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to add a particular product to the formulary and, if a product is to be added, how that should be done. “Are we going to approve these in addition to what’s on formulary?” he posed as one possibility. “Or are we going to approve this [specific biosimilar] as a preferred product and take the brand name off of the formulary?” Perhaps a temporary name. FDA chose filgrastim-sndz as Zarxio’s nonproprietary name, calling the hyphenated name a “placeholder” while the agency decides on its “comprehensive naming policy for biosimilar and other biological products.” But “filgrastim-sndz,” Anderegg said, may be mistaken for “filgrastim” by users of computerized prescriber order-entry systems and personnel in pharmacy storage areas. “It’s just another four letters at the end of the typical generic name,” he said of the placeholder, and not everyone reads the final letters in a familiar-looking drug name. In Jenkins’s prepared remarks for the media, the FDA official said the agency intends “in the near future” to issue draft guidance on how companies should name their biosimilar products for the U.S. market. Not without a fight. How soon the biosimilar product will be available for U.S. healthcare professionals to prescribe is unclear. A lawsuit by Amgen against Sandoz is under consideration by a federal judge. At issue is whether Sandoz violated a provision of the Biologics Price Competition and Innovation Act, part of the Affordable Care Act. According to the legal news service Law360, statements made on March 13 by the federal judge presiding over the case put in doubt Amgen’s ability to obtain a preliminary injunction preventing Sandoz from immediately launching its biosimilar product. —Cheryl A. Thompson DOI 10.2146/news150028

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Florida hospital embraces pharmacist-led chronic care in physician offices

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community-based health system’s corporate-level decision to place pharmacists in primary care offices both improves the care of complex patients and aligns with Medicare’s shift toward payment for value instead of volume. The Comprehensive Health Management service at Martin Health System of Stuart, Florida, targets patients with multiple chronic conditions and high use of the health system’s services, said Dave Harlow, assistant vice president for professional services and chief pharmacy officer for Martin Health. About 140 people have enrolled in the service, which began in early 2014 and targets patients with diabetes, hypertension, hyperlipidemia, heart failure, chronic obstructive pulmonary disease, and asthma. Most enrollees have at least three disease states, and diabetes and hypertension are the most common conditions affecting the participants. “We want the ones that are out of control, so that we can actually make a difference and make their lives easier,” said Debra Ann Antoon, corporate manager of ambulatory care pharmacy services and manager for the Comprehensive Health Management service. Antoon and other clinical pharmacists work onsite at several physician practices that serve a Medicare-rich population on south Florida’s Treasure Coast. Potential enrollees are identified by acute care, transitions-in-care, or emergency department pharmacists at Martin Health and by the health system’s primary care physicians. Antoon said the referral process for the service is built into the health system’s electronic medical record system. Potential patients appear in the work queue and are then screened over the telephone or in the office to determine whether they meet the service’s requirements. Once enrolled, the patient meets with Antoon or another clinical pharmacist. The initial visit takes about an hour and follows a structured format that includes

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a health literacy assessment, physical examination, disease state–specific assessment, allergy and immunization screening, medication reconciliation, goal setting, and other elements. Subsequent follow-up occurs in the office and over the telephone at intervals that are based on the patient’s individual needs and progress. According to data provided by Antoon, early indicators from a survey of enrollees suggest that about 90% were satisfied with the care they received from their clinical pharmacist. One survey respondent claimed in a written comment that participation in the service “probably has saved my life.” Team-based care. Harlow emphasized that the service isn’t a “pharmacycentric” initiative. “It is team based,” he said. “The pharmacists are not owners of these patients. But pharmacists are the touch points for the physician and for the patient to steward these patients to success.” Harlow emphasized that all of the protocols for the service are evidence based, developed by consensus, and approved by the appropriate physician specialty leadership and the medical executive committee. And Antoon and her colleagues have been receptive to primary care physicians’ potential concerns about the service as they have introduced it into their practice sites. “The thing we’re very sensitive to at the beginning is, we’re not here to tell them how to do their job,” Antoon said. She said the pharmacists observe the office’s workflow and look for ways to support the staff. “In all of the offices we’ve gone to, we’ve been very well received. Because I think we’ve listened to what they need,” Antoon said. Heather Robertson, ambulatory care pharmacy services provider for the ComContinued on page 597

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prehensive Health Management service, said it’s helpful to be in the primary care office, where physicians can introduce her to new patients. “It shows the patient that we’re working as part of the healthcare team with the physician. So that increases the patients’ willingness to come back to see us,” she said. And Harlow said physicians’ willingness to make referrals to the program shows that they recognize that the clinical pharmacists are “making a significant, substantive difference in their patients’ care.” Payment model. Finding ways to pay for pharmacists’ services in primary care offices can be a barrier to positioning them in these settings. But Harlow questioned the logic that separates financial support for ambulatory care and hospital-based pharmacy services. “We have had pharmacists in the hospital doing fantastic work for decades,” he said. “Nobody comes to me on a regular basis and says, ‘What’s the return on investment on pharmacists on the fifth floor?’ But when it comes to the primary care areas, it’s the first question everybody asks.” He said the pharmacists in the primary care offices have their own cost center but are treated as hospital staff. Martin Health could seek Medicare reimbursement for the office-based pharmacists’ services through Medicare’s new chronic care management program and other incident-to service and billing models. But Harlow said the health system chose not to do so because these models require the collection of additional copayments from patients who are already subject to many copayments. Antoon echoed Harlow’s comments. “Our patients have told us, ‘If I had to pay a copay two, four, six times in between my doctors’ visits, I probably wouldn’t have come back,’” she said. Harlow said he’s open to the idea of having his pharmacists perform and bill for Medicare wellness visits, which don’t require copayments from patients.

He said Martin Health recognizes that by shifting routine care of the system’s most complex chronic care patients to pharmacists, primary care physicians have more time to see new patients, which increases revenue. And when the enrollees’ health improves, that boosts quality-of-care scores for the organization and Medicare reimbursement rates that are based on quality metrics. “If we can get their care better, they actually use less of everything. And . . . that actually decreases your cost per Medicare beneficiary,” Harlow said. Martin Health also has an agreement with Humana that provides bonus payments for care that meets the insurer’s quality criteria. Harlow said the health system’s investment in placing pharmacists in primary care practices reflects institutional support for population-based care. And that, he said, meshes with the Medicare program’s transition to a system that rewards quality instead of volume. The Centers for Medicare and Medicaid Services (CMS) in late January announced its goal of tying 50% of Medicare fee-for-service payments to alternative payment models such as accountable care organizations by 2018. About 20% of reimbursement today is for care delivered in such settings. CMS also wants (by 2018) to tie 90% of feefor-service payments under Medicare to

programs such as the Hospital ValueBased Purchasing Program and Readmissions Reduction Program. “Because of all the changes in how organizations are being reimbursed, [population-based care] is something that pharmacy must do,” Harlow said. “And we are a very good example of what can be done, right this very second, that is meaningful to organizations.” Harlow said the Comprehensive Health Management service began as a three-year pilot project but is here to stay. “This is actually part and parcel of what we do now” as pharmacists, he said. “Everybody is involved in it, to some degree.” Antoon and Robertson cited instances of success with their patients, including several with long-term uncontrolled diabetes who have dramatically improved their glycosylated hemoglobin levels. Harlow said a large proportion of patients, before they were enrolled in the program, “were using many more resources and were certainly more predisposed to [hospital] admissions” than they are now. Harlow said official outcomes data for the service will be analyzed through an agreement with Virginia Commonwealth University. —Kate Traynor DOI 10.2146/news150029

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Florida hospital embraces pharmacist-led chronic care in physician offices.

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