Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases

AMERICAN ASSOCIATION FOR RESPIRATORY CARE
9425 N. MacArthur Blvd, Suite 100, Irving, TX
75063-4706
(972) 243-2272, Fax (972) 484-2720
http://www.aarc.org, E-mail: info@aarc.org

July 10, 2007

Ms. Francina Spencer
Centers for Medicare and Medicaid Services
Room C1-12-13 Central Building
Mail Stop: C1 -09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

RE: NCA for Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases (CAG-00354N)

Dear Ms. Spencer:

On behalf of the American Association for Respiratory Care (AARC), I am pleased to submit comments as the Centers for Medicare and Medicaid Services (CMS) considers the merits of issuing a national coverage policy for nebulized medications to treat lung diseases.

The AARC is a 43,000 member national professional association of respiratory therapists who treat high risk patients with chronic conditions such as asthma and chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis. Respiratory therapists are the only health care providers who receive extensive formal education in aerosol therapy and who are tested for competency in aerosol therapy. The administration of prescription drugs via the lungs is a major component of the scope of practice for all respiratory therapists.

The AARC is disappointed that CMS has elected not to issue a national coverage policy for aerosolized medications to treat lung diseases at this time. According to CMS, this decision is based on its conclusion that there is lack of published medical evidence that would enable CMS to define specific patient populations that would benefit from certain nebulizer medication therapy, even though there are statistically significant outcomes that indicate the effective therapeutic use of nebulizers. Our comments and concerns regarding CMSS

• decision are outlined below.

Comment:

As the prevalence of COPD increases and the Medicare system is poised to begin covering the large cohort of Baby Boomers afflicted with COPD, the AARC believes the time has come for CMS to issue a national coverage policy or national guidelines for the appropriate use of nebulizers. To permit an ad hoc, inconsistent set of local determinations to evolve is not clinically appropriate and patently unfair to Medicare beneficiaries who suffer from debilitating lung diseases.

Currently, Medicare will cover the use of a nebulizer under Part B when the physician has determined that the patient has failed to achieve results when using a metered dose inhaler or dry powdered inhaler (MDI/DPI), now covered under most Part D drug plans.

However, without a definitive national policy or guidelines in place, it is up to the local contractor to determine what constitutes appropriate evidence that using a nebulizer in lieu of an MDI/DPI is warranted. CMS only indicates that the patient must have

• tried and failedd
• to use the MDI/DPI before Medicare will consider covering the nebulizer for medication delivery.

Therefore, each contractor may set its own trigger for when a patient has

• failedd
• on the MDI/DPI, and thus is qualified for a nebulizer. The acceptable physician documentation on the clinical need for a nebulizer or number of failed trials on the MDI/DPI can vary from one contractor to another. In the meantime, as the MDI/DPI trial and error process unfolds, patients for whom a nebulizer is the most appropriate medication delivery system are prevented from having coverage of the nebulizer until some arbitrary hurdle has been met.

The absence of a national coverage policy or set of guidelines that would establish coverage parameters is very similar to what has occurred with Medicare coverage a pulmonary rehabilitation services. Because there is no national coverage policy for pulmonary rehabilitation, there has evolved across the country an inconsistent patchwork of coverage policies for these important services. For example, a Medicare patient in need of pulmonary rehabilitation services in Florida, which has a clear coverage policy, will receive such services. However, if the same Medicare patient resided in Wyoming, this beneficiary would receive no pulmonary rehabilitation services, as the contractor for this state has historically refused to cover these services.

A patientt

• s diagnosis that determines the need for aerosol therapy does not clinically differ from state to state. Thus, a Medicare beneficiary should not have to meet arbitrary criteria that changes depending on where the patient lives.

There needs to be an agreed upon and nationally accepted criteria ( such as recognizing patient inability with MDI technique or what constitutes a poor MDI response) that can be used by physicians and accepted by contractors to fairly assess the clinical need to use a nebulizer in lieu of an MDI. A national coverage policy would achieve this goal.

Comment;

CMS should recognize that there are patients with specific physical, cognitive conditions or limitations for whom use of a nebulizer is the first and most appropriate choice for aerosol delivery. These patients should not be required to undergo a

• trial and errorr
• period with an MDI/DPI in order to meet an arbitrary benchmark set by a contractor before Medicare will cover a nebulizer. The physician should be permitted to make this determination accompanied with proper documentation. To optimize the clinical value of any aerosolized medication therapy, be it delivered by MDIs/DPIs or nebulizers, there must be the proper device selection, proper patient assessment and proper training of the patient. Aerosol therapy, no matter what the delivery mode is more than just
• aim and shoott

We urge CMS to take this opportunity and either issue a national coverage policy for the utilization of nebulizers or provide clear guidelines and standards that local contractors must adhere to when determining the appropriateness of a Medicare patient utilizing a nebulizer rather than the MDI/DPI.

The AARC recognizes that for most patients, the use of the MDI/DPI will be the clinically appropriate and cost efficient delivery system for aerosol therapy. However, there are patients who because of clinical or cognitive issues simply cannot perform effective MDI/DPI medication administration techniques. Thus, for this cohort of patients, a nebulizer will become the most appropriate delivery system for their aerosol therapy.

For this group of patients, who have been assessed by a clinician and it has been determined that the patient cannot effectively manipulate the MDI/DPI, the use of a nebulizer becomes the only practical alternative.

We do not support the current required Medicare

• trail and errorr
• process. A patient must try and fail an unspecified number of times on a MDI/DPI before a contractor will approve use of a nebulizer. The trial and error methodology permits the local contractor to determine, however it sees fit, what exactly constitutes trail and error and when a patient may be permitted to use a nebulizer that will be covered by Medicare.

We believe it is important to establish a national coverage determination or a national guidance document with clear parameters that would remove the current policy of local contractor determination of

• trial and errorr
• for nebulizer qualification. For example, there are certain patient characteristics defined below that should enable Medicare beneficiaries meeting these characteristics to bypass the trial and error policy and directly qualify them for Medicare coverage of a nebulizer.

The use of nebulizers is medically necessary in a number of Medicare patients for the following reasons including:

• Frailty
• Arthritis
• Sight impairment
• Memory lose or decreased mental capacity
• Exacerbation of a chronic condition such as COPD
• Inability to understand how to effectively use MDIs
• Inadequate hand/breath coordination
• Inadequate inspiratory force and volume

Both nebulizers and MDIs create a mist which must be inhaled in order to be deposited in the lungs. Maneuvers such as breath holding, adequate inspiratory flow, and hand/breath coordination are indispensable to effective use of all drug delivery systems. A nebulizer permits the patient to continue normal breathing patterns, thus not requiring an inspiratory pause (breath hold) for delivery of the medication, something that is necessary when using MDIs/DPIs.

A physician assessment of the patientt

• s overall physical, cognitive and clinical condition coupled with an assessment of the patientt
• s ability to effectively use a MDI/DPI should be the guiding parameters in determining the appropriateness of using a nebulizer over that of the MDI/DPI. The physician should be permitted to make this determination accompanied with proper documentation.

Further, we believe the determination of the appropriateness of substituting a nebulizer for the MDI/DPI should not be left to arbitrary decisions which will fluctuate on a local contractor level.

Recommendation:

For the reasons stated above, the AARC strongly urges CMS to reconsider its proposed decision and to issue a national coverage determination for nebulizer therapy in treating lung diseases. We support the issuance of such policy and recommend that it address the patient characteristics and documentation requirements for the coverage of a nebulizer, without requiring the current trial and error process for prior use of a MDI/DPI, as discussed in our comments.

As the incidence of lung illnesses increases, as more effective medications are available to treat these diseases, and as Medicare increases its responsibility to provide medical coverage of beneficiaries suffering from lung diseases, it is critical that Medicare have a coherent national coverage policy for aerosol medication therapy.

The AARC would be happy to offer its clinical expertise to CMS in the development of a national coverage policy or guidance document on this subject.

Sincerely,

Toni Rodriguez, EDd, RRT
President

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