by Christopher Paris
VP Operations, Oxebridge Quality Resources International

The Accreditation Commission for Healthcare (ACHC) has released an entirely revamped set of standards for durable medical equipment (DME) companies who must be accredited in order to bill their products under Medicare. The Centers for Medicare and Medicaid Services (CMS), which manages Medicare, has mandated that all such DME providers become third-party accredited through CMS-approved bodies, one of which is ACHC. Each such body publishes its own standards for DME companies, which are based on primary “DMEPOS Supplier Standards” issued by CMS. Where the CMS standards act as a minimal “skeleton” of basic requirements, each CMS-approved body is then given the right to expand on those minimal requirements, and publish their own interpretive standards. DME companies must adopt the standards of the accreditation body they select.

Because Oxebridge has designed its CMS Accreditation Preparation program around the standards of ACHC, we have monitored these standards closely, including the latest versions, released in May 2011. Purportedly driven by continual improvement efforts, the revised ACHC standards offer little new in the way of benefits to end users, and instead introduce a host of (potentially expensive) problems.

Ironically, ACHC is itself ISO 9001 certified, but they could have learned a few things from the problems faced by ISO in the past, when it released “improved” updates to its standards.

Never Renumber

While much of the text of the standards remains identical to the previous version, ACHC took an inexplicable path towards utter confusion and renumbered the clauses of their standards. ISO learned this was a nightmare when it moved from ISO 9001:1994 to ISO 9001:2000, and users complained of having to rewrite whole systems to align with the new numbering scheme. Well, now ACHC users have to do likewise.

Certainly, clients could ignore the numbering of the ACHC structure, but would do so at risk. ACHC auditors are notoriously famous for expecting everything to be addressed exactly as it appears in the standards, and any renaming or renumbering causes confusion which can lead to nonconformities during audits. Far-fetched? Not so… at the beginning of our CMS Accreditation Prep program, Oxebridge developed an ISO 9001 style “Corrective Action Request” system for our clients, which was designed to meet ACHC’s requirements for an “incident report” system. Even though our documentation clearly stated that the “corrective action system acts as the incident reporting system”, the fact that the forms weren’t explicitly named “Incident Report” resulted in three of our clients receiving negative findings from ACHC auditors. In one case, the auditor bluntly stated, “just rename the form and you will be fine.” This contradicts ACHC’s public training, which emphasizes some degree of flexibility.

Likewise, a failure to number your Policy and Procedure Manual sections to align with the ACHC standard numbers can lead to confusion with the auditors. Some Oxebridge clients received negative findings from ACHC even though the manuals were numbered correctly, however; this was because we attempted to fix some redundancies in the standards by simply indicating that information in one clause could be found in a later clause (“see section XYZ for more on this information.”) The auditors refused this, expecting to see the exact language in the exact location of the manual.

ACHC has adopted a numbering system that H. P. Lovecraft’s Cthulhu would find arcane. Rather than a simple decimal based system, every standard is affixed with the horrid “DRX” prefix followed by a dashed set of numbers and letters, so that standards are now numbered DRX1-1C, DRX4-9A. One suspects that a million years from now, archaeologists from the future will ponder the meaning of these strange glyphs. Problems arise when referencing a range of standards, because that just adds another hyphen to the formula For example, if you dare reference “DRX1-1A – DRX1-1C” you risk unlocking the human genome, rather than presenting comprehensible data.

(Oxebridge tip: drop the “DRX” prefix and hope that ACHC auditors can still navigate their way to understanding that “1-1C” means “DRX1-1C.”)

English As a Second Language

Since the extraterrestrials who wrote the revised standards are not native English speakers, it is somewhat understandable, then, that the language of the standards themselves are not in a human tongue. ACHC may be an expert organization on accreditation, but grammar seems to have failed them.

Clumsy, and often just incorrect, sentence structure peppers the wording here. “The organization has written policies and procedures and ensures the implementation [SIC] concerning …” is a clause that appears in a few spots. The proper wording would be “the organization has written and implemented policies and procedures…”, and such missteps only make the confusion over how to implement a requirement even worse. But perhaps I nitpick, with far bigger fish left to fry.

Irrational Exuberance

With Medicare, one can never be sure of final regulations; they change daily, on a whim, often without any legal backing or rationale, and are communicated poorly while enforced randomly. (One truism: if you’re a small DME company, you are more likely to be harassed by CMS than the “big guys” leading many to believe the accreditation and competitive bidding process were nothing but an attempt to destroy small competitors.)

So it’s unclear where some of the new ACHC rules come from. CMS/Medicare mandates? Other government agency requirements? Federal law? Or just ACHC standards authors having had a bit too much coffee that day?

In any event, the ACHC standard DRX7-4C (just for example) now requires DME companies to educate their patients on “emergency preparedness”, including topics on “Individual planning for emergencies/disasters such as evacuation plans, medications, food/water, important documents, [and] care for pets.”

Mind you, this standard applies to all DME and medical supply providers, not just those doing in-home direct care. (The requirement aligns with what was, under the old standard scheme, a “core” requirement for all accreditation clients.) That means that ACHC now wants you to forget FEMA, your local news or government officials for information on what to do during an earthquake, tornado, or flood, and contact the guy who sells you diabetic strip refills.

Likewise, standard DRX4-6A now requires that DME company employees, who (again) may merely be supplying the public with simple products such as ankle braces, canes, or replacement hoses for equipment sold by someone else, be trained on “concepts of death and dying and bereavement, emotional support, psychosocial, and spiritual issues, pain and symptom management [and] stress management.”

This means that your local DME van driver (whose job description may consist only of having a driver’s license and being able to lift 40 lbs) must now become a psychologist, grief counselor, spiritual advisor and ad hoc pain management physician for anyone he delivers to.

In fairness, I have written to ACHC and requested some clarity on these over-the-top requirements, raising the issue that expecting such masters-degree level proficiency in all DME company employees is a lawsuit waiting to happen, so we will see what they say.

The standards go deeper into realms of HR management that, in this expert’s opinion anyway, are far afield of whichever goal CMS tacks onto the accreditation requirement for the moment (CMS can’t decide if accreditation is a quality improvement or anti-fraud initiative.) ACHC can now poke around employee wages, benefits, and other areas that it has no business in.

Ironically, it was this kind of auditing that kept Oxebridge from selecting JCAHO when we were designing our CMS Accreditation Preparation program, and the lack of such nuttiness was what drove us towards ACHC.

Crosswalk? Try Jaywalking Instead

ACHC provides what is supposed to be a handy “crosswalk” between the previous standards and the new version, but this consists of a confusing set of two tables, one of which is a poorly formatted Excel table in which its authors couldn’t even be bothered to turn cell grids off).  To use the two tables requires bouncing back between both. And taking lots of acetaminophen.

Gone is any organized structure to the Preliminary Evidence Report (PER), which is (was?) the document you completed when sending in your Policy and Procedure Manual for a “desk review” by ACHC prior to the on-site audit. Now, the PER is simply a list of clause numbers, without any instructions or even an address as to where to send it. ACHC is still requiring the PER, they are just not telling anyone how to submit it. Oxebridge has written to ACHC for clarification on this, too.

Making matters worse is how you obtain the standards. Because the standards can apply to a variety of sub-industries within the DME industry (home medical equipment, fitter services, medical supply providers, etc.) and you download the correct set by checking some boxes on the ACHC website, which then generates a “custom” PDF which includes only the rules applicable to your industries. The logic here sounds okay, but there is no “complete” set of all the rules in one place to use as a reference, to be sure that what the ACHC website is generating is accurate. And you won’t know if you’ve missed a clause until ACHC comes in and audits you, and writes a negative finding! Not reassuring.

What To do

For now, DME and medical supply companies can’t do anything but follow the new rules, and they don’t have long to do so. (ACHC mandated that systems be updated in 120 days from when they were published. At press time, I am not sure if this rule is still in place, since the standards themselves had been delayed. I suspect, however, that it is.)

If you’ve numbered your Manual according to the old standards, you will have to renumber them. Don’t expect auditors to use the ACHC crosswalk.

You will have to develop an Employee Handbook, which is something CMS consultants, such as Oxebridge, cannot do properly, since an Employee Handbook may have to address local laws which would require a labor law consultant instead.

You will have to address the new requirements, specially those for HR management and employee orientation, as well as many others.

You will have to submit a new PER — although it’s still not clear how.

And remember — when that plague of flaming, rat-infested giant locusts comes shuddering over the hills to eat your house and all its inhabitants, don’t call the US Army. Call Joe, the guy who delivers the oxygen tank to elderly Mr. Jones across the street. Apparently, Joe’s an expert in all disasters.

Now if only someone was an expert in the disaster that is Medicare accreditation.

UPDATE MAY 26, 2011: ACHC RESPONDS BY DROPPING, CLARIFYING REQUIREMENTS.

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