Standards 28 and 30: What the Changes Could Mean for You

By all accounts, the effects of CMS’ proposed revision and
expansion of supplier standards for DMEPOS will be far-reaching. In
a special series for HomeCare Monday leading up to the March 25
deadline for comments, health care attorney Neil B. Caesar,
president of the Health Law Center, Greenville, S.C., will help
provide clarification and insight on several provisions of the
draft rule. This week, Caesar’s comments are directed to proposed
new standards 28 and 30, which have to do with day-to-day
operations.

Standard No. 28 focuses on record-keeping. It requires that
certain records be maintained for seven years after a claim has
been paid. The specific records that must be kept [include] all
information regarding how the HME was ordered, how it was referred
and who referred it, and the National Provider Identifier. This
would enable CMS to track what equipment was ordered and by who,
including physicians, nurse practitioners, physician assistants,
clinical social workers or certified nurse midwives.

CMS contends that “all DMEPOS supplies are ordered and referred
by [the above listed practitioners].” Consequently, CMS states, “we
believe that it is essential that DMEPOS suppliers maintain
documentation regarding the specific individual who ordered or
referred a Medicare beneficiary for DMEPOS.” CMS further contends
that the seven-year requirement is merely “codifying” a
pre-existing seven-year rule.

This requirement will have significant implications for many
suppliers. The obligation to identify all information regarding the
ordering and referring of the equipment–including identifying from
where the orders came–is interpreted by CMS to cover notes and
other data that adequately supports medical necessity for the
DMEPOS item.

It would seem to be a bit of a stretch to conclude that ordering
and referral documentation necessarily includes evidence supporting
the coverage criteria for the items ordered. Nonetheless, that is
CMS’ position. This will mean that suppliers must be able to
demonstrate from the records in their possession that the coverage
criteria have been satisfied and medical necessity has been
demonstrated. A supplier would no longer be able to seek the
supporting materials after the inadequate record has been
identified.

An inadequate record would now be deemed a supplier standard
violation. The only exception to this rule would be equipment that
was known not to be medically necessary but for which a patient
signed a properly executed Advance Beneficiary Notice of possible
denial.

Proposed Standard No. 30 would specify that a suppliers’
business must be “open to the public a minimum of 30 hours per
week, except for those DMEPOS suppliers who are working with
custom-made or fitted orthotics and prosthetics.”

Thirty hours per week translates into six hours per weekday of
“open to the public” operations. That strongly suggests very small
suppliers would be unable to maintain this schedule plus handle
deliveries, repairs and off-premises warehousing duties within a
normal workweek. Further, for such suppliers, the new rule would
mean off-premises activities such as deliveries would need to be
conducted early in the morning or in the early evening.

CMS’ rationale for this rule is strange. The agency first
proposes that the rule makes sense because some providers “have
posted business hours that are so restrictive that it makes it
nearly impossible for [the NSC to conduct an] onsite visit.” It is
strange that CMS would choose to channel how a supplier organizes
its daily activities in order to make the NSC’s life more
convenient.

CMS also justifies the change because “Medicare beneficiaries
may not be able to find transportation during limited operating
hours, [and so] the DMEPOS supplier must be open and available for
periods long enough for beneficiaries to readily access their
facility.”

I sincerely question whether CMS’ conclusion is the result of
credible research, as beneficiaries should be able to work around
limited hours of operation as long as they are clearly posted and
consistently maintained. Probably the real reason for this proposal
is CMS’ belief “that most legitimate DMEPOS suppliers are open to
the public for more than 40 hours per week.”

From this “belief,” CMS reaches its conclusion: “All legitimate
DMEPOS [suppliers need] to be open a minimum of at least 30 hours
per week (six hours a day for five days a week or five hours a day
for six days a week) in order to attract, retain and serve Medicare
beneficiaries.”

This is a marked change from CMS’ position of the last several
years where its representatives have repeatedly stated that a
supplier may have limited hours as long as they were clearly posted
and honored. Further, CMS’ logic ignores the needs of closed-door
pharmacies and specialty suppliers who rarely, if ever, receive
Medicare beneficiaries or other customers on their premises.

I believe this standard will be a proverbial “wolf in sheep’s
clothing” for many small suppliers.

View the proposed standards.

Electronic comments, due by March 25, can be submitted at
www.regulations.gov. Follow the instructions
under the “Comment or Submission” tab and enter the file code
CMS-6036-P.