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National Coverage Analysis (NCA) Tracking Sheet

Noninvasive Positive Pressure RADs for COPD

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Issue

HCFA is reviewing the use of (RAD) for severe chronic obstructive pulmonary disease (COPD) patients to determine if these devices for COPD patients meet the reasonable and necessary provision at section §1862(a)(1)(A) of the Medicare statute.

We have received inquiries from manufacturers, clinicians, and professional associations and groups, expressing concerns and requests for changes in the regional medical review policy (RMRP) for RAD used for category II patients with severe COPD. The National Association for Medical Directors of Respiratory Care hosted a multi-disciplinary consensus conference addressing specific applications for RAD in February 1998. The RMRP adopts all of the recommendations of the consensus conference, with exception of one. The recommendation not adopted concerns use of the device for severe chronic obstructive pulmonary disease (COPD) patients.

The RMRP for RAD is divided into four categories: (1.) restrictive thoraic disorders, e.g., neuromuscular disorders such as amyotrophic lateral sclerosis, (2.) severe chronic obstructive pulmonary disease (COPD), (3.) Central sleep apnea, i.e., apnea not due to airway obstruction, and (4.) obstructive sleep apnea (OSA). The RMRP for RAD used for COPD patients requires among other things, a facility-based polysonogram to rule out obstructive sleep apnea in order to initiate Medicare coverage, with a prerequisite trial of noninvasive ventilation without a backup rate and treatment with continuous positive airway pressure devices. We have been asked to review the RMRP for RAD for COPD patients and we will review entire RAD policy with the intent to make a national coverage decision.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
HCFA Coverage and Analysis Group N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/07/2000
Expected NCA Completion Date
11/04/2000
Public Comment Period
03/08/2000 - 04/08/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
06/29/2001

Contacts

Lead Analysts
Francina C. Spencer
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

February 17, 2000

Intent to review current policy regarding use of RAD in COPD applications and if necessary develop a national coverage policy posted on HCFA website.

April 25, 2000

Met with representatives of the Coalition of Respiratory Care Manufacturers and the American Association for Homecare. They requested that the scope of this review be more narrowly defined to include "a small subgroup of very severely ill COPD patients, who require RAD with backup rate."

May 7, 2000

Due date revised. HCFA has extended its original date to August 7, 2000 to accomodate a requested change in focus of the review to a narrower subgroup of very severely ill COPD patients who require RAD with backup rate in the home setting and should not be subject to a trial on a RAD without backup. Requesters suggest this subgroup of patients are those who have recently been discharged from prolonged hospitalization during which RAD with backup rate was required for an extended period and now need to continue use of RAD in the home setting. While we are continuing to analyze this coverage issue, we are requesting evidence that supports the use of RAD devices for this subgroup of very severely ill COPD patients, identifies the population, and establishes the criteria to be used for this population of COPD patients when these devices are used in the home.

August 4, 2000

Received two articles as evidence to support use of the ventilator with backup rate for severely ill COPD patients during this period and revised due date for coverage decision to November 4, 2000, to adequately consider the evidence.

June 29, 2001

Final Decision Memorandum posted.
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