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fight back
Payors fight back, citing value and access
Coalition Slams Mandatory White Bagging
Payor-mandated “white bagging” is jeopardizing patient safety and exacerbating supply chain problems for hospitals and health systems, the ASHP and 61 health systems and group purchasing organizations recently told FDA Commissioner Janet Woodcock, MD, in a letter requesting a meeting to discuss the practice.
But payors and other stakeholders in managed care are pushing back against the criticism, citing hundreds of millions of dollars in patient savings that white bagging provides. They also refute the claim that the policy always is a mandatory affair that stifles ready access to potentially lifesaving medications.
“In 2020, we delivered $10.2 million in savings to Tennessee employers through our Advanced Specialty Benefit Management program,” said Natalie Tate, PharmD, the vice president of pharmacy management for Blue Cross Blue Shield (BCBS) of Tennessee. “Using our specialty pharmacy network, our members can save money right away. Someone whose employer participates in this program and has a high-deductible health plan would see their share of the cost for a specialty drug drop for each visit. If a member is taking [infliximab], for example, they could see their cost drop by around $400 per treatment.”
Dr. Tate also said that, for her organization at least, white bagging is not a requirement but a choice. “We’ve offered multiple options for our in-network providers based on their feedback, including one that allows them to continue a ‘buy and bill’ approach. We started by offering a six-month continuity of care program— essentially a transition period during the first half of 2020. During that time, we expanded our specialty pharmacy network and gave providers the option to join it. We had at least one large hospital system and six infusion centers join the network. We’re also offering ‘dispensing provider agreements’ to in-network providers. That’s like a middle ground. Providers can continue to buy and bill for specialty drugs, but at the same rates as our in-network specialty pharmacies. But they don’t have to actually become or set up a true specialty pharmacy.”
What Is White Bagging?
What’s not up for debate are the basic details of how white bagging works. The practice typically involves clinician-
administered drugs given to nonhospitalized patients—often infusion-based drugs that patients cannot take safely on their own. Historically, hospitals purchased these drugs in advance and held them in stock, and when a patient needs the drug, the hospital compounds and administers the drug and is reimbursed by the medical plan. Under white bagging, payors move these drugs from the medical benefit to the pharmacy benefit, barring the hospital from purchasing the drug itself and requiring that a prescription be sent to a payor-designated specialty pharmacy for fulfillment and shipment to the hospital.
“A primary motivator for payors to adopt white bagging is that they can dictate who the purchaser of the drug is, mandating that the drugs come from a specific source—often a plan-affiliated specialty pharmacy that is not associated with the health system,” explained Kyle Robb, PharmD, a state policy and advocacy associate with ASHP, during a webinar on the topic. “They believe white bagging gives them more control in negotiating the pricing, reimbursement and distribution channels for these drugs.”
White bagging has been around for years, but hospital and health-system pharmacies have reported an increase in the practice recently, with many of the white-bagging restrictions now being a mandatory component of the drug’s dispensing. The practice “is growing at astronomical rates of double digits per year,” Dr. Robb said. “More
than 10% of the annual [drug] spend year-over-year is being shifted from the medical benefit to the pharmacy benefit for many of these drugs.”
“White bagging takes formulary development and health system-specific policies and procedures around safety and completely disrupts this,” said David Chen, BSPharm, the assistant vice president for pharmacy leadership and planning at ASHP. “This process adds at least 10 extra steps for each patient unique for that payor, and this is happening with multiple payors. It runs counter to all Lean and patient safety models to reduce risk and ensure the best outcomes.”
In addition to potential treatment delays and other difficulties for patients in accessing their medications, Mr. Chen noted that white bagging disrupts the ordering process and potentially introduces errors. “With the complexity of these treatments, a complete drug therapy plan
Report Cites Lower Costs— If Best Practices Followed
A2019 report from the Massachusetts Health Policy Commission (HPC) on third-party specialty pharmacy use for clinician-administered drugs in that state found that commercial drug prices could be substantially lower with white bagging. In 2013, the per-unit drug price for three drugs analyzed in the report ranged from 15% lower to 38% lower through white bagging than via buy and bill; in 2015, the difference ranged from 12% lower to 24% lower. Patient cost sharing per unit went up in most cases, although the differences were relatively minimal, with increases ranging from $2 to $14.
Overall, the report found that white bagging can be used safely and may even offer advantages for small providers, but “the use of best practices to support patient safety and access is critical,” wrote lead author Sarah Sadownik, the deputy director of the HPC’s Research and Cost Trends Department.
The report also recommended that payors requiring white bagging offer site- neutral payment for white-bagged drugs, allowing providers the option to use the buy-and-bill method with reimbursement for the drug set at the third-party specialty pharmacy rate. “The site-neutral payment option would only need to apply to the drugs for which a payer required white bagging,” it said. “This policy lowers drug prices, reduces provider administrative expenses associated with compliance with multiple different policies, and addresses concerns about safety and access.” ‘[White bagging] is growing at astronomical rates of double digits per year. More than 10% of the annual [drug] spend … is being shifted from the medical benefit to the pharmacy benefit for many of these drugs.’
—Kyle Robb, PharmD
is often built into our electronic health records, and this disrupts that. It also can require duplicate ordering and management [processes] because this is technically a patient’s own medication.”
An FDA representative told Specialty Pharmacy Continuum that the agency “is aware of payor-mandated white bagging activities and is looking further into these and other models that may impact patient safety and supply chain security.”
Mr. Chen said ASHP and its members are concerned that payor-mandated white bagging is touted for its savings. In reality, he noted, coordinating the care of patients with white-bagged medications actually adds costs and risks to the equation. The practice also negatively affects transitions of care and leads to medication waste that occurs as a result of misdirected and inappropriately dispensed white-bagged medications from payor-designated pharmacies.
Mr. Chen added that cases of the detrimental effects of payor-mandated white bagging policies are mounting nationwide. “ASHP is receiving case studies daily, ranging from a premature baby requiring palivizumab [Synagis, Sobi] for prevention of RSV [respiratory syncytial virus] that took over 13 days to resolve, patients who had their MS [multiple sclerosis] and RA [rheumatoid arthritis] treatment delayed by more than two months due to complications with the payor-designated specialty pharmacy, and medications being sent to the provider multiple days after the treatment dose was due.”
More Questions on Cost
At Citizens Memorial Hospital and Health Care Foundation (CMH), in Bolivar, Mo., a rural health care network that provides care to the residents of eight counties in southwestern Missouri, 17 patients are currently affected by white bagging requirements. “They have a lot of frustration with the process,” said Mariah Hollabaugh, PharmD, the system pharmacy director. “At least five of those patients have had to be rescheduled and had delays in care because the specialty pharmacy didn’t have their drugs here on time. We do not have those delays when we order the drugs in advance through our wholesaler.”
Dr. Hollabaugh estimated that the patients, three of whom are taking omalizumab (Xolair, Genentech/ Novartis) for asthma, one who is taking belimumab (Benlysta, GlaxoSmithKline) for lupus, and one who is taking rituximab (Rituxan, Genentech/Biogen) for RA have experienced average treatment delays of one to two weeks due to white bagging. “When you are talking about conditions that flare up if there is a delay in a monthly medication, and you have the window for treatment delayed by up to 50%, that definitely affects their health,” she said.
One patient, who receives IV iron for chronic anemia, hasn’t just had her treatment delayed—she hasn’t been able to get it at all since January. “We have the drug, but we aren’t allowed to supply it,” Dr. Hollabaugh said. “Their specialty pharmacy hasn’t been able to ship it to us for some reason, while we can get it from our wholesaler and could give it to her tomorrow. At some point, if we continue to be unable to get this drug through their specialty pharmacy, she will probably have to travel somewhere else to get her infusion. But that will mean more inconvenience for her. If we aren’t able to offer someone an infusion here, most of our patients have to travel between 40 and 90 minutes one way to Springfield.”
BCBS’s Dr. Tate noted delays in treatment should not be a problem. “The specialty pharmacies in our network can deliver drugs in under 24 hours and make sure they’re handled appropriately based on the drug’s requirements. Because they are delivering individual doses just in time for treatment, these specialty pharmacies should also be prepared to handle any type of recall situation as they fulfill orders for our members.”
Smaller Facilities Vulnerable
Smaller hospitals and health systems, such as CMH, are particularly affected by white bagging requirements because of their limited negotiating power. Truman Medical Centers/University Health in Kansas City, two hours northwest of Bolivar, also has faced pressure to accede to these arrangements. “It’s become more frequent over the last few months,” said Joel Hennenfent, PharmD, the chief pharmacy officer. “But our pharmacy team has successfully worked with finance to let the payors know that our policies do not allow that practice and our medical staff does not support it from a safety perspective. We then have to work at negotiating the contract to change the terminology to stipulate that we do not accept medications from outside our inhouse pharmacy for safety reasons.”
But CMH is an 86-bed rural health care system and Truman is a 298-bed medical center with twice the patient revenue. “When you’re talking about a handful of patients per payor at our institution, they aren’t going to listen to us when we say no,” Dr. Hollabaugh said. “Their stance is that you have to use their pharmacy and there’s no wiggle room. Then, once the delayed product finally gets here, sometimes we get three months of doses because they overshipped to ‘rectify’ the situation from earlier. So, now we have storage issues as well as workflow problems. Our system is designed to charge for medications that we supply; interrupting that and changing the coding adds to our process. We always have to maintain a list of patients for whom we have to undo our documentation, coding and billing. That doesn’t even touch on the thousands in lost revenue for not being able to bill on those medications, when we barely break even every year.”
There is no one simple answer or solution to white bagging; “it’s completely site-of-care dependent,” said pharmacy consultant Bonnie Kirschenbaum, BSc, MS, a member of the SPC editorial advisory board. “Some hospitals will be radically opposed to it and want to keep their buy-and-bill model, because the loss of revenue looms very large. But there are other facilities that want to retain patients and avoid a devastating cost of product themselves, and stave off financial toxicity for their patients. They will take a completely different attitude toward white bagging.”
Ms. Kirschenbaum pointed to a recent AIS Health Daily industry poll, which asked readers’ views on white-bagging policies: 50% of respondents supported the practice, 43% opposed it, and 7% were neutral.
White bagging is only likely to increase going forward, said Dea Belazi, the president and CEO of AscellaHealth. “They’ve already tackled much of the low-hanging fruit in terms of saving money on specialty pharmacy. Now they’re looking at targets that may be more challenging and this is inherently the next thing to do. It’s been done for years in a selective fashion, but now we’re seeing it become mandated. They may not be able to do this across the board immediately, but it will continue to expand.”
100
—Natalie Tate, PharmD
Buy-and-bill: practice purchases drug from distributor White bagging: specialty pharmacy supplies drug to practice Brown bagging: specialty pharmacy dispenses drug to patient, who transports it to practice
Oncology Non-oncology Oncology Non-oncology Oncology Non-oncology Physician-affiliated clinics Hospital outpatient department Home infusion company
Figure. Drug sourcing for infused therapies, oncology versus non-oncology, by practice type and source, 2019.
—Gina Shaw
Rollercoaster Year
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parents, and the tendency was to be more conservative and provide it in a hospital setting,” Mr. LoPresti said. “We had identified patients for the pilot before the pandemic hit, but after that, families who were not in the pilot began asking for in-home therapy, and things ramped up much more rapidly than expected.”
The patients and families in that pilot soon discovered the advantages of home infusion: Children no longer had to be taken out of school to go to the hospital, parents no longer had to take time from work, there were fewer travel costs, and infusions could be scheduled at times most convenient for them. “It was a huge success and will be a published study soon,” he said.
All over the country, home infusion providers were stepping up to new demands for their services in a world where, suddenly, no one wanted to leave home unless it was necessary.
“We’ve seen at least a 50% increase in our patient load over the past year compared with the previous year,” said
Jeston Whitsell, PharmD, the pharmacy manager for Arkansas-based Delta Medical Infusion. “We’ve also been providing care outside of our normal service area, so we’ve increased staffing with another pharmacist, another nurse and an additional driver.”
Critical Source of Support
“During the pandemic, home infusion providers have been playing a critical role in supporting health systems and patients, making sure [those] who may not previously have been our patients receive the care they need at home,” said Connie Sullivan, BSPharm, the president and CEO of the National Home Infusion Association (NHIA). “Our providers have seen more patients than ever before.”
Ms. Sullivan added that home infusion providers “have been treating more patients in categories of care” than was the case prior to the pandemic, including chemotherapy and other complex specialty drugs. “They’ve had to develop new policies and protocols and do additional training for nurses and pharmacists to meet those needs; and because of the way the pandemic rolls through communities in unexpected ways, it’s been costly, challenging and unpredictable to know how to respond.”
In a Feb. 9 letter to former Acting Secretary Norris Cochran of the Department of Health and Human Services and Acting Administrator Liz Richter of the Centers for Medicare & Medicaid Services (CMS), Ms. Sullivan asked the Biden administration to consider four recommendations to improve access to care in the home setting for Medicare beneficiaries while also improving care for COVID-19: 1. Engage home infusion providers to vaccinate vulnerable and homebound populations. 2. Promote home infusion for COVID-19 treatments. 3. Provide all Medicare beneficiaries with home infusion access. 4. Waive in-person requirements for home infusion services during the public health emergency.
The request for home infusion access for all Medicare beneficiaries calls for the administration to address significant
shortcomings in Medicare’s coverage policies. “Medicare fee-for-service is the only payor that currently does not offer a comprehensive home infusion benefit,” Ms. Sullivan said.
At present, Medicare only covers home drug administration services for a limited subset of drugs that are covered under the durable medical equipment (DME) benefit because they are administered via an external infusion pump. For most home-infused drugs, such as IV antibiotics, monoclonal antibodies and hydration with electrolytes, which do not require a mechanical pump, supplies and professional services are not covered.
In its letter, NHIA asked that CMS add coverage for the related services and disposable supplies under Medicare Part B for drugs billed to Medicare Part D when they are used in the home setting. “Under this model, home infusion providers would receive a bundled supplies and services payment for each day a patient receives the drug, which would be designed to cover the costs associated with care coordination, patient assessments, plan of care development, clean room certification and maintenance, and other services provided by the pharmacy,” Ms. Sullivan wrote. The recommended change could be easily implemented by CMS in a demonstration project for infusion medications currently covered under the Part D benefit. “This model has been overwhelmingly effective in commercial plan coverage at lowering costs by shortening hospital stays and avoiding longterm care admissions.”
Another New Benefit
NHIA also met with CMS representatives about the new home infusion therapy services benefit that was implemented in January 2021. Historically, CMS did not cover the cost of nursing components for administering home infusion therapy. The 21st Century Cures Act, enacted in December 2016, established a new benefit for home infusion therapy services, including nursing services; training and education not otherwise covered under the DME benefit; remote monitoring; and other monitoring services.
CMS’s physical presence requirement for face-to-face visits from a nurse for implementation of the home infusion therapy benefit is another hurdle reducing access to home infusion services when vulnerable individuals are particularly interested in receiving home care whenever possible to avoid exposure to COVID-19, Ms. Sullivan noted.
“We [are] concerned about the rollout of that benefit and the disruption of care that it is creating,” she said. “The new benefit sounds good, but it was not intended to be solely a faceto-face nursing benefit for patients who receive infusion therapy under Medicare Part B, which is, unfortunately, how it has been applied. So now, providers are reimbursed significantly less for providing those therapies, and continuing to be able to provide that therapy depends on being able to locate a nurse when needed. There is very low enrollment at this point, and we have heard from several home infusion providers that they are struggling to find nursing care or another pharmacy to take those patients.”
Before 2021, Ms. Sullivan explained, a pharmacy home infusion provider could partner with a home health agency for higher-acuity patients who require nursing care, such as patients with congestive heart failure. “Seamlessly, the patient would have one nurse come out to do everything that was needed,” she said. “Now the nursing component has to be part of the Part B benefit, and many home health agencies are not participating in this benefit. We are very concerned; these are some of the most vulnerable seniors in the Medicare benefit. It’s not a lot of patients, but this is a very vulnerable population.”
NHIA is working with bipartisan members of Congress to reintroduce legislation from the last session, the Preserving Patient Access to Home Infusion Act (H.R. 6218), which is designed to ensure Medicare patients have access to Part B home infusion medications by, among other things, removing the requirement that a nurse be physically present in the patient’s home for providers to be reimbursed under the benefit.
“While the Part B benefit is important to fix, we also feel very strongly that this benefit only works for the small number of drugs that require infusion pumps,” Ms. Sullivan said. “We are urging CMS, through the Innovation Center, to explore a more comprehensive, straightforward infusion benefit for a broad array of drugs. The pandemic has really exposed this gap in coverage, when many people would like to receive care at home or at least have the option to.”
—Connie Sullivan, BSPharm
Upstate HomeCare, based in Clinton, N.Y., has seen increasing numbers of patients seeking at-home care for complex conditions such as primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy.
—Gina Shaw
