From the Hill
Medicare Drastically Revises Quality Standards
By Walter Gorski, AOPA Government Affairs Department
In August, the Centers for Medicare and Medicaid Services (CMS) published the final version of DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) quality standards. Meeting these standards, along with facility accreditation, will become a mandatory condition for payment under Medicare.
CMS will require that all organizations accrediting O&P facilities incorporate these quality standards into their programs. As of this writing, both the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist/Prosthetist Certification (BOC) will be submitting applications to be recognized as accreditation organizations by CMS.
Revisions contained in the final version of the standards were the result of intensive advocacy by AOPA and the newly formed Orthotic & Prosthetic Alliance.
Nevertheless, AOPA continues to have some concerns with the final standards and will be working with CMS officials to seek modifications.
Of note, CMS has not yet selected the accreditation entities that will be charged with enforcing the standards, nor has the agency specified when compliance with both the standards and accreditation will become effective. CMS officials say this information will be forthcoming.
Some good news
There are several noteworthy provisions
contained in the final standards. These changes show that when AOPA and
the O&P Alliance make a concerted effort, policy makers do listen.
First, the standards further differentiate O&P from durable medical equipment. This has been accomplished through an entirely separate set of clinical guidelines for O&P. Coupled with past advocacy efforts, we are continuing to make progress differentiating O&P from DME.
Moreover, while we continue to be classified as "suppliers" under Medicare, the standards refer to O&P practitioners as health care professionals on the same level as physical, occupational and respiratory therapists. We all knew this, but this is the first time it has been mentioned in an official Medicare document.
Next, the standards have been simplified from the initial version published last year. AOPA argued that compliance with last year’s draft standards would have provided significant and unnecessary hurdles to all O&P patient care facilities—particularly smal—that could severely impact access to O&P services. CMS heard our message and made changes.
Finally, it appears that any entity that currently has a supplier number and bills Medicare for a DMEPOS item or service, whether an O&P patient care facility, physician’s office or physical therapy practice, must meet the quality standards and accreditation requirements. Practitioners also will be required to satisfy continuing education requirements.
Specific details
The standards are organized in the same basic
structure outlined in the draft standards published in September 2005.
However, the requirements have been simplified and their scope scaled
back, which is likely to make compliance less burdensome, particularly
for small businesses.
There are still three main sections to the standards.
The first two sections, "General Business" and "General Product-Specific Standards," apply to all DMEPOS suppliers, regardless of the types of services or devices they provide.
The third section, "Product-Specific Standards," is only for those suppliers who provide the specific items or services identified by these product- specific standards, including custom orthotics, prosthetics and therapeutic shoes and inserts.
Two other sections of the standards apply exclusively to respiratory equipment, and to wheelchairs and power-mobility devices.
General business quality standards
The general business standards contain seven separate sections:
- Administration
- Financial Management
- Human Resource Management
- Consumer Services
- Performance Management
- Product Safety
- Information Management.
These are not new. What is new is that the requirements under each heading are far less prescriptive. Rather than dictating a single, specific method for compliance, suppliers can meet the requirements in a variety of ways. Further, many of the most onerous provisions have been eliminated.
For example, the original draft of the financial management section called for DMEPOS suppliers to report to CMS and the accreditation organization when they became aware of adverse financial conditions which could result in delayed payments or bankruptcy. This provision has been eliminated.
Also, requirements mandating formal balance sheets and statements of cash flows have been eliminated.
Now, the new requirements stipulate that suppliers must implement financial management practices that ensure accurate accounting and billing, reflecting cash or accrual-based accounting practices.
CMS also altered administration requirements. Suppliers will no longer be mandated to be open 40 hours a week or maintain toll-free telephone lines.
These are just a few of the changes that have been made.
Custom orthotics quality standards
The provisions contained in the product-specific
standards related to O&P show that CMS sought to find the least
burdensome approach to ensuring acceptable clinical practice.
Of note is that CMS is requiring that providers of customized O&P services offer access to a facility with the equipment necessary to provide follow-up treatment and fabrication/modification of the specific device.
However, there are some important details under this section, as well as other sections, that AOPA believes require improvement. We will be working to seek adjustments that do not impede the practice of O&P but also ensure that patients receive quality care.
What's next?
Timing is everything.
Unfortunately, many of the critical details explaining the new requirements are still missing.
When will competitive bidding begin? Where will it begin? What off-the-shelf orthotic devices, if any, will be subject to competitive bidding? When do facilities need to be accredited? Who will be selected as approved accreditation organizations?
These questions still remain unanswered.
AOPA, however, will not only be developing programs that help navigate the new complex environment and allow O&P facilities to thrive, but will also keep you abreast of the latest breaking news.
To view a copy of the final standards published by Medicare, please go to AOPA's Web site at www. AOPAnet.org.
Walter Gorski is the director of legislative and regulatory affairs for the American Orthotic & Prosthetic Association (AOPA).
