Will You Be Prepared?

In September, CMS issued draft quality standards with which all durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers will have to comply at some time in the not-so-distant future. Most would agree that universally applicable quality standards can serve a number of positive functions.

First, if properly implemented, they reduce the risk that a Medicare beneficiary will be victimized by an unscrupulous provider. Accrediting entities will act as a private validation of a provider’s business processes, policies and actions. Second, the standards can serve as an important compilation of federal requirements for DMEPOS suppliers. Third, they create the opportunity for providers to improve their service to beneficiaries and the efficiency of their operations.

There are, however, significant concerns with the draft quality standards. First, preparing for accreditation is a very intensive and time-consuming process. Smaller suppliers will be disproportionately impacted because they are less likely to have the personnel to dedicate to the task. In many instances, the draft standards impose requirements that do not reflect the reality of small business operations or that may create particular hardship for small businesses.

Second, in many instances, the draft quality standards take an encyclopedic approach that will bind suppliers. Individually, many of these standards are not objectionable, but their separate delineation will require separate documentation during the accreditation process. Where possible, CMS should reduce the number of standards and make them more general.

CMS also will have to recognize that quality standards are likely to increase the standards with which all businesses will be required to comply if they wish to serve Medicare beneficiaries. The aggregate cost of all standards included in this proposal will significantly increase the cost of doing business with Medicare at a time when CMS is looking for ways to reduce its overall reimbursement rates for DME products. This must be taken into consideration as CMS compares its pricing schedule to other payers as it sets future fee schedules. With competitive bidding implementation looming closer and closer, suppliers will have to understand their total delivered costs in order to submit bids that are realistic.

Although not directly addressed in the draft standards, CMS needs to make its intentions clear about how it will deal with previously accredited suppliers. Currently, there is no requirement that suppliers be accredited, and once the quality standards are published and accrediting organizations named, there will be a significant bottleneck for the accrediting agencies. A clear policy statement from CMS on this issue favors all stakeholders and will encourage providers to seek accreditation now, promoting a smooth transition later when the standards are final. CMS should allow providers who are currently accredited to be “grandfathered” under the new standards at least until the provider’s next survey by the accrediting body.

Standards for financial management, performance management and compliance plans are included in the draft proposal. All of these types of standards require CMS to provide additional guidance on how scalability might be achieved. Unfortunately, the financial management standards demonstrate that the writers of the draft quality standards did not understand the business operations of small DMEPOS suppliers. The accounting standards would, at a minimum, impose a significant burden on small suppliers and, at worst, be insurmountable. While there is value in the function of quality improvement programs in encouraging providers to upgrade their performance continuously, this section is too detailed and will be burdensome on small suppliers.

CMS will issue a final set of quality standards next spring along with further information about next steps for accreditation organizations to obtain “deemed” status. Should you start the accreditation process if you are not already accredited, even though there are still multiple unknowns? Absolutely!

The 109-page draft set of standards, which includes many details that are mandatory reading for any HME provider, is available on the CMS Web site at www.cms.hhs.gov.

A specialist in health care legislation, regulations and government relations, Cara C. Bachenheimer is vice president, government relations, for Invacare Corp., Elyria, Ohio. Bachenheimer previously worked at the law firm of Epstein, Becker & Green in Washington, D.C., and at the American Association for Homecare and the Health Industry Distributors Association. You can reach her by phone at 440/329-6226 or by e-mail at [email protected].