Nobody is crying wolf this time. If you are reading this column, you owe it to yourself to sit down at your computer and compose written comments in response to the May 1, 2006, NPRM.

This column and the HME industry have issued so many calls to action over the years that a comparison can be made with the boy who cried wolf. However, nothing in the past has threatened the industry more than the Notice of Proposed Rule Making (NPRM) on competitive acquisition (competitive bidding) published in the May 1, 2006, Federal Register. The NPRM is a masterpiece of vague obfuscation that can’t be left unchallenged.

The federal rule-making process requires the agency to consider every comment received and address the concerns in the final rule. That is why it is imperative that every provider take the time to carefully draft and submit concerns about the proposed rule. In the past, this task has been handled by trade association staff members, representatives of large provider networks, and manufacturers.

But this issue is too important to leave to this small group, no matter how professional they may be. If the industry is serious about slowing the implementation of competitive acquisition until it can get Congress to reconsider this policy, it must inundate CMS with comments. If you don’t know what to say in your comments, read on for some of the more outrageous examples contained in this hastily written NPRM.

It appears that CMS intends to include information from unqualified bidders in calculating the “single payment amount” (the winning bid amount). This means that a business that is incapable of meeting the financial and quality standards to be a provider under the competitive acquisition program can submit a “lowball bid” that will fundamentally taint the calculation of the final amount.

The NPRM introduces the concept of “consumer rebates.” The idea came out of thin air and runs counter to decades of health law that prohibits suppliers from offering inducements to beneficiaries, because that “inducement” may result in inappropriate Medicare expenditures. The lack of specificity could leave providers open to allegations of fraud and abuse.

By failing to identify the specific products that will be included in the competitive acquisition program, CMS prevents providers from accurately evaluating all the costs associated with procuring, delivering, and servicing those products. This is another transparent attempt to elicit lowball bids that can’t be sustained over time. Letters commenting on the NPRM should demand that a list of the products subject to competitive acquisition be published at least 12 months in advance of the date that bids are due.

The same thing can be said about the CMS failure to identify the geographic regions where competitive acquisition programs become effective in 2007. By waiting until the final rule is published, CMS makes it impossible for providers to begin gathering the necessary data to submit realistic bids. Remember, once the single payment amount is established, winning providers will have to live with it for years. While CMS says that this payment will be adjusted each year for inflation, Congress has a nasty habit of freezing Medicare payment rates.

The NPRM references quality standards but these standards have yet to be published in final form. Commenting on draft standards published last September, the industry proposed strong standards similar to those used in accreditation. CMS seems to be resisting strong standards. People commenting on the NPRM should tell CMS that providers need sufficient time to become accredited, once accreditation organizations have received “deemed status” from CMS. CMS has put the cart before the horse by publishing the NPRM on competitive acquisition before the quality standards have been published.

The grandfathering and transition policies are both unworkable and unfair. Use home oxygen services to demonstrate this point. The NPRM says that while losing suppliers may continue to service their oxygen patients at the new single payment amount, if they choose not to, “winning bidders” will have to serve these patients. A winning bidder could inherit an unknown number of patients who have been receiving home oxygen therapy for 20 or 30 months. The Deficit Reduction Act caps oxygen payments at 36 months when ownership of the equipment transfers to the beneficiary. How can a provider factor in these unknowable costs?

These are just some examples of what CMS has failed to address in the NPRM or of its proposed language that is either confusing or contrary to existing laws. The point is that the NPRM provides lots of fodder for comments. Comments are due on June 30, 2006, and may be submitted electronically to CMS at: www.cms.hhs.gov/eRulemaking.

Nobody is crying wolf this time. CMS has proposed rules that pose incalculable harm to the HME industry. If you are reading this column, you owe it to yourself to sit down at your computer and compose written comments in response to the NPRM.

Cara C. Bachenheimer, JD, is vice president of government relations for Invacare Corp, Elyria, Ohio. David T. Williams is a political and legislative strategy consultant.