Noninvasive Positive Pressure Ventilation Letter Campaign Points

The ruling by the Health Care Financing Administration (HCFA) for Noninvasive Positive Pressure Ventilation (NPPV) was issued June 1, 1999, with an October 1, 1999, effective date, with several changes that are in conflict with current clinical practice and legal uses of NPPV. It is important that members and others concerned with patient safety write to their Senators and Representatives to urge them to take action with the HCFA Administrator. Please include the issues marked required and other specific points in your letter.

Required Background:

• The matter concerns: Provisions of the June 1, 1999, Durable Medical Equipment Regional Providers (DMERCs) Medical Policy for Noninvasive Positive Pressure Ventilation (NPPV) ventilators, and the Health Care Financing Administration's (HCFA) position on the payment category for NPPV.
• The policy was changed without proper fairness and due process, at the last minute, and not subject to an open and timely comment period.
• Urge (as strongly as possible) your Senators and Representatives to take immediate action by contacting the HCFA Administrator. They should ask HCFA to fully conform, with no exceptions, to the clinical criteria agreed to by the nation's leading physicians during the 1998 Consensus Conference.
• Ask your Congress member to tell the HCFA Administrator that any attempt to claim that NPPV ventilators were miscoded in 1992 is: in contradiction to Congress' actions in 1993, the FDA's actions in 1995, and the Consensus Conference in 1998. Current reimbursement practices, which have been in effect for nearly eight years, classify NPPV ventilators in the "Frequent and Substantial Servicing" category. Coding changes by HCFA require advanced­approval by Congress.

Background Information (you may selectively include):

• The June 1, 1999, DMERC policy raises issues not included in the July 27, 1998 Draft Medical Policy.
• The policy is inconsistent (or in conflict) with clinical criteria outlined in the February 1998 Consensus Conference on Noninvasive Positive Pressure Ventilation, attended by the nation's leading physicians.
• Policy is inconsistent with the Medical Literature.
• Policy requires physicians to write "off label" prescriptions (or to use the NPPV ventilators in ways they are not intended) for a prerequisite trial of up to three months as a respiratory assist device, before NPPV ventilators can be prescribed.
• The policy is inconsistent with Classification and labeling determinations of the FDA's 1995 Guidance Document, in which NPPV was cleared for treatment of respiratory insufficiency and failure while respiratory assist devices were cleared to treat adult obstructive sleep apnea.
• Inconsistent with HCFA's Medicare Carriers Manual.
• The Policy denies NPPV coverage for COPD patients with CO2 levels below 55 mm Hg, a policy that is contrary to clinical criteria agreed to during the 1998 Consensus Conference and medical literature.
• HCFA coded the payment category as "Frequent and Substantial Servicing" (EO453) in 1992. This coding was reaffirmed and codified in1993 of Section 1834 (a)(3)(A) of the Social Security Act and in the 1995 FDA Guidance on Ventilators, which stated that NPPV was used to treat more sick and different patients that the respiratory assist devices in the "Capped Rental Category". The 1998 Consensus Conference reinforced the long­standing clinical practice of providing "Frequent and Substantial Servicing" for NPPV. Medicare has been coding NPPV as Frequent and Substantial for almost eight years.

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