Accreditation has taken off. Where do we stand, and what's coming next?
by Mary Ellen Conway, RN, BSN

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.