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.
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.