June 15, 1999

Mr. Joel Kaiser
Health Care Financing Administration
Room C5-06-27
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Mr. Kaiser:

The American Association for Respiratory Care (AARC), a 36,000 member professional association of respiratory therapists and other health care professionals has serious concerns with the provisions of the June 1999 policy on noninvasive positive pressure ventilation (NPPV). The policy is referred to by the Health Care Financing Administration (HCFA) as Respiratory Assist Devices (RAD).

The AARC is particularly concerned with two specific aspects of the final policy: Payment Reclassification and Restrictive Coverage Criteria.

Issue #1: Payment Reclassification

We believe HCFA's proposal to reclassify, for payment purposes, NPPV ventilators from the "frequent and substantial servicing" category to the "capped rental" category arbitrarily reinterprets current statutory law, ignores years of documented transmittal and coding precedents, and dismisses the clinical complexities involved in providing safe and effective NPPV therapy.

The AARC unequivocally opposes HCFA's effort to reclassify NPPV ventilators from the "frequent and substantial servicing" category to the "capped rental" category for payment purposes. We believe HCFA has neither the legal authority, nor the support of the Food and Drug Administration (FDA), nor the support of historical precedent, nor the clinical justification to support such a decision.

Legal Authority
In 1993, Congress enacted explicit language to the Social Security Act that specifically established two exceptions to the list of ventilators classified under the "frequent and substantial servicing" category. The Social Security Act, Section 1834 (a) (3) (A) states:

Payment for a covered item (such as IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or intermittent assist devices with continuous airway pressure devices) for which there must be frequent and substantial servicing in order to avoid risk to the patient's health shall be made on a monthly basis for the rental of the item....

It is clear that Congress had opportunities to include NPPV ventilators as additional exceptions to the "frequent and substantial servicing" category. It was the intent of Congress not to add NPPV ventilators to the exceptions list. At the time this provision was enacted, the AARC was intimately involved in discussions with the Senate Finance Committee and the House Ways and Means Committee regarding the structure of this provision. It is this Association's contention that Congress made a deliberate and conscious decision to keep NPPV ventilators as part of the "frequent and substantial servicing" category.

Food and Drug Administration (FDA) Classification
NPPV ventilators can be readily distinguished from "intermittent assist devices with continuous pressure devices" or other respiratory assist devices currently classified under the "capped rental" category. NPPV ventilators are completely different in their structure, function, and potential to fail in service.

The FDA device clearances make unambiguous distinctions between devices that are "intermittent assist devices with continuous pressure devices" and ventilators. The FDA applies the same level of scrutiny to NPPV ventilators as it does in determining the safety and effectiveness of invasive ventilators. The FDA clearly recognizes that there are differences in the underlying clinical conditions that are treated with intermittent assist devices and NPPV ventilators. NPPV ventilators are indicated for critical, acute, and/or long-term treatment of respiratory insufficiency and respiratory failure, whereas the FDA has cleared intermittent assist devices for obstructive sleep apnea, a less critical condition. NPPV ventilators and respiratory assist devices are two mutually exclusive medical products used to treat different patient populations with separate medical protocols and procedures.

Historical Precedent
Throughout the last seven years the Medicare program has, without question, classified NPPV ventilators in the "frequent and substantial servicing" category. This fact has been communicated through a vast array of program pronouncements, transmittals, coding clarification letters, Medicare Carriers newsletters, correspondence from DMERC Medical Directors, and others. HCFA has established the unequivocal interpretation that EO453 appropriately encompasses NPPV ventilators.

By implementing this policy, HCFA will reverse seven years of definitive and documented confirmation that NPPV ventilators are appropriately part of the "frequent and substantial servicing" category. We do not believe the Agency can simply rename NPPV ventilators as "respiratory assist devices" and, thereby, justify the reclassification to the "capped rental" category.

Based solely on statutory restrictions, FDA clearances, and overwhelming historical precedent, the Agency must abandon any consideration of NPPV ventilator reclassification to the "capped rental" category.

Clinical Justification
Moreover, it appears that as HCFA contemplates such a reclassification, no consideration has been given to the unacceptable health risk patients will face if this inappropriate reclassification were to occur. Reclassification of NPPV ventilators from the "frequent and substantial servicing" category to the "capped rental" category for payment purposes will virtually eliminate the key clinical component -- that is the assessing of the patient and the servicing of the ventilator that permits NPPV therapy to be an effective medical intervention.

NPPV ventilators are prescribed by the physician for patients suffering from specific and severe respiratory disorders. The ventilators initiate breaths, control intervals between breaths, and inflate the patient's lungs. As with all ventilators, NPPV ventilators require: frequent servicing, adjustments to the ventilator, and clinical assessment of the patient's medical condition in order to assure (1) that the patient's safety and health are not being jeopardized and (2) that the patient is maximizing the medical benefits of NPPV therapy.

The health risks of suboptimal servicing and care for patients utilizing NPPV ventilators are so serious, that it is the medical standard of care for home care providers to use the skills and knowledge of respiratory therapists in providing frequent patient assessment and servicing of the equipment. Suboptimal settings or ventilator failure for NPPV patients with severe COPD can result in toxic levels of carbon dioxide in the blood, carbon dioxide narcosis, carbon dioxide psychosis, irreversible brain damage, or death.

Respiratory therapists are the essential health care providers employed in servicing the patient on NPPV therapy. The primary purposes of respiratory therapy patient visits are: (1) to assess the patient's physical condition and response to the therapy, (2) to ensure the ventilator is set properly in response to the patient's changing physical condition, (3) to ensure the ventilator is operating properly in a home environment that supports the proper use of the ventilator itself, and (4) to convey to the prescribing physician the patient's clinical and overall response to the NPPV therapy.

It is an accepted medical standard of care that a respiratory therapist will visit the patient five to six times during the first week of therapy, three times during the second week of therapy, twice during the third week of therapy, and once during the fourth week of therapy. Thereafter, it is expected that a respiratory therapist will, at a minimum, assess the patient, the ventilator, and the home environment once every four weeks. Aggressive patient follow-up is considered the most important factor in determining the long-term success of NPPV therapy.

The AARC believes that reimbursement reclassification will place patients, physicians, and at-home care providers in an untenable situation. Physicians will be reluctant to prescribe NPPV therapy in a reimbursement environment that will not support the necessary critical medical assessment and servicing infrastructure. Home care providers will no longer have the financial resources to provide the clinical and servicing structural supports needed for the provision of safe and effective NPPV therapy. Patients who do receive this therapy will be at risk, because optimum medical standards of practice will no longer be provided.

We believe HCFA must consider the overall picture of providing NPPV and the clinical ramifications of this effort to reclassify, for solely payment purposes, NPPV ventilators. Ignoring patient safety and effective NPPV therapy standards of care will result in serious medical complexities.

Issue #2: Restrictive Coverage Criteria

The final policy continues to selectively dismiss medical recommendations, guidelines, and criteria established by the medical community in regards to the provision of NPPV therapy. Of particular concern is the overly restrictive coverage criteria for NPPV therapy as it pertains to chronic obstructive pulmonary disease (COPD) patients.

Clinical Comments
The AARC recommends that HCFA revise the clinical coverage criteria of this final policy to fully conform to the recommendations set forth in this statement and to the provisions of the two nationally recognized medical consensus conference reports regarding the appropriate clinical indicators qualifying a patient for NPPV therapy.

These medical consensus conferences were convened to address the comprehensive aspects of providing NPPV therapy as a medically appropriate and beneficial treatment for patients afflicted with a variety of restrictive thoracic diseases. Both the 1997 "Noninvasive Positive Pressure Ventilation" conference sponsored by the American Respiratory Care Foundation and the 1998 "Clinical Indications for the Use of Noninvasive Positive Pressure Mechanical Ventilation" conference sponsored, at the request of HCFA, by the National Association for Medical Directions of Respiratory Care (NAMDRC) developed consensus statements that delineated disease characteristics that best respond positively to NPPV therapy.

While the AARC acknowledges that HCFA revised the 1998 proposed coverage policy to, in some instances, more closely conform with the medical consensus document, the criteria in the final policy, as it pertains to the clinical criteria necessary for a COPD patient to qualify for NPPV therapy, remains inadequate.

The coverage policy continues to strictly adhere to a limited set of defined diagnostic indicators as the only avenue for qualifying for NPPV therapy. The AARC agrees that specific physical parameters and diagnostic tests are essential components in determining the appropriateness of NPPV therapy; however, these indicators should not be the sole criteria in therapy coverage determination.

The policy does not acknowledge that a physician's medical judgment, experience, and individual assessment of a specific patient's condition and circumstance plays any factor in the determination of the appropriateness for NPPV therapy coverage. The AARC continues to recommend that the frequent hospitalization or re-hospitalization of a COPD patient be acknowledged in the medical coverage criteria as a legitimate indicator that NPPV therapy is appropriate.

Polysomnographic Study Sites
In the final policy only facility-based laboratories can be the sites for the performance of sleep study tests. The policy fails to recognize that such a curtailment in available testing entities will have a far-reaching effect on the patient's ability to qualify for NPPV therapy.

The AARC's August 1998 comments raised the issue of patient access, cost, physical hardship, and inconvenience to Medicare patients who must travel to facility-based labs for the testing procedures. We also commented that HCFA assumes that there will be unimpeded availability of appointment times for the patients to undergo the testing. A delay in patient testing will delay the start of NPPV therapy, thus jeopardizing the health of the patient. We emphatically reiterate our support for the development of operational and personnel standards to assure that other sites of care, such as mobile laboratories or at-home testing units can safely, appropriately provide required sleep study testing.

Patients with Restrictive Lung Disease
The final policy requires that patients with restrictive lung disease meet all defined criteria. The NAMDRC Consensus Conference statement recommends that a patient meeting any one of the defined criteria should be considered a candidate for NPPV therapy. Thus in accordance these recommendations, we request the policy be revised to eliminate the prescriptive requirement for all criteria.

Furthermore, the Consensus Conference statement recommends that a patient be considered for NPPV therapy if the noninvasive measurement of forced vital capacity is less than 50% predicted or the maximal inspiratory pressure is less than 60 cm H2O. The AARC exhorts the adoption of this criteria in accordance with recommendations of the Consensus Conference.

Patients with Chronic Obstructive Pulmonary Disease (COPD)
The coverage policy continues to strictly adhere to a limited set of defined diagnostic indicators as the only avenue for qualifying for NPPV therapy. The AARC agrees that specific physical parameters and diagnostic tests are essential components in determining the appropriateness of NPPV therapy; however, these indicators should not be the sole criteria in therapy coverage determination.

The policy, again, requires that all criteria must be met by the patient in order to qualify as a candidate for NPPV therapy. This is not in accordance with the recommendations set forth in the Consensus Conference.

The policy does not acknowledge that a physician's medical judgment, experience, and individual assessment of a specific patient's condition and circumstance plays any factor in the determination of the appropriateness for NPPV therapy coverage. The AARC advises that the frequent hospitalization or rehospitalization of a COPD patient be acknowledged in the medical coverage criteria as a legitimate indicator that NPPV therapy is appropriate.

CONCLUSION

The AARC strongly urges HCFA to adopt the criteria recommendations on the coverage of NPPV therapy as set forth by the medical consensus conference documents.

Furthermore, given the statutory requirements, FDA clearances, years of voluminous historical precedent, and, most importantly, the unambiguous health risks to the patient, HCFA must not remove NPPV ventilators from the "frequent and substantial servicing" category.

Sincerely,

Dianne N. Kimball, RRT
President


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