Specialty Pharmacy Continuum - May / June 2021 by McMahon Group

Serving managed care, health system and specialty decision makers Volume 10 • Number 3 • May/June 2021 • specialtypharmacycontinuum.com

TECHNOLOGY Flexibility, telepharmacy keep PAPs on track during COVID-19 ................

CLINICAL 7 habits of effective COVID-19 treatment managers ...............................

Propylene glycol-free melphalan passes safety test .............................

POLICY Raising the SBAR for safer cleanrooms during a pandemic ........

Strategies for boosting biosimilar uptake .............

OPERATIONS & MGMT Coalition slams mandatory white bagging—and payors fight back ..........................

REVIEW ARTICLE

Management of

Chronic Obstructive Pulmonary Disease See page 8.

Providers urge feds to prioritize home-based care

Mitigating risk:

A Rollercoaster Year For Home Infusion Rx J

Opioid-Benzo Combination Eyed by Payors

ust over one year ago, like so many other businesses across the country, Upstate HomeCare went from normal operations to sequestered virtually overnight as the COVID-19 pandemic hit the United States. Senior Vice President and CEO Greg LoPresti sent approximately 40% of the staff of his Clinton, N.Y. home health care service agency, which serves the Albany, Syracuse, Rochester and Buffalo regions, to work from home. Meanwhile, the staff who had to work in person— including drivers, nurses and pharmacists—needed to readjust their care models. “Many of the core services we provided, like postsurgical home infusions, dried up overnight,” Mr. LoPresti said. “Meanwhile, we had more specialty and chronic care cases for patients with conditions like primary immunodeficiency and CIDP [chronic inflammatory demyelinating polyneuropathy]. The neurology practices were all open, and while they tried to minimize routine patient care to minimize exposure, patients with these severe chronic conditions had to be seen. Patients who would have gone to more traditional outpatient infusion facilities to get care came to us in droves.” Upstate HomeCare also was in the middle of a pilot study, in partnership with pediatric gastroenterologists at Golisano Children’s Hospital at the University of Rochester Medical Center, to assess the safety and effectiveness of home infusion of anti–tumor necrosis factor therapies for pediatric patients with chronic conditions such as Crohn’s disease and ulcerative colitis. “This is standard for us, but with a pediatric population, there had been concern about doing these infusions in the home, especially for the

ith the concurrent use of benzodiazepines and opioids involved in approximately 16% of fatal overdoses, according to the CDC, management of the medications represents a significant challenge for payors. Benzodiazepines are FDA-labeled for conditions such as seizures, insomnia, generalized anxiety disorder and panic disorder, and usually are intended for short term—weeks to months, said Kimberly Lenz, PharmD, the director of clinical and operational pharmacy for MassHealth, the Massachusetts Medicaid program, at the University

Continued on page 22

Continued on page 18

Special Focus:

Sterile Compounding See pages 14–16

Continued on page 12

Home Infusion Audits, Low Pay: Action Needed

ome infusion pharmacy clinicians can make the most of reimbursement opportunities and minimize risk in payor audits with basic understanding of key reimbursement concepts, including pricing, contracting, prior authorizations (PAs), and billing for waste, experts reported at the 2021 virtual annual meeting of the National Home Infusion Association (NHIA). “Resist the temptation to dismiss these topics by thinking ‘we have a revenue cycle team that handles all that,’” said Ryan Garst, PharmD, MBA, the NHIA’s senior director of clinical services.

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Specialty Pharmacy Continuum • May/June 2021

TECHNOLOGY

During COVID-19:

Teamwork, Digital Tools Keep PAPs on Track Being flexible, embracing technology and making more coordinated efforts to service providers and patients are all lessons that drug manufacturers and patient assistance programs (PAPs) can take from the COVID-19 pandemic, according to a panel of experts at Informa’s PAP Critical Update 2021 virtual event. Despite it being a difficult year, there were some positive notes to draw from, said Tommy Bramley, PhD, the president of the Lash Group, a patient support services division of AmerisourceBergen, during a discussion about forging a better path for patients in the wake of a pandemic. Lash Group and others adapted quickly to meet the demands of the COVID-19 crisis in different ways, including working with manufacturers and health care providers to ensure patients received uninterrupted access to their medications.

Remote Teams Ready Xcenda, a consulting and field reimbursement services company that is also part of AmerisourceBergen, already had remote field teams in place that it quickly leveraged to ensure the company was offering engaging services to its providers, said Katie Wilson, the vice president of innovative field solutions. When the pandemic hit, staff had to rapidly determine how best to showcase their program materials and make them available digitally, as well as train employees on how to have meaningful communications with providers virtually and use web conferencing technology. “We leveraged our existing provider relationships, and that turned out to be instrumental as the pandemic continued,” Ms. Wilson said. “As [physician] offices figured out how they would see patients and how to use telemedicine, we were able to meet them where they were, give them what they needed and have meaningful interactions.” With a significant decrease in patients visiting provider offices and job uncertainty amid a spike in unemployment rates, Lash Group worked with manufacturers to identify what they needed for their specific patient populations to ensure the most vulnerable patients would receive care, said Todd Wells,

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the vice president of operations. They developed multiple contingency plans for how to support patients in a variety of different scenarios, working with manufacturer partners. “Thankfully we didn’t have to implement those extreme contingencies, but we were certainly ready,” he said. “While we all hope to never experience another pandemic, the experience showcased a collective ability to embrace virtual interactions and automation,” Mr. Wells said. “We’ve seen the adoption of a virtual patient portal we launched continue to increase, as well as the use of virtual injection training services,” he added. Manufacturers also were open to accelerating technology to optimize the patient experience. “I don’t see us going backward,” Mr. Wells said. “In fact, we will continue to automate every step we can to allow our ... counselors to focus on the most complex cases and direct patient contact.”

10 Steps to Ensure PAP Success 1. Leverage existing provider relationships 2. Take a close look at hurdles 3. Close the knowledge gap 4. Understand patients and their needs 5. Use predictive analytics

6. Be flexible 7. See what partners are doing 8. Give policymakers patient-centric ideas 9. Embrace innovation 10. No entity is an island

Taking a Deeper Dive There’s been a lot of movement from manufacturers and PAP administrators to take a much closer look at the effects of the economy on patients and providers using these program, noted Dale Hanna, the director of product management at Lash Group. One hurdle has been the affordability of treatment, and some of the inequities associated with that “really came to light” during the pandemic, Mr. Hanna said. “A lot of patients actually dropped off treatment,” he added. “As a society, we’re actually going to see a much longer-term impact to overall patient health because of that.” Many providers and patients are not aware of PAPs, including those offering copay assistance to help overcome financial barriers. This knowledge gap presents an opportunity for

manufacturers to build better awareness, Mr. Hanna said. His division has been helping its manufacturer clients look at what flexibility they have. As just one example, he noted, payors and manufacturers can work together to change thresholds for patient eligibility. Manufacturers also can simplify processes for their providers and patients, perhaps allowing patients to self-manage their own assistance and benefits online or helping providers enroll patients without needing a lot of clicks outside of electronic health records, Mr. Hanna noted. The presenters cited several additional steps for ensuring PAP success: • Understand the patients and their therapy services, including social and economic barriers to care. • Use predictive analytics to see where

falloff occurs and intervene. • Be flexible with program design. • Look to partners to see what’s going on at a broader level. • Be a part of the solution as it relates to health care policy. • Approach policymakers with constructive ideas that are patientcentric. • Embrace innovation, whether digital technologies, automation or other ideas. • Lean on partnerships. As Mr. Wells noted, “A great business partner has the benefit of seeing what’s working across the board and can bring those ideas to you.”

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Founded in 1972, McMahon Publishing is a family-owned medical publisher of clinical newspapers and specialty periodicals, and creates continuing medical education programs and custom publications. As the second largest publisher of medical newspapers, McMahon produces Anesthesiology News, Gastroenterology & Endoscopy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News, Pharmacy Practice News and Specialty Pharmacy Continuum.

Specialty Pharmacy Continuum • May/June 2021

CLINICAL

7 Habits of Effective COVID-19 Rx Managers The extraordinary amount of scientific activity marshalled to fight COVID-19 has led to a full pipeline of medications and vaccines— and an opportunity for pharmacists to help deliver the potentially lifesaving treatments to the right patients. G. Caleb Alexander, MD, MS, a professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, in Baltimore, proposed guiding principles to help pharmacists navigate the evolving landscape of COVID-19 medical management. “The evidence base remains completely dynamic and staying up-todate with treatment guidelines is a must, but there are some overarching principles of effective treatment that can help us achieve the holy grail, which is getting the right drug to the right patient at the right time,” Dr. Alexander said at the Academy of Managed Care Pharmacy’s 2021 virtual annual meeting. To help pharmacists in their decision-making process, Dr. Alexander suggested these seven strategies:

Know the evidence base. “Not all evidence is equal,” he said, pointing to reliable syntheses of evidence such as the Infectious Diseases Society of America’s COVID-19 treatment guidelines (bit.ly/3nT6Vvj). He encouraged pharmacists not to be afraid to challenge convention, saying that “if I had a nickel for every time I’ve seen things done clinically because ‘that’s what we do,’ rather than because of good evidence, I could retire a little earlier.” Initial enthusiasm about hydroxychloroquine, despite a lack of evidence, and the subsequent decline in its use after data became available, is a good example of how clinical practice changes as data arise. “There are lots of opportunities to take a close look at the evidence base and improve our application of it,” Dr. Alexander said.

Understand the limits of evidence. In his own survey of the COVID-19 literature, Dr. Alexander found significant study design limitations. For example, during the early stages of the pandemic, he found that: • roughly one-third of clinical trials of COVID-19 therapeutics excluded clinical end points; • nearly 50% of trials enrolled fewer than 100 patients; and • roughly two-thirds were open-label. “Once complete, many of these studies are likely to yield only preliminary evidence of a given treatment’s safety and effectiveness,” he said. Other limitations include the use of “usual care” arms—a grab bag of approaches not always defined in a study. Outcomes in these groups can vary widely, he indicated. For example, he pointed to a meta-analysis of corticosteroids for COVID-19 that found mortality rates in control arms ranged from 16% to 59% (JAMA 2020;324[13]:1330-1341). Stratify treatments based on patient characteristics and

Managed Care Seeking More Equity in COVID-19 Therapy

ddressing disparities in access to COVID-19 vaccinations and care should be a top priority for managed care pharmacists. “Building disparity and vulnerability data—from social determinants of health to socioeconomic status, lifestyle and patient health care access preferences—into our reporting tools at Kaiser Permanente has translated to more effective approaches to vaccinating our populations and improving the provision of care,” said Dan Kent, PharmD, a clinical pharmacy quality coordinator at Kaiser Permanente of Washington, in Kent. The Kaiser team has found that a subset of its patients who are Latinx agricultural workers and have a body mass index over 35 kg/m2 are less likely to travel to one of the organization’s vaccine clinics, largely because of difficulty taking time off work. That barrier to care is compounded by the fact that Latinx individuals are twice as likely as the general population to develop COVID-19, three times as likely to be hospitalized and 2.3 times more likely to die from COVID-19, Dr. Kent noted, citing a report from the CDC (bit.ly/3xBrlO6). “Now, instead of waiting for them to come to the vaccine clinics, we’ve taken the vaccines to them, to their places of employment,” he said during the Academy of Managed Care Pharmacy’s 2021 virtual annual meeting. However, racial factors aren’t the only ones to affect

the management of COVID-19. Patients with obesity, cancer, HIV and diabetes—independent of race—as well as those receiving treatment with steroids and immunosuppressants, are at higher risk for COVID-19 and poorer outcomes, Dr. Kent noted. Analyzing these factors can help pharmacists not only develop more targeted vaccination campaigns and treatments, but also create “new decision pathways, internal guidelines and care methods, and find better ways of reaching out to those that are isolated or have barriers to care,” he said. In addition to including COVID-19 risk factors when building vaccine and care interventions, Kaiser Permanente also continuously monitors its patients to detect who is not receiving vaccinations and providing these individuals with additional education, “whether it’s by phone, through mail, email, text messaging, video calls and even automated calls,” Mr. Kent said. “It’s been important to share the evolving evidence regarding both vaccines and treatments with our members.” —D.W.

severity. “This is a fundamental concept that’s important for us to consider in selecting treatments,” Dr. Alexander said. Rather than being homogeneous, different groups have different prognoses and “incredibly different mortality rates. We should be thinking about these as we steward what are invariably scarce, and in some cases, incredibly costly treatments.” Recognize the role of virus variants. Variants affect not just the effectiveness of vaccines, but “they may [also affect] some therapeutics.” This has led the FDA to issue revisions to fact sheets on monoclonal antibodies, addressing possible resistance of SARSCoV-2 variants to this class of drugs. Be familiar with vaccine adverse events. Although COVID-19 vaccines are a boon to public health and individual care, instances of thrombocytopenia in patients receiving vaccines manufactured by AstraZeneca and Johnson & Johnson are examples of the challenges of vaccine selection. Don’t skimp on prevention. “We can’t let use of therapeutics come at the expense of preventive intervention,” Dr. Alexander said. In their interactions with patients, pharmacists should underline the importance of wearing masks, social distancing and handwashing in COVID-19 prevention and highlight their importance in helping communities achieve a return to normalcy as soon as possible, he said. Keep an eye out for inequality. Various racial, ethnic and socioeconomic groups have seen stark differences in rates of infection, hospitalization and death, as well as in vaccine access (sidebar). “While these differences are multifactorial, they are important for health systems to acknowledge and address when designing interventions,” Dr. Alexander said. —David Wild The sources reported no relevant financial disclosures beyond stated employment.

Specialty Pharmacy Continuum • May/June 2021

CLINICAL

Propylene Glycol–Free Melphalan Passes Safety Test Toxicity issues related to propylene glycol–free melphalan in patients with multiple myeloma undergoing autologous hematopoietic cell transplant (auto-HCT) may be overblown, according to new research. Generic melphalan contains propylene glycol (PG) as a solvent. After the FDA approved PG-free melphalan (Evomela, Acrotech) in 2016, contradictory reports emerged about its toxicity, said Ko Maung, MD, of Duke Cancer Institute in Durham, N.C. “At Duke, we used PG-free melphalan since May 2017, but switched to generic melphalan in November 2017 due to the concern for increased toxicity. We hypothesized that PG-free melphalan is associated with more toxicity than generic melphalan,” he said. Dr. Maung and his colleagues evaluated myeloma patients undergoing their first auto-HCT, comparing those treated with PG-free melphalan and those given generic melphalan (J Natl Compr Canc Netw 2020). Of the 63 patients in the study population, 27 received PG-free melphalan and 36 received generic melphalan. The two groups were similar with respect to relevant factors. All patients received outpatient auto-HCT and were admitted if acute issues arose. Early treatment response was assessed at 60 to 90 days after transplant.

melphalan,” David Frame, PharmD, a clinical pharmacist at Michigan Medicine in Ann Arbor, told Specialty Pharmacy Continuum. “The largest report, from the Mayo Clinic, evaluated 416

myeloma patients [Bone Marrow Transplant 2019;54(4):587-594], most of whom were also outpatient transplants with similar outcomes as reported here. “At the University of Michigan, we switched to the PG-free melphalan in early 2017 due the significantly extended stability time of four hours versus one hour for the PG-containing product,” Dr. Frame said. “It can be very challenging” to make melphalan

and deliver and infuse it before it expires,” he added, noting that this resulted in waste of “many bags of drug, which was quite costly.” He said “this waste was virtually eliminated with the PG-free product.” —Caroline Helwick and Sarah Tilyou The sources reported no relevant financial disclosures.

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Similar Clinical Outcomes Seen The analysis showed no statistically significant differences in time to count recovery, toxicities or resource utilization between the groups. The rate of treatment response also was similar: 33% with PG-free melphalan and 39% with generic melphalan (P=0.0655). “Our auto-transplant data for myeloma did not show significant difference in toxicities between PG-free melphalan and generic melphalan. Generic melphalan seemed to be associated with a higher early treatment response, but, again, this was not statistically significant,” Dr. Maung said. Despite the findings, he said the Duke bone marrow transplant program “decided to keep using generic melphalan.” He further noted that “PGfree melphalan is convenient because it is stable, without crystallization at room temperature. But we did not have evidence that one is better than the other in terms of efficacy or toxicity, and, at least at Duke, PG-free melphalan is much more expensive. Considering everything, we didn’t feel it’s reasonable to use PGfree melphalan,” he said. “This retrospective report adds to those previously published demonstrating similar efficacy and toxicity between the PG-free and PG-containing

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Specialty Pharmacy Continuum • May/June 2021

CLINICAL

Safe at Home: mAb Infusions for COVID-19 Home infusion providers can successfully administer monoclonal antibody (mAb) therapy to COVID-19 patients in long-term care facilities with minimal side effects, according to a new report released by the National Home Infusion Association (NHIA). However, barriers to reimbursement continue to pose challenges for home infusion providers seeking to continue to provide mAb therapy to their patients after the conclusion of the pilot project,

according to association officials. NHIA partnered with the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human

Services (HHS) for the pilot program (bit.ly/3vz95mO), in which ASPR agreed to provide direct allocations of bamlanivimab to home infusion pharmacies for use in high-risk settings, as part of HHS’s Special Projects for Equitable and Efficient Distribution. In early February, the FDA issued an emergency use authorization (EUA) for bamlanivimab (LY-CoV555, Eli Lilly) to treat mild to moderate COVID-19 in

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adults and children (≥12 years of age, weighing ≥40 kg) who are at high risk for progressing to severe COVID-19 and/or hospitalization. A later EUA authorized use of 700 mg of bamlanivimab with 1,400 mg of etesevimab (Lilly), and the FDA revoked the EUA for bamlanivimab alone at Lilly’s request (bit.ly/3tqudd6-SPC). Because of the EUAs’ timing, the NHIA pilot included only bamlanivimab. “The willingness of home infusion providers to participate in this program was overwhelming. They wanted to do whatever it took to be part of the effort to combat COVID-19,” said Ryan Garst, PharmD, NHIA’s senior director of clinical services. “We launched the program on Dec. 14, 2020, and within two weeks, we had 36 provider organizations and 172 individual provider locations enrolled, with at least one location in 46 of 50 states.” One of those providers was Delta Medical, which serves patients throughout northern Arkansas. “In January 2021, we administered the first dose of bamlanivimab in Arkansas to be given outside a hospital,” said pharmacy manager Jeston Whitsell, PharmD. “We had very good results. Among the 30-plus patients we took care of during the pilot, none had any adverse effects or infusion reactions and no one entered the hospital, so the results from the pilot overall were very similar to our experience. I think we did a great job in keeping those folks out of the hospital.” Overall, home infusion providers administered a total of 426 doses of bamlanivimab during the 10-week pilot. “We found that the medication was effective and safety was very strong,” Dr. Garst said. “In our analysis, 93% of patients had no adverse events. Of those that did, most of them were quite mild, and only two were hospitalized.”

Improved Access Beginning March 1, HHS and the FDA opened the allocation process to allow easier access to mAb COVID-19 therapies, which outside the pilot program had been required to be ordered through individual state health departments. Now, providers can directly order mAbs available via the EUA, including casirivimab plus imdevimab (Regeneron) and bamlanivimab plus etesevimab, through Medicare. The current Medicare reimbursement model for mAbs is covered using Centers for Medicare & Medicaid Services’ (CMS’s) reimbursement authority for COVID-19 vaccine administration, directly through the Medicare Administrative Contractors (MACs), meaning that the Medicare rules regarding enrollment and billing as a mass immunizer

Specialty Pharmacy Continuum • May/June 2021

CLINICAL

for the COVID-19 vaccines also apply to enrolling to administer the mAbs. “Entities wishing to participate in home infusion of monoclonal antibodies must enroll with their state’s A/B MAC [Part B MAC],” explained Bill Noyes, NHIA’s senior vice president of reimbursement policy. “Home infusion pharmacies typically bill to the DME [durable medical equipment] MAC; this A/B MAC mass immunizer hotline enrollment is temporary, good only during the public health emergency.” “Now, with the direct ordering process, all home infusion providers—not just those in our pilot program—can get access to all of these monoclonal antibody therapies for their patients,” Dr. Garst said. “That’s a positive, but inadequate reimbursement means we are missing an opportunity to help thousands more patients in the home setting.”

A Closer Look At Reimbursement The Medicare reimbursement rate for the COVID-19 mAbs, applicable to all infusion sites, is based on the reimbursement rate for complex infusion and monitoring in the hospital outpatient setting. That’s a flat rate of $309.60—an amount that may fall short in some sites of care, Mr. Noyes noted. “It may have worked well in a group home setting where, in many cases, you are administering the drug to more than one resident while you are there, but it’s not conducive to more than one patient at a time in their home,” he explained. “That’s much more costly.” NHIA’s report on the pilot program calculated the costs of home infusion for bamlanivimab, including onboarding, nursing, direct costs, other pharmacy services such as dispensing and billing, and general administration, at a total range of $584 to $1,746.

‘Even if [CMS increases] the reimbursement rate [for monoclonal antibody home infusions], by keeping these patients out of the hospital, Medicare will still be paying far less for this treatment than they otherwise would have paid for their care.’ —Jeston Whitsell, PharmD “As more and more people are vaccinated for COVID-19, there will be less need for the monoclonal antibodies, but

until all of the high-risk patients are vaccinated, we have a window of opportunity right now to get these products where

they are most needed,” Mr. Noyes said. “But that window is closing.” —Gina Shaw The sources reported no relevant financial disclosures other than their stated employment.

More on Web NHIA’s President and CEO Connie Sullivan, BSPharm, offers monoclonal antibody lessons learned during COVID-19. Access at www. specialtypharmacycontinuum.com.

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Better at Home Infusion pharmacies are eager to provide these services to patients at home, Dr. Whitsell noted. “These therapies have the potential to be very successful in home infusion, and we want to be able to provide them to the people who need them,” he said. “But, ultimately, the reimbursement will have to be there. It’s important to look at the results: Even if they increase the reimbursement rate, by keeping these patients out of the hospital, Medicare will still be paying far less for this treatment than they otherwise would have paid for their care.” In February, NHIA wrote to HHS and CMS, asking that reimbursement for administration of mAbs at home be increased to account for the additional costs associated with delivering these medications in the home setting.

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Specialty Pharmacy Continuum •May/June 2021

CLINICAL

Management of

Chronic Obstructive Pulmonary Disease NISHITA HIRA, PHARMD, CSP Clinical Program Manager AllianceRx Walgreens Prime Orlando, Florida

hronic obstructive pulmonary disease (COPD) is a respiratory disease characterized by blockage of airflow from the lungs, which results in

progressively worsening shortness of breath, coughing, wheezing, and production of excessive phlegm or mucus.

For the more than 15 million Americans diagnosed with COPD, declining lung function, increasing hospitalizations, and comorbidities can make engaging in daily activities difficult, leading to diminished quality of life (QOL).1 Although there is no

cure for COPD, medications coupled with lifestyle changes can help lessen respiratory symptoms and reduce exacerbations.1

Medications Disease presentation and pro-

gression, as well as treatment regimens, may vary from person to person, but the goals of COPD treatment

Table. Selected Agents Used to Treat COPD

remain constant: alleviating symptoms, preventing exacerbations, and improving overall health, with the intent of slowing disease progression and improving QOL.2

Short-acting • Albuterol bronchodilators • Ipratropium • Levalbuterol • Ipratropium/albuterol

Inhale every 4-6 h as needed

Dry mouth, headache, cough

Long-acting bronchodilators (single agent)

• Aclidinium (Tudorza, AstraZeneca) • Arformoterol (Brovana, Sunovion) • Formoterol • Glycopyrrolate • Salmeterol (Serevent, GlaxoSmithKline)

Inhale twice daily

Dry mouth, dizziness, tremors, runny nose, irritated or scratchy throat, upset stomach

• Olodaterol (Striverdi Respimat, Boehringer Ingelheim) • Revefenacin (Yupelri, Mylan) • Tiotropium (Spiriva, Boehringer Ingelheim) • Umeclidinium (Incruse Ellipta, GlaxoSmithKline)

Inhale once daily

• Aclidinium/formoterol (Duaklir Pressair, AstraZeneca) • Glycopyrrolate/formoterol (Bevespi Aerosphere, AstraZeneca)

Inhale twice daily

Bronchodilators Bronchodilators continue to be first-line therapy for patients with COPD, regardless of disease severity.3 These orally inhaled agents relax the muscles around the lungs, which allows the airways to open, making breathing easier.2 For patients with mild COPD, a short-acting bronchodilator alone may be adequate.2 Short-acting bronchodilators, such as albuterol and ipratropium, are effective for about 4 to 6 hours and typically are used at the onset of acute symptoms.2,4 Long-acting bronchodilators are added to regimens for patients with moderate to severe COPD to improve symptoms and prevent exacerbations.2-4

• Tiotropium/olodaterol (Stiolto Respimat, Boehringer Ingelheim) • Umeclidinium/vilanterol (Anoro Ellipta, GlaxoSmithKline)

Inhale once daily

LABAS, LAMAS, AND COMBINATION BRONCHODILATORS

• Budesonide/formoterol (Symbicort, AstraZeneca) • Fluticasone/salmeterol • Budesonide/glycopyrrolate/formoterol (Breztri Aerosphere, AstraZeneca)

Inhale twice daily

• Fluticasone/vilanterol (Breo Ellipta, GlaxoSmithKline) • Fluticasone/umeclidinium/vilanterol (Trelegy Ellipta, GlaxoSmithKline)

Inhale once daily

• Roflumilast

Oral, once daily

Treatment Category

Long-acting bronchodilators (combination)

Corticosteroids (combination)

PDE4 inhibitor

Drugs

Recommended Dosing Common AEs

Headache, sore throat, voice changes, nausea, cold-like symptoms, thrush

Weight loss, diarrhea, headache, nausea, cramps, tremors, insomnia

AEs, adverse events; COPD, chronic obstructive pulmonary disease; PDE4, phosphodiesterase-4. Based on references 2-8.

Long-acting bronchodilators are further classified into 2 groups—longacting beta-2 agonists (LABAs) and long-acting muscarinic antagonists (LAMAs).3 Although there are no specific recommendations as to which class of long-acting bronchodilators should be used as first-line therapy, data indicate LAMAs are more effective in preventing exacerbations but show no measurable difference between LABAs and LAMAs for symptom management.3 Selection of the most appropriate bronchodilator should be based on treatment goals, efficacy, tolerance, and convenience.3,5

Specialty Pharmacy Continuum • May/June 2021

CLINICAL

Over the past several years, the advent of ultra-LABA and -LAMA medications, which are dosed once daily, has provided COPD patients with a favorable alternative to traditional twice-daily bronchodilators due to their efficacy and convenience.3 Studies have shown that these newer agents—olodaterol (Striverdi Respimat, Boehringer Ingelheim) and umeclidinium (Incruse Ellipta, GlaxoSmithKline)— are safe and effective in the longterm management of moderate to severe COPD and are associated with significant improvements in lung function and QOL.3 For patients who continue to experience symptoms and exacerbations despite treatment with a single long-acting bronchodilator, combination LABA/LAMA medications may be an option.3 Combination bronchodilators include umeclidinium/ vilanterol (Anoro Ellipta, GlaxoSmithKline), tiotropium/olodaterol (Stiolto Respimat, Boehringer Ingelheim), glycopyrrolate/formoterol (Bevespi Aerosphere, AstraZeneca), and aclidinium/formoterol (Duaklir Pressair, AstraZeneca).4 Clinical trials have shown these medications to improve lung function and QOL and reduce the number of exacerbations.3,5 For patients who prefer nebu l i z e r t r e a t m e n t , t h e F DA recently approved 2 additional longacting bronchodilators—glycopyrrolate (Lonhala Magnair, Sunovion) and revefenacin (Yupelri, Mylan)— both of which were shown to result in clinically significant improvements in lung function.3,4,6 These and other bronchodilators for COPD treatment are listed in the Table.

in lung function and exacerbations.7 Likewise, budesonide/glycopyrrolate/ formoterol showed a clinically significant decrease in the rate of annual exacerbations.8 However, an increased risk for pneumonia in patients taking triple combination products should be considered.4,8 Additional steroid combination medications for use in COPD are listed in the Table. Phosphodiesterase-4 (PDE4) inhibitor Roflumilast is a PDE4 inhibitor that works by reducing inflammation in

the lungs, opening up the airways and making breathing easier.9 Unlike other COPD medications, roflumilast is an oral tablet taken once daily.4 Results from several clinical trials have shown nominal improvements in lung function and number of exacerbations.9 However, patients receiving roflumilast had a greater incidence of gastrointestinal and psychiatric adverse events compared with patients given placebo. Based on these data, the use of roflumilast may be limited to addon therapy for patients who continue

to have symptoms or exacerbations despite maximal treatment with bronchodilators and corticosteroids.

Role of the Specialty Pharmacist Specialty pharmacists can play a key role in supporting patients with COPD. By providing medication-specific education along with counseling on the importance of lifestyle changes, specialty pharmacists can help patients remain adherent to therapy see COPD, page 10

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CLINICAL

COPD continued from page 9

and preserve QOL. Patients may find it challenging to effectively manage their complete COPD regimen, which may include multiple inhaler devices with varying inhalation techniques and newer delivery methods, along with medications for comorbid conditions. Thus, education about proper inhalation technique is essential to help ensure patients understand how to take their medications

properly. With ongoing support from the specialty pharmacist, administration difficulties and other barriers to adherence can be uncovered and resolved in a timely manner. Educating patients about their disease— including discussing the importance of vaccinations and counseling on lifestyle changes, such as smoking cessation and improving diet and exercising—is another area in which specialty pharmacists can make a positive impact.2 Through these comprehensive interventions, specialty

pharmacists can have a beneficial effect on patient outcomes.

References 1.

CDC. Basics about COPD. Updated July 19, 2019. Accessed April 28, 2021. https:// www.cdc.gov/copd/basics-about.html

2. National Heart, Lung, and Blood Institute. COPD. Accessed April 28, 2021. https:// www.nhlbi.nih.gov/health-topics/copd 3. Rosenberg SR, Kalhan R. Recent advances in the management of chronic obstructive pulmonary disease. F1000Res. 2017;6: 863. https://dx.doi.org/10.12688%2F f1000research.9819.1

4. Healthline. COPD drugs: a list of medications to help relieve your symptoms. Updated December 7, 2020. Accessed April 28, 2021. https://www.healthline.com/ health/copd/drugs 5. Burkes RM, Panos RJ. Ultra long-acting Ð-agonists in chronic obstructive pulmonary disease. J Exp Pharmacol. 2020;12:589-602. https://dx.doi. org/10.2147%2FJEP.S259328 6. DailyMed. Label: Yuperli-revefenacin solution. Updated May 29, 2019. Accessed April 28, 2021. https:// dailymed.nlm.nih.gov/dailymed/drugInfo. cfm?setid=6dfebf04-7c90-436a-9b16750d3c1ee0a6 7. DailyMed. Label: Trelegy Ellipta. Updated September 9, 2020. Accessed April 28, 2021. https://dailymed.nlm.nih.gov/ dailymed/drugInfo.cfm?setid=b5a81d5a4648-4c7a-951d-33c014a63c7e 8. Rabe KF, Martinez FJ, Ferguson GT, et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. N Engl J Med. 2020;383(1):35-48. 9. Janjua S, Fortescue R, Poole P. Phosphodiesterase–4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2020;5(5):CD002309.

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Specialty Pharmacy Continuum • May/June 2021

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Opinion:

Applying SP Expertise to Rare and Orphan Diseases Dea Belazi President and CEO, AscellaHealth

any stakeholders envision a world where genetic blindness, severe muscular dystrophy, cancer, sickle cell anemia, blood disorders and many other diseases are not simply treated but cured by gene therapies. Today, these novel drugs represent a paradigm shift in how payors and plan sponsors address the incidence and growing prevalence of some of these rare or orphan diseases among patient populations—and how they manage utilization and cover costs, which have led to sticker shock. For example, a new spinal muscular atrophy gene therapy, onasemnogene abeparvovec-xioi (Zolgensma, AveXis), has a one-time price of $2.12 million (bit.ly/ 3eAtaDw). The first approved one-time DNA-altering gene therapy voretigene neparvovec-rzyl (Luxturna, Spark Therapeutics), indicated for the treatment of patients with confirmed biallelic RPE65 mutation–associated retinal dystrophy, costs $850,000. Gene therapies are not simply another new class of specialty drugs to treat symptoms of a given disease; they aim to cure by correcting the underlying genetic abnormalities causing the disease (bit.ly/2Q7WCXU). With more than 900 Investigational New Drug applications for ongoing clinical studies of gene therapy products underway (bit.ly/ 3hmYnM6), and the FDA predicting they will be approving 10 to 20 gene therapies per year, the availability of these groundbreaking drugs is becoming an emerging driver of change in specialty pharmacy benefit management (SPBM). To improve outcomes and impact costs, the understanding, expertise and experience of clinicians and health care business executives at specialty pharmacy partnering organizations have been successful in drastically reducing costs for ultraexpensive gene therapies and other specialty drug therapies.

therapies financially feasible for payors and plan sponsors will continue to emerge, giving gene therapy manufacturers high market expectations for increased utilization and expanded therapeutic choices. Long-awaited, timely solutions that go beyond the traditional pharma–payor/pharmacy benefit manager (PBM) frameworks

to enable affordability will help payors to manage the extraordinary costs for such novel products. Specialty drug management programs that maximize therapeutic opportunities for the treatment of orphan and rare disorders represent a proactive response versus the typical PBM, which falls short in optimizing gene therapy

efficacy and cost containment. While traditional PBMs usually manage pharmacy networks, conduct drug utilization review and attempt to engage in disease management, they are generally larger and lack the focus of specialty benefits management companies and specialty pharmacies. see SP EXPERTISE, page 13

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A Dangerous Mix continued from page 1

of Massachusetts Medical School, in Worcester. “In practice, they should be prescribed for behavioral health conditions while the primary treatment lines are ramping up, then transitioned to as-needed or breakthrough treatment only. But in reality, they continue to be used as a scheduled medication, while the primary treatment is often stopped or used at subclinical doses,” Dr. Lenz said during the Academy of Managed Care Pharmacy’s 2021 virtual annual meeting. A common case, she noted, involves a patient with a behavioral health condition, such as anxiety, who is prescribed

member triage and an algorithm to identify those high-risk members. “We needed to get answers to the questions that would allow us to evaluate clinical cases for appropriateness of prescriptions, and triage those members at highest risk to our therapeutic case management [TCM] group,” said Michael Jones, PharmD, a clinical consultant pharmacist with Commonwealth Medicine at the University of Massachusetts Medical School, who led the COBI initiative. “Clinically, there are scenarios where the ‘acute’ concurrent use of opioids and benzodiazepines is appro-

‘The [opioid] taper needs to be slow. Depending on the dose and duration of therapy, a patient could experience seizures, be physically dependent or experience worsening anxiety during the taper.’

63% of all opioid-related deaths also involved other drugs. 34% Cocaine

33% Benzodiazepines

12% Methamphetamine

—Kimberly Lenz, PharmD a benzodiazepine while a selective serotonin reuptake inhibitor (SSRI) medication is being titrated. “After approximately four to six weeks, the benzo should be tapered to PRN [as needed, pro re nata], but many times the patient has side effects from the SSRI or doesn’t feel like it’s helping, and they drop it or remain on a lower dose while continuing the benzodiazepine. Fast-forward down the road and they experience an injury requiring an opioid, and you have a potentially dangerous combination of chronic benzodiazepine use with opioids.” So, why isn’t everyone managing this high-risk combination more aggressively? Dr. Lenz said although she suspects most payors are likely doing some oversight, such as a “soft edit”—in which the pharmacist is alerted to the safety concern but may override—the circumstances often are complicated. “It’s hard to work with providers on tapering patients who are stable on these medications, especially with chronic pain, where the opioid can’t be tapered or reduced,” she said. “A critical point is that a benzodiazepine taper needs to be slow. Depending on the dose and duration of therapy, a patient could experience seizures, be physically dependent or experience worsening anxiety during the taper.” In late 2019, MassHealth launched its Concomitant Opioid Benzodiazepine Initiative (COBI), aimed at mitigating harm from concomitant prescribing through a combination of claims edits, prior authorization (PA), high-risk

priate, so one of our key tasks was to define chronic use,” Dr. Jones said. “We used claims data to identify any member with overlap of an opioid and a benzodiazepine for at least 60 days within a 90-day period.”

Rejected at the Point of Sale Because there are more agents to recommend as alternative therapies for benzodiazepines than for opioids, the COBI project decided to recommend that the benzodiazepine, not the opioid, be the rejected agent at the point of sale. “If a member has pain severe enough for opioids, alternatives are lacking,” Dr. Jones explained. As for the benzodiazepine, “our goal was not to get a member already on the drug off that agent completely,” she said. “We looked at each case individually and when clinically appropriate, recommended a slow taper to be used on an asneeded basis. Of course, that is easier said than done.” In other words, this means no outright denials of PA requests for the benzodiazepine—something that is atypical in managed care. “Every PA request is submitted for varying durations, with the provider receiving a specialized message at the point of rejection regarding what is required for the PA to be approved and the availability of emergency supplies,” Dr. Jones said. Those requirements included: • documentation of the clinical diagnosis for which the drugs were being prescribed;

Source: CDC, 25 states, January-June 2018.

• attestation that the patient had either been prescribed or offered naloxone; and • trial of alternatives. “The variety of approval durations depended on the clinical picture, but in general, there was a six-month approval duration during which the taper was planned,” Dr. Jones said. Because of the high volume of these prescriptions, the COBI developed an algorithm based on 11 risk factors related to current medications, substance abuse history and demographic factors, such as age and comorbid chronic respiratory disorders, to identify the highest-risk members for the TCM intervention. Providers were educated about the initiative beginning in early 2019, went live in November 2019 and claims began to be rejected roughly two months later, in January 2020. Dr. Jones cited several key outcomes: • 1,378 members were evaluated for dose changes. • 79% had no changes in dosage. The remaining members were split between increases and decreases. • 37 members had a benzodiazepine dosage decrease of 5% or greater. “We saw considerable prior authorization volume, with a dip in approvals beginning in April and May 2020, but as the offices began to have a better understanding of the initiative

and what criteria needed to be met, we began to see more approvals,” Dr. Jones said. Of 67 cases reviewed by the TCM work group, 38.8% resulted in a tapering of either the benzodiazepine or opioid dosage, he reported, and 35.8% had fills of a naloxone prescription after provider outreach.

‘Small but Encouraging’ Gains Reported “Our success in the first year has been small, but encouraging,” Dr. Jones said. “We’ve had to temper our expectations, given what everyone has had to endure over the last year with the pandemic. Our greatest impact was with the TCM workgroup, given that these are very difficult patients to treat.” Dr. Jones stressed the importance of naloxone conversations with providers. “‘I’m not prescribing the opioid, therefore I shouldn’t have to prescribe naloxone,’ is a line I’ve heard many times,” he said. “That’s the wrong stance. Our goal should be to provide high-risk patients with adequate support services and mitigation strategies in any way possible, regardless of who is prescribing what.” —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • May/June 2021

CLINICAL

SP EXPERTISE continued from page 11

SPBM companies serve as a hybrid of traditional and innovative approaches that target specific populations that have an acute or chronic condition. They ensure that individuals and caregivers are aware of programs and empowered after diagnosis and referral, taking a personalized approach that provides a preferred formulary, evidence-based clinical policy bulletins and pathways, step therapy, lab and other clinical assessments. Some of the targeted therapy areas for SPBM include oncology, infectious disease, neurology, hematology, endocrinology, nephrology, ophthalmology, respiratory, cardiovascular, immunologic, and orphan or rare conditions. SPBM programs facilitate ongoing positive patient outcomes through persistence, adherence, compliance and just-in-time collaborative patient management. Professional teams regularly measure and track program effectiveness and, across the continuum of providers, validate savings and opportunities for continuous improvement. Unlike typical PBMs, SPBM programs also offer the benefits of technology, analytics and clinical services designed for specialty and gene therapy cost containment. As a result, they are better able to manage these drugs covered under the pharmacy benefit, including some that may be going through retail pharmacy, and those that are prescribed and covered under the medical benefit. Innovative SBPM programs help to reduce prescription drug costs and improve care quality for the benefit of patients and payors alike. The best SPBM programs offer specialty pharmacy and infusion networks that specialize in data, analytics and cost modeling, as well as real-time frontend prescription triage to help patients receive the right care at the right time. These programs also use technology to manage and streamline the specialty prescription process among the physician, patient, specialty pharmacy and health insurance plan—which means more coordinated care and cost savings. Take, for example, an SPBM hemophilia program that is based on an all-encompassing data analytics interface technology solution. This allows the program to capture, integrate and provide unlimited amounts of prescription data and health care outcome analytics in a real-time platform, providing accurate insights into patient care, provider prescription value, prescription trends, specialty pharmacy performance, dose optimization, treatment paths and other clinical intervention reports. The hemophilia program’s therapy optimization for a 55-year-old man led to savings of $284,000 per year. For a 25-year-old patient changing drugs in the middle of the month, the program

discovered $27,000 in drug waste and inappropriate therapy. The same SPBM’s infusion management program delivered significant cost savings while maintaining optimal patient care by using proprietary financial models combined with superior technology and analytics. This translated into a flexible, tailored drug management solution driven by actual client needs. These types of programs increase patient safety, improve patient health outcomes, identify appropriate sites of care for treatment, reduce waste and cost, and

offer negotiated dispensing rates, as well as increased transparency. For instance, annual savings by condition for this program include $708,000 for hereditary angioedema, $466,232 for spinal muscular dystrophy, $99,480 for hemophilia, $18,012 for cystic fibrosis and $392,124 for hypophosphatasia. What’s more, the average case-by-case cost savings with this SPBM program is 10% to 42%. An SPBM company that takes a patientcentered approach means they go the extra mile, providing clinicians, patients/ members and payors with high-quality

information designed to enhance patient care, clinical outcomes and cost management approaches. This strategy is ideal for value-based pharmacy management because it delivers innovation and customization to meet the challenges of reimbursement based on outcomes, as well as the need for payors to track realworld outcomes associated with specialty products to ensure efficiency. AscellaHealth is a national PBM serving commercial, Medicare and Medicaid segments.

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Tool addresses unsanitary conditions, PPE shortages and other issues during pandemic

The SBAR Method for Cleanroom Compliance If the last several years of hurricanes and floods, changes in sterile compounding regulations and the COVID-19 pandemic have demonstrated anything, it’s that preparation and communication for planned or unplanned cleanroom closures or equipment shortages related to remodeling, inspection reports or natural disasters are essential. At the 2021 annual meeting of the National Home Infusion Association (NHIA), Gene Decaminada, BS Pharm, RPh, the pharmacy manager with MCP Home Infusion Pharmacy at Yale New Haven Health (YNHH) Services, in Connecticut, discussed some of these possible interruptions in the cleanroom process and methods for dealing with them in a clear and consistent way. “It is important to note that referring to the list of insanitary conditions involves potential safety concerns, not just an FDA citation,” he said. Common reasons for closures or interruptions include inspections from the State Board of Pharmacy and the FDA, Mr. Decaminada said. “I’ve been through many FDA inspections over the past few years, and they can be on-site for the better part of seven days or more. Other issues that can lead to process interruptions include cleanroom growth, such as actionable growth (i.e., mold and/or fungus) in your ISO [International Organization for Standardization] 5 areas; remodels and updates that require you to shut down your cleanroom or relocate your processes for days or weeks; and everything from harsh winters to power failures to floods. So it’s important to consider how these situations might change your cleanroom policies or practices with regard to patient safety and achieving a controlled environment.”

Unsanitary Conditions to Heed Mr. Decaminada cited a list of unsanitary conditions that could result in several FDA Form 483 citations, such as anything from missed microbial contamination under laminar flow hoods to moisture buildup from HVAC ductwork above the cleanroom, to processing beta-lactams and non–beta-lactams in the same laminar flow hood, to inadequate donning and doffing processes for personal protective equipment (PPE). “During site inspections, the FDA has also questioned proper smoke studies performed in laminar flow hoods by total parenteral nutrition compounders,” he said. “They want to see active compounding or mimicked dynamic compounding during smoke pattern testing. Make sure you are saving those videos for review with your cleanroom staff.”

Processes for conserving PPE, given pandemic-related shortages, must also be documented, Mr. Decaminada said. “You can’t just say you’re conserving PPE without building an addendum into your standard operating procedure [SOP]. If your SOP states to don a new gown every time someone exits the cleanroom and you’ve had to change to one gown per person per day for conservation purposes, you have to back up that SOP addendum in writing.” Other conservation measures he recommended include limiting the number of personnel engaged in compounding activities, staging supplies outside the compounding area to minimize trips into the cleanroom, and resanitizing sterile gloves after exiting ISO 5 areas.

Communication Is Key To communicate these changes to your cleanroom policies and PPE conservation plans if you have a busy pharmacy or multiple cleanrooms, Mr. Decaminada recommended a framing mechanism known as SBAR: Situation, Background, Assessment and Recommendation, which is endorsed by the Institute for Healthcare Improvement (IHI). “The SBAR communications method has been used successfully in many hospitals and health systems,” he said. “It’s an easy-to-remember method for structuring any conversation, but particularly critical ones requiring immediate attention and action. For example, we use SBAR at Yale New Haven Health for communicating any decisions about PPE conservation that has to come from pharmacy leadership to the cleanroom staff.” The SBAR technique, developed by Michael Leonard, MD, a physician leader for patient safety at Kaiser Permanente of Colorado, includes the following steps: Situation: a concise statement of the problem; Background: pertinent, brief information related to the situation and what has led up to it; Assessment: analysis and consideration of options; and Recommendation: action requested or recommended. The Department of Pharmacy at the University of Michigan, in Ann Arbor, has been using the SBAR method for several years, according to compounding

The University of Michigan’s SBAR Situation: The COVID-19 pandemic is constraining staff resources in compounding and the pharmacy needs to free up staff time.

Background: Current USP standards for low- and medium-risk compounds require media fill testing every 12 months. Only high-risk compounds require testing every six months. Assessment: The pharmacy does only low- and medium-risk compounding. We assess that it is acceptable to move to a 12-month frequency for media fill testing. Recommendation: Implement 12-month testing intervals until COVID-19–related staffing constraints are resolved. compliance team manager Jamie Tharp, PharmD. “We employ it in both verbal communication and in writing. So many people can struggle with how to tell a story effectively and get off the beaten path. SBAR readies the listener to receive your assessment and recommendations.” The “background” segment of SBAR often can be the longest, Dr. Tharp said. “It’s where you may spend a lot of time talking about the rules, the standards and the regulations. I often use this section to provide references that could help support my transmission of information. Overall, we try to keep SBARs to less than a page, but if there is a lot of content or data, we might make an exhibit for a second page, or use a separate reference section if a lot of technical policies, laws and standards are involved.” SBAR proved very useful to the compounding compliance team during COVID-19, Dr. Tharp said. “For example, our standard had been to do media fill tests for aseptic technique every six months, which was above and beyond the minimum required. It was part of our commitment to best practices and preparing for future standards. But during the pandemic we had a crunch with staffing, and wrote an SBAR to inform senior leadership about what we thought would be a good way to conserve staffing resources [see box]. “After the SBAR was [routed] through our leadership and approved, we posted the SBAR with the decision to our policy webpage as an interim plan during the pandemic,” Dr. Tharp said. “SBAR is also

very useful as we audit the work we are doing at our compounding sites. If one of my technicians has found an issue, such as damaged equipment or someone not following a policy, I will ask them to share an SBAR with a supervisor. They are full of factual information and can take the sting out of a recommendation for improvement.” In addition, SBARs are easy to write, Dr. Tharp said. “I can write even a very detailed SBAR in 90 minutes or less, and if it’s very simple, in a quick five-minute email. It’s particularly helpful if you have to escalate details to stakeholders outside the pharmacy, because it gives necessary background to people who might not be involved in the day-to-day work. It also provides a useful breakdown of content that allows people who already know the background intimately to zoom right to the recommendations.” The only change Dr. Tharp would make to the SBAR method would be to add a D for Decision at the end. “That’s the piece I think is missing. You should have a section at the end of your SBAR (D) to record what decision was made based on your recommendation. Was it accepted or not? Maybe you gave two options, preferred and alternative, and you need a record as to which one was accepted. It’s amazing how much clarity this method can bring to your decisionmaking process.” —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • May/June 2021

POLICY

Sterile compounding exam gains traction

Certify Your Expertise With sterile compounding becoming increasingly complex and regulated, the Board Certified Sterile Compounding Pharmacist (BCSCP) examination has both personal and organizational benefits that many pharmacists should consider, according to several compounding experts. The certification—the newest issued by the Board of Pharmacy Specialties (BPS)—“is a credential for eligible pharmacists who, in their unique practice, are responsible for ensuring that sterile preparations meet the clinical needs of patients, satisfying quality, safety and environmental control requirements,” said Matthew Burrichter, PharmD, BCSCP, a clinical pharmacist at Penn Medicine, in Philadelphia, during the 2021 annual meeting of the National Home Infusion Association (NHIA). “I’ve been working with sterile products for about six years and developed expertise, but previously there was no way to prove that [level of skill],” he noted. “Now, we have the opportunity for high-level proof of our expertise, which can provide improved recognition in an increasingly competitive marketplace. With the BCSCP, we can also become an educational resource for our colleagues.” Dr. Burrichter predicted the BCSCP certificate will become preferred by most employers, with pharmacies that have significant compounding volume choosing the certified candidate over the noncertified one, all other things being equal. “It may also present the potential for increased salary and new opportunities,” he said. “COVID-19 has increased the use of home infusion centers for patients to get therapeutics, so there will be increased demand for more pharmacists with sterile compounding experience in the future. Pharmacists with this certification can elevate their organization’s entire practice of pharmacy with a demonstrated commitment to best practices.” The BCSCP differs from most other BPS certifications because it is not

focused on a specific clinical area, such as oncology, pediatrics, cardiovascular or nuclear pharmacy, but instead an operational area. “Someone I know who took the first exam said that it is really the first exam that a staff pharmacist, someone in the trenches, is likely to do,” Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety for Cardinal Health, told Specialty Pharmacy Continuum. “In general, the path to rise in pharmacy has been focused on coming up through the clinical ranks, but this certification is in an operational area and allows someone in the trenches to become board-certified based on very specific training and the ability to keep up with changing operational requirements,” added Ms. Kienle, who was among the first group of pharmacists to earn the certification in the fall of 2019.

Another Early Adopter Brittany Singleton, PharmD, BCPS, BCSCP, a clinical assistant professor of pharmacy at Xavier University of Louisiana, in New Orleans, was one of the first two pharmacists in her state to earn the sterile compounding certification. “It really helps to inform my teaching,” Dr. Singleton said. “I teach the sterile compounding topics in the standard curriculum, and I also developed a sterile compounding elective course for my students. The certification has really helped me to build those courses to the best they can be in terms of sterile compoundng content and aseptic manipulations.” She agreed that the BCSCP also makes a pharmacist more marketable. “I frequently have my students look at what

‘COVID-19 has increased the use of home infusion centers for patients to get therapeutics, so there will be increased demand for more pharmacists with sterile compounding experience in the future.’ —Matthew Burrichter, PharmD, BCSCP pharmacy jobs are available, especially in our neighboring state of Texas, which has very strict requirements, and they see that many positions [encourage] advanced training and certification such as the BCSCP. I always encourage them to get the requisite experience and then apply to take the exam.” As for how much experience is needed, Dr. Burrichter noted that 4,000 hours spent in the field of sterile products handling is required “before you can even sit for the [BCSCP] exam,” he said. “That’s a good amount of time to become familiar with the standards involved.” He noted that CriticalPoint also offers modules to prepare for the BCSCP, and that ASHP also offers a preparation course. Dr. Singleton said she took the ASHP preparation course to ensure she was upto-date before sitting for the examination. “I’m very comfortable with this area and have worked in it for quite some time, and I teach it as well, but there were still a couple of questions that challenged me,” she said. “The item writers are good. You definitely have to prepare, no matter how experienced you are in this area.”

Ms. Kienle noted it would be hard to assess interest in the BCSCP yearover-year, because the first exam was given less than six months before the COVID-19 pandemic began spreading in the United States, and any figures for 2020 likely would not be representative. “I think it’s going to grow significantly,” she said. “There is so much more focus from state boards of pharmacy, as well as the FDA, on sterile compounding, and this is a way to establish your knowledge base. I see this as a growing opportunity.” —Gina Shaw Ms. Kienle is a member of the USP Compounding Expert Committee, but her comments are her own and not affiliated with nor endorsed by USP. Dr. Burrichter had no relevant financial disclosures.

Web only Thinking of taking the BCSCP exam? Know that it covers five key domains. For more details, see expanded version of this article at www. specialtypharmacycontinuum.com.

56% Rate of Compounding SOP Adherence ‘Crazy’

he USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems, home infusion providers, specialty pharmacies and other practice sites that perform compounding employ technology to safeguard the sterile drug workflow process, according to field surveyors and other regulators. But have compounders reached the optimal level of compliance? That’s what the Institute for Safe Medication Practices (ISMP) wanted to know. So last July, ISMP launched a Pulse Check survey (bit.ly/

3qN37fF). More than 600 pharmacists, technicians and others allied with pharmacy responded. The answer was that although progress in achieving compounding safety has been made, significant gaps remained. Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, RPh, the ISMP medication safety specialist who presented the findings during a virtual Omnicell Illuminate meeting. The errors ranged from incorrect dose or concentration to faulty labeling to wrong drug

used (Table, page 16). Some were found and corrected before dispensing, Ms. Michalek said, while others came to light only after leaving the pharmacy. She noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products brought into an organization,” she said. The areas of risk include when and how medications are prescribed and the processes of verification and communication, she noted. That risk also extends to the workplace environment, see ADHERENCE, page 16

Specialty Pharmacy Continuum • May/June 2021

POLICY

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ADHERENCE continued from page 15

Only 56% said always? That’s crazy,” Ms. Kienle told Specialty Pharmacy Continuum. “It shows that some people still aren’t doing what they should have been doing for decades. People need to have procedures that match what they actually do and that are compliant with USP <797> and <800> standards, state regulations and best practices.” Although COVID-19 appears to have played little part in the survey results, Ms. Kienle said she is worried that the COVID-19 pandemic’s practice pressures might have caused people to become “even more lax on things like certification of their areas and maintain-

where the lack of standardized practices, production pressures and the absence of technology can take their toll, Ms. Michalek noted. An even more complete picture of compounding safety challenges emerged from an open-ended question. By far the biggest barrier, she said, “was the inability of pharmacists to accurately verify compounded sterile preparations using indirect processes such as the syringe pull-back method.” Closely following was the difficulty in complying with USP General Chapters <797> and <800> standards. Rounding out Table. Sterile Compounding Errors the list were staff training and Error Mentions, % competency issues, a lack of technology, not enough workIncorrect dose or concentration 58 space and heavy workloads. Incorrect base solution 51 Insufficient leadership support and work supervision also Incorrect base solution volume 43 were cited. Issue or error with labeling of CSP 41 The survey also addressed (including omission) technology. A total of 361 respondents (57%) reported Incorrect reconstitution of drug 36 using at least some technolog(volume or diluent) ical tools in sterile compoundIncorrect drug 35 ing. They included barcode verification with and withWrong preparation technique (e.g., 26 out images, multiple ingreimproper filtering, wrong tubing) dient compounding devices, Expired drug, base solution or CSP 16 gravimetric verification and robotic compounding. Wrong timing (e.g., preparing 12 Respondents were asked to antineoplastic on wrong date) rate the implementation level Omission of a drug 5 of nine ISMP-defined compounding best practices. The CSP, compounded sterile preparation greatest extent of implementation (73%) related to cleanroom/sterile compounding area practices, ing and really upgrading the environincluding having enough workbenches to mental pieces” that are fundamental to support only one staff member at a time USP <797> and <800> standards. per primary engineering control—laminar airflow workbench, biological safety cabi- Compounding Stewards net, compounding aseptic isolator or comMs. Michalek ended on an upbeat pounding aseptic containment isolator. note. “Pharmacists and technicians have The survey also focused on standard done some amazing work to continuoperating procedures (SOPs). Were they ally improve the care and delivery of defined and what was the level of com- sterile injectable medication,” she said. pliance? More than half of respondents “As stewards of medication use, they (56%) reported that SOPs were “defined are really in the best position to move and always followed.” About one-third forward with more improvements and (34%) said they were defined and “often more safety around compounded sterile followed,” while 10% said they were preparations.” —Bruce Buckley “never, rarely or sometimes” defined and followed. Ms. Michalek reported no relevant financial Patricia C. Kienle, RPh, MPA, the direcdisclosures. Ms. Kienle is a member of the tor of accreditation and medication safeUSP Compounding Expert Committee, ty at Cardinal Health, found the results but her comments are her own and not affiliated with nor endorsed by USP. pertaining to SOPs “pretty alarming.

Specialty Pharmacy Continuum • May/June 2021

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Up to 70% adoption rates, millions in savings reported

Strategies for Boosting Biosimilar Uptake Use of biosimilars could increase if stakeholders, from manufacturers to payors and pharmacists, united to employ all the tools at their disposal, an expert told attendees of the 2021 virtual annual meeting of the Academy of Managed Care Pharmacy (AMCP). Hospitals and health systems that have taken part in comprehensive approaches to biosimilar utilization report enjoying full adoption of biosimilar use and saving millions of dollars every year, according to Catherine Pham, PharmD, MPH, a postdoctoral fellow in pharmacoeconomics and policy at Kaiser Permanente, in Los Angeles. “Education, communication and collaboration among stakeholders are key strategies to drive utilization of biosimilars,” Dr. Pham said. On the regulatory end of the stakeholder spectrum, the FDA and Federal Trade Commission took a step to address biosimilar adoption in early 2020, when they committed to working together to regulate false or misleading promotional statements regarding the drug class (bit. ly/3aOD1mX). As for the nature of the false or misleading claims, examples can be seen in a Citizen Petition that Pfizer sent to

Dr. Pham said such policies are more likely to succeed if providers have tools built into the electronic health record to guide prescribing and workflow. These tools and others, including therapeutic equivalence protocols, are most effective when developed by pharmacists in collaboration with providers, she noted. At Boston Medical Center, for example, pharmacy leaders established therapeutic equivalence for a switch from reference infliximab (Remicade, Janssen) to infliximab-dyyb (Inflectra, Pfizer) for inflammatory bowel disease (J Manag Care Spec Pharm 2020;26[4]:410-416). This protocol included gathering European and American clinical evidence on the efficacy of infliximab–dyyb, consulting with European providers about their

‘Education, communication and collaboration among stakeholders are key strategies to drive utilization of biosimilars.’ —Catherine Pham, PharmD, MPH the FDA in 2018. Pfizer, which manufactures several biosimilar products, including infliximab-dyyb (Inflectra) and filgrastim-aafi (Nivestym), cited statements by several reference biologic manufacturers which suggested that patients often react differently to biosimilars than to their reference products (bit.ly/3nJRIwV). The petition also cited a YouTube video that indicated switching between a biologic and biosimilar “is not a good idea if your medicine is working for you.”

What Providers Can Do For their part, providers can use formulary policies to encourage use of biosimilars, Dr. Pham noted. “A biosimilar can be officially preferred for use in treatment-naive patients, and policies can also be put in place to switch patients from a reference product to a biosimilar,” she explained.

experiences switching to the biosimilar, and documenting outcomes in their adult IBD patients after switching to the biosimilar and in those remaining on the reference biologic. The strategy resulted in a 97% switch rate to infliximab-dyyb.

What Payors Can Do Dr. Pham said payors can play their part in increasing uptake by using shared savings programs and other tools to incentivize biosimilars billed through the medical benefit. She anticipates more biosimilars to be processed through the pharmacy benefit in coming years and, for these products, “familiar strategies like formulary tiering, prior authorizations and step therapy requirements can be leveraged to place biosimilars on the same playing field as reference products.” Data from Magellan Rx Management, in Phoenix, demonstrated that step therapy is indeed one of the most

effective strategies that plans can use to encourage biosimilar uptake. “In our analysis, we’ve seen that plans that implement a step therapy policy at the time of biosimilar launch and that have also taken proactive steps like provider outreach, consultation with key opinion leaders, and having P&T committees develop biosimilar-first clinical policies have been able to take the greatest advantage of the savings potential of biosimilars,” Jim Rebello, PharmD, Magellan’s vice president of specialty strategy, told AMCP meeting attendees in a separate presentation. The analysis found that plans using step therapy achieved 68% and 70% adoption of biosimilar versions of bevacizumab and trastuzumab, respectively,

one year after their launch, and 39% uptake of biosimilar versions of rituximab in the nine months after launch. In contrast, plans without a biosimilar step therapy requirement had 13% and 16% uptake of biosimilar versions of bevacizumab and trastuzumab, respectively, and 9% uptake of biosimilar rituximab during the same periods.

Deep Discounts With the study showing 25% to 40% discounts for biosimilars compared with their reference biologics, plans that don’t use step therapy requirements and maximizing uptake would do well to reconsider their approach, Dr. Rebello suggested. “We’re seeing some natural uptake across all plans, but with a membership size of around 2.3 million lives, the plans with a parity policy are potentially losing out on around $30 million in annual savings.” —David Wild The sources reported no relevant financial disclosures.

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Boosting Home Pay continued from page 1

“When clinicians don’t know the basics of how services are reimbursed, it can have a significant impact on both patient care and financial outcomes.” Dr. Garst urged all clinicians to develop a basic understanding of the payor-source makeup of home infusion pharmacy revenue by organizational structure, which includes four primary pools: commercial payors (47.5% of home infusion revenue, according to NHIA data), Medicare Part D (13.6% of revenue), Medicare Part B (8.9%) and Medicaid (5.33%), with other sources making up the remainder. “If clinicians can master this information, they will better understand what questions to ask of their patients,” he said. “For example, Medicaid plans vary from state to state and are typically adequate for drugs and services, but they are dependent on a drug’s NDC [National Drug Code] and vial sizes. So, changing vial sizes at will can create negative downstream consequences for the revenue cycle.” The home infusion pharmacy clinical team also should be aware of the life cycle of a medication’s PA, Dr. Garst noted. “Just because you had a PA previously does not mean it is still good. If your clinicians don’t have access to the authorization or payor fields in the electronic record, then there needs to be another way that they are kept informed as to when a PA expires, such as an alert or user-defined notation that is easily visible during the ongoing management and dispensing process.” PAs are an area in which it’s particularly important for the revenue cycle team and clinical team to work together, Dr. Garst said. If, for example, there is a delay in obtaining a home infusion PA for a high-cost drug, what are the options for the patient? Is it acceptable to skip or delay a dose while waiting for the PA, or should an alternative site of care be used, such as the hospital outpatient department, until the PA is in place? Billing for drug waste—defined as the amount of drug discarded and not administered—also requires education for pharmacists and technicians. “You need a training process for your staff to ensure that the compounding record accounts for any waste,” Dr. Garst said. “The clinical team should know that there are times when vial size is very important.” As an example, a patient is prescribed drug A at a dose of 860 mg every two weeks. Drug A is available in two vial sizes, 100 and 400 mg. Prescribing three 400-mg vials yields a total dose of 1,200 mg, resulting in waste of 340 mg. Alternatively, prescribing two 400-mg vials plus a single 100-mg vial yields a total dose of 900 mg and waste of only 40 mg. “Vial selection as illustrated in the first option

could trigger a payor audit as to why so much drug is being wasted,” Dr. Garst said. “Randomly interchanging vial sizes can be a nightmare for the revenue cycle team. I saw this happen sometimes even after training my team. It seems elementary but can easily get lost in the shuffle of other items clinicians are working on.” Many payors now require the use of “level of effort” (LOE) codes for compounded medications. These complexity codes, defined by the Agency for Healthcare Research and Quality, range from 1 to 5, with 1 representing minimal complexity and/or requiring only one to four minutes of a pharmacist’s time. An LOE designation of 5 is reserved for very highrisk services that involve extensive diagnosis or treatment options, an exceptional amount or complexity of data, and/or requiring 60 minutes or more of the pharmacist’s time. “It’s important to ensure that both the intake team and the clinical team understand [these LOE] designations,” Dr. Garst said. “Not all payors require it, so the best practice is to use it. If the claim is rejected, it should say why, and then you can adjust accordingly.” These processes can be improved with templates to facilitate consistent capture of data regarding therapy or drug class, method of administration, physician orders and refills, Dr. Garst said. “Most electronic records have the capability for dropdowns, checkboxes and limited free text, but some providers don’t use these functions. They provide consistent documentation for all parties involved and help you better meet payor requirements.”

Watch Your Data Claims rejections are not something that happens at the whim of CMS; the culprit usually is faulty documentation, noted Greg Miller, RPh, a senior consultant with BluePeak Advisors, a division of Gallagher Benefit Services and a Medicare compliance consulting firm. That’s why it is crucial for providers to critically review their data before submission. This is particularly important with formulary administration (FA) and coverage determinations, appeals and grievances (CDAG), Mr. Miller said. Ensure that universes are within the time frame that CMS plans to study. Be certain that coding is correct and that PA effectuations have not been entered into the claims adjudication system incorrectly—a top finding in FA audits. Also review calls to make sure any CDAG cases are handled and classified correctly, and that member letters are easy to understand and include elements such as the language preferred by the member and appeal rights information. Bonnie Kirschenbaum, BSc, MS, a pharmacy consultant specializing in

reimbursement and a member of the Specialty Pharmacy Continuum advisory board, agreed that data integrity is key to maximizing reimbursement. She expects the growth of home care to continue. “As the move away from inpatient services to alternate sites of care continues, a variety of home infusion services become attractive offerings both to patients and providers,” Ms. Kirschenbaum said. “However, success depends on knowing the intricacies and requirements of each payor and building these into both your clinical and revenue systems to provide appropriate, safe clinical care and be paid. There are no shortcuts here, just lots of methodical step-by-step development to get to this point.” For a primer on key aspects of payment, Ms. Kirschenbaum suggested accessing her “Fundamentals of Drug Reimbursement: An Online Tool Kit to Build Your Expertise!” at www.pharmacypracticenews.com/ToolKit. —Gina Shaw and Karen Blum The sources reported no relevant financial relationships other than stated employment.

Prevent Legal Risk by Avoiding These 5 Home Infusion Documentation Pitfalls

ome infusion providers can protect themselves from legal exposure by heeding several common errors in documenting therapeutic encounters, said Elizabeth Rudolph, JD, MSN, RN, the founder and CEO of Jurex Center for Legal Nurse Consultants, during the 2021 virtual annual meeting of the National Home Infusion Association. Among the common mistakes she described are the following: 1. Not documenting contemporaneously. “Whenever possible, you should document the encounter contemporaneously rather than summary charting at a later point in time,” Ms. Rudolph said. “Contemporaneous is more credible in court. However, sometimes it happens that you will have to make a late entry, which is superior to no entry at all. If you have to make a late entry in the record, follow your organization’s policies and procedures about such entries. Be sure to indicate that it is a late entry so that it does not appear that you have something to hide.” 2. Using unfamiliar terminology. Ms. Rudolph described the case of a home infusion nurse who had checked a box in the medical record, indicating that a patient was “diaphoretic” (excessive sweating/clammy skin). During examination in court, she was asked what “diaphoresis” means, and was unable to answer. “Only use a term if you are very familiar with it and all of its variations,” Ms. Rudolph said.

3. Using vague language. “When you use vague terms such as ‘appears to’ or ‘seems to,’ it calls your credibility into question,” Ms. Rudolph said. “How you put words together tells a lot about you. Be factual and objective.” 4. Using colloquial abbreviations. “Documentation should contain commonly understood medical abbreviations only,” Ms. Rudolph said. “Don’t use terms like ‘FF’ for ‘frequent flyer.’ That kind of thing does not fly with a jury.” 5. Keeping a separate personal diary about clinical encounters. “Such a diary is discoverable in court and is usually not privileged, and it shows that you’re concerned about being sued,” Ms. Rudolph said. “Be very careful about keeping your own notes. The question will arise: Why didn’t you include this in your charting? It’s not a good look to have separate notes. “The health care environment today is much more litigious than it once was. Any patient, at any time, could sue you,” Ms. Rudolph said. “It’s important to know the landscape and the land mines along the way. The medical record is the first piece of evidence anyone suing you will get. You will need solid documentation to rebut any allegations against you and reduce your liability.” —Gina Shaw

Specialty Pharmacy Continuum • May/June 2021

OPERATIONS & MANAGEMENT

Slow Rebound for Drug Sales in 2021 The first few months of 2021 have been marked by a slow rebound in prescribing and drug sales, with effects varying by specialty area, according to new IQVIA data presented at the 2021 virtual annual meeting of the Academy of Managed Care Pharmacy. Doug Long, the vice president of industry relations at IQVIA, said significant drops in provider visits and ongoing use of telehealth are two of the main reasons why he projected a net loss of

by a moving annual total (MAT) of 7% by February 2021, compared with a 2% MAT growth in sales of traditional medications during the same period. Sales of cancer drugs, immunologic

agents and diabetes medications saw the greatest increases in 2020, collectively accounting for 63% of absolute global growth in drug sales, he said.

Telehealth One trend affecting prescribing patterns is the increased use of telehealth, an approach that “is here to stay, but is yet to be seen how much of a role it will play,” Mr. Long said. “The challenge

with telehealth is that it does not generate nearly as many new prescriptions as a regular doctor visit or a regular institutional visit would, and that’s probably because people spend less time on a telehealth call and doctors are less willing to initiate new therapy. But probably the primary reason for that is the lack of taking vitals and diagnostic tests and things of that sort.” —David Wild The sources reported no relevant financial disclosures.

FFree ree CME now available! 0.25 AMA PRA Category 1 Credit™ per module A net loss of

111 million prescriptions is projected through June 2021,

3.8% down from a non-pandemic year

111 million prescriptions through June 2021, or a 3.8% reduction compared with the expected number of prescriptions during a normal year. “During the lockdowns, it was almost impossible to see a doctor,” Mr. Long said. Indeed, in 2020, there were 1 billion fewer provider visits that would normally lead to a diagnosis, representing roughly a 21% reduction in the expected number of “diagnosis visits,” he noted. “The biggest gaps in diagnosis visits were for people who didn’t go see their oncologist, didn’t go see their gastroenterologist, their dermatologist or their ophthalmologist, which means they didn’t get their PSA [prostate-specific antigen], their mammograms and those sorts of diagnostic procedures,” Mr. Long said. “The good news is that, in 2021, we expect diagnosis visits to be down 12% more than what one would expect during a typical year, which is certainly better than last year, but that’s still a gap of 288 million diagnosis visits,” he told attendees. “So we’re not out of the woods yet.” The greatest projected decreases in prescriptions through June 2021 will be in oncology (30% lower than expected) and pediatrics (45% lower than expected), with a nearly absent cough, cold and flu season, accounting for much of the drop in prescriptions in the latter group. Growing specialty drug sales have been a bright spot in medication spending during the pandemic, Mr. Long said, with spending in this area increasing

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Specialty Pharmacy Continuum • May/June 2021

OPERATIONS & MANAGEMENT

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

Report Cites Lower Costs— If Best Practices Followed

2019 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.” —G.S.

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-

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

‘[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 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

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

Specialty Pharmacy Continuum • May/June 2021

OPERATIONS & MANAGEMENT

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.”

‘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.’ —Natalie Tate, PharmD 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

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

Share of covered lives

100

Oncology

Non-oncology

Physician-affiliated clinics

Oncology

Non-oncology

Hospital outpatient department

Oncology

Figure. Drug sourcing for infused therapies, oncology versus non-oncology, by practice type and source, 2019. Source: Drug Channels Institute analysis of MMIT data. Data based on 48 commercial plans representing 126.6 million covered lives. Published on Drug Channels (www.DrugChannels.net) on Sept. 23, 2020. Adapted with permission.

Non-oncology

Home infusion company

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.”

‘Site-of-Care Dependent’ 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.” —Gina Shaw The sources reported no relevant financial disclosures.

Specialty Pharmacy Continuum • May/June 2021

OPERATIONS & MANAGEMENT

Rollercoaster Year continued from page 1

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

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

‘During the pandemic, home infusion providers have been playing a critical role in … making sure that many patients who may not previously have been our patients receive the care they need at home.’ —Connie Sullivan, BSPharm 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

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

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.

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.” —Gina Shaw The sources reported no relevant financial disclosures other than their stated employment.

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Specialty Pharmacy Continuum - May / June 2021

Articles inside

during COVID-19

Strategies for boosting biosimilar uptake

fight back

managers

Raising the SBAR for safer cleanrooms during a pandemic