AAHomecare to CMS: Withdraw Nebulizer Draft LCD

WASHINGTON–The American Association for Homecare is urging CMS
to withdraw its nebulizer draft local coverage determination,
contending that it is not supported by conclusive medical
evidence.

In March, the DME Program Safeguard Contractors proposed the
following coverage changes in a draft LCD:

• Payment for levalbuterol will be based on the allowance for
  albuterol.
• Payment for DuoNeb will be based on the allowance for separate
  unit dose vials of albuterol and ipratropium.
• Coverage of amikacin, atropine, beclomethasone, betamethasone,
  bitolerol, dexamethasone, flunisolide, formoterol, gentamicin,
  glycopyrrolate, terbutaline and triamcinalone will be eliminated
  because there is inadequate support in the medical literature for
  administration using a DME nebulizer. Coverage will be limited to:
  acetylcysteine, albuterol, budesonide, cromolyn, dornase alpha,
  iloprost, ipratropium, isoetharine, isoproterenol, levalbuterol,
  metaproterenol, pentamidine, and tobramycin.
• Maximum milligrams/month for budesonide are defined.

One of the biggest problems with the coverage draft, AAHomecare
said, is the decision to pay no more for Xopenex and non-compounded
combined albuterol and ipratropium bromide than the Medicare
payment amount for different, generic drugs.

According to the association, there is an abundance of
literature available that provides evidence of the therapeutic
differences between branded and generic drugs. However, the PSCs
only provided data from 22 references, AAHomecare said.

“Such a selected literature search provides a slanted view of
two of the primary drugs used for several years to treat the
fourth-leading cause of death, chronic obstructive pulmonary
disease (COPD),” the association said.

Neither providers nor beneficiaries will be able to “subsidize
the financial loss generated by the cost of the drug,” AAHomecare
said, adding that “if implemented as currently written, the draft
nebulizer LCD will essentially eliminate the physician’s ability to
effectively prescribe medically necessary drugs that they believe
will serve the Medicare beneficiary’s health and well being in
accordance with best clinical practice and current standards of
care.”

An estimated one million Medicare beneficiaries require home
inhalation therapy, based on Medicare expenditures from 2003 and
2004, and about a half million currently require either DuoNeb or
Xopenex, according to the association.

“The absence of published science with regard to the drugs
proposed to be eliminated from Medicare coverage does not equate to
an absence of medical necessity on the patient’s part,” AAHomecare
said.

To view CMS’ nebulizer draft LCD,
click here.

The deadline for comments on the draft LCD is today. Comments
should be submitted via e-mail through each DME PSC’s Web site.

To contact your PSC, visit:

• Region A/B, Tricenturion, www.tricenturion.com;
• Region C, TrustSolutions, LLC, www.trustsolutionsllc.com;
  or
• Region D, EDS, www.edssafeguardservices.eds-gov.com.