Delay of Antimicrobial Stewardship CoP Shouldn't Delay Pharmacists
The proposal to require antimicrobial stewardship programs in all acute care and critical access hospitals participating in the Medicare and Medicaid programs seems, at presstime, to be among the pending regulations awaiting arrival of a new administrator at the overseeing agency.
Publication of the final rule that includes the regulations on hospitals’ antimicrobial stewardship programs did not occur before the onset of the Trump administration. Before the end of the administration’s first day, the president’s chief of staff issued a memorandum telling departmental and agency heads not to send for publication any regulation before a presidential appointee or designee reviewed it.
That leaves the Joint Commission’s antimicrobial stewardship standard, which went into effect on January 1, as likely the only national requirement imposed on those hospitals to help reduce inappropriate antibiotic use and antimicrobial resistance.
But not all acute care and critical access hospitals seek accreditation from the Joint Commission. Hospitals have additional options—other national accrediting organizations and the states’ survey agencies—for qualifying to participate in the Medicare and Medicaid programs.
One such national accrediting organization, the Center for Improvement in Healthcare Quality, stated that its hospital accreditation program does not “prescriptively” require antimicrobial stewardship programs but does expect hospitals “to follow industry standards of care.”
The most recently available data from the Centers for Medicare and Medicaid Services (CMS) suggest that 29% of acute care hospitals and 74% of critical access hospitals participate in the Medicare and Medicaid programs without having accreditation from the Joint Commission.
To Debra Goff, infectious disease (ID) specialist at Ohio State University Wexner Medical Center in Columbus, the delay in having a Medicare condition of participation (CoP) regarding antimicrobial stewardship programs will not stop their implementation this year.
Whether those programs achieve meaningful stewardship is a different matter, she said.
A hospital can have an antimicrobial stewardship program that meets the Joint Commission’s criteria, Goff explained, yet does not require personnel to identify which patients have medication orders for unnecessary antimicrobials and then call the prescribers to get the therapies discontinued.
“The stewardship pharmacists’ job [is] to steer the ship,” she said, “but every pharmacist is on that ship, and every pharmacist needs to be contributing in order to make meaningful stewardship interventions.”
Pharmacists throughout the hospital, including those who review medication orders, must evaluate whether patients really need the antimicrobials being prescribed, Goff said.
And as the proposed CoP on antimicrobial stewardship programs lingers at CMS, she said, a lot of hospitals—even those accredited by the Joint Commission—won’t dedicate resources to antimicrobial stewardship.
By itself, the Joint Commission’s antimicrobial stewardship standard lacks a financial penalty. Goff said a hospital administrator can tell personnel, “I’m not going to give you dedicated resources to meet these standards; . . . try to meet this within your current work environments.”
A CoP, however, is a regulatory requirement that a hospital must meet to receive payments from the Medicare and Medicaid programs.
“Whenever you tie something to financial payment to the hospital, it moves a mountain overnight,” Goff said, recalling long-ago debates by surgeons and anesthesiologists regarding effective antimicrobial prophylaxis in surgery.
Once the Joint Commission’s Surgical Care Improvement Project core measures, including the one pertaining to the timing of the preincision antimicrobial dose, were linked to Medicare payments, she said, “everybody got onboard real quick. . . . Just having guidelines and recommendations was not enough to move the bar in that unique situation."
CMS on October 4 published the final rule that adds antimicrobial stewardship to the CoP regarding infection control in long-term care facilities.
Publication of the final rule that includes hospitals’ CoP regarding antimicrobial stewardship programs had been scheduled for November 10, 2016, according to a slide deck prepared by CMS for a presentation last August.
But the results from the November 8 election brought the process to a halt, said Jillanne M. Schulte, ASHP’s director for federal regulatory affairs.
“Generally speaking, when there’s a transition of administrations, there is a grace period . . . where agencies do not finalize new rules until the new administration takes office,” Schulte said.
The proposed new requirement for antimicrobial stewardship programs along with proposed revisions to the CoP regarding infection control are projected by CMS to cost the economy $773 million to $1.1 billion per year. CMS noted that “these costs may be more than offset by the savings, and the overall benefits to patients.”
Schulte on January 6 said there is a chance that the new administrator will want to review the final rule, which may affect 13 CoPs in all, before it becomes public.
The Trump–Pence transition team announced on December 7 that Seema Verma is the nominee for administrator of CMS. Verma is the president, chief executive officer, and founder of a national health policy consulting company.
Schulte said she has not seen any indication of CMS retreating from its stance on the need for hospitals to have antimicrobial stewardship programs.
“It’s a very important public health priority,” she said, “and I don’t think that this is something that they’re just going to drop.”
But CMS does appear to be dropping its plan to start a Medicare Part B drug demonstration, Schulte said.
The planned demonstration, which would have changed the payment formula for Part B–covered drugs, had been “controversial” from the outset, she said. “No stakeholders were completely overjoyed with that particular proposed rule,” including ASHP.
[This news story appears in the February 15, 2017, issue of AJHP.]