Rules have changed. The range of products and services to be reviewed by any accreditation surveyor has increased, and accreditors are reviewing more activities than ever. Because Medicare will eventually require accreditation, the list of products and services that must meet specific standards has expanded.

Historically, most accreditation organizations turned a blind eye to any HME service provided—except rental medical equipment that had been delivered to the patient's residence. The medical equipment provider had to have an "ongoing" relationship with the customer, and services had to be provided in the home. In fact, if a medical equipment company only sold supplies or equipment, they were not even eligible for accreditation by some organizations—with the exception of rehab providers if the period between the initial evaluation and final delivery of the purchased wheelchair met the criteria of an "ongoing relationship."

All this changed last year when accreditation organizations became "recognized" by Medicare as part of the mandatory accreditation process for competitive bidding. Medicare now requires that the next time you see an accreditation representative, the surveyor will review any service that is billed on behalf of the patient, regardless of whether the customer walks in the door to pick it up, it is sent from your business as a mail-order supply, or even if it is drop shipped direct to the patient.

ALL SERVICES, ALL PAYORS

When the Medicare quality standards were released last year in tandem with mandatory accreditation for competitive bidding, confusion reigned. DMEPOS suppliers now have both the 21 supplier standards to demonstrate compliance when a National Supplier Clearinghouse-Medicare visit occurs and the more detailed quality standards reviewed by all accreditation organizations.

Many providers think that the quality standards apply only to their Medicare customers. This is incorrect. The accreditation organizations are applying these standards to all customer relationships. Even if your company never bills Medicare, the accreditation organizations are going to apply the CMS quality standards consistently to eligible services, regardless of what insurance company or government agency is billed. In particular, retail customers and the following products now will be consistently included in the survey process: prosthetics such as mastectomy products; orthotics (either off-the-shelf or custom fabricated); surgical supplies; wound care products; diabetic strips; and urologicals.

If you have not done it already, review the CMS quality standards (www.cms.hhs.gov [PDF]). If your company became accredited prior to 2007, this document details changes that will require an update to your policies and forms.

If you provide mail-order products to patients, note that within the II)?General Product Specific Standards, there is a rule you need to know. The CMS requirement states you must verify that the beneficiary has received training and instructions on the use of items at the time of initial mail-order delivery; and record in the beneficiary's record that such instruction was provided.

Historically, Medicare providers were allowed to bill CMS with the UPS tracking number as confirmation of delivery. This tracking number is not sufficient to meet the new requirement.

For the first (initial) shipped item, your company must ensure the patient received instruction on the item sent. Most diabetic and ostomy supply items have manufacturer-provided instructions; and printed on the box for wound care items are instructions such as "store in a cool dry location … wash your hands with soap and water before handling." You may want to create a one-page information sheet that is tucked into the shipping container and is more clearly identified as "instructions," so the customer realizes they actually were provided with this information.

The other challenge is getting documentation into the patient record that proves the patient actually received this instructional information. Your company may telephone the customer and make a note in the record that confirms receipt of the instructional information.

Since these products are surveyable, customers need to receive the same setup paperwork as a regular DME customer: HIPAA notice, supplier standards, their rights and responsibilities, perhaps a satisfaction postcard, and information about how to contact your company—plus any other accreditation-organization specific requirements.

FINANCIAL EVIDENCE

There is now more emphasis during the survey on financial management within your company. All suppliers now must have a written corporate compliance program that details business practices in line with Medicare billing rules. A typical survey activity is to trace money from billing, through disbursement, to a company account—to ensure accurate business accounting.

A budget is required. The level of detail is not stipulated, but a financial plan for the future does need to exist in writing. Billing and coding error information must be collected and trended in the company's performance management program.

MANDATORY ACCREDITATION

CMS has yet to announce (at press time) a definitive date for all DMEPOS providers to be accredited for Medicare billing (in a competitive bidding city or elsewhere). The "fuzzy" date is 2009 to 2010. If this year is any indicator, the length of time between the date of the formal deadline announcement and the actual deadline could be extraordinarily short. This year, when anxious suppliers complained to Medicare that a 4-month period between the announcement of the competitive bidding sites and the deadline for mandatory accreditation was not enough time, Medicare responded that they had been sending the message to suppliers all along that they needed to be accredited to bid—so the cut-off date (they said) was justified. True, they did eventually extend the date when bidders had to be accredited by 2 months, but in the greater scheme, these additional 60 days were inconsequential.

UNANNOUNCED SURVEYS

It used to be that the initial visit was scheduled months in advance, so the anxiously awaited arrival date of the inspectors was known and anticipated. All surveys are now unannounced, regardless of which accreditation organization you have applied to. For first-timers, a time period "window" for an initial survey is agreed upon when the application is submitted—but the actual date is unknown. Accreditation organizations understand that this is extremely disruptive for small businesses, and the surveyors work hard to accommodate the need to continue operations while undergoing the inspection. The Joint Commission does post when the survey is to occur on its Web site at exactly 7:30 am local time on the day of the inspection. So if you really wanted to, you could get an hour jump on the arrival of the surveyor by logging on as you step into the morning shower, and checking to see if today is the day. The other accreditors just appear without notice.

The ultimate question is: Are you prepared? Do you have a game plan? Some documents that should be readily available are:

• performance improvement data and reports;
• an organization chart with names;
• incident reports (also known as "adverse events");
• complaint reports;
• your policy and procedure manual;
• personnel files—location and who has access to them;
• information about your last emergency drill or actual emer­gency, plus the retrospective evaluation of what worked, what did not work, and what needs modification; and
• data about equipment maintenance—location and access.

SURVEY DAY

Vianna Zimbel

Your key contact person should be able to assist surveyors in planning patient home visit selection (who is on service that day, and may be selected to be visited by the surveyor). The surveyor will review the list of scheduled home visits by type of service. Thus, they may select a home visit for a wheelchair customer with your operations driver dispatcher, and a home visit to observe a respiratory therapist in action with your clinical director.

The surveyor typically wants to perform two patient home visits per day on the survey—thus a 2-day survey would have a total of four home visits. Immediately upon the morning arrival of the surveyor, there is a short 15-minute opening conference, with a review of the surveyor's agenda and requests, and then immediately moving on to work with key management staff to identify ideal candidates for the home visits or phone interviews.

Home visits generally take about 2 hours, and then the afternoon is spent on-site at the business, reviewing documentation and interviewing staff members.

If your company has a retail component, the surveyor will tag along when a customer walks in the door (with customer permission) and observe as they interact with your store person. If your company has mail-order business, the surveyor may have you place phone calls to customers, ask their permission to be interviewed by the surveyor, and then transfer the call to the surveyor who will inquire about the customer's experience with your company.

The surveyors will need work space designated as their "headquarters" for the duration of the survey. A desk or table, telephone, and access to an electrical outlet are desirable, and it would benefit you if this was out of the mainstream of business!

Some survey activities will require a room or area that will accommodate a group of participants. You may end up using your lunchroom or manager's office area if you don't have a conference room. Advance planning will help decrease some of the anxiety associated with the arrival of your surveyor.

Vianna Zimbel, RCP, specializes in accreditation and regulatory consulting for the HME industry. For more than 15 years, her consulting business has successfully guided hundreds of companies through standards interpretation. Zimbel can be reached via e-mail: or through her Web site: www.vzimbel.com.