80_FR_8618 80 FR 8586 - Medical Waivers for Merchant Mariner Credential Applicants With the Following Conditions: Cardiomyopathy; Diabetes Mellitus; Narcolepsy; and Obstructive Sleep Apnea

80 FR 8586 - Medical Waivers for Merchant Mariner Credential Applicants With the Following Conditions: Cardiomyopathy; Diabetes Mellitus; Narcolepsy; and Obstructive Sleep Apnea

DEPARTMENT OF HOMELAND SECURITY
Coast Guard

Federal Register Volume 80, Issue 32 (February 18, 2015)

Page Range8586-8588
FR Document2015-03109

The Coast Guard is seeking public comment on the policy clarification proposed in this document regarding the specific medical documentation the Coast Guard will consider in determining whether a medical waiver is warranted for merchant mariners with cardiomyopathy, diabetes mellitus, or obstructive sleep apnea. Additionally, the proposed policy clarification specifies that narcolepsy, idiopathic hypersomnia, and other hypersomnias of central origin, are medically disqualifying and generally not waiverable due to significant risk of sudden and unpredictable incapacitation of individuals who have these conditions.

Federal Register, Volume 80 Issue 32 (Wednesday, February 18, 2015)
[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Proposed Rules]
[Pages 8586-8588]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03109]


=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2015-0090]


Medical Waivers for Merchant Mariner Credential Applicants With 
the Following Conditions: Cardiomyopathy; Diabetes Mellitus; 
Narcolepsy; and Obstructive Sleep Apnea

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed policy clarification and request for 
comments.

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

SUMMARY: The Coast Guard is seeking public comment on the policy 
clarification proposed in this document regarding the specific medical 
documentation the Coast Guard will consider in determining whether a 
medical waiver is warranted for merchant mariners with cardiomyopathy, 
diabetes mellitus, or obstructive sleep apnea. Additionally, the 
proposed policy clarification specifies that narcolepsy, idiopathic 
hypersomnia, and other hypersomnias of central origin, are medically 
disqualifying and generally not waiverable due to significant risk of 
sudden and unpredictable incapacitation of individuals who have these 
conditions.

DATES: Comments and related material must either be submitted to our 
online docket via http://www.regulations.gov on or before May 19, 2015 
or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0090 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax: 202-493-2251.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of 
Transportation, West Building Ground Floor, Room W12-140, 1200 New 
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5 
p.m., Monday through Friday, except Federal holidays. The telephone 
number is 202-366-9329.
    To avoid duplication, please use only one of these four methods. 
See the ``Public Participation and Request for Comments'' portion of 
the SUPPLEMENTARY INFORMATION section below for instructions on 
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this 
document, call or email Lieutenant Ashley Holm, Mariner Credentialing 
Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202-
372-2357, email [email protected]. If you have questions on viewing 
material in the docket, call Docket Operations at 202-366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    You may submit comments and related material regarding whether the 
policy clarification proposed in this document should be incorporated 
into final policy on the medical evaluation guidelines for mariners 
with cardiomyopathy, diabetes mellitus, narcolepsy or obstructive sleep 
apnea. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have 
provided.
    Submitting comments: If you submit a comment, please include the 
docket number for this document (USCG-2015-0090) and provide a reason 
for each suggestion or recommendation. You may submit your comments and 
material online or by fax, mail or hand delivery, but please use only 
one of these means. We recommend that you include your name and a 
mailing address, an email address, or a telephone number in the body of 
your document so that we can contact you if we have questions regarding 
your submission.
    To submit your comment online, go to http://www.regulations.gov, 
type the docket number (USCG-2015-0090) in the ``SEARCH'' box and click 
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with 
this document.
    If you submit your comments by mail or hand delivery, submit them 
in an unbound format, no larger than 8 \1/2\ by 11 inches, suitable for 
copying and electronic filing. If you submit them by mail and would 
like to know that they reached the Facility, please enclose a stamped, 
self-addressed postcard or envelope. We will consider all comments and 
material received during the comment period.
    Viewing comments and documents: To view comments, go to http://www.regulations.gov, type the docket number (USCG-2015-0090) in the 
``SEARCH'' box and click ``SEARCH.'' Click on ``Open Docket Folder'' on 
the line associated with this rulemaking. You may also visit the Docket 
Management Facility in Room W12-140 on the ground floor of the 
Department of Transportation West Building, 1200 New Jersey Avenue SE., 
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, 
except Federal holidays. We have an agreement with the Department of 
Transportation to use the Docket Management Facility.
    Privacy Act: Anyone can search the electronic form of comments 
received into any of our dockets by the name of the individual 
submitting the comment (or signing the comment, if submitted on behalf 
of an association, business, labor union, etc.). You may review a 
Privacy Act system of records notice regarding our public dockets in 
the January 17, 2008, issue of the Federal Register (73 FR 3316).

Background and Purpose

    46 CFR 10.302 contains the medical standards that merchant mariners 
must meet prior to being issued a merchant mariner credential (MMC). In 
cases where the mariner does not meet the medical standards in 46 CFR 
10.302, waivers may be granted when the Coast Guard determines that 
extenuating circumstances warrant special consideration. See 46 CFR 
10.303. Current Coast Guard guidance in Enclosure (3) to Navigation and 
Vessel Inspection Circular 04-08, Medical and Physical Evaluation 
Guidelines for Merchant Mariner Credentials (NVIC 04-08), which is 
available at http://www.uscg.mil/hq/cg5/nvic/pdf/2008/NVIC%2004-08%20CH%201%20with%20Enclosures%2020130607.pdf.), states that the 
conditions of cardiomyopathy, diabetes mellitus, narcolepsy and 
obstructive sleep apnea \1\ require further

[[Page 8587]]

review. The same guidance publishes the ``recommended evaluation data'' 
that should be submitted for each condition; however it does not 
specify the medical criteria that the Coast Guard will consider in 
evaluating whether the risks associated with these conditions are low 
enough to warrant a medical waiver.
---------------------------------------------------------------------------

    \1\ Enclosure (3) to Navigation and Vessel Inspection Circular 
04-08, Medical and Physical Evaluation Guidelines for Merchant 
Mariner Credentials, Item number 179, specifies that sleep apnea and 
other sleep disorders are subject to further review. Obstructive 
sleep apnea (OSA) is one specific type of sleep apnea and is, 
therefore, subject to further review under the same item number.
---------------------------------------------------------------------------

    Since the issuance of NVIC 04-08 on September 15, 2008, there have 
been several instances where mariners sought waivers for these 
conditions. In some cases, mariners with these conditions were granted 
waivers; in other cases, the conditions were deemed an unacceptable 
risk and medical certification was denied. Published guidance on the 
criteria that will be used in determining whether an applicant's 
medical condition warrants a medical waiver will support Coast Guard 
efforts to consistently evaluate merchant mariners with these 
conditions and assess whether the risk associated with an applicant's 
medical condition is sufficiently mitigated to warrant a medical waiver 
under 46 CFR 10.303.
    Under the proposed policy, a medical waiver will be required for 
the conditions of cardiomyopathy, sleep apnea, and diabetes mellitus.
    In determining whether a mariner having one of the aforementioned 
conditions warrants a medical waiver under 46 CFR 10.303, the Coast 
Guard seeks public input on whether the Coast Guard should consider the 
following specific medical documentation and medical criteria:

    I. NVIC 04-08, Condition #77: Cardiac decompensation or 
cardiomyopathy. Individuals with these conditions may be denied 
medical certification unless they meet the criteria for a medical 
waiver.
    1. Submit a cardiology consultation, nuclear exercise stress 
test, echocardiogram and 24-hour Holter monitor.
    2. Criteria for consideration for a waiver include: a left 
ventricular ejection fraction of >=35%, no symptomatic or clinically 
significant heart failure in the past 2 years (must be New York 
Heart Association Class I), absence of significant ischemia on 
stress testing, exercise capacity of >=8 METs, no history of syncope 
or ventricular arrhythmia in the past three years; and the written 
opinion of the treating cardiologist or electrophysiologist supports 
low risk for sudden death, ventricular arrhythmia, adverse cardiac 
event and sudden incapacitation based upon objective testing and 
standard evaluation tools.
    3. Note: Individuals with cardiomyopathy who have had an 
implantable cardioverter defibrillator (ICD) placed, will be 
evaluated under the criteria for condition #81, Anti-tachycardia 
devices or implantable defibrillators.\2\ Individuals with 
cardiomyopathy who have been advised to undergo placement of an ICD 
by their cardiologist, but have failed to comply, do not meet the 
low risk criteria for consideration for a medical waiver. These 
individuals may be denied medical certification.
---------------------------------------------------------------------------

    \2\ NVIC 04-08 Condition #81, Anti-tachycardia devices or 
implantable cardioverter defibrillators directs that conditions 
requiring use of these devices are ``generally not waiverable.'' 
Enclosure (7) to NVIC 04-08 contains the criteria for consideration 
for a medical waiver for conditions requiring use of these devices. 
The criteria are summarized as follows: (1) The applicant does not 
have a diagnosis of a cardiac channelopathy affecting the electrical 
conduction of the heart (to include Brugada syndrome, Long QT 
syndrome, etc.); (2) The applicant does not have a prior history of 
ventricular fibrillation or episodes of sustained ventricular 
tachycardia within the last three years; (3) The ICD or anti-
tachycardia device was implanted more than three years ago; (4) The 
ICD has not fired nor has the applicant required anti-tachycardia 
pacing therapy within the last three years; (5) There are no 
additional risk factors for inappropriate shock such as uncontrolled 
atrial fibrillation; (6) The applicant's left ventricular ejection 
fraction is greater than 35% with a steady or improving trend; (7) 
There is no history of any symptomatic or clinically significant 
heart failure in the past two years; (8) There is no evidence of 
significant reversible ischemia on myocardial perfusionimaging 
exercise stress testing; (9) The applicant's exercise capacity on 
formal stress testing (using standard Bruce Protocol) is greater 
than or equal to the 8 METs (metabolic equivalents); (10) The 
applicant's treating cardiologist or electrophysiologist provides a 
written assessment of the individual that supports a determination 
that the mariner is at low risk for future arrhythmia, adverse 
cardiac event or sudden incapacitation based upon objective testing 
and standard evaluation tools; (11) The applicant does not have any 
other medical conditions which may alone, or incombination with an 
ICD or anti-tachycardia device, affect the mariner's fitness.
---------------------------------------------------------------------------

    Justification: The Coast Guard recognizes that there is 
significant clinical variation within the population of individuals 
with cardiomyopathy, and that not all individuals with 
cardiomyopathy carry the same risks of sudden incapacitation or 
sudden death. These criteria seek to discern those individuals with 
cardiomyopathy who have factors that mitigate their risk, and who 
have prognostic indicators suggestive of a low risk of sudden 
incapacitation or adverse cardiac event.
    II. NVIC 04-08, Condition # 193: Diabetes mellitus treated with 
insulin or with history of diabetic ketoacidosis (DKA). Individuals 
with this condition may be denied medical certification unless they 
meet the criteria for a medical waiver:
    1. Submit an evaluation from the treating physician documenting 
interval history and two current glycated hemoglobin (HbA1c) levels 
separated by at least 90 days, the most recent of which is no more 
than 90 days old. An ophthalmology consultation may be required. 
Graded exercise testing may be required.
    2. If the evaluation of the treating physician supports good 
compliance with the treatment regimen, the absence of recent, severe 
hypoglycemic episodes,\3\ and the absence of impairing diabetic 
complications, then mariners with a consistent pattern of HbA1c 
levels of less than or equal to 10% may be considered for a waiver, 
with annual reporting requirements.
---------------------------------------------------------------------------

    \3\ Recent, severe hypoglycemic episode is an episode of 
hypoglycemia within the prior 12 months resulting in seizure, loss 
of consciousness or altered consciousness, or requiring assistance 
from another person for treatment.
---------------------------------------------------------------------------

    3. Mariners with HbA1c levels greater than 10% are generally not 
considered for a waiver unless extenuating circumstances confirm 
temporary irregularity due to acute illness, medication interaction, 
or other short-term occurrence that is not likely to recur.
    Justification: Although poorly controlled diabetes can lead to 
long term diabetic complications, the consequences of hypoglycemia 
pose an immediate threat of sudden incapacitation with a greater 
risk to public and maritime safety.
    III. NVIC 04-08, Condition #194: Diabetes requiring oral 
medication.
    1. Submit an evaluation from the treating physician documenting 
interval history and two current glycated hemoglobin (HbA1c) levels 
separated by at least 90 days, the most recent of which is no more 
than 90 days old. Ophthalmology consultation may be required. Graded 
exercise testing may be required.
    2. If the evaluation of the treating physician supports good 
compliance with the treatment regimen, the absence of recent, severe 
hypoglycemic (*) episodes, and the absence of impairing diabetic 
complications, then mariners with a consistent pattern of HbA1c 
levels of less than 8% may be considered for a waiver with biennial 
(every two years) reporting requirements; and mariners with HbA1c 
levels between 8%-10% inclusive may be considered for a waiver, with 
annual reporting requirements.
    3. Mariners with HbA1c levels of greater than 10% are generally 
not considered for waiver unless extenuating circumstances confirm 
temporary irregularity due to acute illness, medication interaction, 
or other short-term occurrence that is not likely to recur.
    Justification: Although poorly controlled diabetes can lead to 
long term diabetic complications, the consequences of hypoglycemia 
pose an immediate threat of sudden incapacitation with risk to 
public and maritime safety.
    IV. NVIC 04-08, Condition # 179: Obstructive Sleep Apnea, 
Central Sleep Apnea, Narcolepsy, Periodic Limb Movement, Restless 
Leg Syndrome or other sleep disorders.
    1. Submit all pertinent medical information, including sleep 
studies and a status report. If surgically treated, please submit a 
post-operative polysomnogram to document cure.
    2. Narcolepsy,idiopathic hypersomnia and other hypersomnias of 
central origin: Due to the significant risk of sudden and 
unpredictable incapacitation of individuals who have these 
conditions, narcolepsy, idiopathic hypersomnia and other 
hypersomnias of central origin are considered disqualifying. 
Additionally, the Coast Guard does not consider the conditions

[[Page 8588]]

of narcolepsy,idiopathic hypersomnia, or other hypersomnias of 
central origin, as low enough risk to warrant consideration for a 
medical waiver.
    3. Obstructive Sleep Apnea (OSA):
    A. Medical waivers for OSA require submission of an annual sleep 
specialist evaluation that documents treatment efficacy, the 
patient's treatment compliance and an assessment for symptoms of 
daytime sleepiness. If treated with CPAP/BiPAP, the evaluation 
should include a compliance information report from the positive 
airway pressure device that covers the preceding 12 months. For OSA 
treated by other means, submit a polysomnogram demonstrating the 
effectiveness of the alternative therapy.
    B. For purposes of receiving or maintaining a medical waiver, 
minimum compliance with positive airway pressure therapy is defined 
as:
    (i) Proper use of the CPAP/BiPAP device for at least four hours 
per night (or per major sleep period) during all major sleep periods 
while acting under the authority of the mariner credential, and
    (ii) Proper use of the CPAP/BiPAP device for at least four hours 
per night (or per major sleep period) on at least 70% of all nights 
(or major sleep periods).


    Authority:  This document is issued under the authority of 5 
U.S.C. 552(a) and 46 U.S.C. 7101 et seq.

    Dated: February 10, 2015.
J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections & Compliance.
[FR Doc. 2015-03109 Filed 2-17-15; 8:45 am]
BILLING CODE 9110-04-P



                                                    8586                Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules

                                                    the collection action’’ occurs when the                    (2) Fax: 202–493–2251.                             unbound format, no larger than 8 1⁄2 by
                                                    agency has terminated collection action                    (3) Mail: Docket Management Facility               11 inches, suitable for copying and
                                                    in accordance with the FCCS or other                    (M–30), U.S. Department of                            electronic filing. If you submit them by
                                                    applicable standards. In any event,                     Transportation, West Building Ground                  mail and would like to know that they
                                                    termination of the collection action will               Floor, Room W12–140, 1200 New Jersey                  reached the Facility, please enclose a
                                                    be deemed to have occurred if the                       Avenue SE., Washington, DC 20590–                     stamped, self-addressed postcard or
                                                    agency has not received any payments                    0001.                                                 envelope. We will consider all
                                                    to satisfy the debt from the particular                    (4) Hand delivery: Same as mail                    comments and material received during
                                                    debtor whose wages were subject to                      address above, between 9 a.m. and 5                   the comment period.
                                                    garnishment, in whole or in part, for a                 p.m., Monday through Friday, except                      Viewing comments and documents:
                                                    period of 1 year.                                       Federal holidays. The telephone number                To view comments, go to http://
                                                      Dated: February 3, 2015.
                                                                                                            is 202–366–9329.                                      www.regulations.gov, type the docket
                                                                                                               To avoid duplication, please use only              number (USCG–2015–0090) in the
                                                    Eric H. Holder, Jr.                                     one of these four methods. See the                    ‘‘SEARCH’’ box and click ‘‘SEARCH.’’
                                                    Attorney General.                                       ‘‘Public Participation and Request for                Click on ‘‘Open Docket Folder’’ on the
                                                    [FR Doc. 2015–02587 Filed 2–17–15; 8:45 am]             Comments’’ portion of the                             line associated with this rulemaking.
                                                    BILLING CODE 4410–AR–P                                  SUPPLEMENTARY INFORMATION section                     You may also visit the Docket
                                                                                                            below for instructions on submitting                  Management Facility in Room W12–140
                                                                                                            comments.                                             on the ground floor of the Department
                                                    DEPARTMENT OF HOMELAND                                  FOR FURTHER INFORMATION CONTACT: If                   of Transportation West Building, 1200
                                                    SECURITY                                                you have questions about this                         New Jersey Avenue SE., Washington,
                                                                                                            document, call or email Lieutenant                    DC 20590, between 9 a.m. and 5 p.m.,
                                                    Coast Guard                                                                                                   Monday through Friday, except Federal
                                                                                                            Ashley Holm, Mariner Credentialing
                                                                                                            Program Policy Division (CG–CVC–4),                   holidays. We have an agreement with
                                                    46 CFR Part 10                                                                                                the Department of Transportation to use
                                                                                                            U.S. Coast Guard, telephone 202–372–
                                                    [Docket No. USCG–2015–0090]                             2357, email MMCPolicy@uscg.mil. If                    the Docket Management Facility.
                                                                                                            you have questions on viewing material                   Privacy Act: Anyone can search the
                                                    Medical Waivers for Merchant Mariner                    in the docket, call Docket Operations at              electronic form of comments received
                                                    Credential Applicants With the                          202–366–9826.                                         into any of our dockets by the name of
                                                    Following Conditions:                                   SUPPLEMENTARY INFORMATION:
                                                                                                                                                                  the individual submitting the comment
                                                    Cardiomyopathy; Diabetes Mellitus;                                                                            (or signing the comment, if submitted
                                                    Narcolepsy; and Obstructive Sleep                       I. Public Participation                               on behalf of an association, business,
                                                    Apnea                                                      You may submit comments and                        labor union, etc.). You may review a
                                                                                                            related material regarding whether the                Privacy Act system of records notice
                                                    AGENCY:   Coast Guard, DHS.                                                                                   regarding our public dockets in the
                                                                                                            policy clarification proposed in this
                                                    ACTION:  Notice of proposed policy                                                                            January 17, 2008, issue of the Federal
                                                                                                            document should be incorporated into
                                                    clarification and request for comments.                                                                       Register (73 FR 3316).
                                                                                                            final policy on the medical evaluation
                                                    SUMMARY:    The Coast Guard is seeking                  guidelines for mariners with                          Background and Purpose
                                                    public comment on the policy                            cardiomyopathy, diabetes mellitus,
                                                                                                            narcolepsy or obstructive sleep apnea.                  46 CFR 10.302 contains the medical
                                                    clarification proposed in this document                                                                       standards that merchant mariners must
                                                    regarding the specific medical                          All comments received will be posted,
                                                                                                            without change, to http://                            meet prior to being issued a merchant
                                                    documentation the Coast Guard will                                                                            mariner credential (MMC). In cases
                                                    consider in determining whether a                       www.regulations.gov and will include
                                                                                                            any personal information you have                     where the mariner does not meet the
                                                    medical waiver is warranted for                                                                               medical standards in 46 CFR 10.302,
                                                    merchant mariners with                                  provided.
                                                                                                               Submitting comments: If you submit a               waivers may be granted when the Coast
                                                    cardiomyopathy, diabetes mellitus, or                                                                         Guard determines that extenuating
                                                    obstructive sleep apnea. Additionally,                  comment, please include the docket
                                                                                                            number for this document (USCG–                       circumstances warrant special
                                                    the proposed policy clarification                                                                             consideration. See 46 CFR 10.303.
                                                    specifies that narcolepsy, idiopathic                   2015–0090) and provide a reason for
                                                                                                            each suggestion or recommendation.                    Current Coast Guard guidance in
                                                    hypersomnia, and other hypersomnias                                                                           Enclosure (3) to Navigation and Vessel
                                                    of central origin, are medically                        You may submit your comments and
                                                                                                            material online or by fax, mail or hand               Inspection Circular 04–08, Medical and
                                                    disqualifying and generally not                                                                               Physical Evaluation Guidelines for
                                                    waiverable due to significant risk of                   delivery, but please use only one of
                                                                                                            these means. We recommend that you                    Merchant Mariner Credentials (NVIC
                                                    sudden and unpredictable                                                                                      04–08), which is available at http://
                                                    incapacitation of individuals who have                  include your name and a mailing
                                                                                                            address, an email address, or a                       www.uscg.mil/hq/cg5/nvic/pdf/2008/
                                                    these conditions.                                                                                             NVIC%2004-08%20CH%201%20with%
                                                                                                            telephone number in the body of your
                                                    DATES: Comments and related material                                                                          20Enclosures%2020130607.pdf.), states
                                                                                                            document so that we can contact you if
                                                    must either be submitted to our online                                                                        that the conditions of cardiomyopathy,
                                                                                                            we have questions regarding your
                                                    docket via http://www.regulations.gov                                                                         diabetes mellitus, narcolepsy and
                                                                                                            submission.
                                                    on or before May 19, 2015 or reach the                                                                        obstructive sleep apnea 1 require further
mstockstill on DSK4VPTVN1PROD with PROPOSALS




                                                                                                               To submit your comment online, go to
                                                    Docket Management Facility by that                      http://www.regulations.gov, type the
                                                    date.                                                   docket number (USCG–2015–0090) in
                                                                                                                                                                    1 Enclosure (3) to Navigation and Vessel

                                                                                                                                                                  Inspection Circular 04–08, Medical and Physical
                                                    ADDRESSES: You may submit comments                      the ‘‘SEARCH’’ box and click                          Evaluation Guidelines for Merchant Mariner
                                                    identified by docket number USCG–                       ‘‘SEARCH.’’ Click on ‘‘Submit a                       Credentials, Item number 179, specifies that sleep
                                                    2015–0090 using any one of the                          Comment’’ on the line associated with                 apnea and other sleep disorders are subject to
                                                                                                                                                                  further review. Obstructive sleep apnea (OSA) is
                                                    following methods:                                      this document.                                        one specific type of sleep apnea and is, therefore,
                                                      (1) Federal eRulemaking Portal:                          If you submit your comments by mail                subject to further review under the same item
                                                    http://www.regulations.gov.                             or hand delivery, submit them in an                   number.



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                                                                        Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules                                                       8587

                                                    review. The same guidance publishes                     defibrillators.2 Individuals with                        absence of impairing diabetic complications,
                                                    the ‘‘recommended evaluation data’’                     cardiomyopathy who have been advised to                  then mariners with a consistent pattern of
                                                    that should be submitted for each                       undergo placement of an ICD by their                     HbA1c levels of less than or equal to 10%
                                                                                                            cardiologist, but have failed to comply, do              may be considered for a waiver, with annual
                                                    condition; however it does not specify                  not meet the low risk criteria for                       reporting requirements.
                                                    the medical criteria that the Coast Guard               consideration for a medical waiver. These                   3. Mariners with HbA1c levels greater than
                                                    will consider in evaluating whether the                 individuals may be denied medical                        10% are generally not considered for a
                                                    risks associated with these conditions                  certification.                                           waiver unless extenuating circumstances
                                                    are low enough to warrant a medical                        Justification: The Coast Guard recognizes             confirm temporary irregularity due to acute
                                                    waiver.                                                 that there is significant clinical variation             illness, medication interaction, or other
                                                                                                            within the population of individuals with                short-term occurrence that is not likely to
                                                       Since the issuance of NVIC 04–08 on                  cardiomyopathy, and that not all individuals             recur.
                                                    September 15, 2008, there have been                     with cardiomyopathy carry the same risks of                 Justification: Although poorly controlled
                                                    several instances where mariners sought                 sudden incapacitation or sudden death.                   diabetes can lead to long term diabetic
                                                    waivers for these conditions. In some                   These criteria seek to discern those                     complications, the consequences of
                                                    cases, mariners with these conditions                   individuals with cardiomyopathy who have                 hypoglycemia pose an immediate threat of
                                                    were granted waivers; in other cases, the               factors that mitigate their risk, and who have           sudden incapacitation with a greater risk to
                                                                                                            prognostic indicators suggestive of a low risk           public and maritime safety.
                                                    conditions were deemed an                               of sudden incapacitation or adverse cardiac
                                                    unacceptable risk and medical                                                                                       III. NVIC 04–08, Condition #194: Diabetes
                                                                                                            event.                                                   requiring oral medication.
                                                    certification was denied. Published                        II. NVIC 04–08, Condition # 193: Diabetes                1. Submit an evaluation from the treating
                                                    guidance on the criteria that will be                   mellitus treated with insulin or with history            physician documenting interval history and
                                                    used in determining whether an                          of diabetic ketoacidosis (DKA). Individuals              two current glycated hemoglobin (HbA1c)
                                                    applicant’s medical condition warrants                  with this condition may be denied medical                levels separated by at least 90 days, the most
                                                    a medical waiver will support Coast                     certification unless they meet the criteria for          recent of which is no more than 90 days old.
                                                                                                            a medical waiver:
                                                    Guard efforts to consistently evaluate                                                                           Ophthalmology consultation may be
                                                                                                               1. Submit an evaluation from the treating             required. Graded exercise testing may be
                                                    merchant mariners with these                            physician documenting interval history and
                                                    conditions and assess whether the risk                                                                           required.
                                                                                                            two current glycated hemoglobin (HbA1c)
                                                    associated with an applicant’s medical                                                                              2. If the evaluation of the treating
                                                                                                            levels separated by at least 90 days, the most
                                                                                                                                                                     physician supports good compliance with the
                                                    condition is sufficiently mitigated to                  recent of which is no more than 90 days old.
                                                                                                                                                                     treatment regimen, the absence of recent,
                                                    warrant a medical waiver under 46 CFR                   An ophthalmology consultation may be
                                                                                                                                                                     severe hypoglycemic (*) episodes, and the
                                                    10.303.                                                 required. Graded exercise testing may be
                                                                                                            required.                                                absence of impairing diabetic complications,
                                                       Under the proposed policy, a medical                    2. If the evaluation of the treating                  then mariners with a consistent pattern of
                                                    waiver will be required for the                         physician supports good compliance with the              HbA1c levels of less than 8% may be
                                                    conditions of cardiomyopathy, sleep                     treatment regimen, the absence of recent,                considered for a waiver with biennial (every
                                                                                                            severe hypoglycemic episodes,3 and the                   two years) reporting requirements; and
                                                    apnea, and diabetes mellitus.                                                                                    mariners with HbA1c levels between 8%–
                                                       In determining whether a mariner                        2 NVIC 04–08 Condition #81, Anti-tachycardia
                                                                                                                                                                     10% inclusive may be considered for a
                                                    having one of the aforementioned                        devices or implantable cardioverter defibrillators       waiver, with annual reporting requirements.
                                                    conditions warrants a medical waiver                    directs that conditions requiring use of these              3. Mariners with HbA1c levels of greater
                                                    under 46 CFR 10.303, the Coast Guard                    devices are ‘‘generally not waiverable.’’ Enclosure      than 10% are generally not considered for
                                                                                                            (7) to NVIC 04–08 contains the criteria for              waiver unless extenuating circumstances
                                                    seeks public input on whether the Coast                 consideration for a medical waiver for conditions        confirm temporary irregularity due to acute
                                                    Guard should consider the following                     requiring use of these devices. The criteria are         illness, medication interaction, or other
                                                    specific medical documentation and                      summarized as follows: (1) The applicant does not        short-term occurrence that is not likely to
                                                    medical criteria:                                       have a diagnosis of a cardiac channelopathy
                                                                                                            affecting the electrical conduction of the heart (to
                                                                                                                                                                     recur.
                                                       I. NVIC 04–08, Condition #77: Cardiac                include Brugada syndrome, Long QT syndrome,                 Justification: Although poorly controlled
                                                    decompensation or cardiomyopathy.                       etc.); (2) The applicant does not have a prior history   diabetes can lead to long term diabetic
                                                    Individuals with these conditions may be                of ventricular fibrillation or episodes of sustained     complications, the consequences of
                                                    denied medical certification unless they meet           ventricular tachycardia within the last three years;     hypoglycemia pose an immediate threat of
                                                                                                            (3) The ICD or anti-tachycardia device was               sudden incapacitation with risk to public and
                                                    the criteria for a medical waiver.                      implanted more than three years ago; (4) The ICD
                                                       1. Submit a cardiology consultation,                                                                          maritime safety.
                                                                                                            has not fired nor has the applicant required anti-
                                                    nuclear exercise stress test, echocardiogram                                                                        IV. NVIC 04–08, Condition # 179:
                                                                                                            tachycardia pacing therapy within the last three
                                                    and 24-hour Holter monitor.                             years; (5) There are no additional risk factors for
                                                                                                                                                                     Obstructive Sleep Apnea, Central Sleep
                                                       2. Criteria for consideration for a waiver           inappropriate shock such as uncontrolled atrial          Apnea, Narcolepsy, Periodic Limb
                                                                                                            fibrillation; (6) The applicant’s left ventricular       Movement, Restless Leg Syndrome or other
                                                    include: a left ventricular ejection fraction of
                                                                                                            ejection fraction is greater than 35% with a steady      sleep disorders.
                                                    ≥35%, no symptomatic or clinically
                                                                                                            or improving trend; (7) There is no history of any          1. Submit all pertinent medical
                                                    significant heart failure in the past 2 years           symptomatic or clinically significant heart failure in   information, including sleep studies and a
                                                    (must be New York Heart Association Class               the past two years; (8) There is no evidence of          status report. If surgically treated, please
                                                    I), absence of significant ischemia on stress           significant reversible ischemia on myocardial            submit a post-operative polysomnogram to
                                                    testing, exercise capacity of ≥8 METs, no               perfusionimaging exercise stress testing; (9) The
                                                                                                                                                                     document cure.
                                                    history of syncope or ventricular arrhythmia            applicant’s exercise capacity on formal stress
                                                                                                            testing (using standard Bruce Protocol) is greater          2. Narcolepsy,idiopathic hypersomnia and
                                                    in the past three years; and the written                                                                         other hypersomnias of central origin: Due to
                                                                                                            than or equal to the 8 METs (metabolic equivalents);
                                                    opinion of the treating cardiologist or                 (10) The applicant’s treating cardiologist or            the significant risk of sudden and
                                                    electrophysiologist supports low risk for               electrophysiologist provides a written assessment of     unpredictable incapacitation of individuals
mstockstill on DSK4VPTVN1PROD with PROPOSALS




                                                    sudden death, ventricular arrhythmia,                   the individual that supports a determination that        who have these conditions, narcolepsy,
                                                    adverse cardiac event and sudden                        the mariner is at low risk for future arrhythmia,        idiopathic hypersomnia and other
                                                    incapacitation based upon objective testing             adverse cardiac event or sudden incapacitation           hypersomnias of central origin are
                                                    and standard evaluation tools.                          based upon objective testing and standard
                                                                                                            evaluation tools; (11) The applicant does not have
                                                                                                                                                                     considered disqualifying. Additionally, the
                                                       3. Note: Individuals with cardiomyopathy                                                                      Coast Guard does not consider the conditions
                                                                                                            any other medical conditions which may alone, or
                                                    who have had an implantable cardioverter
                                                                                                            incombination with an ICD or anti-tachycardia
                                                    defibrillator (ICD) placed, will be evaluated           device, affect the mariner’s fitness.                    months resulting in seizure, loss of consciousness
                                                    under the criteria for condition #81, Anti-                3 Recent, severe hypoglycemic episode is an           or altered consciousness, or requiring assistance
                                                    tachycardia devices or implantable                      episode of hypoglycemia within the prior 12              from another person for treatment.



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                                                    8588                Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules

                                                    of narcolepsy,idiopathic hypersomnia, or                months. For OSA treated by other means,               sleep period) on at least 70% of all nights (or
                                                    other hypersomnias of central origin, as low            submit a polysomnogram demonstrating the              major sleep periods).
                                                    enough risk to warrant consideration for a              effectiveness of the alternative therapy.
                                                    medical waiver.                                            B. For purposes of receiving or maintaining          Authority: This document is issued under
                                                      3. Obstructive Sleep Apnea (OSA):                     a medical waiver, minimum compliance with             the authority of 5 U.S.C. 552(a) and 46 U.S.C.
                                                      A. Medical waivers for OSA require                    positive airway pressure therapy is defined           7101 et seq.
                                                    submission of an annual sleep specialist                as:
                                                    evaluation that documents treatment efficacy,              (i) Proper use of the CPAP/BiPAP device              Dated: February 10, 2015.
                                                    the patient’s treatment compliance and an               for at least four hours per night (or per major       J.C. Burton,
                                                    assessment for symptoms of daytime                      sleep period) during all major sleep periods          Captain, U.S. Coast Guard, Director of
                                                    sleepiness. If treated with CPAP/BiPAP, the             while acting under the authority of the
                                                                                                                                                                  Inspections & Compliance.
                                                    evaluation should include a compliance                  mariner credential, and
                                                    information report from the positive airway                (ii) Proper use of the CPAP/BiPAP device           [FR Doc. 2015–03109 Filed 2–17–15; 8:45 am]
                                                    pressure device that covers the preceding 12            for at least four hours per night (or per major       BILLING CODE 9110–04–P
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Document Created: 2018-02-16 11:10:23
Document Modified: 2018-02-16 11:10:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed policy clarification and request for comments.
DatesComments and related material must either be submitted to our online docket via http://www.regulations.gov on or before May 19, 2015 or reach the Docket Management Facility by that date.
ContactIf you have questions about this document, call or email Lieutenant Ashley Holm, Mariner Credentialing Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202- 372-2357, email [email protected] If you have questions on viewing material in the docket, call Docket Operations at 202-366-9826.
FR Citation80 FR 8586 

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