You already know that CMS issued the Final Quality Standards in August 2006. But you might not be aware that CMS released an update to the standards in October of 2008, so we have Final Standards once again!
The standards can be found at www.cms.hhs.gov/MedicareProviderSupEnroll. On the left column of the page, click "DMEPOS Accreditation," then select the Adobe document titled "DMEPOS Accreditation Standards." The revisions are highlighted in yellow.
One of the first updates is the requirement to track patient and staff infections. It looks as though CMS pasted "and infections" throughout the document. While this may seem a bit odd, it really speaks to the issue that the original Final Standards did not address.
Maintaining proper infection control practices has always been one of the hallmarks of accreditation. By adding a requirement to track infection rates related to the use of equipment for patients and staff, HME providers will have a mechanism to monitor whether staff members may be spreading infection, either their own infections or through improper cleaning and transportation of equipment.
Another update applies to suppliers providing complex rehab wheelchairs and assistive technology. These are the Group 2 and Group 3 power chairs. The Final Standards now require that these providers employ at least one qualified individual per location, designated as a Rehabilitative Technology Supplier (RTS). A qualified RTS is identified as one who has one of the following credentials: Certified Rehabilitative Technology Supplier (CRTS); Assistive Technology Supplier (ATS); Assistive Technology Practitioner (ATP); or Assistance Technology Professional (AT).
And by "employ," CMS means this individual must be a staff employee, not an independent contractor. An employee receives a payroll check and a W-2 at the end of the calendar year. This change may sound small, but could be cumbersome for many providers. Employees are entitled to benefits such as sick time, vacation days and pension or retirement plans.
For orthotic and prosthetic providers, there are now many more definitions and requirements to follow affecting all those who provide therapeutic (diabetic) shoes. The new standards require that suppliers have appropriate equipment and tools for follow-up treatment such as modification, adjustment, maintenance and repair to products when needed.
The revisions state that individuals supplying therapeutic shoes must possess specialized education, training and experience in fitting, and certification and/or licensing. For pharmacies and small suppliers providing these items, compliance may prove to be cost- or labor-prohibitive. The new definitions listed are for such items as "Custom Fitted," and for therapeutic shoes, there are new definitions for "Custom-Molded Shoes," "Depth Shoes" and "Inserts." The requirements continue with additions to intake and assessment and training/instruction.
The revised Final Standards also includes a new Performance Management requirement to measure not just beneficiary satisfaction but to seek input from staff and referral sources. Assessing employee or referral source satisfaction can be done annually to meet this requirement, unless your accreditor has a different expectation.
While there are other minor changes within the standards, one other that bears review is a new requirement found under Product Safety. CMS now requires the provider to verify, authenticate and document the following prior to distribution, dispensing or delivering products to an end-user:
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That products are not adulterated, counterfeit, suspected of being counterfeit and have not been obtained by fraud or deceit; and
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That products are not misbranded and are appropriately labeled for their intended distribution channels.
While we're not really sure where CMS is going with enforcement of this new requirement, suppliers should ensure they are stocking appropriately labeled items and that they have purchase receipts for all items from legitimate wholesalers in case this is ever called into question.
Mary Ellen Conway, RN, BSN, is president of Capital Healthcare Group, LLC, Bethesda, Md., which provides health care management expertise in accreditation preparation and survey follow-up, operations assistance, design of quality improvement programs and outcome measures. You can reach her at 301/896-0193 or through www.capitalhealthcaregroup.com.
