Author: Tristan North

AAA Submits Testimony on Access to Emergency Medications

Written by Tristan North on . Posted in Government Affairs, Legislative.

On July 12, the House Energy and Commerce Subcommittee on Health held a hearing on “Strengthening our National Trauma System.”  As part of the hearing, the Subcommittee heard from witnesses about the Preserving Patient Access to Emergency Medications Act (H.R. 4365).  The AAA strongly supports H.R. 4365 which would ensure that EMS personnel can continue to administer controlled substances to patients. The AAA submitted written testimony for the hearing record which can be accessed here and read below.

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The American Ambulance Association (AAA) thanks the Chairman, Ranking Member, and Members of the Subcommittee on Health for holding a hearing to consider proposals to improve and strengthen the national trauma system. The AAA represents hundreds of ambulance services across the United States that participate in emergency and nonemergency health care and medical transportation. The Association serves as a voice and clearinghouse for ambulance services, and views prehospital care not only as a public service, but also as an essential part of the total public health care system. To that end, we urge Congress to pass the Protecting Patient Access to Emergency Medications Act of 2016 (H.R. 4365) by Congressman Hudson (R-NC). This legislation is necessary to ensure that patients in need of emergency medical care have access to life-saving medications.

A longstanding practice has allowed Emergency Medical Services (EMS) practitioners to administer and deliver controlled substances under the oversight of physicians through directional guidelines known as standing orders. The use of standing orders allows EMS personnel who are the often the entry point into the health care system to administer potentially life-saving drugs as quickly as possible to patients in emergency situations. However, the Drug Enforcement Administration has determined that the Controlled Substances Act as currently written prohibits EMS personnel from administering such medications to patients through standing orders. This endangers lives by limiting access to emergency medications that seriously ill or injured patients may need.

Congressman Hudson’s legislation would remedy this situation by clarifying that EMS agencies are allowed to use standing orders from their medical director to administer controlled substances to patients. Codifying this current practice will ensure that EMS practitioners and patients do not see any disruption in the provision of emergency care. H.R. 4365 would also permit EMS agencies to register directly with the DEA; require each EMS agency to have one or more medical directors; allow a single registration for an EMS agency, not a separate registration for each location; and update requirements for EMS agencies’ receipt, storage, and tracking of controlled substances.

The unique nature of mobile emergency medical services sets us apart from other health care services governed by the Controlled Substances Act. H.R. 4365 is needed to ensure that regulatory oversight to prevent abuse of controlled substances does not threaten the provision of time-sensitive emergency medical care to those with critical injuries and illnesses. The AAA respectfully requests that the Committee move expeditiously to support this vital legislation so that our nation’s EMS practitioners can care effectively for patients in need.

AAA Launches Medicare Audit Activity Survey

Written by Tristan North on . Posted in Finance, Medicare, Member Advisories, Reimbursement.

In an effort to better determine a pattern of Medicare audit issues facing our members, the AAA has launched a survey to identify the different types of audit activity. The AAA will use the survey to inform federal policymakers about problems identified with the audits and how best to address the issues to reduce the burden of the audits on AAA members. It is therefore critical that you complete the survey to help us determine what audit issues your operation is facing.

Start Survey

The survey is comprised of only 14 questions including contact, demographic and characteristic information about your organization and requests data about your claim denial and audit activity. The information will be kept confidential and privileged and will only be reported in the aggregate with no organization identifying information. Contact information will be used only to follow up should we have any questions.

Should you have any questions regarding the survey, please contact AAA Senior Vice President of Government Affairs Tristan North at tnorth@ambulance.org.

Thank you in advance for completing this important survey.

AAA Issues Response to GAO Claims Report

Written by Tristan North on . Posted in Medicare, Member Advisories, Regulatory.

On May 13, the Government Accountability Office (GAO) issued a report entitled “Claim Review Programs Could Be Improved with Additional Prepayment Reviews and Better Data“. In the report, the GAO recommended that CMS be provided legislative authority to allow Recovery Auditors to use prepayment claims reviews to address improper Medicare payments. CMS fortunately disagreed with the GAO on the recommendation and cited better options such as prior authorization to address potentially improper payments.

The AAA has now issued a Formal Statement in response to the GAO report noting the problems with prepayment claims review for ambulance services and promoting the better alternative of prior authorization for nonemergency BLS transports of dialysis patients. The statement is in follow up to our Member Advisory providing an in-depth review of the report. Please feel free to share the statement if you receive questions about the report.

On June 26, 2015, the AAA had participated in a conference call with the GAO officials conducting the report in which AAA representatives had pushed for recommendations in line with our statement. The AAA will continue to advocate for policies to address improper payments that address the issue but are also the least burdensome to AAA members and help ensure our ability to continue to provide high-quality emergency and nonemergency ambulance services to patients.

FDA Issues First Responder Drug Dispenser Guidance

Written by Tristan North on . Posted in Government Affairs, Operations, Professional Standards, Regulatory.

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“.

CMS Publishes Medicare Fee-for-Service Provider & Supplier Lists

Written by Tristan North on . Posted in Government Affairs, Medicaid, Medicare, News.

Earlier today, AAA representatives participated on an invitation-only stakeholder call in which CMS announced the availability of two new public data sets. The first data set shows through an interactive map the availability and use of services provided to Medicare beneficiaries by ground ambulance suppliers and home health agencies. The second data set is a list of Medicare fee-for-service (FFS) providers and suppliers currently approved to bill Medicare. CMS just released the two data sets to the public.

The first data set, the Moratoria Provider Services and Utilization Data Tool, includes interactive maps and a data-set that shows national, state, and county-level provider and supplier services and utilization data that can be used by CMS to determine which geographic and health service areas might be considered for a moratorium on new provider and supplier enrollments. The data provides the number of Medicare providers and suppliers servicing a geographic region, identifies moratoria regions at the state and county levels, and identifies the number of people with Medicare benefits who use a specific health service in that region. The data can also be used to reveal service levels related to the number of providers and suppliers in a geographic region. Utilization data and geographic regions for these services can be easily compared using interactive maps.

You can access the Moratoria Provider Services and Utilization Data Tool at: https://data.cms.gov/moratoria-data
The provider/supplier enrollment data set can be accessed at: https://data.cms.gov/public-provider-enrollment

CMS Releases Ambulance Cost Data Collection Report

Written by Tristan North on . Posted in Cost Survey, Government Affairs, Medicare, Member Advisories, Member-Only, News, Reimbursement.

The Centers for Medicare and Medicaid Services (CMS) has released its report on the feasibility of collecting cost data from ambulance service providers.  Under the American Taxpayer Relief Act of 2012, Congress directed CMS to conduct the report entitled “Evaluation of Hospitals’ Ambulance Data on Medicare Cost Reports and Feasibility of Obtaining Cost Data from All Ambulance Providers and Suppliers”. The report can be accessed here.

The report states that due to the diverse nature of our industry with a majority of providers being small entities, traditional mandatory ambulance cost reporting is not feasible.  While it does not make a recommendation on a data collection system, the report highlights the work of the AAA with The Moran Company and will be helpful in our push for a survey approach to collecting ambulance cost data.  Here is AAA’ summary of the report, AAA Summary of CMS Acumen Cost Analysis.

The survey approach to collecting ambulance cost data is a major component of the Medicare Ambulance Access, Fraud Prevention and Reform Act (S. 377, H.R. 745) which would make the current Medicare ambulance increases permanent.  The data collected through the survey would help the AAA make data-driven recommendations to the Congress and CMS on future changes to the Medicare ambulance fee schedule.

The contractor, Acumen, who developed the report, was also asked to look to see if cost data submitted by hospital-based ambulance service providers would be helpful.  Acumen determined that the data submitted varied significantly and thus was not useful.

For questions about the AAA efforts on cost data collection, please contact AAA Senior Vice President of Government Affairs Tristan North at tnorth@ambulance.org.

AAA Meets with FDA on New Drug Dispenser Regulations

Written by Tristan North on . 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.

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