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  3. NTSB A-09-106
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NTSB · Safety Recommendation

Safety Recommendation A-09-106

Recommendation

TO THE CENTERS FOR MEDICARE AND MEDICAID (UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES): Develop minimum safety accreditation standards for helicopter emergency medical services (HEMS) operators that augment the operating standards of 14 Code of Federal Regulations Part 135 by including, for all flights with medical personnel on board, (a) scenario-based pilot training, (b) implementation of preflight risk evaluation programs, (c) formalized flight and dispatch procedures, (d) safety management systems, and (e) the installation of Federal Aviation Administration-approved terrain awareness warning systems, night vision imaging systems, flight data recording systems for monitoring, and autopilots if a second pilot is not used.

Safety Issue and Context

This recommendation letter addresses the helicopter emergency medical services (HEMS) industry and is derived from testimony provided at the NTSB’s public hearing concerning this industry, as well as investigations of recent HEMS accidents. As a result, the NTSB is issuing four safety recommendations to the Department of Health and Human Services’ Centers for Medicare & Medicaid Services (CMS). Information supporting these recommendations is discussed below. The NTSB would appreciate a response from you within 90 days addressing the actions you have taken or intend to take to implement our recommendations.

Additional recommendations have been addressed to the Federal Aviation Administration (FAA), the Department of Homeland Security’s Federal Interagency Committee on Emergency Medical Services (FICEMS),1 and 40 public HEMS operators. Calendar year 2008 was the deadliest year on record for the HEMS industry with 12 accidents (8 fatal accidents) and 29 fatalities. As a result of this increase in fatal accidents involving HEMS operations, the NTSB placed the issue of HEMS safety on its Most Wanted List of Transportation Safety Improvements on October 28, 2008, and also conducted a 4-day public hearing to critically examine safety issues concerning this industry.

Based on testimony given at this public hearing, in addition to findings from recent HEMS accidents, the NTSB believes that CMS needs to take action to evaluate the reimbursement policies for helicopter emergency medical transport and its relationship to the level of service provided by the HEMS operator.

Response History

April 23, 2014 · NTSB Correspondence · United States Department of Health and Human Services

We were pleased to see that, on February 21, 2014, the Federal Aviation Administration (FAA) published its long-awaited final rule, “Air Ambulance and Commercial Helicopter Operations, Part 91 Helicopter Operations.” This rule addressed, in full or in part, a number of important safety recommendations that we had made to the FAA regarding HEMS safety. We agree with you that CMS does not have the expertise or authority to regulate aircraft safety, and that the FAA is the more appropriate organization to take the actions specified in Safety Recommendations A 09 106 and 107. Accordingly, these recommendations are classified CLOSED—RECONSIDERED.

March 11, 2014 · Recipient Response · United States Department of Health and Human Services

-From Marc Hartstein, Director, Hospital and Ambulatory Policy Group, Center for Medicare: Thank you for your letter to Secretary Sebelius requesting additional information regarding the Department of Health and Human Services' progress on addressing the National Transportation Safety Board's (NTSB) recommendation for helicopter emergency medical services (HEMS) safety. I am responding on behalf of the Centers for Medicare and Medicaid Services (CMS) to your letter.

Your letter makes reference to CMS' original response to the NTSB's recommendations on April 16, 2010. Our response suggested that while HEMS safety is an important public policy priority, we do not believe that CMS has either the expertise or the authority to regulate aircraft safety.

We believe the Federal Aviation Administration (FAA) is far better qualified to evaluate your HEMS safety recommendations and noted that your recommendations to the FAA were similar to the ones for CMS. We understand that the FAA published final regulations to address the NTSB's concerns on February 21, 2014 proposed rule (79 FR 9932) entitled "Air Ambulance and Commercial Helicopter Operations,

Read Recommendation

Recommendation Facts

Status
Closed - Reconsidered
Issued
September 24, 2009
Priority
CLASS II
Recipient
United States Department of Health and Human Services
Adopted
September 1, 2009
Closed
April 23, 2014
Related Investigation
DCA09SH001
Related Report
None
Part 91
Helicopter Operations." This regulation is effective April 22, 2014.

On November 29, 2010, CMS adopted a final regulation clarifying that HEMS operators enrolled in the Medicare program are required to be in compliance with all federal laws including, but not limited to, having an FAA certification. The rules require a HEMS operator to report a revocation or suspension of a Federal or State license or certification. The certifications, when revoked, that need to be reported are the specific pilot certifications, such as instrument and medical certifications as well as airworthiness certificates. The HEMS operator is responsible for notifying the designated Medicare contractor for their State when FAA revokes or suspends any license or certification.

If a HEMS operator is not in compliance with FAA regulations, it loses its ability to furnish and be paid for providing air ambulance services to Medicare beneficiaries.

In addition to addressing reporting requirements for license revocation and suspension, the November 29, 2010 final rule addresses our authority to require accreditation of air ambulances which could, potentially, serve the public policy purpose implicit in your recommendations. In response to a public comment the final rule states "Currently, we do not have the statutory authority to establish an accreditation program for ... air ambulance operators."

At this point, CMS does not have any further plans to take action in response to the NTSB's recommendations as we believe that aircraft safety is better handled by the FAA and we do not have the statutory authority to require accreditation of HEMS operators.

January 24, 2014 · NTSB Correspondence · United States Department of Health and Human Services

The CMS’s only letter concerning Safety Recommendations A-09-104 through -107, dated April 16, 2010, stated that the CMS considers HEMS safety to be an important public policy priority, but does not consider the recommended actions to be necessary or under its jurisdiction. On February 17, 2011, in lieu of a written response to that letter, NTSB Member Robert Sumwalt and members of our staff met with CMS Administrator Dr. Donald Berwick and members of his staff to discuss these recommendations. The discussion centered on the fact that simple single engine helicopters like the Bell 206 are not able to carry the medical equipment carried by larger helicopters because of weight limitations.

This limitation reduces EMS personnel’s ability to provide the same level of patient care as can be provided on larger aircraft. The CMS staff stated that they had not been aware of this fact and were concerned that their reimbursement practices are predicated on an established level of care. Dr. Berwick directed his staff to continue the dialog between NTSB and the CMS to further define the problems associated with HEMS and the CMS’s potential role in addressing these concerns. However, to date we have not received any additional correspondence or communication from the CMS regarding these recommendations, which are currently classified “Open—Await Response.”

We would like to know whether the CMS has made any progress in addressing these recommendations. Thank you for your cooperation.

July 28, 2010 · NTSB Correspondence · United States Department of Health and Human Services

The DHHS indicated that it considers HEMS safety to be an important public policy priority but does not consider the recommended actions to be necessary or under its jurisdiction. In lieu of an official response, the NTSB would like to meet with the DHHS to discuss these recommendations in person and to explain the NTSB’s safety recommendation review process. The NTSB will delay its formal review of the DHHS’s response and classification of the recommendations until after these items have been discussed at the meeting.

An NTSB staff member will be contacting your agency to set up this meeting. If you have any questions, please do not hesitate to contact Dr. Paula Sind-Prunier, Chief, Safety Recommendations and Quality Assurance Division.

April 16, 2010 · Recipient Response · United States Department of Health and Human Services

Letter Mail Controlled 4/27/2010 2:50:33 PM MC# 2100157 - From Kathleen Sebelius, Secretary: We note the recommendations that the NTSB made to CMS are similar to those also being made to the FAA. We believe that the FAA has the required level of expertise to determine regulations that should be adopted to ensure appropriate aircraft safety. While CMS has expertise to regulate health and safety requirements that suppliers and providers of health care services should meet, CMS does not have the expertise to determine aircraft safety requirements. Further, we do not believe that CMS should duplicate the expertise that already exists at the FAA.

Rather, we believe that the FAA should determine the minimum level of safety that HEMS operators should meet. CMS regulations already require that HEMS operators must meet applicable State and Federal laws to be enrolled in Medicare. For instance, the Medicare Program Integrity Manual currently requires that an air ambulance supplier or its leasing company possess a valid charter flight license (FAA Part 135 Certificate) for the aircraft being used as an air ambulance.

[Publication 100-08, Chapter 10, section 4.18] While we do not believe CMS should augment FAA regulations, we do believe CMS should ensure in rulemaking that only those HEMS operators that meet the minimum level of requirements established by the FAA through its regulations are enrolled in Medicare.