FAA Medical Federal Aviation...

•Presented to: AME Seminar

•By: Courtney Scott, DO, MPH

•Date: 1 November 2012

•Federal Aviation•Administration

FAA Medical Certification

5th Annual Aerospace Psychology

SeminarSept 23, 2017Denver, CO

•Federal Aviation•Administration

•Aerospace Medical Certification

Aerospace Medical Certification Division (AMCD)

David O’Brien, MD, MPHDivision Manager

3Federal AviationAdministration

Agenda

• Safety of the National Air Space• Medical Certification Process• Mental Health Regulations and Policy• SSRI Special Issuance Program• Role of Neuropsychology


Safety of the National Air Space is Job #1• PSA flight 182• San Diego, CA• 9/25/78• Cessna 172


Sources of Risk

• Machine e.g. powerplant, flight controls• Operator e.g. training, cognitive

performance, physiology – Normal operator in abnormal environment e.g.

spatial disorientation, hypoxia, machine interface: realm of aerospace medicine

– Abnormal operator in normal environment: realm of clinical medicine

– Abnormal operator in abnormal environment: realm of regulatory medicine


Myth: Flying Same as Driving

• Acceleration• 3 Axes of motion – spatial disorientation• Altitude

– Hypoxia– Barometric pressure changes

• Can’t just pull over and stop• Force = Mass x Acceleration


Conditions of Aeromedical Significance

Sudden incapacitationSudden/unpredictable onset

Subtle incapacitationProgresses unpredictably Difficult to monitor/recognizeSubtle impairment


Chart2

198919891989

199019901990

199119911991

199219921992

199319931993

199419941994

199519951995

199619961996

199719971997

199819981998

199919991999

200020002000

200120012001

200220022002

200320032003

200420042004

200520052005

200620062006

200720072007

200820082008

200920092009

201020102010

201120112011

201220122012

201320132013

201420142014

201520152015

Total Fatal Accidents

Target (not to exceed)

Total Fatalities

Comparison of General Aviation Fatal Accidents/TargetsGeneral Aviation includes General Aviation and Unscheduled Part 135

480

886

469

830

466

845

451

906

423

795

433

811

432

780

381

656

377

710

386

703

362

651

339

379

638

355

379

636

343

379

585

362

374

659

341

349

611

353

343

640

302

337

680

313

331

566

302

325

573

285

269

508

272

270

471

278

266

469

267

261

442

259

257

449

251

243

434

238

239

384

GA Graph Data

HISTORY GA FATAL ACCIDENTS/TARGETS

FYTotal Fatal AccidentsYTD thru Previous MonthTarget (not to exceed)Total Fatalities

1989480480886

1990469469830

1991466466845

1992451451906

1993423423795

1994433433811

1995432432780

1996381381656

1997377377710

1998386386703

1999362362651

2000339339379638

2001355355379636

2002343343379585

2003362362374659

2004341341349611

2005353353343640

2006302302337680

2007313313331566

2008302302325573

2009285285269508

2010272272270471

2011278278266469

2012267267261442

2013259259257449

2014251251243434

2015238238239384

FY04-FY07 targets revised 12/02

FISCAL YEAROCTNOVDECJANFEBMARAPRMAYJUNJULAUGSEPTOTALTotal GA & Non-Sched 135

19884141343236224647375047434761988YearWholeYTDTotal Fatalities

198949443033193825435048505148019891989480480886

199037342022323343404944565946919901990469469830

199132421936313638424462434146619911991466466845

199228303035293442455140424545119921992451451906

199341363222192738354056383942319931993423423795

199440352724253432414747443743319941994433433811

199533362830282042373846375743219951995432432780

199629264033282630224333413038119961996381381656

199736343523162927303339354037719971997377377710

199833213724202736394540382638619981998386386703

199931311917161827473434513736219991999362362651

200026182620211933322943442833920002000339339638

200141242419272130313246431735520012001355355636

200227262325142829272836384234320022002343343585

200326352930203126264235342836220032003362362659

200433233924201622322931413134120042004341341611

200540242831221623273039442935320052005353353640

200622242324202122173040302930220062006302302680

200721283515191832312233273231320072007313313566

200823282116211321343331382330220082008302302573

200925221922121927203233322228520092009285285508

201024211220181818232541351727220102010272272471

201120231714131922242943292527820112011278278469

201224232011202413252325253426720122012267267442

201322342316151915193222251725920132013259259449

20141817129141519213337322425120142014251251434

20152514161771815192424352423820152015238238384

FATAL ACCIDENTS

Count of ev_id

123456789101112Total

1988414134323622464737504743476

1989494430331938254350485051480

1990373420223233434049445659469

1991324219363136384244624341466

1992283030352934424551404245451

1993413632221927383540563839423

1994403527242534324147474437433

1995333628302820423738463757432

1996292640332826302243334130381

1997363435231629273033393540377

1998332137242027363945403826386

1999313119171618274734345137362

2000261826202119333229434428339

2001412424192721303132464317355

2002272623251428292728363842343

2003263529302031262642353428362

2004332339242016223229314131341

2005402428312216232730394429353

2006222423242021221730403029302

2007212835151918323122332732313

2008232821162113213433313823302

2009252219221219272032333222285

2010242112201818182325413517272

2011202317141319222429432925278

2012242320112024132523252534267

2013223423151519151932212518258

201419171291316192133373226254

20152514161661816172315166

Total848794718642580660794874983108810399069926

FATALITIES

Sum of inj_tot_f

123456789101112Total

1988779170537039918358827677867

1989828452554470467395959397886

199068663844525869707874113100830

19916075246271826968821107864845

19924761727858619185968073104906

19936769684245617957631076869795

1994746452504262677279929562811

19956060505361347368727763109780

1996425276625446514079506044656

1997727171482855455754815474710

1998743662363062617574638050703

1999475628362428478464669378651

2000573446314134628244748251638

2001693640505648475348838224636

2002404347422347504249646969585

2003496046553468524878645451659

2004543678403040344948667561611

2005785053564435375047677350640

20063735464343393828526950200680

2007414375263629634742565751566

2008474637334226345969568143573

2009374143462540383953545636508

2010463419424226223546696327471

2011373627202237334346794643469

2012324844163544183837383755442

2013404842322935233154384529446

2014333525132426283952665938438

20153827262372828293926271

Total15051437135711871112126013961544169819461875175618073

GA Graph Data

&R&10 5/13/03

FY04-FY07 targets revised 12/02



YTD thru Previous Month

COMPARISON of GENERAL AVIATION FATAL ACCIDENTS/TARGETS(General Aviation includes General Aviation and Unscheduled Part 135)

Chart1

198919891989

199019901990

199119911991

199219921992

199319931993

199419941994

199519951995

199619961996

199719971997

199819981998

199919991999

200020002000

200120012001

200220022002

200320032003

200420042004

200520052005

200620062006

200720072007

200820082008

200920092009

201020102010

201120112011

201220122012

201320132013

201420142014

201520152015

This pivot table is linked to a query in the Dutyroom database (J:\AAI\Support Files\DUTYROOM FILES\DUTYROOM.accdb) called "ntsb annual." If you right click on the table and select "Refresh" it will run the query and update the table. The data behind the query comes from the monthly NTSB download.



Total Fatalities

Comparison of General Aviation Fatal Accidents/TargetsGeneral Aviation includes General Aviation and Unscheduled Part 135

480

886

469

830

466

845

451

906

423

795

433

811

432

780

381

656

377

710

386

703

362

651

339

379

638

355

379

636

343

379

585

362

374

659

341

349

611

353

343

640

302

337

680

313

331

566

302

325

573

285

269

508

272

270

471

278

266

469

267

261

442

259

257

449

251

243

434

238

239

384

Embedded Chart

DDGAFatalAccTar

FYTotal Fatal AccidentsYTD thru Previous MonthTarget (not to exceed)TitleSubtitleNoteModifiedTotal Fatalities

1/1/89480480Comparison of General Aviation Fatal Accidents/Targets(General Aviation includes General Aviation and Unscheduled Part 135)FY04-FY07 targets revised 12/02Updated Monthly as of 09/30/2015886

1/1/90469469830

1/1/91466466845

1/1/92451451906

1/1/93423423795

1/1/94433433811

1/1/95432432780

1/1/96381381656

1/1/97377377710

1/1/98386386703

1/1/99362362651

1/1/00339339379638

1/1/01355355379636

1/1/02343343379585

1/1/03362362374659

1/1/04341341349611

1/1/05353353343640

1/1/06302302337680

1/1/07313313331566

1/1/08302302325573

1/1/09285285269508

1/1/10272272270471

1/1/11278278266469

1/1/12267267261442

1/1/13259259257449

1/1/14251251243434

1/1/15238238239384

Sheet1

Sum of inj_tot_f

123456789101112Total

1988779170537039918358827677867

1989828452554470467395959397886

199068663844525869707874113100830

19916075246271826968821107864845

19924761727858619185968073104906

19936769684245617957631076869795

1994746452504262677279929562811

19956060505361347368727763109780

1996425276625446514079506044656

1997727171482855455754815474710

1998743662363062617574638050703

1999475628362428478464669378651

2000573446314134628244748251638

2001693640505648475348838224636

2002404347422347504249646969585

2003496046553468524878645451659

2004543678403040344948667561611

2005785053564435375047677350640

20063735464343393828526950200680

2007414375263629634742565751566

2008474637334226345969568143573

2009374143462540383953545636508

2010463419424226223546696327471

2011373627202237334346794643469

2012324844163544183837383755442

2013404842322935233154384529446

2014333525132426283952665938438

20153827262372828293926271

Total15051437135711871112126013961544169819461875175618073


Office of Aerospace Medicine

Federal Air Surgeon

Deputy Federal Air Surgeon Director, Civil Aerospace Medical Institute

Medical Specialties Division

Aerospace Medical Certification Division

Program Management Division

Aerospace Medical Education Division

Drug Abatement Division

Aerospace Human Factors Research Division

Regional Aerospace Medicine Divisions

Aerospace Medical Research Division

Occupational Health Division

Chief Psychiatrist Clinical Psychologist

MEDICAL SPECIALTIES DIVISION

Federal Air Surgeon

Director, Civil Aerospace Medical Institute

Deputy Federal Air Surgeon

Medical Specialties

Division

Aerospace Medical Certification Division

Aerospace Medical

Education Division

Program Management

Division

Aerospace Human Factors Research Division

Drug Abatement

Division

Aerospace Medical

Research Division

Regional Aerospace

Medicine Divisions

Occupational Health

Division

Clinical Psychologist

Chief Psychiatrist

Division Manager,

------------------------------------------

Deputy Division Manager,

Medical Appeals Branch

Health Clinic

Aeromedical Standards & Policy Branch

AAM-230

Internal Substance Abuse Branch

Chief Psychiatrist


Medical Certification Process

• MedXpress – pilot medical history• AME exam• Transmission to FAA• Certification decision

– Eligible– SODA– Special Issuance– Denial


Decision Level 1-- AME

• No significant medical history• No abnormal findings on exam• Common medical conditions specified in

the AME Guide when stable• Medical conditions which require review of

additional information • Medical conditions which can be cleared

with completion of CACI worksheet• Defer


Decision Level 2—AMCD or RFS

• Eligible +/- warn• SODA/MFT• Special Issuance

– AME Assisted (AASI) 6 years with annual follow-up– Time limited

• Defer to Federal Air Surgeon’s Office• Deny

– General denial appeals to Federal Air Surgeon– Final denial appeals to NTSB


Decision Level 3 — Federal Air Surgeon

• Any complex case referred by AMCD or RFS• Initial special issuance for antidepressants• All heart transplants• General denial appeals• Air Traffic Control appeals


Aeromedical Certification( CY 2015)

378,263 Total applications received

Class 1 Class 2 Class 3 TOTAL

212,617 67,080 98,566 378,263


Aeromedical Certification(CY 2015)

Class 1 Class 2 Class 3 TOTAL

15,992 5,884 11,728 33,604

Special Issuance Certificates Granted


Aeromedical Certification(CY 2015)

4,288 denials (1.13% of all applications)• 4,088 failed to pursue or failed to

provide requested information

• 200 denials (0.052% of all applications) when all information requested is provided


Myth: Denial Is a Common Event• 378,263 Applications submitted CY2015• 33,604 Special Issuances (9%)• 4,288 Initial denials (1%)• 200 provided all required follow-up but

denial sustained (0.05%)


Special Issuances Categories(CY 2015)

Diagnosis TotalCardiovascular 12,621Diabetes 6,702 Sleep Disorders 6,523Cancer 2,304Psychiatric 998Substance use 1,333SSRI 293Neurologic 654Transplants 178


The FARs:Title 14, CFR Part 67-Standards –Mental Specific

“No established medical history or clinical diagnosis of …”

• Personality Disorder severe enough to have repeatedly manifested itself by overt acts

• Psychosis• Bipolar Disorder


Title 14, CFR Part 67- Standards-Mental - General• No other personality disorder, neurosis, or

other mental condition that the Federal Air Surgeon, based on the case history and appropriate, qualified medical judgment relating to the condition involved….

• Makes the person unable to safely perform the duties or exercise the privileges of the airman certificate applied for or held


Other generally disqualifying conditions include:

• Depression• ADD/ADHD• OCD• Anxiety• Other Personality Disorders


Psychiatric Special Issuances (as of 8/31/16)

Conditions #

Depression 471

Anxiety 283

Bipolar spectrum 5

ADD/ADHD 40

Obsessive Compulsive 18

PTSD 53


Current Special Issuances Psychiatric – Aug 2016

1st Class 2nd Class 3rd Class Total

278 129 494 901


Title 14, CFR Part 67-Standards-MentalSubstance Dependence

No substance dependence, except where there is established clinical evidence, satisfactory to the Federal Air Surgeon, of recovery, including sustained total abstinence from the substance(s) for not less than the preceding 2 years.


Title 14, CFR Part 67-Standards-MentalDependence (cont.)Substance'' includes: Alcohol; other sedatives and hypnotics; anxiolytics; opioids; central nervous system stimulants such as cocaine, amphetamines; hallucinogens; phencyclidine; cannabis; inhalants; and other psychoactive drugs and chemicals; and


Title 14, CFR Part 67-Standards-MentalDependence (cont.)

Substance dependence'' means a condition in which a person is dependent on a substance, other than tobacco or ordinary xanthine-containing beverages (e.g., caffeine), as evidenced by …


Title 14, CFR Part 67-Standards-MentalDependence (cont.)

Increased tolerance, ORManifestation of withdrawal

symptoms, OR Impaired control of use, ORContinued use despite damage to

physical health or impairment of social, personal, or occupational functioning.


DSM 5

Substance Use Disorders• A cluster of cognitive, behavioral, and

physiological symptoms indicating continued use of the substance despite significant substance-related problems.


DSM 5

Alcohol Use Disorder• A problematic pattern of alcohol use

leading to clinically significant impairment or distress as manifested by at least two of the following criteria, occurring within a 12 month period.


• Alcohol Use Disorder – Criteria (11)1. Often taken in larger amounts and longer time than intended

2. Persistent desire or unsuccessful efforts to cut down or control use

3. Increased time obtaining, using, recovering

4. Craving to use

5. Use results in failure to fulfill obligations

• DSM 5

32Federal AviationAdministration32

DSM 5• Alcohol Use Disorder – Criteria (cont.)6. Continued use despite problems

7. Social, occupational, recreational activities are given up

8. Recurrent use in physically hazardous situations

9. Use despite knowledge of alcohol caused physical or psychological problems

10. Tolerance

11. Withdrawal


DSM 5Alcohol Use Disorder• Qualifiers:

o Mild - 2 to 3 symptoms

o Moderate - 4 to 5 symptoms

o Severe - 6 or more symptoms


Title 14, CFR Part 67-Standards-MentalNo substance abuse within the preceding 2 years defined as:

Use of a substance in a situation in which that use was physically hazardous, if there has been at any other time an instance of the use of a substance also in a situation in which that use was physically hazardous

A verified positive drug test result acquired under an anti-drug program or internal program of the U.S. Department of Transportation


Title14, CFR Part 67 Standards MentalNo substance abuse within the preceding 2 years defined as: (cont.)

Misuse of a substance that the Federal Air Surgeon, based on case history and appropriate, qualified medical judgment relating to the substance involved, finds ….


Title 14, CFR Part 67-Standards-MentalNo substance abuse within the preceding 2 years defined as: (cont.)

● Makes the person unable to safely perform the duties or exercise the privileges of the airman certificate applied for or held or

● May reasonably be expected, for the maximum duration of the airman medical certificate applied for or held, to make the person unable to perform

37Federal AviationAdministration37

Current Special Issuances for Substance Abuse(By class of exam as of 8/31/16)

1st Class 2nd

Class3rd

Class Total

Alcohol Dependence 522 50 73 645

Alcohol Abuse 93 73 121 287

Drug Dependence 75 10 36 121

Drug Abuse 105 43 71 219

795 176 301 1272


Role of the HIMS AME

Evaluate the quality of an airman’s Recovery Program and make a recommendationto the FAA regarding the Special Issuance of his or her FAA Medical Certificate.

* Human Intervention Motivation Study


Antidepressants

• Mild/moderate depression or other diagnosis

• Stable 6 months• No history psychosis, suicidal ideation,

multiple meds, electroconvulsive therapy• Use of fluoxetine, sertraline, citalopram or

escitalopram only• SSRI specification sheet


Antidepressants

• Ongoing monitoring by psychiatry, treating doc, neuropsych testing, HIMS AME

• No dosage changes or medical monitor changes without prior coordination

• Changes in condition must be reported to HIMS AME and FAA immediately

• Minimum 6 months treatment before SI consideration


SSRI Renewal Process Improvement

• Created certification aid• Created AME checklist• AME authorized to issue if all items green• All documentation still goes to FAA


FAA Certification Aid

• Cog screen results– Specify norm used and session number– Address LRPV, Taylor factors, base rates– Submit entire (approx 13 pages) report– Submit results and rationale for any additional

testing done• Clinical neurocognitive evaluation

– Overall neurocognitive status**Agree to notify FAA/AME immediately for adverse changes in condition


SSRI Follow Up PathAirman with SSRI Special Issuance

First Class(Certification 6 to 12 months)

Third Class(Certification 24 months)

Airman must send to HIMS AME:•Current status report from treating physician

•Psychiatric consultation status report every 6 months

Letter From airline management every 3 months for those flying under FAR Part 121 or 135

CogScreen AEtesting every 2 years

CogScreen AEtesting annually Review by HIMS AME

FAA Decision*

Second Class(Certification 12 months)

*Note: HIMS AME may issue if subsequent certification exam does not coincide with required neurocognitive testing and if all follow-up material is acceptable


Antidepressants(as of 1/11/2016)

Class 1 Class 2 Class 3 Total

SI 109 37 147 293

Deny 17 11 40 68

Processing 17 2 42 61

Totals 143 50 229 422


Safety of the National Air Space is Job #1

SSRIHIVSubstance abuseBrain injuryAging aviatorNeurodegenerative

Diseases


BasicMed: FAA Extension, Safety, and Security Act (FESSA) 2016• This is a Flight Standards rule that is an alternative

to third-class medical certification to fly certain small aircraft14 CFR Part 68

• 14 CFR Part 67 has not changed and third-class medical certification is not going away

• Final Rule was published in January 2017• Short Title -- BasicMed


The Basics: What Does a Pilot Need to Use BasicMed??

• A valid U.S. driver's license• An FAA Medical Certificate that was valid at any time

after July 14, 2006.• The most recent application for a

Medical Certificate was not denied.• The most recent Medical Certificate was not

revoked, suspended, or withdrawn.• Requires a one-time authorization for Special Issuance of

a Medical Certificate for the following conditions:


Conditions Requiring a One Time Special Issuance Authorizations Under BasicMed

• Mental: 4

• Neurology: 3

• Cardiac: 4


Conditions Requiring a One Time Special Issuance Authorizations Under BasicMed

• Mental: Personality Disorder

Psychosis

Bipolar Disorder

Substance Dependence


Questions?

• We’re all headed the same direction

FAA Medical Certification��5th Annual Aerospace Psychology�Seminar�Sept 23, 2017�Denver, CO�Aerospace Medical Certification Division (AMCD)AgendaSafety of the National Air Space is Job #1Sources of RiskMyth: Flying Same as DrivingConditions of Aeromedical Significance�Slide Number 8Slide Number 9Office of Aerospace MedicineMedical Certification ProcessDecision Level 1-- AMEDecision Level 2—AMCD or RFSDecision Level 3 — Federal Air SurgeonSlide Number 15Slide Number 16Slide Number 17Myth: Denial Is a Common EventSlide Number 19The FARs:�Title 14, CFR Part 67-Standards – Mental SpecificSlide Number 21Other generally disqualifying conditions include:Psychiatric Special Issuances (as of 8/31/16)Current Special Issuances �Psychiatric – Aug 2016Slide Number 25Slide Number 26Slide Number 27Slide Number 28Slide Number 29Slide Number 30Slide Number 31Slide Number 32Slide Number 33Slide Number 34Slide Number 35Slide Number 36Current Special Issuances �for Substance Abuse�(By class of exam as of 8/31/16) Role of the HIMS AME Antidepressants AntidepressantsSSRI Renewal Process Improvement FAA Certification AidSSRI Follow Up PathSlide Number 44Safety of the National Air Space is Job #1BasicMed: FAA Extension, Safety, and Security Act (FESSA) 2016The Basics: �What Does a Pilot Need to Use BasicMed??Conditions Requiring a One Time Special Issuance Authorizations Under BasicMedConditions Requiring a One Time Special Issuance Authorizations Under BasicMedQuestions?

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