Most HME providers are aware that the Secretary of the US Department of Health and Human Services (HHS) is required by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 to establish and implement quality standards for suppliers of items and services described in the Act. What does this mean to you? The quality standards will be applied by recognized independent accreditation organizations (to be designated) and suppliers shall be required to comply.

HHS has appointed a committee called the Program Advisory and Oversight Committee (PAOC), which will give advice to the Secretary and CMS regarding the quality standards. The new quality standards will definitely be more comprehensive because the Act states they cannot be less stringent than they are already. Also stated in the Act is that the accreditation organizations are to apply these new standards within 1 year after the Secretary has developed the new quality standards, but there is no date when the standards must be implemented. The goal of the standards is to rid the industry of questionable suppliers who abuse the program.

No specific time frame has been given for the recommended implementation. It does state, however, that the Secretary may establish the quality standards by program instruction or otherwise, to be applied prospectively. In addition, the Secretary shall designate the accreditation organizations within 1 year after development. The PAOC last met on March 2, 2005, and committee members were presented with a draft outline of the quality standards. The committee was informed that proposed regulations would be published in the Federal Register by summer 2005 with comments reviewed by fall 2005—and final review and publication in the Federal Register by spring 2006.

In Denial
During the past year, I have had a lot of contact with HME providers across the United States through consulting, surveying, lecturing at state association meetings, and attending Medtrade conventions. Initially, the majority of providers I spoke with were in denial of the reality of the HHS mandate. Requirements for accreditation coupled with unknown new quality standards, reimbursement cuts, price freezes, and competitive bidding were simply too much to confront. But recently, I sense an acceptance that it is time to start planning for the impending changes.

Yes, the preparation process will require time and money to improve organizations and comply with accreditation standards. With professional help, you and your staff may be able to accomplish the task in a much more timely and cost-efficient manner. A consultant can help by providing a policy and procedure manual, by educating your staff to new or existing processes, and organizing, restructuring, and identifying noncompliant areas of your company. Also, consultants can design a plan to monitor and implement standard changes so your organization remains compliant and ready for accreditation. You don’t have to remortgage your home to complete the necessary compliance changes for the accreditation process. The fear of exiting the industry because it is just more than you can accomplish need not be a fear.

Don’t risk losing your Medicare supplier number because you have procrastinated. Putting off the inevitable could place the accrediting body you have selected in the position of not being able to survey your organization by the government’s deadline. Your decision to begin the process will decrease the annoyances you endure and quiet that little voice that says, “You should have started sooner.”

Unanswered Questions
• Will one or more of the current accreditation organizations be approved to accredit the 18,000 plus companies billing Medicare?
• Do the yet-to-be-approved accrediting bodies have the resources to survey and accredit the nonaccredited companies in the time frame required by HHS?
• Will the corporate compliance program that the OIG encouraged the industry to implement become mandatory?
• Will external benchmarking be required?
• Will advisory committee input be required for all HME providers?
• What are the 10 metropolitan statistical areas (MSAs) that will comprise the competitive bidding program to be implemented by 2007? (with 80 MSAs by 2008 and additional MSAs by 2010)?

Wayne M. Link is the founder and president of Link Consulting Group Inc, Columbus, NC, a firm that specializes in HME consulting services. He can be reached via email: wml990@alltel.net.