Standards, Standards Everywhere!
By Kathy Dodson, AOPA Government Affairs Department

Just when you think you have one set of Medicare standards down pat, another version shows up. This is happening for both the quality standards that were introduced last year and the supplier standards that have been around for quite a while. Since you must meet these standards in order to remain eligible to bill Medicare, let’s go over what is happening for each of these regulations and how they may affect your business.

Quality standards
Medicare’s first draft of the quality standards, which were mandated by the Medicare Modernization Act of 2003, came out in August 2006. Since then, the Centers for Medicare and Medicaid Services (CMS) has made a number of changes and issued a “final” version last year.

However, CMS recently came out with more changes and asked for comments from interested parties. AOPA, in conjunction with the O&P Alliance, provided formal comments, but CMS has not yet announced its decision on the changes. You can see these comments by going onto the AOPA Web site at www.AOPAnet.org.

Here is a summary of the proposed changes, for you to review to see if you are in compliance. (You can find the full version of these at www.AOPAnet.org.) If you are not in compliance, consider what changes you would make to meet the standards, but remember that these are not yet final. As soon as they are, AOPA will publish the approved version.

Proposed changes

1.     Facilities must have job descriptions for their professional staff that specify personnel qualifications, training, certifications/licensures where applicable, experience and continuing education requirements.

2.     Both written and oral instructions on use, maintenance and potential hazards must be given to the patient and/or caregiver.

3.     The make and model number of any non-custom equipment provided must be documented in the patient’s file.

4.     Within five calendar days, the facility will notify the referring physician if it cannot or will not provide the equipment prescribed.

5.     Facilities will seek input from employees, customers, and outside sources when assessing the quality of its operations and services.

6.     Facilities must verify, authenticate and document that products are not adulterated, counterfeit, have not been obtained by fraud or deceit, are not misbranded and have been obtained through a distributor or wholesaler authorized by the manufacturer.

7.     The patient’s prescription and applicable documentation must be kept, unaltered, in the patient’s record.

8.     The facility must ensure that all equipment is consistent with the prescribing physician’s orders and other patient needs, risks and limitations.

9.     For initial equipment, the facility must verify and document that the patient and/or caregiver has received instructions on the use of the equipment.

10. The facility must ensure that the patient can use all the equipment safely and effectively in the settings of anticipated use.

11.     Facilities must have access to equipment necessary to be able to modify, adjust, maintain and repair devices.

12.     Individuals providing devices must possess specialized education, training and experience in fitting devices and, when appropriate, must be certified and/or licensed.

13.     Practitioners must assess the patient’s need for and use of the device (e.g., comprehensive history, pertinent medical history, skin condition, diagnosis, demographics, family dynamics, previous use of a device, work history, vocational activities, results of diagnostic evaluations and patient expectations).

14.     Facilities must determine the appropriate device based on the patient’s needs, to ensure optimum therapeutic benefit and appropriate strength, durability and function.

15.     The patient and/or caregiver must be informed of the procedures for repairing, replacing and/or adjusting a device, the possible risks and the estimated time involved.

16.     The practitioner must perform an in-person, diagnosis-specific, functional clinical examination as it relates to the use of and need for a device.

17.     Goals and expected outcomes for the use of the device must be established, with feedback from the prescribing physician and/or patient as necessary to determine the effectiveness of the device.

18.     There must be a face-to-face fitting/delivery.

19.     Instructions must be provided to the patient and/or caregiver on use, maintenance, hygiene, donning/doffing, adjusting closures, skin issues, use of appropriate interfaces and how to report any problems.

20.     The practitioner must establish an appropriate wear schedule and continue to assist the patient until the device reaches optimal fit and function.

Clearly, there are still issues with many of these proposed standards and we have made the field’s concerns clear to CMS staff. As soon as CMS announces its decisions on these, we will make them available to the membership.

Supplier standards
For a number of years, any company enrolling to bill the Medicare program has had to attest that it would comply with 21 supplier standards. The standards were included as part of the Form 855S that had to be completed to apply for a Medicare supplier number.

Several years ago, CMS announced four proposed new standards having to do with accreditation, but never fully implemented them. Now, however, a new 855S has been put in place and these four standards are included in it:

22.     All suppliers of DMEPOS and other items and services must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services for which the supplier is accredited in order for the supplier to receive payment for those specific products and services.

23.     All DMEPOS suppliers must notify their accreditation organization when a new DMEPOS location is opened. The accreditation organization may accredit the supplier location for three months after it is operational without requiring a new site visit.

24.        All DMEPOS supplier locations, whether owned or subcontracted, must meet the DMEPOS quality
standards and be separately accredited in order to bill Medicare. An accredited supplier may be denied enrollment or their enrollment may be revoked, if CMS determines that they are not in compliance with the DMEPOS quality standards.

25.  All DMEPOS suppliers must disclose, upon enrollment, all products and services, including the addition of new product lines for which they are seeking accreditation. If a new product line is added after enrollment, the DMEPOS supplier will be responsible for notifying the accrediting body of the new product so that the DMEPOS supplier can be re-surveyed and accredited for these new products.

If you must send in a new 855S form, you will need to attest to these new requirements.

In addition to these, CMS has recently come out with even more new standards and asked for comments. AOPA and the O&P Alliance submitted formal comments on them and are waiting to hear the final CMS decision. You can see a copy of these comments on the AOPA Web site.

A summary of these last new standards, numbers 27 through 31 (number 26 is currently held in reserve), follows below.

27.        This relates to the provision of oxygen and is not applicable to O&P suppliers.

28.        This new standard requires that suppliers maintain ordering and referring documentation, including the NPI received from the physician, nurse practitioner, physician assistant, clinical social worker or certified nurse midwife, for seven years after the claim is paid.

29.        This standard prohibits suppliers from sharing a practice location with another Medicare supplier, including a physician/physician group or another DMEPOS supplier.

30.        This standard requires that supplier facilities be open a minimum of 30 hours per week, but excludes orthotic and prosthetic suppliers.

31.        The final standard would require that suppliers not have any IRS or state taxing authority tax delinquencies.

As you can see, there are a lot of new requirements with which you will be expected to comply, either immediately or in the near future. So take a look at the actual quality and supplier standards on the AOPA Web site and start assessing what, if any, changes you need to make at your facility.

To help you with this task, AOPA will be presenting a one-day seminar on September 14 in Chicago (the day after the AOPA National Assembly) on the new quality and supplier standards. Watch your AOPA In Advance newsletter for more information, or contact me at kdodson@AOPAnet.org with any questions on content. For registration information, contact Erin Kennedy at ekennedy@AOPAnet.org or (571) 431-0834.  

Kathy Dodson is the senior director of government affairs for AOPA. Questions? Call (571) 431-0810 or visit www.AOPAnet.org.