Draft of letter of Medical Necessity for Cough Assist (In-Exsufflator)
From Dr. Bach (www.doctorbach.com).
Medical Necessity for CoughAssist™ Cough Stimulating Device
for person with neuromuscular disease (NMD)
or high-level spinal cord injury (SCI)
There are many medications and medical devices that assist a patient in loosening bronchial
secretions for easier removal. These medications and devices are useful for patients suffering
from cystic fibrosis, chronic bronchitis, pneumonia, and other conditions where an excess of
thick secretions build up within the lungs.
Once loosened, the bronchial secretions are then removed from the lungs through a "productive
cough" which moves the secretions up the trachea and out the mouth. A cough is produced when
the diaphragm and chest muscles work to expand the lungs (full inhalation) and then rapidly
contract the lungs to expel the air (explosive exhalation), and along with the air, the loosened
secretions.
Patients with neuromuscular disease (NMD) or high-level spinal cord injury (SCI) often lack the
muscle strength (NMD) or muscle control (SCI) to create the full inhalation/explosive exhalation
required to cough and thereby remove bronchial secretions from the lungs. Without removal of
these secretions bacterial infection (pneumonia) and oxyhemoglobin desaturation (low blood
oxygen) can occur resulting in respiratory failure, hospitalization, and death.
The situation is exacerbated for patients with poor bulbar (swallowing) muscle control as they
may also "aspirate" saliva, foods, or liquids into the lungs. If the aspirated material is not
removed, bacterial infection (pneumonia) and oxyhemoglobin desaturation (low blood oxygen)
can occur resulting in respiratory failure, hospitalization, and death.
For patients with a tracheostomy (breathing tube inserted into the trachea through the neck), it is
common practice to utilize a suctioning device for removal of bronchial secretions. A small
"vacuum cleaner" hose is inserted directly into the lungs through the tracheostomy opening (or
through the attached ventilation hoses) to suction out the secretions.
For patients without a tracheostomy, the only device of which we are aware that provides the full
inhalation/explosive exhalation required for clearing the lungs of bronchial secretions and
aspirated matter is the CoughAssist™ (J H Emerson Co, Cambridge, Massachusetts), formerly
known as the In-Exsufflator, based on the Cofflator from O.E.M. Corporation. The
CoughAssist™ is distributed by Respironics, Inc.
The CoughAssist™ is a portable electrically powered device that utilizes a blower and a valve to
alternately apply positive then negative pressure to the patient's airway in order to assist the
patient in clearing retained bronchial secretions. Air is delivered to/from the patient via a
breathing circuit incorporating a flexible tube, a bacterial filter, and either a facemask or
mouthpiece.
Cough Stimulating Device
Medicare HCPCS Code E0482
E0482 - Cough stimulating device, alternating positive and negative airway pressure
 Effective January 1, 2002
 Formerly covered under E1399
 Medical necessity documentation is required
 Coverage: 15 months capped rental
 Medicare Fee Schedule reimbursement range: $363.71 to $427.89
 After 15-month rental cap, maintenance and servicing fees may be billed once every 6
months.
To the best of our knowledge there is only one product covered by this code: CoughAssist™ (J
H Emerson Co, Cambridge, Massachusetts), formerly known as the In-Exsufflator, and
distributed by Respironics, Inc.
The CoughAssist™, based on the Cofflator from O.E.M. Corporation used during the polio
epidemics in the 1950s, is a proven technology that fell into disuse in the early '60s after
tracheostomy and suctioning became more popular. It has regained acceptance as a noninvasive
alternative for clearing airway secretions. By avoiding invasive surgery (tracheotomy) when
noninvasive alternatives are viable, both quality of life and mortality rates are improved as
documented in Chest, Am J Phys Med Rehabil, Arch Phys Med Rehabil, Rehabilitation R&D
Progress Reports (Veterans Health Administration), Distrofia Muscolare, Bull N Y Acad Med,
and other medical sources.
Use of the CoughAssist™ is indicated for the management of retained secretions where the
patient is unable to generate a sufficient unassisted cough flow rate to clear secretions (< 160 to
270 L/min).
The adoption of a noninvasive protocol (the use of CoughAssist™ in conjunction with
noninvasive positive pressure ventilation) has been shown to increase patient's quality of life,
decrease respiratory-related hospitalization from 21 days/year to less than 2 days/year, and
prolong life, in many cases by over 50 years. (Prevention of Pulmonary Morbidity).
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This patient suffers from ___ neuromuscular disease / high-level spinal cord injury.
This patient has an insufficient cough flow rate to clear secretions (_____ L/min).
This patient has diminished bulbar function that results in aspiration of saliva, food
and/or liquids.
There is an absolute medical necessity for this patient to have prompt access to a
CoughAssist™ device for removal of bronchial secretions.
There is an absolute medical necessity for this patient to have prompt access to a
CoughAssist™ device for removal of aspirated matter.
Failure to provide this patient with prompt access to a CoughAssist™ device will likely
result in repeated oxyhemoglobin desaturation, bronchial infection, pulmonary failure,
hospitalization, and death.
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The only viable alternative to the use of a CoughAssist™ device is invasive surgery to
install a tracheostomy tube resulting in hospitalization, higher medical care and
equipment costs, lower quality of life, and premature death.
Contact Information:
J.H. Emerson Company
22 Cottage Park Avenue
Cambridge, Massachusetts 02140-1691
1-800-252-1414
www.CoughAssist.com
www.JHEmerson.com
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh, PA 15221-4401
1-800-638-8208
www.Respironics.com
Prepared by:
Rich Clingman, Webmaster www.DoctorBach.com
Revised:
April 16, 2002