The pace of Medicare policy changes this year keeps increasing at exponential levels. We have been dealing with massive proposed and final changes to the Medicare power wheelchair benefit, CMS is moving forward with implementation of competitive acquisition, and CMS has issued a 109-page draft set of financial and quality standards, to name just a few imminent regulatory changes. Congress is considering serious cuts to the HME industry to, in part, pay for hurricane relief efforts and reconciliation packages. The list of issues seems endless, and just when you begin to think you understand the latest development on an issue, something else rears its ugly head and changes.

What to do? If you are reading this, you have made a choice to help consumers live better lives in their homes. That seems to be the reason so many in this industry continue to slog through the issues, figure out ways to be more cost-effective, and deliver better quality than the competition.

So if you are in this industry, you have made a choice. If you have made this choice, you must act responsibly about that choice. Acting responsibly means making sure policymakers hear your views on the policies that impact how you do business. Right now we are faced with a draft set of financial and quality standards for DMEPOS suppliers that will apply to all suppliers (not just those directly impacted by competitive acquisition). Your responsibility this month is to submit comments to CMS on its draft set of financial and quality standards. The deadline is November 28, and you can submit your comments by sending them to this e-mail address:

DMEPOS_Quality_Standards_Public_Comments@cms.hhs.gov.

CMS issued the draft standards on September 23, 2005. You can view and download the draft document at the CMS Web site: http://www.cms.hhs.gov/suppliers/dmepos/compbid/default.asp.

The Medicare Modernization Act of 2003 (MMA) requires the Secretary of Health and Human Services to establish and implement quality standards for suppliers of DMEPOS. Suppliers will be required to comply with these quality standards to furnish any item or service for which payment is made under Medicare Part B, and to receive and retain a supplier billing number. These standards will apply to all suppliers, not just those in a geographic area chosen for competitive bidding.

We do not yet know the specific date that CMS will require suppliers to comply with the standards, once they are in final form. The MMA also permits CMS to allow suppliers to meet the standards through accreditation programs; but the accreditation programs will have to apply to CMS for “deemed status” once the standards are final—meaning that CMS has determined that the accreditation organization’s standards are consistent with the quality standards.

The Draft Standards
The draft standards are in two sections; the first are business standards that apply to all suppliers and focus on standards for administration, financial management, human resource management, beneficiary services, performance management, equipment and safety, beneficiary rights and ethics, and information management. The second section includes general supplier product service requirements, and specific product service requirements for the following products: oxygen and home invasive mechanical ventilation therapy; noninvasive continuous positive airway pressure (CPAP) and bi-level positive airway pressure; intermittent positive pressure breathing (IPPB); power wheelchairs; manual wheelchairs; diabetic equipment and supplies; customized orthotics and prosthetics; enteral nutrition; electric and manual hospital beds; support surfaces; walkers, canes, and crutches; commodes; and bedpans and urinals. In Phase 2, CMS has said it is developing standards for 18 additional product categories.

Product-specific services requirements include inspection and preparation (intake, service plan, and equipment management), delivery and setup (training/instruction to the beneficiary and caregiver), and follow-up. Each product-specific section details these requirements based on the product.

Importantly, once these standards are required, suppliers will not only have to be in compliance with them, but they will also have to document their compliance. You must read through the draft—the additional documentation responsibilities under the draft are enormous. There are also important “details” such as having a compliance program.

Don’t delay. Your comments need not be formal or legalistic, but you do need to provide recommendations on what the standards should say. Be constructive! DP

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