BALTIMORE — With 340 listeners on the call at a special Open Door Forum Thursday, CMS' Sandra Bastinelli, who has oversight of the agency's DMEPOS accreditation program:
- Reminded providers that the mandatory accreditation deadline is Sept. 30. "If [you are] not exempt and you are billing, or have a billing number (which is your DME enrollment number) or you wish to obtain one between now and the deadline, or keep it after Oct. 1, in order to bill for DMEPOS you need to be accredited."
- Encouraged providers to get a completed application into an accreditation organization by Jan. 31 to ensure an accreditation decision by Sept. 30. "If you're thinking, 'What if I send my application in February … Will they still get it?' Yes, [accreditors] will still accept it. However, just note it's taken in order of how they come in and when they are completed, so the later you wait, the greater the possibility the accrediting organization will not be able to process your application. They will let you know at that time."
- Noted that accreditation cannot be used as a "bargaining chip" in a potential sale. "If you are looking to sell your company, I would not get accredited because you can't transfer that accreditation decision. Once you sell your company, that accreditation decision is null and void."
- Emphasized that if providers choose not to get accredited, they must change their 855S enrollment agreement application. "After Oct. 1, if your enrollment application still has any DMEPOS supplies on it and you are not an 'exempt professional' or 'other person,' you will be denied payment through your contractor."
Nothing new. But after Bastinelli's presentation, the questions began, many from pharmacists still looking for answers about accreditation — and incredulous at its "overwhelming" demands, as one caller put it.
"Was CMS' intent with the accreditation policy to lessen competition by forcing smaller suppliers to drop out of the network?" one caller asked.
"No," Bastinelli answered, "... it's about the safety and the quality of services that beneficiaries receive."
"Could I ask your honest opinion of what you think this is going to do to the marketplace?" the caller responded. "The question is because of the burden of this on a small individual operation ... many of them are just going to throw the towel in because it's too expensive to comply with what CMS is asking us to do. Because of that you're going to be left with all the major corporations as being the only suppliers of product, and to me it looks like that was their intent, to lessen the number of billers and not have to work with as many providers."
Bastinelli said CMS estimates there are some 25,000 pharmacy locations already accredited, "so we don't see any trend of that occurring to date."
Another caller did the math. "Geez, with 25,000, that's $100 million. That's a lot of money, isn't it," he commented.
"We at CMS do not receive any of that money," Bastinelli said.
"I really didn't imply that. I just thought that was a lot of money," the caller continued. "How many pharmacies are there in the United States?"
After hearing Bastinelli's estimate of 54,000, he figured, "That's $220 million every three years, then, right?"
"I don't know. I'm sorry, I'm missing your point," Bastinelli said.
"I think everybody else is getting it, though," the caller shot back.
Bastinelli also addressed the issue of beneficiary access in this exchange with a pharmacist from a rural area:
Caller: "We're a very rural location; we have a county of about 9,000 people. There are no DME suppliers in the county within 20 miles in every direction, and no other pharmacies within 20 miles every other direction. Right now, we are stressed just spending the hundreds of hours and thousands of dollars complying with pharmacy requirements — HIPAA, privacy, security, policy and procedures, fraud.
"We have been providing DME products more as a service to our patients than anything else. We do about $20,000 a year. It's going to cost me over $4,000 just to apply for this accreditation. Obviously for $20,000 a year, we were barely breaking even to begin with; there was no way we were going to spend $4,000 on this.
"My question is, has CMS considered what they are going to do for my patients in my county that have no other options?"
Bastinelli: "Those issues were addressed with the competitive bidding process so far as access to delivery of supplies you offer, that is, by way of national chains or mail order supplies. We do hear you; we thought we had answered the access question, and the other is certainly a business decision, but I understand as a clinician that it is a cost issue considering how little of a volume you do provide. The only thing we can say is that we did not find anywhere in the U.S. where it was an access issue."
Caller: "Then what do I tell my 80-year-old patient that has acute bronco spasms that the doctor needs her to head to the pharmacy for her nebulizer?"
Bastinelli: "A nebulizer is a drug, and you can still offer that as a Part B drug. That is not under DMEPOS."
Caller: "That's fine, [but what if] the patient comes to me and I say, 'I have the solution, but you have to drive 20 more miles somewhere.' It's the same for diabetics. It's an acute situation. You are leaving an entire county without an acute service. By the way, mail order service of these supplies does not eliminate the need to talk with these patients and fix their glucose monitors when they go bad, or change the battery, or anything. It can't be done on a timely basis on mail order."
Bastinelli: "Anyone we do accredit has to follow up, including mail orders. If they provide services, they have to provide care 24/7. That is a requirement. If they don't do that, we don't accredit them."
When several callers posed questions about participating vs. non-participating providers, Bastinelli did not give answers and she would send clarification through CMS' list-serv.
CMS said a replay of the Jan. 8 teleconference (ID 79431075) would be available by Friday, Jan. 16, at www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp.
