The View from 30,000 Feet

It’s time to take a 30,000-foot view of what has happened with mandatory accreditation for DMEPOS suppliers. Where are we? What have we learned and where are we headed? Let’s go back a bit to review, and look ahead at what’s coming next.

Accreditation History 101

In December of 2003, the Medicare Modernization Act was signed into law. This legislation required accreditation for any Part B supplier who planned to bill Medicare, whether they were a participating or non-participating supplier. The mandate included all Part B suppliers providing DMEPOS, such as pharmacies providing diabetic supplies, physicians providing “bent metal,” physical therapists providing rehab equipment, orthotists, pedorthists and more.

The Centers for Medicare and Medicaid Services realized the need for a process that could ensure suppliers were meeting quality standards and to provide onsite visits. The agency turned to accreditation.

Additionally, the MMA established a competitive bidding program for DMEPOS and required that all suppliers who wished to bid must be accredited. Since there was a wide disparity of requirements among existing accrediting organizations, CMS developed its own quality standards and said it would name approved, or “deemed status” accreditors that would adopt these standards.

The agency also changed the way accreditation for DMEPOS (previously voluntary) was conducted, requiring that its accreditors provide the “items” each supplier was accredited to provide.
Today (and since 2008), if a supplier submits a claim for an item that does not match the list of accredited items provided by their accrediting organization, the claim is denied.

In 2005, CMS issued its “Draft Quality Standards,” a 104-page document that was judged by many to be over-the-top in proposed requirements, among them having a certified wound-ostomy nurse involved in the setup of every support surface and requiring a face-to-face meeting with all mail-order recipients. CMS received over 5,600 comments on the draft from the HME community.

After digesting these comments, CMS issued its much simplified 14-page “Final Quality Standards” on Aug. 14, 2006, and announced the deemed status accreditors on Nov. 16, 2006.

It wasn’t until 2007, however, that CMS announced the Oct. 1, 2009, mandatory — or “drop dead” — accreditation deadline for HME companies. The agency also announced that all suppliers who planned to bid in Round 1 of competitive bidding would need to be accredited by Sept. 1, 2007.

In July 2008, the Medicare Improvement for Patients and Providers Act was passed. Along with the delay of competitive bidding, this act also exempted physicians and other licensed practitioners from the mandatory accreditation deadline.

In October 2008, CMS issued updates to the Final Quality Standards. These are the standards we operate under today. (You can find these standards on the CMS website at www.cms.gov/MedicareProviderSupEnroll/Downloads/DMEPOS AccreditationStandardsCMB.pdf.)

But It Wasn’t Over Yet

As the Oct. 1, 2009, accreditation deadline grew closer, suppliers who had dragged their feet were hoping for a delay, but CMS was not budging.

In advance of the deadline, the agency sent out instructions for non-accredited suppliers advising those who were not going to be accredited by the deadline, or were unsure if they would, to revoke their supplier number voluntarily via their 855-S form. That way, CMS said, when suppliers did become accredited, their number could be reinstated as of that date. Thousands of suppliers did as they were told and voluntarily revoked their numbers. The accreditors maintained a frantic pace, trying to visit as many suppliers as possible before the deadline.

But just as we thought things might calm down, all hell broke loose.

When a supplier number is deactivated, there is a mandatory one-year waiting period before the number can be reinstated, so thousands of 855-S forms poured into the National Supplier Clearinghouse in the weeks before the deadline from suppliers who were waiting on their surveys. Suppliers who did have their surveys and were accredited in the weeks following Oct. 1 then sent their reactivation information back in.

At that point, suppliers’ numbers were not being reinstated as of their accreditation date but as of the date their applications were being processed (when the NSC got to it). The firestorm that ensued was enormous.

Suppliers sought the assistance of federal legislators, buying groups went to bat for their members and the situation was ugly. Suppliers who had provided services to Medicare beneficiaries as of the date of their accreditation were facing huge financial losses since their reinstatements were occurring weeks or even months after that date.

Additionally, the National Association of Chain Drug Stores (NACDS) and the National Association of Community Pharmacists (NCPA) were able to get emergency legislation passed that allowed pharmacies an accreditation extension until Jan. 1, 2010. Pharmacies that had voluntarily revoked their supplier numbers had to communicate with the NSC again to reinstate them since now they were not subject to the deadline.

Since the October deadline, there have been additional developments. The health care reform law provides an exemption from the accreditation requirement for pharmacies that can meet certain criteria. Early this month, CMS issued a fact sheet setting out the new information for pharmacies. (See accompanying sidebar.)

Note that there is no exemption for a new pharmacy. Providers who wish to open a new pharmacy must be accredited, whether or not they currently have an exempted site. Also, any pharmacy considering participating in the competitive bidding program at any time must be accredited.

Pharmacy providers who do not meet these exceptions now have until Jan. 1, 2011, to become accredited.

Now What?

According to CMS, after all of the chaos of the last few years, there are currently 98,675 suppliers, and much of the backlog at the NSC has cleared.

So now that all of these companies are accredited, what are the main areas they need to watch not to let slide? What should an “accreditation maintenance” program look like? If you are an accredited supplier, you have many balls to keep in the air in order to maintain your accreditation, but here are some that should be key areas of focus:

• Human Resources
  Keep up with your personnel files. Make sure all of your employee files have signed job descriptions, completed orientation checklists for new employees, competency evaluations upon hire and annually, current Tb vaccination and Hepatitis B status (when applicable) as well as annual evaluations. These files can easily get out of control, but they also can easily stay in control if you pay attention to them each month.
• Infection Control
  Make sure you educate your staff each year about bloodborne pathogens. Ensure they are wearing gloves when appropriate, washing their hands, using alcohol gel when needed and protecting clean and dirty boundaries for equipment both in your warehouse and on your delivery vehicles.
• Documentation
  Audit your documentation. Make sure that you have signed copies of the complete paperwork customers receive. Check to be sure you have complete orders for all items, and when physician notes are required, that you have complete documentation on hand that includes all required elements.
• Performance Improvement program
  Do not let your PI requirements get away from you. Make sure you are tracking the required indicators listed in the Final Quality Standards:
  • Beneficiary satisfaction and complaints;
  • Timeliness of response to questions, problems and concerns;
  • Impact of business practices on adequacy of beneficiary access to items, services, information;
  • Frequency of billing/coding errors;
  • Adverse events to beneficiaries due to inadequate service(s) or malfunctioning equipment and/or item(s) (e.g injuries, accidents, signs and symptoms of infection, hospitalization); and
  • Documentation of patient and staff infections.

• Compliance program
  The new health reform legislation requires that all health care providers have a formal compliance program. Most suppliers became accredited by having something that resembles a compliance “statement.” Watch for CMS to announce the date that all suppliers must have an identified plan that includes such items as scheduled record audits, specific and detailed annual compliance education for staff and much more.

Your Accreditation Timeline

Another change since the October 2009 accreditation deadline is when you can expect to see your surveyor for re-accreditation. Note that CMS is enforcing the accreditation “expiration” date.

For example, a supplier who had been accredited for three years as of Jan. 15, 2006 — once they filed re-accreditation paperwork with the accreditor and met all of their requirements — could expect to see their surveyor generally any time between Oct. 1, 2008, and April 1, 2009, for re-survey.

Now, however, your accreditor needs to conduct your re-accreditation visit well in advance of your expiration date so that if deficiencies are found, you have time to correct them, file a plan of correction, have the plan approved, complete a re-visit (if needed) and file the updated information with the NSC so that there is no lapse or gap in accreditation status.

You must begin accreditation renewal nine to 12 months before your expiration date in order to have adequate time to complete the process. Be sure to contact your accreditor early for guidance on your expected timeframe.

Switching Accreditors

There are many reasons you might want to change accreditors. Just because CMS has awarded “deemed status” to an accrediting organization does not mean that every payer requiring DMEPOS accreditation recognizes all of them. You could find that your accreditor is not recognized by some of your payer sources.

Other reasons to change might include switching from accreditors that require annual renewals, leaving an organization that you feel has requirements beyond the Final Quality Standards or simply having a bad experience with a particular accrediting body.

When you are considering switching accrediting organizations, what are the factors you should consider?

• CMS is not your only payer!
  There are many other Medicaid and third-party payers that require accreditation, so make sure you select an organization that is approved by all of your payers.
• What is the accreditor’s schedule and what are the requirements for in-between?
  There are accreditors that provide either annual or triennial (every three years) accreditation. Some require follow-up that must be done at the 18 month mark of your three year cycle. Know what you are getting into.
• Fees paid vs. administrative costs
  There are no savings in selecting an accreditor that charges a lower dollar amount for your accreditation but causes you to add additional staff and higher administrative costs in order to maintain your accreditation. Research what your ongoing requirements are before you jump to another accrediting organization.
• Other services (infusion, home health)
  If you have other services, you’d be wise to get them all accredited by the same body and meet similar requirements across the board, as well as having one survey that covers all areas.
• The process
  Is the accreditor’s process electronic or paper? Can you get much of the process accomplished prior to the survey?
• Conduct an “interview.”
  Talk to all of the accrediting organizations you are considering. Visit them at state shows, Medtrade, their offices, wherever you can. See how they relate to you, how they respond to your concerns, discuss what your perceptions are and ask questions.
• Your peer’s experience
  Ask your peers about their experience with their accreditor. Ask the accreditor you are considering if you can speak with some of the suppliers they have accredited whose companies are similar in size and scope to yours.

What Have We Learned, and What’s Coming Next?

We’ve seen that the pharmacy lobbyists won a round in this battle by getting some of their constituents off of the hook for the accreditation requirements. But those who choose to be exempt need to consider several factors, such as the documentation that must be in place to support the low volume of DMEPOS sales over the three-year period and their inability to open a new location (which must be accredited) quickly.

One of the most important items to consider is that all Part B suppliers must have surety bonds in place with the NSC. In the event that CMS decides that this non-accredited group poses an increased fraud risk, this could become a new area of focused DMEPOS claim review. And if a supplier is found to have billing errors, that surety bond will be recovered quickly as the supplier’s fight against the judgment gets started.

We know that you must make sure you’re accredited to provide any new products your considering. We’ve also learned that CMS is monitoring the now-designated “accreditation expiration date,” and that you must get going on your accreditation renewal in plenty of time.

Be sure to stay tuned for any additional updates as they occur in the next year.

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, or follow Conway on Twitter at @MEConway1.

Fact Sheet for Pharmacies

Early this month, CMS made available a new fact sheet containing accreditation information for pharmacies under the Affordable Care Act, which amends the Medicare Improvements for Patients and Providers Act of 2008 by extending the deadline for pharmacy accreditation until Jan. 1, 2011. In addition, pharmacies that furnish DMEPOS may qualify for an exemption if the pharmacy meets the following criteria:

1. The total billings by the pharmacy for DMEPOS are less than 5 percent of total pharmacy sales for the previous three calendar years; and
2. The pharmacy has been enrolled as a supplier of durable medical equipment, prosthetics, orthotics and supplies and has been issued a provider number for at least five years; and
3. No final adverse action has been imposed on the pharmacy in the past five years and
4. The pharmacy submits an attestation, in the manner and at the timeframe to be determined, that the pharmacy meet the criteria listed in 1-3 and
5. The pharmacy agrees to submit materials as requested during the course of an audit conducted on a random sample of pharmacies selected annually.

According to the fact sheet:

• Total DMEPOS billings are considered as less than 5 percent of the total pharmacy revenue. For example, if a pharmacy is part of a larger location, such as a grocery store that also has a pharmacy or a pharmacy that sells other items; the total DMEPOS sales would be less than 5 percent of the total pharmacy sales, not that of the total grocery/store receipts.
• Newly opened locations are required to be accredited because they do not meet the exemption requirement of having been enrolled in the Medicare program as a DMEPOS supplier for at least five years. Therefore, newly opened locations within chains or single locations would have to be accredited.
• If a location is part of a franchise, then that location is not considered a chain and thus each location would have to receive a separate accreditation decision, if required. Accordingly, each location in this case is reviewed separately to determine whether it meets all of the exemption criteria.

Remember Your Surety Bond, Too

According to CMS, some 11,000 DMEPOS providers had their Medicare numbers revoked as a result of the accreditation and surety bond requirements. Don’t let this happen to you. Make sure you begin your accreditation renewal in plenty of time to avoid a lapse, and that you have a surety bond in place to prevent a coverage gap.

MLN Matters Article 6854 (MM6854), released in March, outlines scenarios in which suppliers are required to report surety bond changes to the NSC. A DMEPOS supplier must submit an addendum to the existing bond (or, if preferred, a new bond) to the NSC if there is:

1. a change in bond terms;
2. a change in the bond amount; or
3. a location on a bond covering multiple non-chain locations is being added or deleted.

Medicare’s surety bond requirements are summarized in detail in article MM6392 on the CMS website at www.cms.gov.

The list of approved sureties can be found on the Department of the Treasury’s website at www.fms.treas.gov/c570/c570_a-z.html.