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

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

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.

CMS | Increased Medicare Payment for Life-Saving COVID-19 Vaccine

From CMS on March 15

Biden-Harris Administration Increases Medicare Payment for Life-Saving COVID-19 Vaccine

On March 15, CMS increased the Medicare payment amount for administering the COVID-19 vaccine. This new and higher payment rate will support important actions taken by providers that are designed to increase the number of vaccines they can furnish each day, including establishing new or growing existing vaccination sites, conducting patient outreach and education, and hiring additional staff. At a time when vaccine supply is growing, CMS is supporting provider efforts to expand capacity and ensure that all Americans can be vaccinated against COVID-19 as soon as possible.

Effective for COVID-19 vaccines administered on or after March 15, 2021, the national average payment rate for physicians, hospitals, pharmacies, and many other immunizers will be $40 to administer each dose of a COVID-19 vaccine. This represents an increase from approximately $28 to $40 for the administration of single-dose vaccines and an increase from approximately $45 to $80 for the administration of COVID-19 vaccines requiring two doses. The exact payment rate for administration of each dose of a COVID-19 vaccine will depend on the type of entity that furnishes the service and will be geographically adjusted based on where the service is furnished.

These updates to the Medicare payment rate for COVID-19 vaccine administration reflect new information about the costs involved in administering the vaccine for different types of providers and suppliers, and the additional resources necessary to ensure the vaccine is administered safely and appropriately.

CMS is updating the set of toolkits for providers, states, and insurers to help the health care system swiftly administer the vaccine with these new Medicare payment rates. These resources are designed to increase the number of providers that can administer the vaccine, ensure adequate payment for administering the vaccine to Medicare beneficiaries, and make it clear that no beneficiary, whether covered by private insurance, Medicare, or Medicaid, should pay cost-sharing for the administration of the COVID-19 vaccine.

Coverage of COVID-19 Vaccines:

As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers are prohibited from charging patients any amount for administration of the vaccine. To ensure broad and consistent coverage across programs and payers, the toolkits have specific information for several programs, including:

Medicare: Beneficiaries with Medicare pay nothing for COVID-19 vaccines and there is no applicable copayment, coinsurance, or deductible.

Medicare Advantage (MA): For calendar years 2020 and 2021, Medicare will pay providers directly for the COVID-19 vaccine (if they do not receive it for free) and its administration for beneficiaries enrolled in MA plans. MA plans are not responsible for paying providers to administer the vaccine to MA enrollees during this time. Like beneficiaries in Original Medicare, Medicare Advantage enrollees also pay no cost-sharing for COVID-19 vaccines.

Medicaid: State Medicaid and Children’s Health Insurance Program agencies must provide vaccine administration with no cost sharing for nearly all beneficiaries during the Public Health Emergency (PHE) and at least one year after it ends. Through the American Rescue Plan Act signed by President Biden on March 11, 2021, the COVID vaccine administration will be fully federally funded. The law also provides an expansion of individuals eligible for vaccine administration coverage. There will be more information provided in upcoming updates to the Medicaid toolkit.

Private Plans: CMS, along with the Departments of Labor and Treasury, is requiring that most private health plans and issuers cover the COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing during the PHE. Current regulations provide that out-of-network rates must be reasonable, as compared to prevailing market rates, and reference the Medicare reimbursement rates as a potential guideline for insurance companies. In light of CMS’s increased Medicare payment rates, CMS will expect commercial carriers to continue to ensure that their rates are reasonable in comparison to prevailing market rates.

Uninsured: For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).

More Information:

 

Webinar 3/25 | What the Vaccine Means for EMS Operations

From EMS.gov

What the Vaccine Means for EMS Operations

Tune in on Thursday, March 25, at 1 pm ET for the latest edition of EMS Focus, a federal webinar series hosted by NHTSA’s Office of EMS

Register Now

Millions of EMS clinicians and members of the public across the nation have now received a COVID-19 vaccine. But exactly what does that mean for EMS systems and organizations? In this webinar, learn what we know, and what we don’t know yet, about how the vaccines are changing our approach to the coronavirus pandemic. You’ll hear from experts helping to create and implement guidance for EMS services during these unprecedented times. They’ll address topics such as:

  • Testing and quarantine implications
  • EMS clinicians who have not been vaccinated
  • Vaccines and coronavirus variants

Register Now

Panelists Include:

Bryan E. Christensen, PhD, is an epidemiologist and industrial hygienist with the Division of Healthcare Quality Promotion (DHQP) in the National Center for Emerging and Zoonotic Infectious Diseases at Centers for Disease Control and Prevention (CDC). He is also an environmental health officer in the U.S. Public Health Service. During the COVID-19 response, Bryan has been deployed in several capacities and has served on the Prehospital/EMS Team as part of the Federal Healthcare Resilience Working Group.

Kenneth A. Scheppke, MD, FAEMS, is Florida’s State EMS medical director. A board-certified EMS and emergency physician, he also serves as chief medical officer for several fire-rescue agencies in southeast Florida, and has been a leader in the state’s response to coronavirus.

Jon Krohmer, MD, director of NHTSA’s Office of EMS and team lead for the Federal Healthcare Resilience Working Group EMS/Prehospital Team, will moderate the webinar.

Attendees will be encouraged to submit questions during any point of the discussion. The webinar and Q&A will last approximately one hour.

About EMS Focus

EMS Focus provides a venue to discuss crucial initiatives, issues and challenges for EMS stakeholders and leaders nationwide. Be sure to visit ems.gov for information about upcoming webinars and to view past recordings.

EMS.gov | Training Resources for Vaccination Programs Using EMTs

From EMS.gov on February 10

These resources can serve as just in time training for vaccination programs utilizing emergency medical technicians:

Training video on COVID-19 intramuscular vaccine administration
This video created by the Maryland Institute of Emergency Medical Services Systems (MIEMSS) can be used to provide EMTs with didactic knowledge to administer IM injections. With the exception of the MIEMSS link referenced in the video, it can be used by EMTs in any state or territory. It should be accompanied by a skills assessment, which is discussed below.

Intramuscular Injection Skill Checklist
A clinical skills assessment checklist for EMTs preparing to administer IM injections.

SARS-CoV-2 Vaccine Training for EMTs
A written description of the skills required of EMTs to administer the vaccine.

Moderna and Pfizer Vaccine Comparison
A simple side-by-side comparison of the Pfizer and Moderna SARS-CoV-2 vaccines

Vaccine Update Video
In this presentation from late January 2021, Florida State EMS Medical Director Kenneth Scheppke, MD, provides an overview of the latest science related to COVID vaccines.

COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals
CDC recommended resources to prepare healthcare workers to administer COVID-19 vaccines.

EMS Vaccine Administration Program Manual
This guide from the State of Indiana can serve as a resource to help state and local officials and EMS organizations with the creation and implementation of EMS vaccination programs.

CDC | Essential Workers Vaccine Communication Toolkit

CDC has designed a COVID-19 Vaccination Communication Toolkit for Essential Workers to help employers build confidence in this important new vaccine. The toolkit will help employers across various industries educate their workforce about COVID-19 vaccines, raise awareness about the benefits of vaccination, and address common questions and concerns.

Access Toolkit

The toolkit contains a variety of resources including:

  • key messages,
  • an educational slide deck,
  • FAQs,
  • posters/flyers,
  • newsletter content,
  • a plain language vaccine factsheet (available in several different languages),
  • a template letter for employees,
  • social media content, and
  • vaccination sticker templates.

This toolkit will help your organization educate employees about COVID-19 vaccines, raise awareness about the benefits of vaccination, and address common questions and concerns.
Access Toolkit

NIH | Promising Interim Results from NIH-Moderna Vaccine

From the National Institutes of Health on November 16

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.

Continue Reading►

 

Opioid Bill Heads to President Trump’s Desk

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.

Update on Opioid Legislation & Rural EMS Grant Program

The AAA continues to push on policy issues important to our members we are happy to provide an update on two pieces of legislation that we have been actively monitoring. Congress is proceeding with consideration of several legislative vehicles as they address key topics prior to the November elections.

First Responder Opioid Grant Program

The AAA is pleased to report that language we supported on grant funding for opioid protection training for first responders has passed the Senate. Based on an analysis by counsel, we believe all ambulance service agencies would be eligible to apply for the grants.

In 2017, the Administration officially labeled the Opioid Crisis as a public health emergency, and in response Congress has finally taken action. On Monday, the Senate overwhelmingly passed the Opioid Crisis Response Act with a bipartisan vote of 99-1. 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. Counsel has provided us with an analysis that all types of ambulance service organizations would be eligible for the described grants. While this legislation is not a solution to every aspect of the opioid crisis our country is currently experiencing, it is an important first step in providing resources to the ambulance industry and others to help combat this public health emergency.

Rural EMS Grant Program

The AAA is diligently working on amending the SIREN Act (S. 2830H.R. 5429) which would reauthorize the Rural EMS Grant program. In an effort to ensure the funding would go to the most needy, small, and rural EMS providers, the language of the SIREN Act would change the eligibility to just governmental and non-profit EMS agencies. Therefore, small rural for-profit ambulance service providers would no longer be eligible to apply for grants. The AAA will continue to work to ensure that all provider types will be able to apply for these grants.

Language similar to the SIREN Act has been included in the Farm Bill (S. 3042/ H.R. 2) that passed both the House and Senate. The Farm Bill is now in Conference Committee between the House and Senate to reconcile differences before final passage. Over the past weeks, the AAA has been pressing Senator Durbin as well as other co-sponsors and Farm Bill conferees to revise the language to ensure small rural for-profit providers would still be able to apply for grants. Our team has met with all co-sponsors of the House and Senate SIREN Act Bills as well as members of the Farm Bill Conference Committee to ensure that they are well informed of the impact this legislation will have on their local providers.

The AAA team has also been conducting targeted outreach to AAA members asking them to get involved by contacting their Members of Congress, especially those on the Conference Committee. It is important for Congress to hear that grants like this one, should be open to all provider types. We thank those members who have already sent letters to their representatives. With Congress trying to wrap up the Farm Bill by the end of September – although looking unlikley, the AAA is pushing hard to change the current language and make sure that all providers might have access to these grants once they are reauthorized.

The AAA will continue to keep you updated on any new developments.

Is Narcan the Answer?

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

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.

Read more about fentanyl.

 

NHTSA and NASEMSO Host Panel on EMS Practices

The National Association of State EMS Officials (NASEMSO) and the National Highway Transportation Safety Administration (NHTSA) hosted a series of meetings for subject matter experts to discuss revisions to the National EMS Scope of Practice model. The experts reviewed the model’s practices, examined education and training procedures, and discussed what certification level, if any, is needed for specific treatments that are now widely-used among EMS professionals. The panel focused on five specific procedures that are commonly practiced: hemorrhage control, Naloxone use, CPAP use, therapeutic hypothermia in cardiac arrest, and pharmacological pain management.

Over the next several months, the panel will continue to examine information and recommend changes to the Scope of Practice model, with final recommendations tentatively set to be submitted in August 2018. For more information, please visit NASEMSO’s website.

 

 

HHS to Administer $70 million in Funds to Combat Opioid Crisis

The Department of Health and Human Services (HHS) announced $70 million in grants to help communities and health care professionals combat the ongoing opioid crisis that is ravaging communities across the U.S. The majority of the money will be used to help prevent opioid-induced deaths and to provide treatment for people with opioid use disorders, including $28 million allotted for medication-based treatment. More than 33,000 lives were claimed in 2015 due to opioid overdoses.

$41.7 million of the funding is set to expand resources and training for first responders on how to use emergency treatments, such as Narcan, to help reverse and treat overdoses. In many cases, first responders are often the difference between life and death for opioid users who experience an overdose, so it is imperative health care professionals have access to the needed resources and training to help save lives. The additional funding aims to help paramedics, EMTs and other emergency service personnel gain access to much-needed resources.

“The grants we announce today clearly demonstrate our efforts to meet the opioid crisis with every tool at our disposal,” said Substance Abuse and Mental Health Services Administration Acting Deputy Assistant Secretary Kana Enomoto. “The evidence-based training, medication, and behavioral therapies provided here will save lives and help people with addictions start a path toward reaching their potential.”

In addition to the most recent grants, $485 million in grants were awarded in April to treat and prevent opioid abuse.

To read more about the grants, please visit the HHS web site.

Savvik: Beat the EpiPen (Epinephrine) Price Surge!

Savvik Buying GroupYou may have seen in the American Ambulance Association’s Digest newsletter that many ambulance services are facing a 400% price increase in the price of  EpiPen epinephrine injections. AAA members are beating the surge through AAA’s partnership with the Savvik Buying Group (formerly the North Central EMS Cooperative). Members, save big on Epi-Pen and Epi-Pen Jr today!

Epinephrine Auto-Inject Adult

0.3MG 2/Pk
Item# 2771282
Savvik Price for AAA Members: $360.32
Compare at : $689.00—Save 47%

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New to Savvik? Get linked to AAA’s Savvik account, FREE! No volume commitment, just buy what you need.
Already signed up with Savvik?  Order now, or call your Henry Schein sales rep

Epinephrine Auto-Inject Jr

0.15MG 2/Pk
Item# 2771281
Savvik Price for AAA Members: $360.32
Compare at : $689.00—Save 47%

Order Now

New to Savvik? Get linked to AAA’s Savvik account, FREE! No volume commitment, just buy what you need.
Already signed up with Savvik?  Order now, or call your Henry Schein sales rep

 

AAA Members, need help establishing a Savvik account? Call 1-888-603-4426, or email office@savvik.org.

Not yet an AAA member? Join today to gain access to Savvik savings, plus many more benefits to keep your ambulance service running!

 

AAA Meets with FDA on New Drug Dispenser Regulations

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.