NWOC Aerospace Medicine Updates New Orleans 27 February 2015 Susan Northrup, MD, MPH Regional Flight Surgeon Southern Region

Overview Regional Program Safety Data Certification Data Recent Decisions and Issues Medical Condition Update Questions

Office of Aerospace Medicine

9 FAA Regions [Seminar city] is in the [which one] region right here. There are 8 other geographical regions, along with the international, military and federal “region”.

Southern Region Stakeholder Base 700 Aviation Medical Examiners 147,000 Pilots 6,700 FAA Employees Includes 4,800 Safety-Related Employeesoyees Self explanatory

Certification and AME Staff Dr John Barson and Dr Arnie Angelici Cert analysts Sharon Baker, Kadesha Lawson, Areta Williams AME Program analyst: EE Williams Quality Assurance analysts Hope Wright, Cristi Willbanks Phone: 404-305-6150 Analysts can handle 99% of calls – rarely do they need flight surgeon input. Here are the people in this region who are here to help you in any way we can.

Airman Medical Certification Share certification workload with CAMI Handle re-certification of special issuances and SODAs Handle hotline & inflight incapacitation reports. Work enforcement cases - FAA Legal & Flight Standards When you defer a case, it goes into a queue. Regional Flight Surgeons as well as medical certification officers at CAMI have access to that queue and work those cases. Call your region if you have questions.

Airman Medical Certification Region vs CAMI CAMI handles all initial Class I and II Pacemaker, Valve, MI/Angina Coronary Interventions Regions can handle other Special Issuances and SODA. Workload sharing with CAMI. Try not to work same cases at both Region and CAMI simultaneously

Regional Medical Programs Airman Medical Certification Aviation Medical Examiner System Air Traffic Controller Health Program Occupational Health Program Internal Substance Abuse Program Airman Education Here’s what we do in the region

Aviation Medical Examiner Program Initial AME designations Senior AME designation Performance tracking with CAMI Seminar training, phone support Investigate complaints Termination of AME designations For the AME program, here is what the region is responsible for.

AME Surveillance Program Visit all new AMEs within 1 year of designation document all equipment is as stated on list Evaluate office policies and procedures relating to conduct of airman medical examinations Provide guidance and assistance as needed Evaluate AME performance on an on-going basis, including reviewing sample of examinations completed and transmitted through AMCS to AMCD Visit all AMEs in a 5 year cycle New AMEs, we mentor you. Our goal is that you have all the support you need to make good aeromedical decisions. We don’t want anyone feeling like they are operating in a vacuum.

Safety Data

Certification

Airman Medical Certification Review and Appeals Process AME AEROSPACE MEDICAL CERTIFICATION DIVISION OR REGIONS FEDERAL AIR SURGEON NATIONAL TRANSPORTATION SAFETY BOARD ADMINISTRATIVE LAW JUDGE FULL BOARD U.S. COURT OF APPEALS U.S. DISTRICT COURT SUPREME COURT

Aeromedical Certification ( CY 2013) 382,990 Total applications received Class 1 Class 2 Class 3 TOTAL 208,876 71,257 102,857 382,990

Aeromedical Certification (CY 2013) 3,405 denials (0.9% of all applications) 3,193 failed to pursue or failed to provide requested information 212 denials (0.06% of all applications) when all information requested is provided

Special Issuance Certificates Granted Aeromedical Certification (CY 2013) Special Issuance Certificates Granted Class 1 Class 2 Class 3 TOTAL 16,920 6,778 13,474 37,172

Special Issuances Categories (CY 2013) Diagnosis Total Cardiovascular 6,501 Diabetes 4,524 Cancer 1,833 Psychiatric 853 Substance use 795 SSRI 174 Neurologic 399 Transplants 106

Recent Events DIWS Web deployment Furlough Backlog in AMCD medical certification processing Personnel changes

Medical Certification Update Transition brings change… Loss of Docs and training new ones brings many challenges to keep up with the workload Looking at new ways to reduce the workload (CACI) Directing AME calls to specific departments depending on the case type PLEASE BE PATIENT WITH US

Effort to Safely Decrease Number of Special Issuances Required 2011 – Early discussions of process 2012 – Review all SIs, determine low risk diagnoses, determine simple process for AMEs to issue 2012 – 18 conditions and protocols proposed to Federal Air Surgeon (15% of all SIs)

Conditions AME Can Issue - CACI 18 Proposed Conditions Arthritis Asthma Carotid Stenosis Colitis Glaucoma Hepatitis C Hypertension Hypothyroidism Kidney Stones Migraines Pre-Diabetes Bladder Cancer Colon Cancer Hodgkin’s Disease Leukemia Prostate Cancer Renal Cancer Testicular Cancer

Colon Cancer Lymphoma Leukemia Carotid Stenosis Hodgkin’s Disease Postponed Conditions Colon Cancer Lymphoma Leukemia Carotid Stenosis Hodgkin’s Disease

Obstructive Sleep Apnea

FAA released proposed guidance late 2013 OSA – Brief History NTSB has recommended improved OSA screening for all modes of transportation. “Most Wanted List” FAA released proposed guidance late 2013 Pushback by many (AOPA, ALPA, AMAS…) Legislative Action was taken After considering feedback, revised OSA guidance Scheduled for deployment March 2, 2015

What you can expect No change to the front of the 8500-8 for right now Questions from AME Education Risk factors as stipulated by the American Society of Sleep Medicine Airman will be placed in one of six groups Nearly everyone will be issued at the time of exam May need to provide evaluations and studies within 90 days Airman considered an immediate safety risk will be deferred

OSA Groups Group 1, airmen with an existing authorization Will follow the authorization guidance Group 2, airmen currently receiving treatment but not yet on an authorization Will receive a Specification Sheet A and be given 90 days to submit documentation to the FAA AME will issue if the airman is otherwise qualified Group 3, airmen with no risk factors AME will issue

OSA Groups Group 4, OSA risks but not determined to be High Risk AME will provide educational materials Issue if otherwise qualified Group 5, High risk for OSA Given OSA Specification Sheet B, with 90 days to comply AME will issue if otherwise qualified Group 6, OSA with Immediate Safety Risk Given OSA Specification Sheet B Defer

Risk Factors High Risk for OSA Obesity, congestive heart failure, atrial fibrillation, refractory hypertension, Type 2 diabetes, nocturnal dysthythmias, stroke, pulmonary hypertension, high-risk populations, preoperative for bariatric surgery OSA related questions Is the patient Obese Retrognathic Daytime sleepiness Snorer Hypertension

LIGHT SPORT AIRCRAFT (Sport Pilot) “Sport” pilots are required to hold either valid airman medical certificate or current valid U.S. driver’s license * 2. Must comply with restrictions and limitations of driver’s license * Sport pilot medical provisions: Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61.3, 61.23, 61.53, 61.303 and Guide for Aviation Medical Examiners, page 8

LIGHT SPORT AIRCRAFT (Sport Pilot) * Meet eligibility requirements (speak, read, write, understand English) Must be 17 (16 for a student) Current valid Driver’s License or current airman certificate issued under part 67 * Sport pilot medical provisions: Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61.3, 61.23, 61.53, 61.303 and Guide for Aviation Medical Examiners, page 8

LIGHT SPORT AIRCRAFT (Sport Pilot) * NOT been denied (if applied for airman medical certificate) NOT had most recent medical certificate revoked or suspended NOT had most recent Authorization withdrawn (if ever granted authorization) A Special Issuance is not a denial * Sport pilot medical provisions: Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61.3, 61.23, 61.53, 61.303 and Guide for Aviation Medical Examiners

SPORT PILOT * Sport pilots may NOT use driver’s license in lieu of valid airman certificate if they know or have reason to know of any medical condition that would make them unable to operate a light-sport aircraft in a safe manner. * * FAR 61.23/303, and AME Guide

What is a Medical Certificate? Under Title 14, Code of Federal Regulations (14 CFR), Part 1: FAA defines a medical certificate as “acceptable evidence of physical fitness on a form prescribed by the Administrator.” Goal to protect not only those who would exercise the privileges of a pilot certificate but also air travelers and the general public. Individuals required to hold a medical certificate must have it in their personal possession at all times when exercising the privileges for which they are licensed.

Validity of Medical Certificates * 1st Class: Airline Transport Pilot, valid for 1year if under age 40, and 6 months if over age 40. 2nd Class: Commercial Pilot (receiving compensation) and flight engineer, navigator, air traffic controller, valid for one year. 3rd Class: Private Pilot valid for five years under age 40, and two years over age 40.

Exemption of need for 3rd Class Medical Certificate

House Bill – 3708 Senate Bill – 2103 General Aviation Protection Act 2014 10 limiting conditions covering the pilot, aircraft and flight parameters

FAA Announcement of Rule Making Project April 2, 2014

Part 61.53 * Prohibition on operations during a medical deficiency (a) . . . A person who holds a current medical certificate issued under part 67 of this chapter shall not act as pilot in command, or in any other capacity as a required pilot flight crewmember, while that person: * Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61, and AME Guide page 11

Part 61.53 * (1) Knows or has reason to know of any medical condition that would make the person unable to meet the requirements for the medical certificate necessary for the pilot operation; or * Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61, and AME Guide, page 11

Part 61.53 * (2) is taking medication or receiving other treatment for a medical condition that results in the person being unable to meet the requirements necessary for the pilot operation. * Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61, and AME Guide, page 11

Part 61.15 * Applicant must report alcohol or drug offenses (i.e. motor vehicle violation) on the history part of the medical application. It does not relieve the airman of responsibility to report each motor vehicle action to the FAA Security Division within 60 days: Civil Aviation Security Division, AAC-700, P.O. Box 25810, Oklahoma City, OK 73125-0810 * Under Title 14 of the Code of Federal Regulations (14 CFR), Part 61.15, and AME Guide page 33

Airman Does NOT Meet Standards: AMCD or RFS * informs applicant medical conditions not meeting FAA standards require further evaluation Many common medical problems just require additional information for approval FAA depends on the quality of the medical report to determine pilot is safe to fly * AMCD – Aeromedical Certification Division RFS – Regional Flight Surgeon

Airman Does NOT Meet Standards: FAA expects that a pilot will not resume piloting aircraft until: The medical condition has stabilized No significant adverse effects or complications Airman meets the appropriate FAA standards, or is granted a waiver for standards (as determined by medical records forwarded, reviewed by Aerospace Medical Certification Division)

What is a Waiver ? Two types of FAA waivers for medical conditions that do not meet standards of Federal Aviation Regulations (FAR), 14 CFR, Part 67.401: Special Issuance: Waiver for medical condition has stabilized, but potentially progressive. The Federal Air Surgeon, may grant an Authorization for Special Issuance of a Medical Certificate (Authorization Letter), valid for a specified period SODA:(Statement of Demonstrated Ability) for fixed defect (monovision, loss of limb, etc). The Federal Air Surgeon may authorize a special medical flight test.

Denials Final denials: To be issued for only one of the 15 specifically disqualifying conditions or a denial by the FAS for any other condition not part of this group General denials: Generally used for all other conditions requiring a denial. The AME should only deny when the airman clearly does not meet the standards

Medical Appeal of Denial * Within 30 days after the date of the denial, airman appeals to: Federal Air Surgeon Attention: Manager, Aeromedical Certification Division, AAM-300 Federal Aviation Administration P.O. Box 26080 Oklahoma City, Oklahoma 73126 * Section 67.401 under 14 CFR sets forth the appeal process within the FAA for applicants

How the Appeal Process Works AMCD or RFS* inform applicant of right to appeal AMCD will review the application and inform the applicant of the decision Denial is final for specifically disqualifying conditions set forth under Part 67 and is appealed to the NTSB A General Denial is appealed to the Federal Air Surgeon (FAS). Denial NOT specifically disqualifying (denied by FAS) appeal to the National Transportation Safety Board (NTSB).

How the Appeal Process Works Unfavorable decision by the FAS may be appealed to the NTSB* Administrative Law Judge (ALJ) holds a hearing on the applicant’s eligibility ALJ’s decision (if) unacceptable to applicant or the FAA, then appealed to the full board (NTSB). If full board affirms the denial, applicant may seek review by a U.S. Court of Appeals, then review by the U.S. Supreme Court. * NTSB – National Transportation Safety Board FAS – Federal Air Surgeon

DRUGS-Regulations, Rules, & Guidelines Over-the-counter (OTC) medications As with all drugs, side effects may vary with the individual, and with changes in altitude and other flight conditions, such as:* Drowsiness Impairment of judgment Disturbance of vision Any of these could cause an impairment that might lead to incapacitation while flying.*

DRUGS-Regulations, Rules, & Guidelines Common sense advise: Read and follow the label directions for use of OTC medication*. If the label warns of side-effects, do not fly until twice the recommended dosing interval has passed*. Remember, the condition being treated may be as disqualifying as the medication*. *(see Publication AM-400-92/1) available from the Aerospace Medical Education Division

DRUGS-Regulations, Rules, & Guidelines Generally, drugs that affect the Central Nervous System (CNS) are not acceptable for aeromedical purposes. CNS depressants: sedatives, hypnotics, narcotics, antidepressants (including SSRI’s) {can cause drowsiness and/or impaired performance} CNS stimulants: amphetamines, and related drugs such as methylphenidate (Ritalin,Concerta), pemoline (Cylert), modafinil (Provigil), etc. [not all inclusive] {over-stimulation may cause agitation, confusion, or psychosis}. Discontinuance after prolonged use or high doses may cause fatigue and/or depression.

DRUGS-Regulations, Rules, & Guidelines Anti-seizure medication If used for treatment of a seizure disorder, the condition and the medication are disqualifying. If used for other than seizure disorder (e.g. pain control) is not acceptable because it may cause drowsiness or depression.

DRUGS-Regulations, Rules, & Guidelines Misc. drugs: Drugs that can cause a person to suddenly fall asleep during activities of daily living (e.g., pramipexole[Mirapex], ropinirole[Requip], pergolide[Permax]) Others-Anticholinergics, Chemotherapy, Investigational or Experimental drugs.

Binocular Multifocal Devices Intraocular Lenses (Multifocal or Accomodating Intraocular Lens Implant) 3 Month recovery after cataract surgery 1 month recovery after multifocal contact lenses

General Comments on Certification Falsification and Omissions… Don’t let us find it, report it Block 18 “have you ever in your life…” Medical interactions Please don’t ignore letters from the FAA Keep copies

Questions?