What has happened with mandatory accreditation for DMEPOS Suppliers?

1. The
View from
30,000 Feet Accreditation has taken off. Where do
we stand, and what’s coming next?
I
BY MARY ELLEN CONWAY, RN, BSN
t’s time to take a 30,000-foot view of what has hap-
pened 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 thera-
pists providing rehab equipment, orthotists, pedorthists and more.
The Centers for Medicare and Medicaid Services realized the need for a pro-
cess 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 sup-
plier was accredited to provide.
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.
26 | JULY 2010 | www.homecaremag.com

2. 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.
Today (and since 2008), if a supplier submits a claim for an were being processed (when the NSC got to it). The firestorm
item that does not match the list of accredited items provided that ensued was enormous.
by their accrediting organization, the claim is denied. Suppliers sought the assistance of federal legislators, buy-
In 2005, CMS issued its “Draft Quality Standards,” a 104- ing groups went to bat for their members and the situation
page document that was judged by many to be over-the-top was ugly. Suppliers who had provided services to Medicare
in proposed requirements, among them having a certified beneficiaries as of the date of their accreditation were facing
wound-ostomy nurse involved in the setup of every support huge financial losses since their reinstatements were occurring
surface and requiring a face-to-face meeting with all mail- weeks or even months after that date.
order recipients. CMS received over 5,600 comments on the Additionally, the National Association of Chain Drug Stores
draft from the HME community. (NACDS) and the National Association of Community Phar-
After digesting these comments, CMS issued its much simpli- macists (NCPA) were able to get emergency legislation passed
fied 14-page “Final Quality Standards” on Aug. 14, 2006, and that allowed pharmacies an accreditation extension until
announced the deemed status accreditors on Nov. 16, 2006. Jan. 1, 2010. Pharmacies that had voluntarily revoked their
It wasn’t until 2007, however, that CMS announced the supplier numbers had to communicate with the NSC
Oct. 1, 2009, mandatory— or “drop dead”—accreditation dead-
line for HME companies. The agency also announced that all
suppliers who planned to bid in Round 1 of competitive bid- Fact Sheet for Pharmacies
ding would need to be accredited by Sept. 1, 2007.
In July 2008, the Medicare Improvement for Patients and Early this month, CMS made available a new fact sheet
Providers Act was passed. Along with the delay of competitive containing accreditation information for pharmacies under the
bidding, this act also exempted physicians and other licensed Affordable Care Act, which amends the Medicare Improve-
practitioners from the mandatory accreditation deadline. ments for Patients and Providers Act of 2008 by extending
the deadline for pharmacy accreditation until Jan. 1, 2011. In
In October 2008, CMS issued updates to the Final Quality addition, pharmacies that furnish DMEPOS may qualify for an
Standards. These are the standards we operate under today. exemption if the pharmacy meets the following criteria:
(You can find these standards on the CMS website at www. 1. The total billings by the pharmacy for DMEPOS are less than
cms.gov/MedicareProviderSupEnroll/Downloads/DMEPOS 5 percent of total pharmacy sales for the previous three
AccreditationStandardsCMB.pdf.) calendar years; and
2. The pharmacy has been enrolled as a supplier of durable medi-
But It Wasn’t Over Yet cal equipment, prosthetics, orthotics and supplies and has
been issued a provider number for at least five years; and
As the Oct. 1, 2009, accreditation deadline grew closer, sup-
3. No final adverse action has been imposed on the pharmacy
pliers who had dragged their feet were hoping for a delay, but in the past five years and
CMS was not budging. 4. The pharmacy submits an attestation, in the manner and at
In advance of the deadline, the agency sent out instructions the timeframe to be determined, that the pharmacy meet
for non-accredited suppliers advising those who were not going the criteria listed in 1-3 and
5. The pharmacy agrees to submit materials as requested dur-
to be accredited by the deadline, or were unsure if they would,
ing the course of an audit conducted on a random sample
to revoke their supplier number voluntarily via their 855-S form. of pharmacies selected annually.
That way, CMS said, when suppliers did become accredited,
According to the fact sheet:
their number could be reinstated as of that date. Thousands
N Total DMEPOS billings are considered as less than 5 percent
of suppliers did as they were told and voluntarily revoked their
of the total pharmacy revenue. For example, if a pharmacy is
numbers. The accreditors maintained a frantic pace, trying to part of a larger location, such as a grocery store that also has a
visit as many suppliers as possible before the deadline. pharmacy or a pharmacy that sells other items; the total DMEPOS
But just as we thought things might calm down, all hell sales would be less than 5 percent of the total pharmacy sales,
broke loose. not that of the total grocery/store receipts.
N Newly opened locations are required to be accredited because
When a supplier number is deactivated, there is a mandatory
they do not meet the exemption requirement of having been
one-year waiting period before the number can be reinstated, enrolled in the Medicare program as a DMEPOS supplier for at
so thousands of 855-S forms poured into the National Supplier least five years. Therefore, newly opened locations within chains
Clearinghouse in the weeks before the deadline from sup- or single locations would have to be accredited.
pliers who were waiting on their surveys. Suppliers who did N If a location is part of a franchise, then that location is not
have their surveys and were accredited in the weeks following considered a chain and thus each location would have to receive
a separate accreditation decision, if required. Accordingly, each
Oct. 1 then sent their reactivation information back in. location in this case is reviewed separately to determine whether
At that point, suppliers’ numbers were not being reinstated as it meets all of the exemption criteria.
of their accreditation date but as of the date their applications
28 | JULY 2010 | www.homecaremag.com

3. again to reinstate them since now they were not subject to N Performance Improvement program. Do not let your PI
the deadline. requirements get away from you. Make sure you are tracking
Since the October deadline, there have been additional de- the required indicators listed in the Final Quality Standards:
velopments. The health care reform law provides an exemp- - Beneficiary satisfaction and complaints;
tion from the accreditation requirement for pharmacies that - Timeliness of response to questions, problems and
can meet certain criteria. Early this month, CMS issued a fact concerns;
sheet setting out the new information for pharmacies. (See - Impact of business practices on adequacy of beneficiary
accompanying sidebar.) access to items, services, information;
Note that there is no exemption for a new pharmacy. Pro- - Frequency of billing/coding errors;
viders who wish to open a new pharmacy must be accredited, - Adverse events to beneficiaries due to inadequate service(s)
whether or not they currently have an exempted site. Also, or malfunctioning equipment and/or item(s) (e.g injuries, acci-
any pharmacy considering participating in the competi- dents, signs and symptoms of infection, hospitalization); and
tive 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. Behind everyQuality Champion
is a great coach.
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 accred-
ited supplier, you have many balls to keep
in the air in order to maintain your ac-
creditation, but here are some that should
be key areas of focus:
N Human Resources. Keep up with your
personnel files. Make sure all of your em-
ployee 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 atten-
tion to them each month. HQAA Coach: Stacy
N Infection Control. Make sure you
educate your staff each year about blood-
borne pathogens. Ensure they are wearing
gloves when appropriate, washing their Expert guidance. Another reason to switch to HQAA.
hands, using alcohol gel when needed and HQAA is the only CMS-approved HME accreditation organization that offers expert
protecting clean and dirty boundaries for coaches like Stacy. Coaches are with you throughout the entire documentation
equipment both in your warehouse and process, answering your questions and helping you champion quality care
on your delivery vehicles. in your organization. For more reasons to switch to HQAA, visit
N Documentation. Audit your docu-
www.BiteSizeAccreditation.com.
mentation. 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,
Become a Quality Champion.
that you have complete documenta-
tion on hand that includes all required
elements.
www.homecaremag.com | JULY 2010 | 29

4. - Documentat ion of pat ient a nd sta f f N What is the accreditor’s schedule and what are the require-
infections. ments for in-between? There are accreditors that provide ei-
N Compliance program. The new health reform ther annual or triennial (every three years) accreditation. Some
legislation requires that all health care provid- require follow-up that must be done at the 18 month mark of
ers have a formal compliance program. Most suppliers your three year cycle. Know what you are getting into.
became accredited by having something that resembles a N Fees paid vs. administrative costs. There are no savings
compliance “statement.” Watch for CMS to announce in selecting an accreditor that charges a lower dollar amount
the date that all suppliers must have an identified for your accreditation but causes you to add additional staff
plan that includes such items as scheduled record au- and higher administrative costs in order to maintain your
dits, specific and detailed annual compliance education for accreditation. Research what your ongoing requirements are
staff and much more. before you jump to another accrediting organization.
N Other services (infusion, home health). If you have other
Your Accreditation Timeline services, you’d be wise to get them all accredited by the same
Another change since the October 2009 accreditation deadline body and meet similar requirements across the board, as well
is when you can expect to see your surveyor as having one survey that covers all areas.
for re-accreditation. Note that CMS is enforcing N The process. Is the accreditor’s process
the accreditation “expiration” date. Remember Your electronic or paper? Can you get much
For example, a supplier who had been Surety Bond, Too of the process accomplished prior to
accredited for three years as of Jan. 15, the survey?
2006—once they filed re-accreditation According to CMS, some 11,000 N Conduct an “interview.” Talk to all
paperwork with the accreditor and met DMEPOS providers had their Medi- of the accrediting organizations you are
all of their requirements—could expect care numbers revoked as a result of considering. Visit them at state shows,
to see their surveyor generally any time the accreditation and surety bond Medtrade, their offices, wherever you can.
requirements. Don’t let this happen
between Oct. 1, 2008, and April 1, 2009, to you. Make sure you begin your ac- See how they relate to you, how they re-
for re-survey. creditation renewal in plenty of time spond to your concerns, discuss what your
Now, however, your accreditor needs to to avoid a lapse, and that you have perceptions are and ask questions.
conduct your re-accreditation visit well in a surety bond in place to prevent a N Your peer’s experience. Ask your peers
advance of your expiration date so that if coverage gap. about their experience with their accredi-
deficiencies are found, you have time to MLN Matters Article 6854 (MM6854), tor. Ask the accreditor you are considering
correct them, file a plan of correction, have released in March, outlines scenarios in if you can speak with some of the suppliers
which suppliers are required to report
the plan approved, complete a re-visit (if surety bond changes to the NSC. A DME- they have accredited whose companies are
needed) and file the updated information POS supplier must submit an addendum similar in size and scope to yours.
with the NSC so that there is no lapse or to the existing bond (or, if preferred, a
gap in accreditation status. new bond) to the NSC if there is: What Have We Learned, and What’s
You must begin accreditation renewal (1) a change in bond terms; Coming Next?
(2) a change in the bond amount; or
nine to 12 months before your expiration (3) a location on a bond covering We’ve seen that the pharmacy lobbyists
date in order to have adequate time to multiple non-chain locations is being won a round in this battle by getting some
complete the process. Be sure to contact added or deleted. of their constituents off of the hook for the
your accreditor early for guidance on your Medicare’s surety bond require- accreditation requirements. But those who
expected timeframe. ments are summarized in detail in ar- choose to be exempt need to consider sev-
ticle MM6392 on the CMS website at eral factors, such as the documentation that
Switching Accreditors www.cms.gov. must be in place to support the low volume
There are many reasons you might want The list of approved sureties can be of DMEPOS sales over the three-year period
to change accreditors. Just because CMS found on the Department of the Trea- and their inability to open a new location
sury’s website at www.fms.treas.gov/
has awarded “deemed status” to an accred- c570/c570_a-z.html. (which must be accredited) quickly.
iting organization does not mean that every One of the most important items to con-
payer requiring DMEPOS accreditation sider is that all Part B suppliers must have
recognizes all of them. You could find that your accreditor is surety bonds in place with the NSC. In the event that CMS
not recognized by some of your payer sources. decides that this non-accredited group poses an increased
Other reasons to change might include switching from ac- fraud risk, this could become a new area of focused DMEPOS
creditors that require annual renewals, leaving an organiza- claim review. And if a supplier is found to have billing errors,
tion that you feel has requirements beyond the Final Quality that surety bond will be recovered quickly as the supplier’s
Standards or simply having a bad experience with a particular fight against the judgment gets started.
accrediting body. We know that you must make sure you’re accredited to pro-
When you are considering switching accrediting organiza- vide any new products your considering. We’ve also learned
tions, what are the factors you should consider? that CMS is monitoring the now-designated “accreditation
N CMS is not your only payer! There are many other Med- expiration date,” and that you must get going on your accredi-
icaid and third-party payers that require accreditation, so tation renewal in plenty of time.
make sure you select an organization that is approved by all Be sure to stay tuned for any additional updates as they oc-
of your payers. cur in the next year.
30 | JULY 2010 | www.homecaremag.com