Meeting Medicare’s New Quality Standards
By Kathy Dodson, AOPA Government Affairs

The release of the new quality standards is both good news and bad news for the O&P profession. The good news is that the new quality standards are an improvement over earlier draft versions. The bad news is that they could certainly be better for the field. 

The final version of the new quality standards is an improvement on recent iterations. (See “AOPA’s Work on the New Standards,” below, for more background.) 

AOPA and the O&P Alliance have conveyed to the Center for Medicare and Medicaid Services (CMS) our concerns regarding these standards and continue to work with CMS to improve them for O&P providers. As of mid-October, CMS had not yet announced when the new quality standards will be implemented or whether they will go into immediate effect nationwide or only initially in competitive bidding regions. 

The standards 
The standards have three sections pertaining to O&P: 

• Business services 
• General product-specific service standards 
• Appendix C, which refers specifically to custom-fabricated, custom-fitted and custom-made orthoses; prosthetic devices and therapeutic shoes and inserts. 

Meeting these standards is not optional, unlike the Office of the Inspector General compliance standards put out several years ago. You have to comply with these standards in order to obtain the accreditation that will be required to bill Medicare. You must also still meet the current 21 Medicare supplier standards. 

Due to the critical nature of compliance with these standards, AOPA is developing a quality standards compliance product to give you expert, step-by-step guidance on meeting these new requirements. Also, in the near future we will present in-person seminars and telephone audio conferences on this topic. All of these opportunities will be announced in the O&P Almanac and the AOPA In Advance newsletter, so stay tuned. 

While there is not enough space here to go into detail on all of the standards, here are some examples of each type here. You can find the complete list of standards on the AOPA Web site at www.AOPAnet.org, under the section “Hot Issues In O&P.” 

Business services 
Business services standards must be met by anyone who provides DMEPOS devices and services. The standards are divided into the following seven categories: 

Administration. Most of these standards are nothing more than restatements of current Medicare requirements or of ones already in current accreditation programs. For example, your organization needs to have at least one person who performs leadership functions, have a physical location, and supply some DMEPOS services. 

One change is that this document specifically states services will have to meet “applicable Food and Drug Administration regulations and medical device effectiveness and safety standards.” 

The section goes on to say that you will have to comply with Medicare coverage, claim processing and payment policies, as well as with the disclosure of ownership requirements included in the Medicare supplier number application. 

You will also have to designate one or more of your leadership staff to address compliance issues. While you must currently have a compliance officer for HIPAA issues, now this person, or someone else, should be responsible for Medicare standards compliance as well. 

Financial management. Medicare expects you to have accurate, complete and current financial records that link devices or services to patients through invoices, receipts and deposits. You will also have to have an operating budget and a mechanism to track actual revenue and expenses. These requirements are a significant reduction of Medicare’s earlier expectations, which included extensive financial reporting requirements and audited financial statements. 

Human resources management. This section requires O&P facilities to have policies specifying personnel qualifications, training, experience and continuing education requirements “consistent with the specialized equipment, items and services it provides.” 

But one area needs further clarification. The section says, “Professional personnel shall be licensed, certified, or registered and function within the scope of practice as required by the state standard under which the professional is licensed.” However, it does not define “professional personnel.” In addition, it also does not speak to whether a professional staff member who is not licensed, certified or registered may provide Medicare services if he is supervised by someone who meets these requirements. 

Consumer services. This section, which discusses how facilities should interact with patients, is in line with current practices in the field. For example, it requires that you provide clear instructions on devices’ use, maintenance and potential hazards and document the patient’s receipt of the item. 

However, it does also impose some very specific new requirements. If you find that you cannot provide the prescribed item, you must notify the referring physician within five calendar days. Unfortunately, it does not identify when the five-day period starts. It is assumed that this would be five days from the time you realize that you cannot provide the item, but that must be clarified with CMS. 

Another new requirement states that within five calendar days of receiving a patient’s complaint, you will notify the patient that you received it and are investigating. This investigation must then be completed and the written results sent to the patient within 14 calendar days. 

Performance management. This section covers outcomes, billing practices and adverse events. Some facilities may find that they must document their current practices or establish new ones. At a minimum, facilities will have to measure the following: 

• Patient satisfaction with and complaints about your services/devices 
• Timeliness of response to the patient’s questions, problems and concerns
• Impact of your business practices on patient access to care
• Frequency of billing and coding errors
• Injuries, accidents and hospitalizations due to inadequate or malfunctioning devices. 

Product safety. This section identifies the requirements to promote safe use of equipment and minimize safety risks and hazards, for both your staff and patients. It includes requirements for a plan to identify, monitor and report equipment failure, repair and preventative maintenance. You will also have to investigate any incident or injury in which an O&P device may be a contributing cause of a patient’s hospitalization or death. Such investigation must start within 24 hours of being notified of the problem. For less serious incidents, you have 72 hours to begin the investigation. For product safety, you will also have to have a contingency plan to allow your patients to be cared for in the case of an emergency or disaster that renders you incapable of providing their care. 

Information management. The final business services standard requires you to be HIPAA compliant, as well as meet any other applicable state standards. 

General product-specific service standards 
Like the business services standards above, the general product-specific standards must be met by anyone who provides DMEPOS items and services. These standards are divided into the following categories: 

Preparation. Medicare requires you to comply with its regulations, policies and DMERC/DMEMAC policies and articles. It also requires you to consult with the referring physician as needed to confirm an order or suggest any changes to the prescription, and that you ensure that the item is consistent with that prescription and the patient’s needs.

Delivery and setup. These requirements pose a problem. For example, they require that a loaner item be provided to a patient waiting for a repair. Clearly, this is not possible with any customized item. Confusingly, under Appendix C, CMS states clearly that the delivery and setup requirements do not apply to O&P. We have asked that CMS correct this section to say so as well. 

Training and instruction. You must provide the patient with information on the item’s features, use, cleaning, troubleshooting and maintenance, as well as advise the patient on safety. The patient’s chart must document that you have done so.

Unfortunately, the description of how you must tailor this training to your patient’s needs is unrealistically broad, stating that you must meet the patient’s “needs, abilities, learning preferences, language, and readiness to learn.” This is another area that we continue to discuss with CMS. 

Follow-up. Luckily, the follow-up section is innocuous, simply requiring that you provide follow-up services consistent with the type of equipment and the recommendations of the prescribing physician. 

Appendix C
This section covers custom-fabricated, custom-fitted and custom-made orthotics; prosthetic devices; somatic, ocular and facial prosthetics; and therapeutic shoes. However, its definitions of these terms are occasionally missing elements or are clearly just wrong. 

For example, under custom-made orthotics, the definition of how a molded-to-patient-model device can be fabricated leaves out measurements, which is contrary to CMS’ own definition in TLSO/LSO medical policy.

In addition, it has included direct-formed as a type of molded-to-patient-model device, when clearly this is not the case. 

Most perplexing, CMS has defined a prosthesis as a replacement for an internal body part, totally ignoring artificial limbs. All of these problems need to be resolved. 

Appendix C contains similar subcategories as earlier sections.

Preparation. Under preparation, CMS is looking for compliance with its regulations and policies. Practitioners must perform a diagnosis-specific clinical exam and, when appropriate, document with photographs. 

In addition, the O&P facility must establish patient goals, solicit patient feedback on the device’s effectiveness, discuss risks and benefits and refer the patient back to his or her referring physician if the treatment needed is beyond the practitioner’s scope of practice.

Training/instruction. These requirements encompass all of a practitioner’s usual activities, such as reviewing how to care for and maintain the device with the patient and monitoring for complications. 

Follow-up. An O&P facility must provide appropriate follow-up care, discuss repair/replacement options and timing, have (or have access to) equipment necessary to modify or adjust an item and urge appropriate follow-up as needed with the referring physician. 

Kathy Dodson is the senior director of government affairs for the American Orthotic & Prosthetic Association (AOPA). 

Questions? Call (571) 431-0810 or visit www.AOPAnet.org.