent indication of fraud or abuse. Ambulance providers and suppliers should indicate in the documentation that a signature was not able to be obtained because of COVID-19. However, we note that Medicare Part B covers ambulance transport services only if they are furnished to a Medicare beneficiary whose medical condition is such that other means of transportation are contraindicated, and the beneficiary’s condition must require both the ambulance transportation itself and the level of service provided in order for the billed service to be considered medically necessary.

The full Q&A document can be accessed here.

CMS Waives Restrictions on Ground Ambulances During COVID-19 Pandemic

The Centers for Medicare and Medicaid Services (CMS) promulgated an interim final rule with comment period (IFC) entitled “Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency.”  Consistent with the recommendations the AAA made to CMS, for the duration of the public health emergency (PHE), the IFC allows ground ambulance service providers and suppliers to transport patients both on an emergency or non-emergency basis to any destination that is equipped to treat the condition of the patient consistent with Emergency Medical Services (EMS) protocols established by state and/or local laws where the services will be furnished.  In related guidance, CMS has suspended most Medicare Fee-For-Service (FFS) medical review during the emergency period due to the COVID-19 pandemic, waived patient signature requirements, and is pausing the Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model. The policies of the IFC are effective retroactively to March 1, 2020.

On March 11, the AAA sent CMS a letter specifically requesting for the agency to waive during the COVID-19 pandemic the regulatory restrictions that prevent coverage for transport to alternative destinations.  Separately, the AAA has been pressing CMS to provide relief from signature requirements. The AAA had also been working with CMS to lifting of these restrictions and others to eliminate barriers the current Medicare regulations in responding to the COVID-19 crisis.

Paying for Transports to Alternative Destinations.  During the duration of the crisis, CMS has expanded the list of destinations for which Medicare covers ambulance transportation to include all destinations, from any point of origin, that are equipped to treat the condition of the patient consistent with Emergency Medical Services (EMS) protocols established by state and/or local laws where the services will be furnished.

These destinations may include, but are not limited to: any location that is an alternative site determined to be part of a hospital, critical access hospital (CAH) or skilled nursing facility (SNF), community mental health centers, federal qualified health clinic (FQHCs), rural health clinics (RHCs), physicians’ offices, urgent care facilities, ambulatory surgery centers (ASCs), any location furnishing dialysis services outside of an ESRD facility when an ESRD facility is not available, and the beneficiary’s home.

This expanded list of destinations applies to medically necessary emergency and non-emergency ground ambulance transports of beneficiaries during the PHE for the COVID-19 pandemic.  The IFC does not waive the medically necessary requirements for ground ambulance transport of a patient in order for an ambulance service to be covered.

The AAA is working closely with CMS to confirm that patients who require isolation meet the medical necessity requirements.

Suspension of Audits and Relief on Patient Signatures.  In guidance released separately, CMS indicates that it is suspending nearly all audits of providers and suppliers for the duration of the PHE.

CMS has suspended most Medicare Fee-For-Service (FFS) medical review during the emergency period due to the COVID-19 pandemic. This includes pre-payment medical reviews conducted by Medicare Administrative Contractors (MACs) under the Targeted Probe and Educate program, and post-payment reviews conducted by the MACs, Supplemental Medical Review Contractor (SMRC) reviews and Recovery Audit Contractor (RAC). No additional documentation requests will be issued for the duration of the PHE for the COVID-19 pandemic. Targeted Probe and Educate reviews that are in process will be suspended and claims will be released and paid. Current postpayment MAC, SMRC, and RAC reviews will be suspended and released from review. This suspension of medical review activities is for the duration of the PHE. However, CMS may conduct medical reviews during or after the PHE if there is an indication of potential fraud.

CMS also indicates in this guidance that a beneficiary’s signature will not be required for proof of delivery, as it relates to durable medical equipment services, during the PHE.  In a follow-up exchange with CMS, the AAA has confirmed that this policy of not requiring a beneficiary’s signature also applies to ground ambulance providers and suppliers. The AAA has requested that this clarification for ground ambulances also be provided in a written FAQ.

Pause in the Non-Emergency Prior Authorization Model.  CMS has paused the claims processing requirements for the Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model, effective March 29 until the end of the PHE.  During this pause, claims for repetitive, scheduled non-emergent ground ambulance transports for the COVID-19 pandemic in States in which the model operates will not be stopped for pre-payment review if prior authorization has not been requested by the fourth round trip in a 30-day period. During the pause, the MAC will continue to review any prior authorization requests that have already been submitted, and ambulance suppliers may continue to submit new prior authorization requests for review during the pause. Claims that have received a provisional affirmative prior authorization decision and are submitted with an affirmed unique tracking number (UTN) will continue to be excluded from future medical review. Following the end of the PHE for the COVID-19 pandemic, the MACs will conduct postpayment review on claims otherwise subject to the model that were submitted and paid during the pause.

Telehealth Services.  While CMS does not provide authority for ambulance organizations to bill directly for telehealth services, it does modify for the duration of the PHE the “direct supervision” requirements to allow physicians enter into a contractual arrangement with an entity that provides ambulance services to allow the physician to use the ambulance organization’s personnel as auxiliary personnel under a leased agreement.  Under such circumstances, the provider or supplier would seek payment for any services it provided from the billing physician and would not submit claims to Medicare for such services directly.

Ongoing work of the AAA.  The rule does not address two critical issues:  (1) reimbursement for treatment in place and (2) direct reimbursement for telehealth services.  The AAA will continue to work with CMS and the Congress to address these issues that are critical to meeting the needs of patients and your community during the epidemic.

CMS Grants State of Florida’s 1135 Waiver Request for Coronavirus Response

On March 16, 2020, CMS approved an 1135 Waiver request submitted by the State of Florida. The State had requested the flexibility to waive prior authorization requirements, streamline its Medicaid enrollment process, and allow care to be provided in alternative settings to the extent an existing health care facility needs to be evacuated. The key provisions of the waiver are summarized below:

1. Payments to Out-of-State Providers: Under current CMS coverage guidelines, the Florida Medicaid Program had the authority to reimburse out-of-state providers that were not enrolled in the Florida Medicaid Program provided certain criteria were met. However, this authority was limited to situations involving: (a) a single instance of care furnished over a 180-day period or (b) multiple instances of care furnished to a single Florida Medicaid beneficiary over a 180-day period. Under the waiver, CMS is removing the 180-day restriction for the duration of the emergency.

2. Expedited Enrollments: With respect to providers that are not currently enrolled in the Medicare Program or with another State Medicaid Agency, CMS is waiving the following screening requirements: (a) the payment of the application fee, (b) the fingerprint-based criminal background checks, (c) the required site visits, and (d) the in-state/territorial licensing requirements. Under the waiver, the state would still be required to check enrolling providers against the OIG exclusion list, and confirm that the out-of-state provider is properly licensed in their home state.

3. Cessation of Revalidation Efforts: CMS granted Florida the authority to temporarily cease the revalidation of enrolled in-state Medicaid providers and suppliers who are directly impacted by the emergency.

4. Waiver of Prior Authorization Requirements: CMS has granted Florida the right to waive any prior authorization requirements that are currently part of the State Medicaid Plan. This waiver applies to services provided on or after March 1, 2020, and will continue through the termination of the emergency declaration.

5. Waiver Allowing Evacuating Facilities to Provide Services in Alternative Settings: CMS will allow facilities, including nursing facilities, intermediate care facilities for individuals with intellectual and developmental disabilities, psychiatric residential treatment facilities, and hospitals to be reimbursed for services rendered during an emergency evacuation to an otherwise unlicensed facility. This waiver will extend for the duration of the declared emergency; however, CMS will require the unlicensed facility to seek licensure with the state after 30 days.

Understanding Medicare, Medicaid, and SCHIP Coverage of Ambulance Services under a Declared National State of Emergency

On March 13, 2020, President Donald J. Trump announced a national state of emergency in response to the COVID-19 pandemic. Previously, HHS Secretary Alex Azar had declared a public health emergency under Section 319 of the Public Health Service Act in response to COVID-19.

This has prompted many AAA members to ask what impact, if any, these declarations have on the coverage of ambulance services under federal health care programs?

The short answer is that these declarations give CMS the authority under Section 1135 of the Social Security Act to waive certain Medicare, Medicaid, and SCHIP Program requirements. This waiver authority includes, but is not necessarily limited to:

• Waiving certain conditions of participation and/or certification requirements;
• Waiving certain pre-approval requirements;
• Waiving the requirements that a provider or supplier be licensed in the state in which they are providing services;
• Waiving EMTALA requirements related to medical screening examinations and transfers; and
• Waiving certain limitations on payments for services provided to Medicare Advantage enrollees by out-of-network providers.

One situation where an 1135 waiver may be of use to an ambulance provider or supplier would be where the ambulance provider or supplier is sending vehicles and crews to a state that is outside its normal service area. The ambulance provider or supplier is unlikely to be licensed by the state in which it is responding. As a result, under normal circumstances, it would be ineligible for payment under federal health care program rules. The 1135 waiver would permit it to submit claims for the services it furnishes in the other state.

Of more immediate significance to the current national emergency, an 1135 waiver may permit hospitals and other institutional health care providers to establish an off-site treatment center for initial screenings of patients. For example, hospitals may establish triage sites in parking lots and other open spaces for the initial intake of patients suspected of being infected with the COVID-19 virus. In theory, this waiver could also extend to drive-thru testing sites to the extent they are operated by the hospital or another health care provider. When a hospital has obtained an 1135 waiver to operate an off-site treatment center, the off-site area becomes a part of the hospital for Medicare payment purposes. Therefore, ambulance transports to an approved off-site treatment area should be submitted to Medicare using the “H” modifier for the destination.

COVID-19 Coronavirus EMS Advisory 1

This guidance is written to offer American Ambulance Association members the situational background and a list of resources and websites with which to draw guidance and further updates on the latest situation with COVID-19, colloquially referred to as “Coronavirus.” Key information for this update has been drawn from the NHTSA EMS Focus series webinar What EMS, 911 and Other Public Safety Personnel Need to Know About COVID-19, which took place on February 24, 2020. The on-demand recording is available below.

General Information

Background

The COVID-19 Coronavirus Disease was first reported in Wuhan China in December 2019. CDC identifies that it was caused by the virus SARS – CoV-2. Early on, many patients were reported to have a link to a large seafood and live animal market. Later, patients did not have exposure to animal markets which indicates person-to-person transmission. Travel-related exportation of cases into the US was first reported January 21, 2020. For reference the first North American EMS experience of  COVID-19 patient transport, including key lessons learned, can be found in the EMS 1 article Transporting Patient 1.

Spread and Identification

Global investigations are now ongoing to better understand the spread. Based on what is known about other coronaviruses, it is presumed to spread primarily through person-to-person contact and may occur when respiratory droplets are produced when an infected person costs or sneezes. Spread could also occur when touching a surface or object that has the virus on it and when touching the mouth, nose, or eyes. Again, research is still ongoing, and advice and guidance will inevitably follow.

For the cases that have been identified so far, those patients with COVID19 have reportedly had mild to severe respiratory illness with symptoms including fever and shortness of breath. Symptoms have typically appeared 2 to 14 days after exposure. Both the WHO and CDC advise that patients that have been to China and develop the symptoms should call their doctors.

COVID-19 Prevention and Treatment

To date, 30 international locations, in addition to the US, have reported confirmed cases of   COVID-19 infection. Inside the US, two instances of person-to-person spread of the virus have been detected. In both cases, these occurred after close and prolonged contact with a traveler who had recently returned from Wuhan, China.

The CDC activated its Emergency Operations Center (EOC) on January 21 and is coordinating closely with state and local partners to assist with identifying cases early; conducting case investigations; and learning about the virology, transmission, and clinical spectrum for this disease. The CDC is continuing to develop and refine guidance for multiple audiences, including the first responder and public safety communities.

As at the date of publication there is still no specific antiviral treatment licensed for   COVID-19, although the WHO and its affiliates are working to develop this.

The following are recommended preventative measures for  COVID-19 and many other respiratory illnesses:

  • Wash your hands often with soap and water for at least 20 seconds.
  • Use an alcohol-based hand sanitizer with at least 60% if soap and water are not readily available.
  • Avoid touching your eyes, nose, and mouth with unwashed hands.
  • Avoid contact with people who are sick.
  • Stay home when you are sick.
  • Cover your cough or sneeze with a tissue, then throw it away.
  • Clean and disinfect frequently touched objects and surfaces.

Interim Guidance for EMS and 911

The Centers for Disease Control (CDC) has issued its Interim Guidance for Emergency Medical Services (EMS) Systems and 911 Public Safety Answering Points (PSAPs) for COVID-19 in the United States.

The guidance identifies EMS as vital in responding to and providing emergency treatment for the ill. The nature of our mobile healthcare service delivery presents unique challenges in the working environment. It also identifies that coordination between PSAPs and EMS is critical.

Key points are summarized below:

Recommendations for 911 PSAP Locations

The link between PSAPs and EMS is essential. With the advent of COVID19 there is a need to modify caller queries to question callers and determine the possibility that the call concerns a person who may have signs or symptoms and risk factors for COVID19.

The International Academy of Emergency Dispatch (IAED) recommends that agencies using its Medical Priority Dispatch System (MPDS) should use its Emerging Infectious Disease Surveillance (EIDS) Tool within the Sick Person and Breathing Problem protocols. For those that are not MPDS users, IAED is offering its EIDS surveillance Tool for Coronavirus, SRI, MERS and Ebola-free of charge under a limited use agreement.

Recommended Personal Protective Equipment (PPE)

The CDC recommends that while involved in the direct care of patients the following PPE should be worn:

  • Single pair of disposable examination gloves
  • Disposable isolation gown
  • Respiratory protection (N95 or higher)
  • Eye Protection (goggles or disposable face shield)

EMS Transport of a Patient Under Investigation (PUI) or Patient with Confirmed COVID19

  • Notify receiving healthcare facility so appropriate precautions can be put in place
  • Discourage family and contacts from riding in transport vehicle
  • Isolate the vehicle driver from the patient compartment by closing the windows between compartments and ensuring that the vehicle ventilation system is set to the non-recirculated mode
  • Document patient care

Cleaning EMS Transport Vehicles After Transporting PUI or Patient

  • Don PPE for cleaning with disposable gown and gloves, facemask, and goggles or face shield if splashes are anticipated
  • Routine cleaning and infection procedures should follow organizational standard operating procedures
  • Use protect use products with EPA-approved emergent viral pathogens claims

Once transport is complete, organizations should notify state or local public health authorities for follow up. Additionally agencies should (if not done already) develop policies for assessing exposure risk and management of EMS personnel, report any potential exposure to the chain of command, and watch for fever or respiratory symptoms amongst staff.

Employers Responsibilities

While not specific to COVID-19, agencies should:

  • Assess current practices and policies for infection control
  • Job- or task-specific education and training
  • PPE training and supply
  • Decontamination processes and supplies

Local EMS Considerations

  • PPE supplies
  • 911 and EMD call taking activities
  • Appropriate approach to potential patients
  • Educational resources for EMS personnel
  • Interaction with local public health/healthcare systems/emergency management
  • Interaction with local fire and law enforcement
  • Considerations for local jails

Further Reading

Conclusion

The COVID19 situation constantly evolving. Agencies should defer to their local EMS authorities, Public Health departments, and the CDC for definitive guidance. Going forward, the AAA will continue to both monitor the disease and alert issues to the membership.

Non-Emergency Transport: Avoiding the Fraud Trap [Sponsored]

By Eric van Doesburg, MP Cloud Technologies
This sponsored post is not endorsed by the American Ambulance Association. It reflects the views of the author.

Did you know that one of the most common practices in our industry could put your company at financial risk? Transporting patients not qualified for ambulance transportation is a hot topic these days as it has heavily contributed to the rise of Medicare fraud cases. This issue has grown even more relevant recently with a case in Florida, where not only was the EMS company found liable of fraud, but it was the first time several hospitals were held culpable as well.¹


While the burden of proof falls on the government to satisfy the statutes in the Federal False Claims Act, the fact is investigators are becoming more aggressive in fighting these types of billing schemes.

“The fact is investigators are becoming more aggressive in fighting these types of billing schemes.”

Yes, there are some bad actors in our industry like any other, but more times than not employees simply may be unaware of the qualifications needed when dispatching non-emergency transport.

Thankfully, a company can protect its financial future simply by having the necessary protocols in place.


For ambulance transportation to be covered by Medicare for a patient, the answer must be “yes” to at least one of the three criteria listed below:

  • “Is the patient bed-confined?”
  • “Does the patient require assistance to get out of bed?”
  • “Is the patient unable to safely sit in a wheelchair for the duration of the transport?”

Dispatchers must ask these specific questions in order to understand the scope of the situation – a step that should be incorporated into your business’ procedures immediately. If it is determined that the patient meets none of the above criteria, then an alternative transportation source must be sought and you have a couple of options.


Non-EMS Transport Options

Rideshare Partnership

Uber™ and Lyft™ have not only affected how we approach transportation as a society but have left a prominent mark on the EMS industry as well. According to a University of Kansas study, the use of ambulance transportation dropped 7% in cities that adopted ride-sharing platforms.² Consider the formation of a partnership with these companies as a low-cost alternative for non-emergency transport that could reduce your liability and develop a sustainable revenue stream for the future without a lot of overhead. Of course, just because the patient may not meet the Medicare criteria for non-emergency transport doesn’t mean that they are in a condition to be able to ride in a car by themselves. This is where the situation can become a little tricky. Is Uber™ or Lyft™ really the bestoption for an elderly person who may have some mild form of dementia and is being released after having a medical episode?

Add Non-Emergency Fleet

As an alternative, another option would be setting up your own fleet of non-emergency transport to cater to your clients’ specific needs. These non-emergency shuttles can ensure a consistent and legal discharge process to keep you in compliance and managing dispatch on your terms. It also allows for a higher level of patient care during the transport than a ride-sharing service can provide.

____________________________________________________________________

With the stakes for fraudulent claims getting higher, you’ll want to make sure you have a protocol in place that protects your business, employees, and clients from any hint of impropriety. However, with the right planning and core systems/partnerships, it will make the process for handling non-emergency transport that much easier… and possibly lead to new revenue channels not available in the past. That’s something we can all get excited about.

¹https://www.modernhealthcare.com/article/20150511/NEWS/150519994

EMS Education – A Look Forward

I have always believed EMS parallels the career trajectory of nursing. This is especially true when you look at the infancy of nursing—1750 to 1893—in what was a subservient apprenticeship with no didactic education. “Most nurses working in the States received on-the-job training in hospital diploma schools. Nursing students initially were unpaid, giving hospitals a source of free labor. This created what many nurse historians and policy analysts see as a system that continues to undervalue nursing’s contribution to acute care.” (History Lesson: Nursing Education has evolved over the decades, 2012, para. 5).

We reached a turning point in 1893 when the Columbian Exposition met, and although Ms. Florence Nightingale was unavailable to attend, she did have a paper presented at the exposition. In essence, the paper proved that a well-educated nursing workforce with standards of practice was needed to improve the health care of the United States.

This is exactly where EMS is now. Young enough to have moved through our growing pains of the late ’60s and early ’70s, but lucky enough to be in an age of extensive medical growth where all levels of providers are looking to enhance the care being provided.

So where do we go from here? We can choose to keep the status quo or we can move forward, hopefully, at a much greater speed than our nursing brothers and sisters. We should consider moving away from being governed by the Department of Transportation and the National Highway Traffic Safety Administration. A much more appropriate body is the Department of Health, which gives us the ability to stop thinking of our discipline as transport to the hospital, and more like bringing a hospital-like service to the to the sick and injured.

“EMS is a critical component of the nation’s healthcare system. Indeed, regardless of where they live, work or travel, people across the US rely on a sufficient, stable and well-trained workforce of EMS providers for help in everyday emergencies, large-scale incidents and natural disasters alike.” (“Education,” 2015, para. 1)

To get there, our education needs to reflect growth, and evidence-based medicine should be the law of the land. If this is proven to be effective, then let’s adopt it. If not, let’s stop teaching the worthless skills of yesterday, just as we have seen with the near extinction of the Long Spine Board. Let’s increase the minimum requirements for every level of provider. Let’s give Paramedics an associate’s degree, a diagnosis’s language, and a licensure, not a certification. Let’s all take the reins of our chosen career paths and have better continuing education that is challenging and accessible, and not an alphabet soup of certifications.

Yes, these are my musings about the future of EMS education. I know places that are very progressive in this country exist. I know there are protocol driven areas too. So let’s stop the segregation and become a health care group with a real mission, an everyday purpose. A place where we act as a group, not as individuals. A place where we treat our patients with the skill, compassion, and talent I know exists. Are you ready to join me?

Scott F. McConnell is Vice President of EMS Education for OnCourse Learning and one of the Founders of Distance CME. Since its inception in 2010, more than 10,000 learners worldwide have relied on Distance CME to recertify their credentials. Scott is a true believer in sharing not only his perspectives and experiences but also those of other providers in educational settings

References

Education. (2015). Retrieved from https://www.ems.gov/education.html

History Lesson: Nursing Education has evolved over the decades. (2012, November 12th, 2012). History Lesson: Nursing Education has evolved over the decades Blog post. Retrieved from https://www.nurse.com/blog/2012/11/12/history-lesson-nursing-education-has-evolved-over-the-decades-

 

REPLICA Compact Enacted

REPLICA Meets Goal, Interstate Compact Becomes Official

May 8, 2017
For Immediate Release
Contact:
Sue Prentiss
603-381-9195
prentiss@emsreplica.org

May 8, 2017 (Falls Church, VA). With the 10th member state enactment, the Recognition of
Emergency Medical Services Licensure Interstate Compact (REPLICA) has become official.
Governor Nathan Deal of Georgia signed Senate Bill 109 on today activating the nation’s first EMS
licensure compact. States that have passed REPLICA to date include: Colorado, Texas, Kansas,
Virginia, Tennessee, Idaho, Utah, Mississippi, Wyoming and Georgia.

Released in 2014, REPLICA’s model legislation creates a formal pathway for the licensed individual
to provide pre-hospital care across state lines under authorized circumstances. According to Keith
Wages, president of the National Association of State EMS Officials (NASEMSO), “REPLICA
represents a collective, nationwide effort to address the problems faced by responders when needing
to cross state borders in the line of their duties.” Wages highlighted the compact’s abilities to
“increase access to healthcare, reduce regulatory barriers for EMS responders, and place an
umbrella of quality over cross border practice not previously seen in the EMS profession.” Wages
also noted that the partnership with the National Registry of Emergency Medical Technicians
(NREMT) has been essential during the advocacy and implementation phases. “We are grateful for
their continued support and contributions.”

Through funding provided by the Department of Homeland Security (DHS), NASEMSO led 23 EMS,
fire, law enforcement organizations and associations as well as key federal partners in the design and
drafting of REPLICA. The National Registry of EMTs (NREMT) currently provides funding to finalize
the development of the Commission.

The compact calls for establishment of an Interstate Commission with each state that has passed
REPLICA holding a seat, as well as a national EMS personnel coordinated database. Member states
will be able to rapidly share personnel licensure information, develop policy focused only on cross
border EMS practice, and hold EMS personnel originating in other states accountable in an
unprecedented way. The National Registry of EMT’s (NREMT) has committed to the development
and hosting of the coordinated database.

Twelve national associations and organizations support REPLICA. Three states have REPLICA bills
under consideration in their legislative sessions. Learn more at www.emsreplica.org.

###

Maintaining Compliance Within an EMS Service

Maintaining compliance within an EMS service can be a daunting task, especially given the number of regulations that we must follow.

One way to look at EMS is if a trucking company married a hospital.

There are rules and regulations to abide by for an entire fleet of vehicles, from safe operation guidelines all the way down to the use and color of lights. Then there are requirements for a group of healthcare providers, which include necessary certifications such as CPR and knowledge of pertinent life-saving skills.

Not only does maintaining compliance keep vehicles and equipment running smoothly, but it can offer employees valuable peace of mind and keep everyone focused on the same goals of providing the best care possible.

I like to consider compliance an investment in common sense.

Employees know what is expected of them at all times, and they know what type of support their employer will provide to keep their skills sharp. In turn, an EMS service gains from being in good standing with regulators and from an engaged, confident workforce.

The benefits of a strong culture of compliance are immense. An organization that lives and breathes compliance can help ensure a smooth-running operation that features top-notch communication and quality providers who offer excellent care.

Journey to Compliance

These six key ways ensure compliance will serve as a roadmap to a strong culture in your organization:

  1. Start from the top: Backing from leadership ensures a strong culture of compliance. For certification and education compliance to stick, it starts with the attitudes of upper management, such as the board of directors, chiefs, officers, and day-to-day operations staff. Leaders must actively support all compliance efforts, including regular compliance-related reports, approving policies and having a general knowledge of the rules that govern EMS providers. Without the right tone from the top, an EMS service’s compliance efforts are usually undermined and ultimately fail. This results in issues with governing bodies, payers, scheduling and staffing.
  2. Commit to resources: Having the right personnel and systems in place are both vital to creating a strong compliance culture. The organization’s compliance staff should have experience in directing compliance efforts and supporting the evaluation of compliance-related risks. When it comes to certifications and education, compliance is always black and white. Knowing how to evaluate and respond to operational issues is important to maintaining compliance and successfully operating an EMS service. Systems that provide information to assist the service in complying with its obligations are a necessity.
  3. Have the write stuff: Developing written policies and procedures for compliance programs and internal controls is essential to adequately address regulatory requirements and an EMS service’s specific risks. Having these policies and procedures in writing sets the expectation of what is required of both managers and employees. Assessing risks before drafting these programs will help identify key areas where controls are needed. A compliance program should include how a service’s policies can be implemented from an operational perspective. This will include internal controls and standard operating procedures.
  4. Provide education: Providing the training for your EMS employees gives them peace of mind that they will be in compliance and acknowledges that the service values them.
  5. Test the system: Subjecting procedures to an independent review and audit ensures the compliance system is working correctly. This review provides an evaluation of where the EMS service’s compliance efforts stand. It also offers an opportunity to correct deficiencies before an outside regulatory audit is performed.
  6. Communicate more: Communication is vital to all organizations, but it can be the most difficult piece of the puzzle to achieve. With compliance-related responsibilities, sharing information is very helpful and, in some cases, required. Communicating expectations within EMS training programs is imperative. Reporting compliance efforts and noting any deficiencies should be a part of a communication strategy, especially if your state has an active medical director and/or board of EMS.

FDA Issues First Responder Drug Dispenser Guidance

In accordance with the Drug Supply Chain Security Act of 2013, the FDA issued regulations last year to require drug dispensaries to build an electronic system to identify and track the distribution of drugs. Many small dispensaries do not have the ability currently to electronically trace small quantities of drugs. The AAA became concerned that hospital and other small dispensers would no longer provide first responders with critical drugs in fear of not being compliant with the new regulations. The AAA joined a coalition of dispensaries, pharmacists and others that also had concerns with the new regulations.

As a result of the efforts of the coalition and the AAA, we were able to delay enforcement of the requirements until today, March 1. The AAA then worked directly with the FDA to educate them about the unique nature that small dispensaries sometimes play in restocking certain ambulance service providers. Upon learning of these transactions, the FDA shared our concerns and worked quickly to release the guidance.

The guidance states that the FDA will not take action against drug dispensaries in providing drugs to first responders if the dispensary follows certain basic recording keeping policies. The agency will also not take any action against the first responder. The guidance is entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry“.

Spotlight: Kathy Lester

Kathy Lester, MPH, JD
Washington, DC
Healthcare Consultant to AAA

Tell us a little about yourself, please.

I am from Indianapolis, Indiana.  I graduated from Warren Central High School, best known for being the high school of Jane Pauley and Jeff George.  My undergraduate degree is from DePauw University.  I had a double major in biology and English literature, with a minor in violin performance.  I also loved philosophy and political science course and was the editor-in-chief of the college newspaper.  I received my JD from Georgetown University Law Center and my Master of Public Health (MPH) from The Johns Hopkins School of Public Health and Hygiene, now known as the Bloomberg School of Public Health.

After law school, I clerked on for The Honorable Michael S. Kanne on the U.S. Court of Appeals for the Seventh Circuit.  I have also worked in all three branches of government.  In addition to the courts, I worked on the Hill for Sen. Richard G. Lugar (R-IN) and in the General Counsel’s Office at the Department of Health and Human Services.

My husband and I met while both working for Senator Lugar.  He retired from the Senate after 20+ years.  We have two children and are trying to succeed in having tropical fish survive for more than a few months.

When and how did you get involved with AAA?

I began working with the AAA several years ago when we began developed recommendations for a quality program.  I believe my first meeting with the group was in Las Vegas.

How do you help AAA?

Currently, I assist on the public policy issues.  This includes working with the Congress to protect the add-ons, as well as develop payment reforms to create stability for Medicare rates.  I help to draft materials for the Hill and legislative language.  As part of this effort, I help with developing more comprehensive Medicare reform recommendations.  I also assist with the regulatory agenda and engage with Centers for Medicare and Medicaid Services (CMS) and other federal agencies.  In addition, I continue to work on quality structural and measurement issues.

What is your typical day like?

Unpredictable and fun!  My days vary greatly.  I can find myself on the Hill or driving to Baltimore to meet with CMS.  I also spend a lot of time talking with AAA members and the staff team.

What are the biggest challenges you foresee for our industry?Any tips or last thoughts?

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It is more important than ever to understand the cost of services and to be able to articulate why these services are necessary.

[/quote_left]All of healthcare is at a crossroads.  While federal policymakers have successfully reduced spending in the Medicare program, the focus for the foreseeable future will be how to reduce the cost of providing services.  It is more important than ever to understand the cost of services and to be able to articulate why these services are necessary.

For ambulance providers and suppliers in particular, there is great promise in the innovative payment models, because they would most likely recognize the high quality of health care services provided by ambulance providers and suppliers.  However, there is also the potential that ambulance services could become subordinate to larger provider organizations.  As this debate unfolds, it is critically important that data drive any reforms and that the industry look carefully at how programs such as value-based purchasing, the Medicare quality reporting programs (facility compare websites and the five star rating programs), and coordinated/integrated care models have worked for other Medicare providers.  At the end of the day, ambulance providers and suppliers need to understand their care and cost models and articulate use these data points to develop meaningful and sustainable reform options.

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