Does Recent High Profile History suggest that the Federal Air Surgeon should consider a Stand Down to review the program?

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FAA 3rd Class Medical Standards Reform

3 Reviews of Push-Backs

The industry concerns about the need to reform the FAA’s 3rd Class Medical standards seemed unduly overwrought to the disinterested observer. The GA community expended so much effort to convince the Hill to act. Was this campaign indicative of broader aviation critique of the FAA medical policies and procedures?

Here are three reviews of recent “push backs” which may be part of the broader attack on the FAA’s Federal Air Surgeon, the third example is quite telling!

 


 

1. The FAA issued a policy concerning sleep apnea and again, after the Congress let the FAA know that the action failed to meet the requirements of the Administrative Procedure Act. The missive from the Hill also questioned the medical procedures prescribed. Here is a string of posts on this subject:

• December 2, 2013 – Flight Surgeon’s BMI/Sleep Apnea “Policy” is a Nightmare Rule subject to APA

Article: NBAA Supports House Bill Calling for FAA to Follow Rulemaking Process on Sleep Apnea Agency Has Suggested Policy May Be Issued Soon Without Industry Consultation The FAA Flight Surgeon has found evidence which he…

• December 12, 2013 – Flight Surgeon’s Sleep Apnea “Policy” is attacked by the Doctors who would implement it

Article: AMEs object to sleep apnea policy It is not going well for the Flight Surgeon’s attempt to establish a policy requiring overweight pilots to get sleep apnea counseling as a precondition to receiving their…

• April 1, 2014 – Flight Surgeon Rekindles the debate about Sleep Apnea Policy and Procedure

UPDATE: FAA Asks Industry to Review Sleep Apnea Guidance The FAA Flight Surgeon has reacted to the criticism of his announcement of a new medical standard for sleep apnea in a way which industry will…

• January 27, 2015 – FAA Flight Surgeon’s sleep apnea rules corrected, but procedural flaw not cured

A new pronouncement by the FAA’s chief medical official has established rules by which pilots’ health will be measured in the future. The new FAA position on sleep apnea has been well received by stakeholder.


 

2. Congress directed the FAA to revise its 3rd Class Medical standards and process; after a seemingly interminable review, a final rule was issued. To the casual observer, the legislative mandate seemed a bit of overkill. According to AOPA, this conflict started in 2007. The change was opposed, in varying degrees, by ALPA, NTSB, AMEs, the DoT Secretary staff and OMB’s OIRA.

 


 

3. Eric Friedman, Petitioner v. Federal Aviation Administration, Respondent

Eric Friedman is a commercial airline pilot, took the FAA to the United States Court of Appeals for the District of Columbia Circuit where he alleged that the FAA, Federal Air Surgeon, Respondent Federal Aviation Administration (“the FAA” or “the Agency”) acted “in an arbitrary and capricious manner in assessing his request for a commercial airline pilot’s license. Friedman has been diagnosed with Insulin Treated Diabetes Mellitus (“ITDM”), and although he holds a third class medical certificate authorizing him to pilot non-commercial flights in the United States, he seeks the first class certificate necessary to serve as a commercial airline pilot. He argues the FAA has impermissibly conditioned issuance of a first class license on ninety days of continuous blood glucose monitoring, a costly and invasive procedure not medically necessary for his care.” (quote from the Friedman Opinion [PDF])

This is what the continuous glucose monitor looks like after it is implanted on the body.

Before discussing the opinion, kudos to Circuit Judge Janice Rogers Brown for quoting a bit of aviation wisdom and a brilliant pun at the beginning of her opinion.

“I’ve never known an industry that can get into people’s blood the way aviation does.”
– Robert Six, founder of Continental Airlines

A diagnosis of ITDM generally excludes a pilot from any medical certificate issued by the FAA pursuant to 49 U.S.C. § 44703(a), Judge Brown lays out the FARs and facts of the Friedman case:

  • The FAA has the discretionary authority to grant exceptions to the medical regulations contained in 14 C.F.R. § 67. See 49 U.S.C. § 44701(f).
  • An Authorization for Special Issuance of a Medical Certificate may be provided to an applicant with a disqualifying condition “if the person shows to the satisfaction of the Federal Air Surgeon that the duties authorized by the class of medical certificate applied for can be performed without endangering public safety during the period in which the Authorization would be in force.” 14 C.F.R. § 67.401(a).
  • Regulations require the Federal Air Surgeon (“FAS”) to make his determination using standards published for each condition as set forth in the FAA’s Guide to Aviation Medical Examiners (“AME Guide”). See id. 67.407(a).
  • For much of its history the FAA enforced a blanket ban on the issuance of medical certificates to individuals with ITDM,
  • but in 1996 it reversed course and established criteria for pilots with ITDM to receive a third class medical certificate (but not a first class certificate).
  • Since the policy change was adopted, there has been no medically related accident, incident, or inflight incapacitation, from any cause, of any such insulin treated special issuance pilot.
  • In light of the strong record of third class pilots with ITDM, and in reliance on the expert analysis provided by an Expert Panel on Pilots with Insulin Treated Diabetes (“Expert Panel”)—convened by the American Diabetes Association (“ADA”) at the FAA’s request—the FAA amended its AME Guide to broaden the third class ITDM protocol to all classes of medical certificates on April 21, 2015.
  • On April 27, 2015, Friedman submitted a completed application for a first class license to the FAA.
  • April 30, 2015 and several times thereafter, the FAA requested supplemental information, including “any and all information that you may have that is relevant to your condition, which may include . . . (if applicable) continuous glucose monitor readings.” JA 73.
  • The next month, Friedman inquired as to the FAA’s method for evaluating glucose testing results and stated “I do not use a continuous glucose monitor.” JA 31–32.
  • Continuous Glucose Monitoring (“CGM”), according to the ADA, is an invasive procedure that “uses a sensor inserted under the skin to check glucose levels in tissue fluid. A transmitter sends information about glucose levels via radio waves from the sensor to a wireless monitor.” ADA Amicus Br. 14.
  • This technique provides a “historical record of glucose levels over time” and can “provid[e] helpful information about historic trends in one’s blood sugar levels and how those levels have been affected by diet and exercise.” Id.
  • However, CGM data is not as accurate as other blood glucose measures like fingersticks. Id. 15–16. Moreover, CGM is costly and is not covered by insurance unless medically necessary.
  • The Expert Panel even submitted a letter in support of Friedman’s application to explain, “CGM systems have value, [but] they are neither necessary nor appropriate for making decisions on medical certification of pilots with diabetes” and are less accurate than the blood glucose data Friedman had already submitted.

The Court then dealt with the jurisdictional question of whether the FAA’s record of repeated demands for the CGM data constituted an appealable final order.

The FAA put forward the following Catch 22-like argument:

“The FAA argues Friedman’s claims are insulated from judicial scrutiny as “there is no law to apply” to the FAA’s determination. Drake v. FAA, 291 F.3d 59, 70 (D.C. Cir. 2002); see also Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971). But the jurisprudence of unfettered discretion is inapplicable here. Several regulations provide the criteria upon which the FAS relies to determine whether Friedman may be granted a first-class certificate…”

Judge Brown disagreed in that the FAA had cited several specific FARs which constituted a “judicially manageable standard”.

Finally, this DC Circuit three judge panel conclusively decides:

It is not for us to say in the first instance whether or how CGM data might be of future use to the FAA in evaluating license applications. But it is clear the FAA has not borne its burden of justification. The FAA’s letters communicating its demand for CGM data to Friedman, despite his many requests for clarification, fail to articulate any rationale for consideration of the additional information. See Safe Extensions, 509 F.3d at 606 (finding no “substantial evidence” to support the FAA’s rationale where it offered “no evidence whatsoever” on the relevant issue).

Notably, the Agency does not identify any FAA statements that could be construed as explaining its denial of Friedman’s application, the determination Friedman calls upon this Court to review. Of course, there is a certain irony inherent in requiring an agency to identify reasons for a denial it never thought it issued. But “recent [D.C. Circuit] cases regarding whether agency actions qualify as orders never consider the adequacy of the record, instead asking only whether the action was final.”

In light of the complete absence of a relevant administrative record to review—and the inherent inequity in passing judgment on this matter without offering the Agency a chance to explain its reasoning—any analysis of the FAA’s denial would be imprudent. Accordingly, we remand this matter to the FAA to offer reasons for its denial of Friedman’s application for a first class medical certificate. Friedman’s additional allegations must await proceedings on remand.

The Court is affording the Federal Air Surgeon the opportunity to explain why he demanded the BCM after the Expert Panel opined that this data would not be more relevant than the petitioner’s submitted record of his blood readings.

 


 

While the FAS is considering the response to the opinion of the three Judges, it might be time for the Administrator and the Federal Air Surgeon to reconsider the standards, processes and positions on these medical issues. The recent 0-3 record (granted these are only three highlighted cases among thousands of unheralded decisions which contributed to aviation safety) should merit a Stand Down with the Administrator and the Associate Administrator for Aviation Safety to assess whether these three cases are indicative of broader issues.

 

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