Drugs & Pharma Archives - American Ambulance Association

What the New DEA PPAEMA Rule Means for EMS Agencies and How to Stay Compliant

Written by AAA Staff on February 26, 2026. Posted in Drugs & Pharma, Human Resources, News, Operations.

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The Drug Enforcement Administration’s final rule implementing the Protecting Patient Access to Emergency Medications Act (PPAEMA) marks a turning point in how EMS agencies manage and document controlled substances.

For decades, EMS agencies operated in a regulatory environment that was functional but imperfect. Controlled substances were often handled under the DEA registration of a hospital, pharmacy, or medical director. While this approach allowed EMS agencies to deliver critical medications in the field, it left gaps in regulatory clarity and accountability.

The new DEA PPAEMA EMS registration rule changes that. For the first time, EMS agencies are formally recognized as DEA registrants in their own right. This designation brings long-needed clarity, but it also introduces direct responsibility for controlled substance compliance, documentation, and chain-of-custody tracking.

For EMS leaders, the PPAEMA isn’t just a regulatory technicality. It fundamentally changes how controlled substances must be tracked, documented, and reported. Understanding the implications of this rule, and how to comply with it, is essential for protecting your agency, your personnel, and your patients.

Why the DEA Created a New EMS Registration Category

The Protecting Patient Access to Emergency Medications Act was passed to address a longstanding disconnect between how EMS agencies operate and how DEA regulations were originally structured.

Traditional DEA regulations were written primarily for fixed facilities such as hospitals, clinics, and pharmacies. EMS agencies, by contrast, operate in highly mobile environments. Controlled substances move across vehicles, stations, shifts, and personnel on a daily basis. This mobility created compliance challenges. When controlled substances were registered under a hospital or physician’s DEA registration, questions could arise about who ultimately bore responsibility for documentation, reconciliation, and compliance. While many agencies developed strong internal processes, the regulatory framework did not always reflect operational reality.

The new PPAEMA rule resolves that ambiguity. EMS agencies can now obtain their own DEA registration, giving them clear authority, and clear responsibility, for managing controlled substances. This change aligns federal regulations with how EMS actually functions and ensures that accountability follows the organization that directly controls the medications. But with that clarity comes increased expectations.

What the New DEA EMS Rule Requires

Under the new PPAEMA rule that takes effect March 9^th 2026, EMS agencies must maintain complete and accurate records documenting the lifecycle of every controlled substance.

The PPAEMA includes documentation of:

Receipt and acquisition of controlled substances
Storage and inventory tracking
Transfers between locations or vehicles
Administration to patients
Partial waste and destruction
Inventory reconciliation and auditing

Most importantly, these records must be “readily retrievable.”

This phrase carries specific weight in DEA PPAEMA compliance. It means that documentation must be accessible quickly and completely during an audit or inspection. Agencies must be able to demonstrate chain-of-custody continuity and inventory accuracy without relying on fragmented or incomplete records. The expectation is not simply that documentation exists, but that it is complete, accurate, and easily accessible. “From the DEA’s perspective, the most important thing isn’t whether an agency made a mistake, it’s whether they can demonstrate a complete chain of custody. If you can’t produce controlled substance records immediately, that’s when a routine inspection becomes a serious problem.” said retired DEA Special Agent Dennis Wichern, in a recent interview with LogRx Founder, Clive Savacool.

Increased Accountability for EMS Agencies

With EMS agencies now recognized as DEA registrants, the responsibility for compliance rests squarely with the agency itself. This means EMS leadership must ensure their organization can demonstrate:

Full chain-of-custody documentation for all controlled substances
Accurate and timely inventory tracking
Complete documentation of administration, waste, and destruction
Reliable audit-ready reporting

The PPAEMA requirements apply regardless of agency size. Whether managing a handful of vehicles or a large fleet across multiple stations, the expectation is the same: controlled substances must be tracked from acquisition through final disposition. This increased accountability protects both patients and providers. It creates transparency, reduces ambiguity, and ensures controlled substances are handled safely and appropriately. “The new EMS registration rule makes EMS agencies fully accountable for controlled substance tracking, and that changes everything.” said Wichern.

Why Manual Controlled Substance Tracking Creates Risk

Many EMS agencies still rely on paper narcotics logs, spreadsheets, or hybrid documentation systems. While these methods may feel familiar, they introduce inherent risks under the new PPAEMA regulatory framework.

Manual tracking systems rely heavily on human consistency and accuracy. Handwritten entries can be incomplete, illegible, or delayed. Paper records can be lost, damaged, or stored across multiple locations. Spreadsheets may lack audit trails or standardized workflows. These gaps often remain invisible until documentation is needed, such as during an audit, discrepancy investigation, or internal review. At that point, reconstructing chain-of-custody history becomes time-consuming and stressful.

Importantly, most documentation gaps do not arise from misconduct. They arise from the practical challenges of managing complex workflows in fast-paced emergency environments. But regardless of intent, incomplete documentation creates compliance risk.

The new DEA PPAEMA EMS rule makes it more important than ever for agencies to maintain reliable, consistent, and accessible controlled substance records.

DEA Audits and the Importance of Audit-Ready Documentation

DEA audits are designed to verify compliance with controlled substance regulations. Investigators typically review inventory records, chain-of-custody documentation, acquisition forms, and destruction records.

Agencies that maintain complete, well-organized records can demonstrate compliance efficiently and confidently.

Agencies with fragmented or incomplete documentation often face prolonged reviews, increased administrative burden, and potential compliance findings.

Audit readiness is no longer something agencies prepare for occasionally. Under the new rule, it must be built into daily operations.

Maintaining accurate, continuous documentation protects your agency, your staff, and your license to operate.

The Role of Technology in Modern EMS Controlled Substance Compliance

As regulatory expectations evolve such as the PPAEMA, so must the tools used to meet them. Digital EMS narcotics tracking systems provide a reliable way to maintain complete chain-of-custody documentation while reducing administrative burden. Instead of relying on paper logs or disconnected systems, digital tracking creates a continuous, time-stamped record of controlled substance activity.

This improves:

Inventory accuracy
Chain-of-custody visibility
Audit readiness
Documentation consistency
Operational efficiency

When documentation is integrated into daily workflow, compliance becomes a natural byproduct of operations, not an after-the-fact administrative challenge. The reality is that the PPAEMA legislation is actually a good thing, with advocacy from groups like the National Association of Emergency Medical Physicians (NAEMSP) and the American College of Emergency Physicians (ACEP), this legislation cemented the role of EMS in the world of first responders in their ability to carry controlled substances and a wide variety of narcotics. Other organizations, such as the American Ambulance Association (AAA) and other state level associations like the California Ambulance Association(CAA) have positive impacts on EMS providers and their ability to provide services to their communities.

Building a Compliance-Ready Controlled Substance Program

The new DEA PPAEMA EMS registration rule provides an opportunity for agencies to strengthen their controlled substance tracking programs. Compliance readiness begins with clear, consistent documentation processes supported by reliable tracking systems. Agencies should ensure they can quickly produce complete records documenting the acquisition, movement, administration, and destruction of controlled substances. Chain-of-custody continuity must be maintained across shifts, vehicles, and personnel. Leadership visibility is also essential. Administrators must be able to monitor inventory, identify discrepancies, and generate reports without relying on manual reconciliation. After all, your staff is only going to take something as serious as you do!

By strengthening documentation systems now, agencies can meet regulatory requirements confidently and avoid compliance risks. Risks that exist regardless of the PPAEMA rules.

How LogRx Supports Compliance Under the New DEA PPAEMA Legislation

LogRx helps EMS agencies meet the documentation, tracking, and reporting requirements established under the new PPAEMA legislation. LogRx helps make all your paperwork easier. Forms like the DEA 222 acquisition form are easier to manage when accurate inventory data is already available in a simple, user-friendly report. As well as the DEA 41 form, so controlled substances are tracked from cradle to grave.

LogRx stores images and helps you track inventory in a compliance-friendly way. You get end-to-end documentation continuity for the life of all controlled substances that you and your team may need to handle on the job.

When your inventory is tracked, and reports are easy to generate, you can quickly see what you have on hand. You can be proactive about ordering and inventory management. The data provided in the LogRx administrative dashboard gives you all the details you need to identify trends, monitor usage, and tell the story of each controlled substance in your organization’s purview.

One of the best features of LogRx is that it works directly from your team’s handheld devices, while they’re on the go. With a simple snap from their phone or tablet, they can scan in medication and log use fast, even while they’re on the go.

It isn’t just digital tracking that helps with maintaining compliance. Having secure locations is also critical with the narcotics chain of custody. This is why LogRx integrates seamlessly with the Knox Company’s MedVaultand Knox StationVault. Providing an all-encompassing solution.

“From a DEA compliance standpoint, controlled substances must be securely stored and accounted for at all times. It’s not enough to know that the medication is somewhere in your system, you must be able to demonstrate exactly where it was stored, who had access to it, and maintain continuous accountability from the moment it was received until it’s administered or destroyed.” – Dennis Wichern, Retired DEA Special Agent

LogRx works out of range, too. Should your team lose cell service while in the field, they can still track, and the information will be updated automatically when they come in range. Real-time tracking is crucial for accuracy and simplicity. It saves the “what happened” scramble at the end of the day.

Compliance with controlled substance reporting rules may not be the most exciting thing on your administrative to-do list, but it protects your team and helps ensure you have exactly what you need on hand when your patients need it.

To see how seamlessly LogRx works with the DEA 222 and 41 forms, as well as all your other compliance needs, reach out. We can demonstrate the process and show you what a difference that LogRx can make for your team. Make drug destruction reporting simple and fast with LogRx.

Note: This article is for informational purposes and does not constitute legal advice. Always follow DEA requirements and your agency’s policies when handling and destroying controlled substances.

Visit the LogRx website at https://logrx.com/

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

Written by AAA Staff on September 24, 2021. 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 Increases Medicare Payment for COVID-19 Vaccinations

Written by Brian Werfel on March 16, 2021. Posted in Drugs & Pharma, Emergency Preparedness, Medicare, Reimbursement.

CMS Increases Medicare Payment for COVID-19 Vaccinations

By Brian S. Werfel, Esq.

On March 15, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it would be increasing the Medicare payment amount for administrations of the COVID-19 vaccines.

The original Medicare reimbursement rate depended, in part, on whether the vaccine being administered required a two-dose regimen (as is the case for the Pfizer-Biontech and Moderna vaccines), or a single dose (Johnson & Johnson vaccine). For vaccinations that require a two-dose regime, CMS initially paid: (1) $16.04 for the administration of the first dose and (2) $28.39 for the administration of the second dose. For vaccines that require only a single dose, Medicare paid $28.39 for the administration of that single dose.

Effective for vaccinations administered on or after March 15, 2021, CMS has increased these payments to $40 per administration. Thus, the total reimbursement for a vaccine requiring a single dose will be $40, while the total reimbursement for a vaccine requiring a two-dose regimen will be $80.

Opioid Bill Heads to President Trump’s Desk

Written by on October 4, 2018. Posted in Drugs & Pharma, Legislative, News.

The AAA is pleased to report that language we supported on grant funding for opioid protection training for first responders has passed both the House of Representatives and the Senate and is now headed to the President’s desk.

On Wednesday, the Senate passed the Opioid Crisis Response Act with a bipartisan vote of 98-1 in the last necessary needed action before being signed into law by the President. The impact of this legislation on the ambulance industry includes providing resources and training so that first responders and other key community sectors, including emergency medical services agencies, can appropriately protect themselves from exposure to drugs such as fentanyl, carfentanil and other dangerous licit and illicit drugs. $36,000,000 will be given annually for each fiscal year from 2019 through 2023. The bill also gives $10,000,000 in supplemental competitive grants to areas that have a record of high seizure of fentanyl to be used toward training of law enforcement and other first responders on how best to handle fentanyl as well as to purchase protective equipment, including overdose reversal drugs.

Lastly, the legislation allows the Department of Labor to award grants to states that have been heavily impacted by the opioid crisis in order to assist local workforce boards and local partnerships in closing the gaps in the workforce for mental health care and substance use disorder. Based on an analysis by counsel, we believe all ambulance service agencies would be eligible to apply for the described grants. It is encouraging to see both parties and chambers come together to pass legislation that takes steps to better our country as a whole and finally help address this growing public health emergency. The President is expected to sign the legislation into law.

Is Narcan the Answer?

Written by Scott McConnell on February 14, 2018. Posted in Community, Drugs & Pharma, Emergency Preparedness, Patient Care, Uncategorized.

There has been a lot of talk recently in social media and the news about leaving Narcan behind after a reversal of an opioid overdose. A new voluntary program in Pittsburgh, PA allows the state to pay for Narcan atomizers that EMS can leave with friends and family of OD patients. The media buzz revolves around the idea that we are enabling this cycle of addiction; “There is some pushback that maybe you’re enabling the problem a little bit, but at least in the short term, reduce the chances that person is going to die and you create more opportunities to get them into treatment,” said Mark Pinchalk, patient care coordinator for Pittsburgh EMS.” (Media, 2018, para. 3) I agree with Mr. Pinchalk that as an EMS Provider we are not there to judge, we are there to render aid.

One of my early instructors said, “Scott, your purpose is to leave the patient better than the way you found them.” I have taken that long ago statement to heart ever since, trying to leave the patient better than the way I found them whether that is medically as in a Diabetic whose blood glucose I raise from 20mg/dl to 130mg/dl or the person who receives a ride to the hospital to be checked out. EMS is about providing care. When we use our own judgements or opinions on our patients, it impedes or influences the care we provide.

These particular cases seem to bring out strong opinions surrounding a delicate issue. Thousands of people die every year from Opioid overdoses. A healthy percentage of them get their start on prescription pain killers. So where do we help? How do we not judge going to the same address three or four times a week to treat the same person in the same situation? These are just some of the tough questions providers and services face every day in America. Although we are trying to hold back the tide with a broom, it is up to us to provide the same level of care each and every time, regardless of the person or situation.

Will leaving Narcan at the scene save lives? Yes, I believe so. Will it encourage more drug use? I can’t be sure. Time will tell.

In comparison, studies show making birth control available to teens actually reduces sexual activity and reported pregnancies. Consider 2017 data that shows “Among adolescent females aged 15 to 19, 42 percent report having sex at least once. For males, that number was 44 percent. The numbers have gradually dropped since 1988, when 51 percent of female and 60 percent of male teens reported having had sex.” (Welch, 2017, para. 4)

So for now, I encourage the opportunity, as the law allows, to provide Narcan, knowing it doesn’t make the problem go away. And I look forward to EMS impacting this youthful epidemic. How? Community Paramedicine are the resource to embrace. Just like any other frequent patient, community paramedics will help those get the services they need including the much-needed follow up care.

Scott F. McConnell is Vice President of EMS Education for OnCourse Learning and one of the Founders of Distance CME, which recently launched a new learning platform. 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

Media, C. (Ed.). (2018, Jan, 26th, 2018). Local EMS starts program to leave Naloxone with OD victims. WPXI.com. Retrieved from http://www.wpxi.com/news/top-stories/local-ems-starts-program-to-leave-naloxone-with-od-victims/689842523

Welch, A. (2017, June 22nd, 2017). Are today’s teens more responsible about sex? CBS News. Retrieved from https://www.cbsnews.com/news/teen-sex-trends-birth-control-cdc-report/

Fentanyl Increasingly Dangerous to First Responders

Written by Matt Swift on June 21, 2017. Posted in Community, Drugs & Pharma, Emergency Preparedness, Field Resources.

Fentanyl is a powerful drug that can be 50 times more potent than heroin. First responders are being warned to take precautions to avoid being exposed to the drug. Photo courtesy of the Drug Enforcement Administration.

The explosion of the opioid epidemic that is responsible for thousands of overdoses and deaths is a consistent problem that EMS and law enforcement encounter on an almost daily basis. Usually, the victims of these powerful drugs, such as heroin and fentanyl, are opioid users, who EMS personnel and law enforcement are regularly called to assist. However, first responders are also being warned about the increased risks they face of being exposed to these deadly drugs, specifically fentanyl—a popular synthetic opioid that is 40 to 50 times more powerful than heroin. To respond to these dangers, the Drug Enforcement Administration (DEA) released a field guide called “Fentanyl: A Brief Guide for First Responders” for EMS and police who find themselves responding to opioid-related calls.

“We need everybody in the United States to understand how dangerous this is,” Acting DEA Administrator Chuck Rosenberg warned. “Exposure to an amount equivalent to a few grains of sand can kill you.”

The warnings have become more urgent in recent months due to numerous cases of accidental overdoses and exposures involving EMS and police.

In May, Chris Green, a police officer with the East Liverpool Police Department, was accidentally exposed to fentanyl during a routine traffic stop after he inadvertently ingested the drug through his skin. Green needed four shots of Narcan, an emergency overdose medication, to be revived after collapsing from the effects of the drug. In another case, two Paramedics and a sheriff’s deputy in Hardford County, Maryland, were treated after showing signs of opioid exposure while treating an overdose victim.

“It is important to get the word out to everyone because it may be the first responder who needs to have Narcan administered,” said Baltimore City Health Commissioner Leana Wen.

The risks of accidental exposure are so high, in fact, that some emergency personnel have even begun carrying Narcan kits for drug-sniffing K-9s, just in case the dogs ingest the deadly drugs.

The DEA guide, along with a National Institute for Occupational Safety and Health manual on preventing fentanyl exposure, suggests certain precautions be taken to lower the risk of coming in direct contact with the substance. Personnel should be able to recognize the signs and symptoms of an overdose, be aware of the ways fentanyl can be ingested, and only allow trained professionals to handle substances that are suspect.

“Assume the worst,” Rosenberg said. “Don’t touch this stuff or the wrappings that it comes in without the proper personal protective equipment.”

The DEA video “Fentanyl: A Real Threat to Law Enforcement” offers advice on how police and EMS can protect themselves from the dangers of fentanyl.

AAA Meets with FDA on New Drug Dispenser Regulations

Written by Tristan North on October 23, 2015. Posted in Drugs & Pharma, Patient Care.

On October 21, the AAA participated in a meeting with stakeholders and the Food and Drug Administration (FDA) about the need to ensure new regulations don’t discourage the transfer of small quantities of drugs between dispensers, hospitals and first responders among others. Under the Drug Supply Chain Security Act of 2013, starting on November 1, drug dispensers must provide a full transaction history for transactions involving even small transfers of drugs. Since these transactions are often done in paper form, it will be difficult for many drug dispensers to be compliant with the new regulation and may opt to not distribute drugs in small quantities.

The AAA is participating in a coalition to ease initial enforcement on small transactions to help ensure those hospital pharmacies that provide first responders with drugs under a safe harbor agreement or direct cost reimbursement will continue to do so. The coalition of stakeholders including the AAA had sent a letter to the FDA on September 24 requesting the meeting.