BALTIMORE — CMS held a Special Open Door call Oct. 13 to clarify confusion over pharmacy exemption from DMEPOS accreditation requirements under new provisions of the Affordable Care Act (ACA), and the steps pharmacies should take now.
Sandra Bastinelli, senior technical advisor of CMS' Center for Program Integrity, said accreditation requirements will not apply to pharmacies if they meet all of three criteria: 1) total billings for DME sales must be less than 5 percent of total pharmacy sales for the previous three calendar years; 2) the pharmacy has been enrolled as a DMEPOS supplier with a provider number for at least five years; 3) no final adverse actions have been imposed on the pharmacy over the last five years, and the pharmacy has not been revoked from any federal programs.
The National Supplier Clearinghouse will send a letter to pharmacies that are not currently accredited attesting to the fact that they are not required to be accredited — as long as they meet the three criteria. Pharmacy owners can expect to get these attestation letters by the end of October.
Upon receipt, they must confirm the facts, the letter must be signed by the company's authorized official and it must be sent back before Jan. 1, 2011. The NSC will follow up with those that have not properly completed the attestations.
For pharmacies that won't receive the letter since they are currently accredited, CMS' Barry Bromberg said a copy of the attestation letter would be posted and available for download on the NSC website (www.palmettogba.com) by mid-November. The letter needs to be completed and submitted to the NSC to request the exemption.
Beginning next year, CMS will randomly audit 10 percent of pharmacies determined to be exempt from the accreditation requirement to make certain they actually do meet the attested criteria. According to Bromberg, the ACA does not actually specify 10 percent, but CMS thought the number was "appropriate." Bromberg also reported that the NSC has already prepared a list of eligible pharmacies.
The CMS officials advised pharmacies planning to drop their accreditation to wait until an exemption letter from the NSC has been received.
The biggest news from the Open Door call, however, is that under the new health reform law, pharmacy chains — which had been designated as those with 25 or more locations — can now opt out individual locations from the accreditation requirement.
"Each location has an enrollment number. If the location is part of a larger company as in a chain, the location must still individually meet the exemption criteria," Bastinelli said. Since all chains are currently accredited, she noted, they would not automatically receive the attestation letter and would have to send it in to apply for the exemption.
"If those locations are accredited and you believe that some, but not all, meet the exemption, once the attestation letter is up on the Web, you can certainly send in that attestation and get that stamp of approval, so to speak, from the NSC," Bastinelli said.
Added Bromberg, "The plan is that if you send in an attestation, we will send you a confirmation by mail. And that confirmation will either say we accepted it, or if for some reason we do not agree with what you have sent in, we will give you an explanation as to why we disagree. For those [letters] that we are sending out, invariably I think it is going to be extremely few that we are ever going to challenge, because we have already prescreened to see that you have met [the criteria]." However, he added, attestation letters from those pharmacies not on the NSC's list could draw additional scrutiny to make sure the exemption criteria are met.
Accreditation consultant Mary Ellen Conway, president of Capital Healthcare Group in Bethesda, Md., wondered if the individual location exemption would work for smaller chains as well.
She questioned Bastinelli on the following scenario: "How would that work for an organization that is not a large chain organization, but a group of pharmacies that are small regional players that might have 20 or so offices, 15 of which they have had for the last five years. And they are accredited right now, but they will be looking at renewal in the next few months trying to decide if they should renew. What if they buy a new store at some point? Obviously all new stores have to be accredited. Do they have to maintain the accreditation for that entire group, or can they drop individual locations?"
Replied Bastinelli, "Because the law has changed since the accreditation requirements became imposed ... and since the ACA does state very clearly by enrollment number, and since enrollment number is by location, we are going to have to allow pharmacies to ask for an exemption for those stores that they believe meet all of the criteria."
Contacted after the call, Conway said, "The big thing, which I find amazing, is that from day one we had a rule that common ownership required accreditation of every piece of the puzzle. You had to look at every common ownership opportunity and make sure that every DME location was accredited. Now, an organization with common ownership of any number of locations can opt out any of their locations. That is a huge takeaway from the Open Door Forum.
"The requirement has always been that whether you had 25 or 300 stores, you had to be sure that every one was accredited, because common ownership was the criteria," Conway said, "and that is what the accreditors required."
CMS said a replay of the call would be posted to the Special Open Door website around Friday, Oct. 22.