January/February 2016 by McMahon Group

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Bridging the gap between the hospital and alternate-site care Volume 5 • Number 1 • January/February 2016 • specialtypharmacycontinuum.com

CLINICAL

3 6 8

Engaging patients in TPN home catheter care pays off. Three specialty pharmacy’s plans for ensuring optimal Coagadex outcomes. MHA documents the beneﬁts of its IG treatment program.

POLICY

12 16

Eight key steps for achieving accreditation success.

Medicare bill gains traction

‘Part D’ the culprit

NHIA Predicts Victory For Home Infusion Pay

MAC Prices Hit LTC Sites Hard: Margin Loss Seen

fter years of frustration with a Medicare reimbursement scheme that fails to cover their costs, leaders in the field of home infusion are optimistic that they are on the cusp of a major victory. Congress appears poised to pass the Medicare Home Infusion Site of Care Act of 2015 (S. 275/H.R. 605), a bipartisan piece of legislation that, if signed into law, would correct a number of long-standing errors in the way home infusion services are reimbursed. In so doing, S. 275/H.R. 605 would give millions of Medicare beneficiaries access to home care, along with all of the clinical, financial and psychosocial benefits that such care provides, advocates noted.

The beneﬁts of home infusion.

OPERATIONS & MGMT

20 21

What do health plans and employers want?

Health systems breaking through the LDN glass ceiling.

Partnership Helps Defray High Cost Of Clinical Testing

“We have been working on this legislation since the beginning of this Congress, although it’s legislation that, in this form, has existed over several past Congresses,” said Tyler Wilson, the president and CEO of the National Home Infusion Association (NHIA), in Alexandria, Va. “The thrust of the legislation is to provide coverage for home infusion services, which are not covered by Medicare, despite being covered by many private and commercial insurers.” The key word is services. The majority of home infusion drugs are largely covered under Medicare Part D, Mr. Wilson said. However, the costs of providing services at the home care site are not. These include pharmacy services, such as compounding and preparing infusion drugs, nursing services, supplies and the

ommonly ordered blood tests such as glycated hemoglobin (HbA1C), triglycerides and liver function panels may not come with the same sticker shock as many specialty drugs, but for patients on a tight budget who are paying for these tests themselves, the bill can still add up, especially for chronic conditions requring repeated testing. Now, for the first time, consumers will have help in paying for these tests. In November 2015, a partnership of several leading consumer health organizations announced the launch of Patient Assistance for Lab Services (PALS). In partnership with a national laboratory,

see PAY VICTORY, page 16

see PALS LAUNCH, page 15

DISEASE STATE SPOTLIGHT

See insert after page 12

obert Warnock, PharmD, realized that he had a problem. The senior vice president of pharmacy services for PruittHealth, Dr. Warnock oversees pharmacy services for five long-term care (LTC) pharmacies affiliated with Pruitt, which operates about 100 skilled care nursing facilities in the Southeast. “Things had been going smoothly with our accounts, and we understood what we were billing and being paid,” he recalled in an interview with Specialty Pharmacy Continuum. “But then a year or so ago, we began to notice that our margins were shrinking.” see MAC PRICES, page 18

The push is on for credentialing and privileging of pharmaclsts.

Immune Globulins: Therapeutic, Pharmaceutical, Cost, and Administration Considerations

FDA Approval Melanoma indication expanded for e Keytruda. See page 11.

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Specialty Pharmacy Continuum • January/February 2016

CLINICAL

Coram/CVS study:

Engaging Patients In TPN Home ome Catheter Care Pays Off A standardized catheter maintenance protocol coupled with an intensive patient education program can slash the rate of infections in cancer patients undergoing total parenteral nutrition infusions (TPN) at home, a new study suggests. “Home parenteral nutrition has gotten a bad reputation, mainly because of a high incidence of catheter-related [bloodstream] infection [CRBSI], but this study shows we can significantly reduce that risk,” said lead researcher Pankaj Vashi, MD, from the Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center, in Zion, Ill. In the study, the investigators evaluated the CRBSI rate in patients receiving active treatment and home TPN, when an intensive TPN education program was in place. The 241 adult oncology patients received home TPN from Coram CVS/ specialty infusion services and active treatment at CTCA. Patients, managed by 12 different branches of the home infusion company, received detailed predischarge teaching by a team of nurses, dietitians and a dedicated case manager before going home with TPN. The first two days of infusion were done at the hospital, where patients were given verbal instruction, written educational materials and a DVD. “Before they go home, we ask our

patients to go over all the steps starting from how they are going to handle the TPN bags (refrigerate them, keep them away from other food), to how they are going to add the nutrients to the bags, wash their hands, etc.,” Dr. Vashi said. “Then a home health nurse goes to the patient’s home for the first couple of days and shows the patient how to do it. By then, the patient has usually become quite familiar with the process and can follow the protocol very strictly.” The protocol included a strict aseptic flushing and dressing change procedure, weekly sterile dressing changes with use of ChloraPrep (BD), and the application of MicroClave connectors (ICU Medical) and SwabCap valve caps (Excelsior Medical) on all lumens that were not in use. The home health nurse performed a weekly assessment that provided details about the patients’ clinical status and compliance with catheter care and TPN, as well as catheter status. The most common cancers were stage III/IV colorectal, pancreatic and gynecologic, and the average length of thera-

To prevent infection, all IV access ports and connectors used to infuse medications and total parenteral nutrition require proper disinfection and protection.

py was 70 days. The bulk of patients had an implanted port (51%) or a peripherally inserted central line (46%), with only 3% having a tunneled catheter. The incidence of CRBSIs was 0.47 per 1,000 catheter-days—a rate that should reassure clinicians who want to recommend TPN, which can significantly improve quality of life and other clinical outcomes, even in advanced cancer patients ((BMC Cancer 2014;14:593), Dr. Vashi noted.

A ‘Significant’ Study “The results of this study are significant because the cost of CRBSIs is so high, the infections require hos-

pitalization and can lead to mortality, and the drugs used for treatment are expensive,” commented Robert Ignoffo, PharmD, a professor of clinical pharmacy at Touro University California, in Vallejo. “Anytime you can standardize a prophylactic treatment, it leads to optimal control of the problem. Pharmacy departments should promote the use of a standardized catheter care protocol.” —Kate O’Rourke Drs. Vashi and Ignoffo reported no relevant ﬁnancial relationships. The study was presented at the 2015 American Society for Parenteral and Enteral Nutrition Clinical Nutrition Week (poster M9).

EDITORIAL BOARD

ART/PRODUCTION STAFF

HOME INFUSION

Michele McMahon Velle, MAX Graphics/Creative Director

Jay Bryant-Wimp, RPh Owner/CEO Accurate Rx Pharmacy Columbia, MO

/ Director, r Frank Tagarello, Senior Art Director/Managing MAX Graphics James O’Neill, Senior Systems Manager

Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH

Dan Radebaugh, Director of Production and Technical Operations

Volume 5 • Number 1 • January/February 2016

specialtypharmacycontinuum.com

Marty Barbieri, Production Manager Brandy Wilson, Circulation Manager

SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA Senior Vice President CVS Health Woonsocket, RI

McMAHON PUBLISHING Michael Sicilian President, Managed Health Care Associates Inc. Florham Park, NJ Donald J. Vidic, RPh, MBA Vice President of Operations and Pharmacy Services Walgreens Specialty Pharmacy Carnegie, PA

Stephanie Holliday, PharmD Clinical Pharmacy Specialist Prosperity Specialty Pharmacy Falls Church, VA Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL Hetty Lima, RPh, FASHP Vice President of Specialty Infusion Services Diplomat Specialty Pharmacy Flint, MI

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Specialty Pharmacy Continuum • January/February 2016

CLINICAL

The New World of CF: Long-Term Survivors When Hanna Phan, PharmD, volunteered at a hospital as a high school student in the mid-1990s, she remembers that a number of patients with cystic fibrosis (CF) were not expected to reach their 21st birthday due to disease severity. That dire prognosis has improved significantly in recent years, thanks to several treatment advances, creating an opportunity for specialty pharmacies to help manage these patients and ensure optimal outcomes. Indeed, CF is no longer a pediatric disease: The average life span of a person with CF today is 41 years, according to the Cystic Fibrosis Foundation. A study published in the European Respiratory Journal (2015;46[1]:133-141) projects that the number of CF patients living into adulthood will increase by 75% by 2025. Dr. Phan, an assistant professor of pharmacy practice & science and pediatrics at the University of Arizona Colleges of Pharmacy and Medicine, in Tucson, has seen her own CF pediatric practice affected, as she now sees CF patients in their 50s, 60s and even 70s. Those improvements in life expectancy were achieved with multifaceted therapy, attributable “to a variety of advances in airway clearance devices, such as the high-oscillator vest, which allows for more independence in airway clearance,” Dr. Phan said. She also cited improvements in medication therapy including inhaled antibiotics, such as aztreonam for inhalation solution (Cayston, Gilead Sciences), and most recently, the addition of CF transmembrane conductance regulator (CFTR) modulators. Approved in 2010, Cayston was the first new inhaled antibiotic for CF in

more than a decade, and helped reduce burdensome daily treatment times, with an administration time of less than five minutes. “If we can cut the amount of time needed to take any medication, that helps enormously with adherence, which can translate into improved outcomes,” Dr. Phan said. With the 2012 approval of ivacaftor (Kalydeco, Vertex) followed by the approval on July 2, 2015, of lumacaftorivacaftor (Orkambi, Vertex), the first drugs to target some of the more than 100 mutations in the CFTR gene that are known to cause CF—and more such therapies in the pipeline—pharmacists treating CF can expect their patients’ life expectancies will continue to increase. These changes in the world of CF bring their own new set of clinical challenges. Adherence is one of those challenges. Poor adherence to therapy has been identified as a significant issue during the period of transition from childhood to adolescence and young adulthood ((Patient Prefer Adherence 2011;5:507515). Studies have found that lack of time, forgetfulness and unwillingness to take medication in public are among the most significant barriers to adherence in this age group.

A Role for Specialty Pharmacy “It’s important for specialty pharmacists to be involved in an interdisciplinary transition effort that begins in late childhood and goes through the late

Cystic fibrosis is caused by mutations in the CFTR gene, which encodes a chloride channel located on the surface of certain epithelial cells. Source: www.hopkinscf.org/what-is-cf/basic-science/cftr.

teens and into adulthood,” Dr. Phan said. “Our patients can lose about 1 to 2 points (FEV1 [forced expiratory volume in one second] percent predicted) of their lung function annually, but with poor adherence, that can worsen and be challenging to recover from.” To minimize adherence problems, transition programs must begin early, Dr. Phan stressed. “I start working with my pediatric patients on knowing what their medications are as early as 8 or 9 years old. I use fun quizzes, prizes and incentives to help them learn and understand what they’re on and why it’s important.” But the childhood-to-adulthood transition is just the beginning. CF care today also must incorporate a focus on comorbid conditions stemming not just from the disease itself but also

Adherence Management in Cystic Fibrosis

hen Lois Adams, MBA, RPh, founded HHCS Health Group of Companies, which includes Freedom Pharmacy and Wellness Centers and specializes in cystic fibrosis (CF), in 1984, she had already been working with CF patients for more than 20 years. “I saw my first patient in 1963. I can remember when we had 7- to 8-year-olds in a croup tent, with their meds being blown in to break up the mucus,” she said. Today, as many of her patients are reaching adulthood, and more than a few are surviving into their 70s, Ms. Adams has a whole new set of comorbidities and adherence challenges to manage. “As the youngster gets older, not only do they have the things that go along with the diseases, but they have things that every other young adult has, including hormonal changes and psychological challenges. It’s a very high-touch business, or it should be. You cannot conveyor-belt this [care].” Still, it is the younger patients with CF who often pose the greatest challenge, particularly when it comes to ensuring adequate adherence levels, Ms. Adams said. Pancreatic enzyme products (PEPs) are a major contributor to CF patients’ increased survival, but frequently 20 or more capsules daily must be taken. “It’s cumbersome, and for young people, it’s also embarrassing. They don’t want their friends to see them taking all that,” she said. “Fortunately, we can cut

down on their pill load by manipulating the number of units that have to be taken. If you have a product that has a multiple of 12,000 units—24,000, 36,000 or 48,000—we work with the doctor to see if it’s an option to give the patient 48,000 units, so they don’t have to take so many pills.” Freedom Pharmacy offers an innovative program to encourage adherence among its patients, whose families often struggle with major medical costs. Patients earn “healthy bucks” through adhering to their medication regimen, and each month they get a report on how many “healthy bucks” they have. Patients can spend those virtual dollars in Freedom Pharmacy/Cystic Fibrosis Pharmacy’s online store at myhealthybucks.com, on various over-the-counter pharmacy and health products ranging from sunscreen to saline nasal spray to chewable aspirin. —G.S.

from aging. “As patients live longer and longer, you are more likely to have multiple comorbidities and with that, polypharmacy,” Dr. Phan said. Two chronic conditions that are more common in people with CF are osteoporosis and diabetes. Not only does pancreatic insufficiency in CF decrease the absorption of fat-soluble vitamins (particularly D and K), but chronic inflammation, treatment with glucocorticoids and lower levels of physical activity all combine to increase the risk for bone loss in people with the disease. Some studies have found that as many as three-fourths of adults with CF have osteoporosis or osteopenia ((Drugs 2004;64[2]:133-147). “We try to do one baseline bone densitometry [DXA scan] before a patient turns 18, and then one every one to five years after age 18, depending on clinical status,” Dr. Phan said. “We also have to carefully monitor any medications that they’re on that may predispose them to osteoporosis or osteopenia.” Bisphosphonates have been found to increase bone mineral density in people with CF, but a 2009 Cochrane review noted that the IV agents can cause severe bone pain and flu-like symptoms, and more data in larger trials would be needed to determine whether the drugs prevent fractures in this population (Cochrane Database Syst Rev 2009;7[4]:CD002010). About half of all people with CF who have reached their 30th birthday have CF-related diabetes (CFRD), a form of the condition that is distinct from either type 1 or type 2 diabetes (Curr Opin Pulm Med 2010;16[6]:611-615). Early recognition of this condition is important to lung health: People with CFRD have lower lung function, more frequent hospitalization and worse mortality than their peers without diabetes. Annual oral

Specialty Pharmacy Continuum • January/February 2016

CLINICAL

glucose tolerance testing is recommended for all CF patients beginning at age 10. Unlike in type 2 diabetes, limiting calorie intake for patients with CFRD (except for simple sugars) is not recommended, because a high-calorie diet is critical to maintaining weight. Because of the lack of clinical trials in this population, glycemic control targets for people with CFRD are currently based on those for diabetes unrelated to CF. Specialty pharmacists also can expect to see an increasing number of patients with CF hospitalized with acute exacerbations of lung dysfunction. The mainstay of therapy for such patients remains IV antibiotics, according to Katherine Yang, PharmD, MPH, a professor of pharmacy at the University of California, San Francisco, who often sees CF patients admitted to her facility who require specialty pharmacy care. “Unfortunately, antibiotic development has not moved forward very quickly, and CF patients feel the brunt of that more than the general population, because their bacteria tend to be multidrug resistant,” Dr. Yang said.

$8 Million Cost For Long-term Survivors? The cost of the new CFTR drugs hasn’t made as many headlines as the latest generation of hepatitis C treatments, but it’s definitely raising eyebrows among payors. In April, Prime Therapeutics released a paper that found the mean total medical and pharmacy cost for individuals using ivacaftor was more than $367,000 per year (lumacaftor had yet to be approved at the time). Taking the drug for 28 years, they calculated, would total $8 million in drug cost alone.

Dr. Phan said her pharmacy has yet to see patients have their coverage denied for either lumacaftor-ivacaftor or ivacaftor, although there had been only a few patients starting these medications as of July 2015. “I’ve heard of possible challenges to coverage elsewhere, however. It would be helpful to proactively collect data in order to document the potential long-term benefits of these drugs to our patients, in case they do get challenged. Examples include monitoring their exacerbation rate and lung function over time.

“We’ve come a long way over the last 10 years,” Dr. Phan noted. “I expect to see a few more CFTR modulators on the market soon, and there are also other forms of inhaled antibiotics in development that will be very interesting. These patients have been waiting a long time, and the pipeline for new CF breakthrough treatments is finally showing exciting momentum.” —Gina Shaw Drs. Phan and Yang reported no relevant ﬁnancial relationships.

Joint Commission Accreditation Helping specialty pharmacies demonstrate performance excellence

Creative Treatments Required That requires pharmacists to “get very creative,” she added, using different drug combinations, varying doses and frequencies, and maximizing the pharmacodynamics of the antibiotic(s). “You have to hit it as hard as you can,” she said. “For Zosyn [piperacillin-tazobactam; Pfizer] or ceftazidime, we give doses sometimes double the normal dose or even higher.” Some CF centers are doing different dosing structures with certain IV antibiotics as well. “Instead of doing a bolus, they’ll do continuous infusion,” Dr. Yang said. “If a dose is typically 2 g every eight hours, they may do constant infusion over the entire dosing interval. This only works with the β-lactams, and the jury is still out on whether or not it is beneficial in CF.” The specialty pharmacist also will play a key role in managing the new drug–drug interactions that come along with the CFTR medications, Dr. Phan noted. “We know they interact quite strongly with medications that undergo metabolism of [the cytochrome enzyme] CYP3A4, for example. So, any kind of strong inducer or medication that undergoes similar metabolism will potentially interact with ivacaftor or lumacaftor-ivacaftor.” Drugs such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin or St. John’s wort may increase the clearance of ivacaftor, risking therapeutic failure. In contrast, CYP3A4 inhibitors, ranging from clarithromycin and erythromycin to grapefruit, can increase concentrations of the CF drugs. “It’s important to be cautious about their use. Make sure patients and health care providers communicate about any new medications, and adjust dosages accordingly,” Dr. Phan said.

Why work with us? Our process fosters better performance, enhanced outcomes, and greater reliability. We provide unparalleled learning opportunities before, during and after survey, led by trusted industry experts. Referrers and payors regard us as the gold standard for quality. They have greater confidence working with care partners who share their robust quality vision.

Visit pages.jointcommission.org/SPinfo for more information on accreditation for specialty pharmacy providers. Or call us, we’d like to help you reach your quality goals. 630-792-5070

Specialty Pharmacy Continuum • January/February 2016

CLINICAL

For New Factor X Rx, Home Infusion Skills a Must Three specialty pharmacies—Option Care, Diplomat Pharmacy and Soleo Health—are part of the network of providers that will be managing the complex clinical needs of patients taking Coagadex (Bio Products Laboratory [BPL]), a newly approved drug for the treatment of hereditary factor X deficiency. Federally funded Hemophilia Treatment Centers (HTCs) also will be part of the care network for these patients, and when inpatient use is required, hospitals will be able to purchase product through BDI Pharma and BioCare, the authorized distributors for Coagadex. The FDA approved Coagadex in October 2015. The drug is the first and only

Blood vessel injury results in bleeding

Blood vessel constricts and clotting factors are activated

The Pharmacist’s Role Barbara Prosser, RPh, the vice president of clinical services at Soleo Health, a national provider of home and alternate-site specialty infusions headquartered near Philadelphia, said that pharmacists can help teach patients to identify symptoms of a bleed (i.e., a bubbling sensation in the joints, pain or swelling) and treat appropriately. The faster patients treatk a bleed, the more they will will minimize their potential for long-term damage. “Patients need to have the drug available to treat their bleed as soon as pos-

were controlled with three or four infusions. The treatment also was evaluated in five participants with mild to severe factor X deficiency who were undergoing surgery; it was effective in controlling blood loss during and after surgery in patients with mild factor X deficiency ( (Haemophilia 2015;21[3]:e260-e280). Coagadex was not associated with serious adverse events or transmission of infectious agents. Six adverse reactions occurred in two patients, including infusion site erythema, back pain, fatigue and infusion site pain. Charlene Smith, MA, the marketing and communications manager at BioCare, noted that specialty pharmacy providers “often have expertise in

‘Many of these patients may be managed by a hemophilia treatment center, and that is where the education begins. As pharmacists, it is our job to reinforce and continue that education in the home.’ —Barbara Prosser, RPh Normal Clotting

Gary Rice, the senior vice president of clinical services, education and human resources at Diplomat, pointed out that until now, physicians have had limited options for treating factor X deficiency. As a result, “patients have had to resort to products containing at least some factor X protein, such as plasma-derived prothrombin complex concentrates [PCCs]

emergency action plans, nursing services and/or infusion training.

Factor X is one of several clotting factors that help the blood to clot

Stable clot forms and bleeding stops

Factor C Deficiency People with low levels of factor X are at risk for excess bleeding

Incomplete clot allows bleeding to continue

Figure. A close look at hereditary factor X deficiency. treatment approved specifically for hereditary factor X deficiency, a rare type of hemophilia that prevents the blood from clotting normally (Figure). All specialty pharmacies distributing the drug have dedicated resources focused on the hemophilia market. “All key personnel at these specialty pharmacies associated with administration or dispensing of Coagadex have passed a certification exam on the factor X deficiency disease state and on the clinical characteristics of Coagadex,” said Chris Core, the vice president of marketing for BPL. Moreover, “the distributors [of the drug] have clinical expertise in bleeding disorders and nursing support available to ensure that patients who choose home infusion of Coagadex can do so with confidence and with the guidance of a specially trained pharmacy partner.”

or fresh frozen plasma [FFP],” Mr. Rice said. “In some cases, vitamin K supplements have been used [if the deficiency is caused by low levels of vitamin K], or, in mild cases, topical agents such as fibrin glue or nosebleed powders.” The most frequently used treatments are the PCCs and FFP, but these treatments carry risks, including allergic reactions, thrombosis (PCCs) and transfusion-related lung injury (FFP), he pointed out. “Preapproval research suggests that [Coagadex] will have safety profiles that are very similar to other clotting factor products on the market today, which have a long safety record,” Mr. Rice noted, adding that all hemophilia treatments are administered intravenously and have special shipping, handling and storage requirements. Clotting factor medications come with detailed clinical care plans, including

sible,” Ms. Prosser said. “Many of these patients may be managed by a hemophilia treatment center, and that is where the education begins,” she added. “As pharmacists, it is our job to reinforce and continue that education in the home.” When a patient is younger, pharmacists should work closely with families. “At every age in the patient’s lifetime, there are different areas of focus,” Ms. Prosser said. “For example, as patients become teenagers, they may be reluctant to take the time to stop and treat a bleed. When we monitor patients, we ask them how soon they were able to treat and help remove any barriers to treatment. Adjunct treatments for bleeds such as a RICE (rest, ice, compression and elevation) protocol may also be part of a treatment plan reinforced by the pharmacist. Teens and adults who are participating in sports or are leading active lifestyles need careful monitoring. Being able to identify and recommend interventions for adverse reactions is also an important role of the pharmacist.”

Safety, Efficacy Data The safety and efficacy of Coagadex was evaluated in the open-label Phase III Ten 01 study involving 16 participants with severe/moderate factor X deficiency ((Haemophilia 2015;21[3]:e260-e280). The investigators found that 98% of the 187 bleeds that occurred were successfully controlled by one or two Coagadex infusions, and the remaining bleeds

hemophilia care that increases compliance, assists with reimbursement issues and improves patient satisfaction.” Joan Couden, the national program director of the bleeding disorder program at Option Care, said the company’s clinical team consists of pharmacists, nurses, a social worker, a hematologist and a Hispanic coordinator who bring years of experience working with patients with rare bleeding disorders. “Many of these clinicians spent several years working for HTCs and are not only in tune to a home infusion patient’s needs, but understand the prescribing patterns and practices of an HTC, so that they can truly collaborate to affect optimal outcomes,” Ms. Couden said. As for the projected market for and supply of Coagadex, BPL’s Mr. Core pointed out that “hereditary factor X deficiency is an extremely rare condition, affecting between 300 to 600 individuals in the United States. Our research indicates that these patients are distributed throughout the U.S., with any one hematologist treating at most one or two patients. Coagadex is a biologic product produced from human plasma with a long and complex manufacturing process, so launch quantity will be relatively limited.” —Kate O’Rourke The sources reported no relevant ﬁnancial relationships other than their stated places of business.

NHIA

Annual Conference & Exposition March 21 – 24, 2016 • New Orleans

education sessions and program highlights by utilizing the 2016 NHIA Session Planners and Schedule-at-a-Glance (located under the Education Program menu)... it’s all waiting for you at www.nhia.org/ac16. You can also scan the below QR code to get details on the many educational offerings NHIA 2016 has to offer!

There’s Still Time to Register for Significant Savings—But Time is Ticking! Early bird registration ends February 10th—it’s fast, easy and secure—be sure to go to www.nhia.org/ac16/reg and reserve your spot today! Registration is also available after the early bird period as well as on-site at the Ernest N. Morial Convention Center—you’ll have your badge and conference materials in no time! Please mention this ad if registering by phone (703-838-2663) or enter code AC16-SPT in the “Other Advertisement” ﬁeld if registering online.

Bring More, Save Big!

Maximizing Success Creating Opportunities

NHIA Member Organizations registering 6 or more employees receive a special discounted group rate—contact Ciara Williams at 703-838-2663 for details. It really does pay to bring your whole team—learn more about NHIA’s company member discounts at www.nhia.org/ac16/discounts. Want to know more about NHIA Membership and how it can positively impact your specialty pharmacy business? Contact Patricia Adair at 703-838-2668.

QUES T I ONS ?

industry experts on topics related to Specialty

Call 703-549-3740 or email info@nhia.org

# N H I A 2 5 St ro n g

Visit the 2016 NHIA Annual Conference & Exposition Website!

Pharmacy Infusion?

Search no further than the 2016 NHIA Annual Conference & Exposition—where you’ll ﬁnd highly valuable educational and networking sessions focused on the compounding and administration of specialty pharmacy infusions in the home and alternate-site setting, including: Take advantage of the Tuesday Breakfast Symposium entitled ed Sterile Compounding and the Proposed Revisions to USP Chapter <797>—Examining the Changes and their Impact for Home Infusion Pharmacies and the Thursday Lunch Symposium entitled, Exploring the Drug Pipeline and Biosimilars—What the Future May Hold for Your Patients and Your Business. Obtain valuable veteran industry expert insights at the 2016 NHIA Executive Pre-Conference, titled Creating Opportunities to Strengthen and Grow Your Home and Specialty Infusion Business. cess Be sure to attend the Clinical Workshop: Central Venous Access cian. Device (CVAD) Considerations for Every Home Infusion Clinician.

Topical Concurrent Track Sessions provide insights into the complex care of your specialty pharmacy infusion patients who often require key strategies for successful management: •

Investigate the latest standards and federal laws/regulations that could impact your specialty pharmacy practice.

•

Examine the newly revised NHIA outcomes deﬁnitions as you consider how to strengthen your own outcomes data collection process in anticipation of future industry-wide benchmarking and value-based payment models.

•

Apply hazardous drug handling standards to a range of home infusion pharmacy practices.

•

Hear from home infusion pharmacy residents as they share critical information needed to safely administer and clinically monitor the new drugs, biologics and biosimilars that entered the market in 2015.

•

Enhance your clinical monitoring skills when providing specialty infusion therapies to geriatric home-based patients.

Acquire Indispensable Continuing Education Credit... Earn up to 26.25 pharmacy and nursing continuing education (CE) credit contact hours—for complete continuing education information and educational objectives, please visit: www.nhia.org/ac16/ce Keeping the Home and Specialty Infusion Therapy Community Connected—Visit www.nhia.org/SocialMedia for More Information

Specialty Pharmacy Continuum • January/February 2016

CLINICAL

CTM Program Improves IG lnfusion Adherence National Harbor, Md.—Implementation of the Clinical Therapy Management (CTM) program for immune globulin (IG) therapy significantly improved patient adherence in this challenging therapeutic space, according to a poster presented at the 2015 annual meeting of the National Association of Specialty Pharmacy. Barnes Precision Specialty Pharmacy, in Gainesville, Fla., implemented the CTM, a professionally peer-reviewed module developed by Managed Health Care Associates (MHA) Inc., beginning in September 2014. Among th he 178 patients in the study, the total nu umber of fills increased from 696 durin ng the six-month period before CTM im mplementation to 943 during the six-mo onth period after. The average number of fills also increased from 3.91 to 5..3 ( =0.001), and average grams perr (P fill increased from 168.54 to 246.29 ( =0.015). (Traditional adherence (P metrics, such as medication possession ratio or proportion of days covered, are not applicable in IG therapy, so these surrogate adher-ence end points were used instead..) Monitoring IG therapy presen nts particular challenges for speciaalty pharmacy because of the wide range r of indications for which it can be used. Immune deficiencies are the most common indication, but on- and offf-label uses for IG number in the dozens, and d range from neurologic conditions to dermatologic, hematologic, immunologic and many other categories. “Finding a way to track and monitor the progress of those patients, no matter what indication they present to the pharmacy with, can be difficult,” said Stacey Ness, PharmD, CSP, MSCS, AAHIVP, MHA’s director of specialty clinical services. “Specialty pharmacists also have to contend with clinical product variations like sugar content,

sodium content, pH and osmolality; route of administration considerations; patient comorbidities such as cardiac impairment, thromboembolic risk and

ic thrombocytopenia, bone marrow transplant and solid-organ transplant. “There are a total of nine disease state categories, with about 20 to 30 different indications under each, which gives the CTM the ability to cover more than 100 indications,” Dr. Ness said. “And for patients not accounted for by disease state pathways, there is the opportunity to complete a general IG assessment.” The CTM establishes a menu of specific outreaches to patients at key intervals during IG therapy for individualized counse counseling, and allows clinicians to track adverrse events over time, reporting events after each infusion to look

The study poster did not include data on outcomes after implementation of the CTM program; it was too soon, said Dr. Ness. “We do have relevant data and are continuing to collect it so that we can assess outcomes, but the program hasn’t been running long enough to do those calculations yet.” Mr. Ford noted that although the study poster is about adherence, the CTM program also will allow his pharmacy to collect data on many other variables that may be related to outcomes. “We’re collecting information on things like infections, pain levels and days missed from work, and storing

‘CTM systems help smaller companies with limited resources extract the data that larger companies can do on their own.’ —John Ford, RPh, BCNSP, CSP for patterns that may allow for modification of therapy tthat can lessen side-effect ffrequency or intensity.

Inttegration a Key Benefit

renal dysfunction; and as with everything else in specialty pharmacy, the increasing need for data.” MHA’s CTM, which has been featured in Specialty Pharmacy Continuum (April/May 2015, page 3), includes comprehensive disease state pathways that encompass the primary indications for which IG is used, including immunodeficiency (with a separate category for neonatal immune deficiencies), neurologic and muscular disorders, idiopath-

Joh hn Ford, RPh, BCNSP, CSP, Barnes’ vice president of clinical services, said his pharmacy reviewed several clinicaal management programs for IG therapy, h and chose MHA’s because of its overall ease of use and foundation in clinical evidence and peer review. “It is also bidirectionally integrated with our dispensing system, CPR+, which is important,” Mr. Ford said. “That system is not common in specialty generally, but it’s huge in infusion. Since the dispensing systems we work with don’t typically offer robust clinical integration, clinical management systems that help you manage that are becoming more important.”

it in SQL [relational] tables that will allow us to retrieve it and do more robust outcome measures than just straight adherence,” he said. Barnes has implemented MHA’s hepatitis C CTM module as well, although that disease is not a primary focus for this pharmacy, and expects to add an upcoming multiple sclerosis module. “CTM systems help smaller companies with limited resources extract the data that larger companies can do on their own,” Mr. Ford said. “If I’m Accredo or Caremark, I can build it in-house. But when you’re smaller, this is a value you can get for relatively low cost compared with some of the other products out there.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships beyond their stated places of business.

Option Care To Provide Novel Nutritional Device Relizorb

ational home infusion provider Option Care Enterprises has been chosen as the contracted provider of immobilized lipase (Relizorb, Alcresta), which helps patients with complex medical conditions digest and absorb the “essential fats” they receive through enteral nutrition (tube feeding). Recently approved as a de novo device by the FDA, Relizorb is a first-of-its-kind digestive enzyme cartridge designed to mimic normal pancreatic function by breaking down fats in an enteral tube feeding formula. Patients with pancreatic dysfunction do not generate the enzymes that are necessary to break down fats. Break-

ing down the fats before digestion allows the delivery of increased absorbable calories from fatty acids and monoglycerides from only about 10% to approximately

90% in most enteral feeding tube formulas. “Tube feeding can be burdensome and uncomfortable, and we want our patients to be able to make the most of the calories that they take in,” said Kimberly Petruccelli, PharmD, MBA, the clinical program manager of specialty infusion programs for Option Care, in an interview with Specialty Pharmacy Continuum. “We are very excited about the opportunity Relizorb presents for patients who are struggling to gain weight and get the nutrition they need from oral supplementation.” —Gina Shaw

Specialty Pharmacy Continuum • January/February 2016

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Q: Is there a network version of MILT 4?

A: MILT 3.0 has been extremely well received by pharmacists in facilities of all kinds and sizes. We would have continued to add features and enhancements indefinitely. But with 64-bit Windows becoming popular, the existing code had to be rewritten to support it. Rather than just reconfiguring MILT 3.0 for 64-bit, we chose to use the knowledge we gained working with so many pharmacists and rewrote the program to even better suit their specific needs.

A: MILT 4 is sold as an unlimited individual-site license. You can install the program on as many computers as you need. It’s easy to share your database with all the computers in just a standard folder on the network—no server installation is required.

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Q: So the new version, MILT 4, requires 64-bit Windows? A: No, MILT 4 works with either 64- or 32-bit Windows. Furthermore, it can even be installed on the same computer where MILT 3.0 is currently installed.

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Q: Which enhancements will make the most difference for pharmacists and staff? A: The faster printing, cleaner fonts and easier interface will be the most obvious improvements for existing users. One of the most asked-for features is the ability to have different date calculations associated with specific medications. MILT 4 will automatically calculate the appropriate beyond-use date each time someone opens that medication. Another requested feature is the ability to be prompted for specific data, like a lot number, each time a medication is selected. Both of these features allow pharmacists to guide their staff toward completing the packaging task correctly, but still allow for intervention when special occasions arise.

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Q: So pharmacists can configure MILT 4 to their specific requirements? A: That’s right. The pharmacist can configure everything from the type of information to be collected, to the rules for how barcodes are created, to easily limiting or expanding the access that staff members have to features within the program, ensuring that those choices are enforced. Labels for each medication type can be customized, and packaging

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Specialty Pharmacy Continuum • January/February 2016

CLINICAL

Off-Pathway Cancer Prescribing Still a Problem Oncologists are like the residents of Garrison Keillor’s Lake Wobegon, according to Michael Kolodziej, MD, Aetna’s national medical director for oncology solutions. “When it comes to following oncology pathways, they all think they’re above average.” apy, laboratory and genetic testing, advanced imaging and end-of-life care. Use of point-of-care, real-time decision support tools (DST). These tools can significantly improve pathway adherence, Ms. Stern said—but only if they are used. A report presented by Cardinal Health at the 2015 annual meeting of the International Society for Pharmacoeconomics and Outcomes Research focused on a two-year project in which 38 oncologists from 15 prac-

Currently implement No plans to implement in next 12-24 mo Plan to implement in next 12 mo

Utilization Implementation, %

100 80

54%

52%

60 40

11%

24%

37%

21%

n=70

0 Percentage of plans

Percentage of lives

Figure 1. Oncology pathway use among payors. Source: 2015 EMD Serono Specialty Digest, 11th Edition.

Methodology 100

Plans with pathways, %

Whether developed by payors such as Anthem, third-party vendors such as Cardinal Health or McKesson, or oncology groups such as the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network, oncology pathways have seen major growth over the past several years. In a 2013 survey, 28% of health plans indicated that they currently use oncology clinical pathways, while another 50% said they would do so within three years (Oncology Business Review, June 2013). In the 2015 EMD Serono Specialty Digest, 11th Edition, 69% of payors said they either already use oncology pathway vendors or plan to do so within the next 12 months (Figure). Nevertheless, off-pathway prescribing remains a significant challenge, according to Debbie Stern, RPh, the senior vice president for strategy and business development in oncology and specialty drugs at eviCore healthcare. “The most common areas where oncologists diverge from pathways include the use of drugs outside of their recommended lines of therapy and inappropriate combinations of drugs within a regimen,” she said. Prescribing that does not adhere to pathways can sometimes lead, paradoxically, to both over- and undertreatment. A 2012 study on the medical appropriate use of white blood cell growth factors, for example, found evidence that colony-stimulating factors (CSFs) are both over- and underused. Only 17% of patients treated with highrisk chemotherapy regimens received CSFs, whereas 96% of CSFs were administered in scenarios where CSF therapy is not supported by evidencebased guidelines. Several key differentiators could improve the uptake of oncology pathways, Ms. Stern noted. These include: Ease of use. “You are asking physicians and staff to interrupt their daily practice to enter information and get results. Any pathway tool has to be simple to use.” Authorization capabilities. “Some tools have automatic e-prior authorization [PA] capabilities that streamline the process. If you have to use a pathway tool to determine the appropriateness of your regimen, then go elsewhere to fax in your PA form; that is inconvenient and a barrier to use.” Inclusion of multiple treatment modalities. These not only include drug regimens, but radiation ther-

tices participating in a payor-sponsored, oncologistdeveloped cancer pathway program incorporated use of a proprietary DST. Of O the 798 physician-generatted chemotherapy selectionss ordered during the study period, 31% were registered in the DST, whereas the remainder were found only upon claims review. Pathway compliance for chemotherapy was 99% for the 250 regimens selected through the DST, compared with 89% for the 548 regimens identified through claims analysis only. Over the two years of the program, IV chemotherapy treatment

80 60 n=16 (plans with oncology pathways)

40 20

69%

38%

25%

Collaborate with oncologists to develop planspecific pathways

Create proprietary pathways internally

19%

0 Utilize thirdthird party vendor pathways

Rely on oncologists to develop their own pathways

Figure 2. Oncology pathway methodology among payors. Source: 2015 EMD Serono Specialty Digest, 11th Edition.

varriability decreased from 51 disstinct drug combinations to o 42. Aetna also has seen a siggnificant increase in eviden nce-based treatment after adopting pathways, Dr. Kolodziej said. In the six months Aetna initiated a m pilot pathway decision support program in six oncology practices, only 62 of every 100 patients received an evidence-based treatment plan, he noted; during the pilot, 87 of every 100 patients were treated with peer-reviewed, evidence-based treatment options—a relative improvement in adherence of 43%.

‘Cookbook Medicine’? One potential roadblock to more widespread pathways adoption is the attitudes of prescribing physicians. Indeed, some oncologists still see pathways as a “cookbook” approach to cancer care, Dr. Kolodziej said. “They say, ‘I treat real-world patients.’ But if you try clinical pathways for awhile, you’ll see that most of the time you agree with the choices.” Just because a planned course of treatment does not entirely comport with a pathway, does not mean it will be rejected necessarily, he added. If a physician chooses an off-pathways treatment regimen that is nevertheless supported by published evidence, “it will be paid,” he said. “Our ‘official’ goal at Aetna is [to achieve] 80% compliance with pathways—which we reward through a performance pool—but our real goal is improvement over time. If there are clinical circumstances that dictate a patient should not be treated on pathway, as long as it’s still compatible with the evidence, it will be paid. We want deviation from the pathways to only happen when it’s truly in the best interest of the patient, not just because your last three patients responded to Gemzar.” According to Ms. Stern, eviCore also finds that about 80% to 85% of clinical presentations will fit into the Pathforward Cancer Pathways that it provides to clients, which are largely based on ASCO’s Choosing Wisely initiative, she noted. “In our experience, only a very small percentage of treatment requests—fewer than 2%—are denied outright, because inappropriate treatment is requested,” she said. “The end result is that over 98% of patients receive clinically appropriate treatment, either on pathway or not.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

Specialty Pharmacy Continuum • January/February 2016

CLINICAL

Avella To Offer $1 Daraprim Alternative

vella Specialty Pharmacy will begin compounding a $1-per-capsule alternative to pyrimethamine (Daraprim, Turing), a drug used to treat or prevent toxoplasmosis and Pneumocystis pneumonia, the company recently announced. In August, Turing Pharmaceuticals sparked outrage when it acquired pyrimethamine, which had long been available at $13.50 per tablet, and quickly raised the price to $750 per tablet—an increase of approximately 5,000%. In November, the company announced that it would cut the drug’s price for hospitals by about 50%, but that was still an enormous increase over its previous cost. The drug has no generic counterpart. Avella’s new compounded therapy contains the same active ingredient as Daraprim—pyrimethamine—along with a type of folic acid that is also commonly prescribed to treat toxoplasmosis. Providers can simply write a prescription for the compounded formulation. Eric Sredzinski, PharmD, AAHIVP, the executive vice president for clinical affairs and quality assurance at Avella Specialty Pharmacy, told Specialty Pharmacy Continuum that Avella is uniquely positioned among specialty pharmacies to meet this need. “There are very few specialty pharmacies in the country that have core competencies in compounding. We have been compounding patient-specific prescriptions since 1996, and were one of the first pharmacies in the country to be certified by the Pharmacy Compounding Accreditation Board,” he said. “We also have longstanding depth in clinical management of HIV and AIDS, and we are licensed

FDA Approval Melanoma Indication Expanded for Keytruda

in all 50 states, unlike most compounding pharmacies that serve smaller areas. We are committed to ensuring that our patients are able to access prescriptions at the lowest cost possible.” On Dec. 1, Express Scripts announced that it also will be making a Daraprim alternative, compounded by Imprimis Pharmaceuticals, available on its formulary at $1 per pill. —Gina Shaw

Chest x-ray (far right) reveals radiologic evidence of Pneumocystis pneumonia characterized by bilateral pulmonary interstitial infiltrates. Photomicrograph (inset) shows brain tissue of patient with neurotoxoplasmosis caused by Toxoplasma gondii. Source: CDC.

APRIL

O • MOSC 2 2 9 1

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6 1 0 2 g n i t ee

CARE & D E G MANA

M l a u Ann

AMCP

ARM H P Y T L SPECIA

NC N FRA A S • WEST

∙

ISCO

Thousands of Managed Care Professionals. Hundreds of Sessions, Abstracts, Special Events and Exhibits. One Great Destination. . .

embrolizumab (Keytruda, Merck) now can be used as a first-line treatment in patients with unresectable or metastatic melanoma—an indication that it was already approved for in July 2015 by the European commission, according to the FDA. Pembrolizumab is now the first anti– programmed cell death protein 1 (PD-1) therapy cleared for previously untreated advanced melanoma patients regardless of BRAF F status. For the new indication, data from the Phase III KEYNOTE-006 trial, which randomly assigned 834 patients with unresectable stage III or IV advanced melanoma to receive pembrolizumab or ipilimumab, demonstrated the safety and efficacy of the therapy. According to the agency report, patients had no prior therapy with ipilimumab, and prior therapy with at most one other systemic treatment.

And a new name to reflect our expanding world! The world of managed care and specialty pharmacy is growing…and AMCP is responding. The AMCP Annual Meeting is still the only event that brings together all the voices and visions of managed care pharmacy, health care, and breakthrough drug therapies. But the new name brings into focus the ingrained and expanding role of specialty pharmacy. Indeed, it’s increasingly said that managed care pharmacy is specialty pharmacy. We will spotlight new developments in a dedicated track and pre-meeting programming, while still bringing you up to date on legislation and regulation, research, formulary management and other concerns of our profession. You can’t afford to miss the Annual Meeting— where all the facets of our growing field come into focus. www.amcpmeetings.org

Specialty Pharmacy Continuum • January/February 2016

POLICY

8 Steps to Accreditation Success By establishing standards that measure and monitor the practice, accreditation helps specialty pharmacies provide much-needed data metrics to pharmaceutical companies and third-party payors, as well as demonstrate a commitment to providing the highest quality patient care. However, achieving accreditation does not “just happen.” It takes planning, commitment and time. Here are 8 steps to make your accreditation process successful, culled from interviews with key stakeholders in the accrediting field.

Dedicate Resources

Choose a champion

Choose the Right Partner

espite the time and money that accreditation requires, many specialty pharmacies don’t do their homework to find the right partner. Instead, they base the choice on word of mouth and/or cost. That approach may not yield the best match. Instead, choose an accreditor that meets yourr specific needs, so the accrediting firm understands the subtle differences in standards and processes that underpin your practice’s patient care and delivery model. Those considerations will influence other decisions such as resource allocation and whether to obtain a consultant, so it’s important to get this step right. The pharmacy’s compliance is assessed according to standards developed by the accrediting agency, so it is critical that operations reflect the accreditation standards and the pharmacy’s own policies and procedures. Too often, the first question asked is: How much does it cost? Maybe it should be: What are your standards and how will your accreditation help our organization improve?

eviewing policies, getting to know the accreditation standards and writing your own compliant standard operating procedures (SOPs) requires time, money and human resources. Make sure you dedicate enough of all three. It can take up to a year to prepare for the accreditation survey. Don’t wait until the last minute or you will be taxing those resources and jeopardizing the entire initiative. Also, dedicate someone to lead the accreditation effort and ensure time in their schedule to properly manage the process. If there are no accommodations made in the person’s schedule, either the job or the accreditation may suffer. If you understand how big a task accreditation preparation is, you are more likely to have realistic expectations about allocating resources.

ind a champion who is respected by others on the team, but not necessarily a supervisor. This is a long process, so the champion has to help the organization maintain its enthusiasm. However, the champion is not the person who is going to do alll the work. The champion’s responsibility is to ensure that everyone realizes the importance of the task at hand, becomes excited about the project and meets the deadlines to achieve success.

Know Your Stuff Get Buy-In

ccreditation requires the participation of key personnel who are hand-picked to review processes and write the standards for each department. For this to work optimally, buy-in from the top to the bottom of the organization is critical. It’s also important not to rely on one person or department to write the standards for another department, because each operational area has different priorities and procedures. Thus, every division will need to review its standards and write the SOPs for itself, so they will be more likely to “own” the standards. Organizations that rely on a team tend to have more success.

S Have a Plan

he organization must develop a project plan. Choose the individuals who will work on the team, review the standards and compare them with the pharmacy’s SOPs and processes, establish a timeline for writing and reviewing, implement the standards, train staff, prepare for the accreditation survey and maintain ongoing compliance. Having a plan with a timeline and deadlines for each step will ensure that you allocate enough time to accomplish everything that is needed to successfully achieve accreditation.

taff must understand exactly what the accrediting standards require before they can develop effective SOPs. Work with your accreditor so that your team is clear on what the standards require and where your organization has deficiencies before writing an SOP or hiring a consultant. Break down the standards into the various areas of your specialty pharmacy, and designate individuals to apply them to your organization. Ask what the standards cover, how they are organized, where they get more in depth and what the scope is to become compliant. Once you understand the standards, review your processes. Be objective. Complete a self-assessment to find your deficiencies. Take advantage of the many resources that accrediting bodies offer to help organizations succeed. Once you know your stuff, sit down, write the SOPs, implement them, train staff and get ready for the auditor.

C P

c p o n a so tl th d e ti im

a a ti th

Spread the Word

he specialty pharmacy market is competitive. You compete for contracts with manufacturers and third-party payors, for referrals and patients. Holding an accreditation is a competitive advantage and a sign of quality that can provide you access to specific contracts, so spread the word! You spend a lot of time and money, devote many staff hours and maybe even hire a consulting firm to help you become accredited, so make sure that you aggressively market that distinction. Don’t forget your staff; make sure they understand how their hard work paid off and how everyone, from patients to the specialty pharmacy, benefit because of their efforts.

Sources: Greg Stowell, the education and consulting manager at Accreditation Commission for Health Care in Orlando, Fla.; Danyell Jones, the senior vice president of marketing at BHM Healthcare Solutions in St. Petersburg, Fla., a consulting ﬁrm that provides assistance to organizations seeking accreditation

Do It All Again

o be genuinely successful, an organization must incorporate the standards into everyday practice. Bask in your success after you achieve your accreditation, but make sure you maintain your standards and are ready to do it all again when it is time for reaccreditation. Too often, organizations do all that work, and two years later, they are panicking, calling a consultant and saying, “Fix me. I have to be reaccredited.” Maintain good communication with the accrediting agency throughout the process, review the standards regularly and make sure the accrediting committee meets often to keep everyone on task.

from bodies such as URAC in Washington, D.C.; Lynnae M. Mahaney, BSPharm, MBA, FASHP, the executive director at the Center for Pharmacy Practice Accreditation in Madison, Wis.; and Sandra Canally, the founder and president of The Compliance Team in Spring House, Pa.

m a ta

BIVIGAM has joined the Kedrion Biopharma Inc. Immunoglobulin Therapies Franchise ®

As of January 19, 20 016 Kedrion has gained commercial rightss to distribute ® BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]. Kedrion also distributes GAMMAKED™ [Immune Globu GAMMAKED ulin Injection (Human), (Human) 10% Caprylate/Chrromatography Purified]. BIVIGAM® [Immune Globulin Intravvenous (Human), 10% Liquid]

GAMMAKED™ [Immune Gllobulin Injection (Human), 10% Caprylate/Chrom matography Purified]

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE See full prescribing information for complete boxed warning.

• Thrombosis may occur with immune globulin

intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. • For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• Thrombosis may occur with immune globulin

products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. • For patients at risk of thrombosis, administer GAMMAKED at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. • For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable.

Please see following page for brief summary, including the black box warnings for BIVIGAM and GAMMAKED. For general inquiries or questions about BIVIGAM or GAMMAKED, please call Kedrion Customer Service at 855-353-7466. BIVIGAM is a registered trademark of Biotest Pharmaceuticals Corporation. GAMMAKED is a trademark of Kedrion Biopharma Inc. ©2016 Kedrion Biopharma Inc. All Rights Reserved. January 2016 CO-0255-00-2016

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIVIGAM® safely and effectively. See full prescribing information for BIVIGAM. BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid Initial U.S. Approval: 2012

HIGHLIGHTS OF THE PRESCRIBING INFORMATION These highlights do not include all the information needed to use GAMMAKEDTM safely and effectively. See full prescribing information for GAMMAKED. GAMMAKED, [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] Initial U.S. Approval: 2003

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE. See full prescribing information for complete boxed warning. • Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. • For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE. See full prescribing information for complete boxed warning. • Thrombosis may occur with immune globulin products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. • For patients at risk of thrombosis, administer GAMMAKED at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. • For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable.

-------------------------------- INDICATIONS AND USAGE -----------------------------BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). ----------------------------------- CONTRAINDICATIONS --------------------------------• History of anaphylactic or severe systemic reactions to human immunoglobulin. • IgA deficient patients with antibodies to IgA and a history of hypersensitivity. ----------------------------- WARNINGS AND PRECAUTIONS ----------------------------events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. • IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available immediately to treat any acute severe hypersensitivity reactions. • Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure. • Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. • Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. • Hemolytic anemia can develop subsequent to treatment with IGIV products. Monitor patients for hemolysis and hemolytic anemia. • Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. • Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. • Thrombotic

---------------------------------- ADVERSE REACTIONS --------------------------------The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. To report SUSPECTED ADVERSE REACTIONS, contact Biotest Pharmaceuticals at 1-800-458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------------------- DRUG INTERACTIONS --------------------------------transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, rubella, and varicella. • Passive transfer of antibodies may confound the results of serological testing. • Passive

----------------------------- USE IN SPECIFIC POPULATIONS ---------------------------Use in pregnant women has not been evaluated. Use BIVIGAM in pregnant women only if clearly needed. • Geriatric Use: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse BIVIGAM at the minimum infusion rate practicable. • Pregnancy:

Visit www.BIVIGAM.com for Full Prescribing Information BIVIGAM is manufactured by Biotest Pharmaceuticals Corporation, Boca Raton, FL 33487

-------------------------------- INDICATIONS AND USAGE -------------------------------GAMMAKED is an immune globulin injection (human) 10% liquid indicated for treatment of: • Primary Humoral Immunodeficiency (PI) • Idiopathic Thrombocytopenic Purpura (ITP) • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ---------------------------------- CONTRAINDICATIONS ---------------------------------or severe systemic reactions to human immunoglobulin. • IgA deficient patients with antibodies against IgA and a history of hypersensitivity. • Anaphylactic

----------------------------- WARNINGS AND PRECAUTIONS ----------------------------deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure. • Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy. • Thrombosis has occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombosis; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. • Aseptic Meningitis Syndrome (AMS) has been reported with GAMMAKED and other IGIV treatments, especially with high doses or rapid infusion. • Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. Monitor patients for hemolysis and hemolytic anemia. • Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). • Volume overload. • GAMMAKED is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. • GAMMAKED is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMMAKED subcutaneously in patients with ITP. • Passive transfer of antibodies may confound serologic testing. • IgA

---------------------------------- ADVERSE REACTIONS --------------------------------Serious adverse reactions which occurred in the clinical trials were an exacerbation of autoimmune pure red cell aplasia in one subject and pulmonary embolism in one subject with a history of PE. The most common adverse reactions observed in 5% patients were: PI: Intravenous: Headache, cough, injection site reaction, nausea, pharyngitis and urticaria. Subcutaneous: Infusion site reactions, headache, fatigue, arthralgia and pyrexia. ITP: Headache, vomiting, fever, nausea, back pain and rash. CIDP: Headache, fever, chills, hypertension, rash, nausea and asthenia. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ---------------------------------- DRUG INTERACTIONS ---------------------------------passive transfer of antibodies may transiently interfere with the response to live viral vaccines, such as measles, mumps and rubella.

• The

----------------------------- USE IN SPECIFIC POPULATIONS ---------------------------human or animal data. Use only if clearly needed. • Geriatric: In patients over 65 years of age do not exceed the recommended dose, and infuse GAMMAKED at the minimum infusion rate practicable. • Pregnancy: No

BIVIGAM and GAMMAKED are distributed by Kedrion Biopharma Inc., 400 Kelby Street, Fort Lee, NJ 07024

Visit www.GAMMAKED.com for Full Prescribing Information

GAMMAKED is manufactured by Grifols Therapeutics Inc., Research Triangle Park, NC 27709

Specialty Pharmacy Continuum • January/February 2016

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PALS LAUNCH continued from page 1

PALS offers access to more than 85 lab tests, such as prostate-specific antigen, bilirubin, thyroidstimulating hormone and white blood cell count. Most tests cost between $5 and $20, although some are priced higher. Here’s how it works: The patient downloads the order form and list of available tests from PALS’ website (www.pals-labs. org), prints them out, and fills out his or her personal information and payment information on the form. The patient’s medical provider then completes and signs the provider section of the form and sends it in. (Although state laws vary and some states allow on-demand patientrequested testing for certain labs, PALS’ system is set up to meet the requirements of the most rigorous states, and requires a doctor’s prescription for all testing.) Within two weeks, the patient receives a box with information on where to have his or her test, which must be brought to the lab. Results are returned within two weeks, with an additional copy sent to the provider if requested. PALS is sponsored by the Own Your Own Health Partnership, a “health awareness co-op” created by the Missouri-based Hep C Alliance and ShowMe Health Services, along with NeedyMeds, a Massachusetts-based group focused on consumer health education and helping people afford their health care. Although PALS, with its national reach and comprehensive array of tests, is brand new, the Hep C Alliance has been providing a similar service to people with hepatitis C virus (HCV) in Missouri for more than a decade.

Roots in HCV Testing Founder Bruce Burkett, himself an HCV survivor who was cured after five different courses of treatment, creat-

Table. Comparison of Listed Pricing for Eight Common Lab Tests Test

PALS’ Price

Request-a-Test’s Price

$29

Comprehensive metabolic panel

$29

TSH

$10

$39

Triglycerides

$49

CBC

$29

HCV antibody testing

$30

$59

HAV total or IgM

$20

$59

HCV RNA PCR qualitative test

$100

$329

A Specialty Pharmacy’s Take

CBC, complete blood count; HbA1c, glycated hemoglobin; HAV, hepatitis A virus; HCV, hepatitis C virus; IgM, immunoglobulin M; PALS, Patient Assistance for Lab Services; PCR, polymerase chain reaction; TSH, thyroid-stimulating hormone

ed the Hep C Alliance in 1999, and since 2004, the alliance has offered free testing to anyone in Missouri, working through 78 of the state’s county health departments. “Whether you’re from that county or not, any resident of Missouri can walk into any one of those 78 health departments and get free HCV antibody testing,” Mr. Burkett said. In 2014, the Hep C Alliance provided testing to a total of 3,500 people in Missouri. The new PALS program can’t provide free testing, but its tests are still dramatically less expensive than elsewhere. “Outside of Missouri, PALS offers HCV antibody testing for $30, compared with between $49 and $159 depending on the lab,” Mr. Burkett said. HCV genotype testing costs $150 through PALS,

test done right away and this is not a ‘right away’ process,” Dr. Sagall stressed. “We’re hoping to find more ways to expedite the timeline and also to expand services to include even more tests.” Mr. Burkett said initial interest in PALS was modest but is starting to pick up, with a handful of phone calls now coming in every day. He said he hopes that more physicians’ offices and pharmacies become aware of what PALS has to offer their patients. The program, which is funded by grants and receives no government money, is “pretty self-sufficient,” he said. “We could expand significantly and do a lot more testing without any real problems.”

compared with around $500 to $600 elsewhere, he noted. To underscore the potential savings, Specialty Pharmacy Continuum compared PALS’ listed pricing for eight common lab tests with prices listed at Request-a-Test, an online direct-to-consumer lab testing service (Table). NeedyMeds is taking the lead in spreading the word about PALS, said Rich Sagall, MD, the organization’s president. “We have a big national presence and information on more than 14,000 clinics that care for the underserved, so we are trying to reach out to make this a big success, using our website, email communications, patient brochures and webinars.” However, “a lot of doctors want to get a

With so many treatments requiring regular lab tests for monitoring, patients are increasingly being hit with coinsurance costs for those labs, said Gary Rice, the senior vice president of clinical services, education and human resources at Diplomat. “There are increasing challenges with lab tests’ affordability. Just as with drugs, payors are cost-shifting cost associated with labs. In some cases, the manufacturer will support the cost of a companion lab test, as with Biogen’s natalizumab (Tysabri) and tests for progressive multifocal leukoencephalopathy. But if, for example, you have chronic myelogenous leukemia and you need quarterly labs, those tests are not supported by any manufacturer. Lab data will continue to be used more frequently for patient management purposes, and a program like this can help support those patients who have affordability challenges.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

HDMA Releases 2015 Specialty Distribution Report

n Dec. 3, the Healthcare Distribution Management Association’s (HDMA’s) Center for Healthcare Supply Chain Research published the latest edition of its annual benchmarking publication, “Specialty Pharmaceutical Distribution: Facts, Figures and Trends (2015 Edition).” Primary survey data were collected from HDMAmember specialty distributors, which manage 40% of the total U.S. specialty volume handled by distributors and reported sales of $1 billion or more in 2014. Among the report’s key findings: • Oncology again represented the highest percentage of sales volume for specialty distributors, at 46.3%— nearly triple the percentage for the next closest category, products categorized as “other” at 13.3%.

• Sales to independent physician-owned and -operated clinics increased to 70% (from 63% in 2013). Meanwhile, sales to hospitals (17%) and hospitalowned/-operated clinics (4%) decreased. • Distributor respondents report having contractual agreements with nearly 160 manufacturers; they also continue to provide a variety of support services to these companies, including supply chain services, patient and provider support, marketing, and financial and regulatory management, among others. “I am awestruck at the growth of oncology,” Karen J. Ribler, the executive vice president and chief operating officer of the Center for Healthcare Supply Chain Research, told Specialty Pharmacy Continuum. “It went from $65 billion in 2013 to a projected $100 billion in

2018, with a predicted 30% annual growth globally by 2020. In the United States, oncology is now holding 26% of the specialty market share.” The report also expanded its coverage of 340B, Ms. Ribler said. “A number of hospitals have been purchasing independent or community oncologists, fueled by the ‘340B advantage,’ so to speak. We’re going to keep our eye on this because 340B is just going to keep growing.” “Specialty Pharmaceutical Distribution: Facts, Figures and Trends” may be downloaded for $250 as a single-use PDF from E-junkie.com. Team and corporate-use licenses also are available. More information is available from the center’s website (www.healthcaredistribution.org/publications/2015-specialtypharmaceutical-distribution).

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Specialty Pharmacy Continuum • January/February 2016

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PAY VICTORY continued from page 1

costs of delivering those supplies, he pointed out. Moreover, in many cases, pharmacists and nurses must be on-call to monitor patients. There is one slight exception, noted Kendall Van Pool, the NHIA’s vice president of legislative affairs: Under the durable medical equipment (DME) benefit offered in Medicare Part B, the costs of infusion pumps, drugs and other supplies are covered for just under 30 infusion drugs. However, since most home infusion drugs are reimbursed under Part D and not Part B, the DME benefit only helps a fraction of home infusion patients. “Clearly, the way that home infusion is covered right now is very fractured,” Mr. Wilson said. “The appropriate way to do this is to bring it all together and make sure that it’s covered in a way that a Medicare beneficiary could work through the system, and make sure that all their home infusions are covered.”

The images above demonstrate some of the professional services, equipment and supplies used for home infusion preparation that are not currently reimbursed by Medicare, according to the National Home Infusion Association (NHIA). The NHIA posted the images as part of a slideshow made possible with the help of Johns Hopkins Home Care Group. Source: www.nhia.org/SlideShow/index.cfm.

‘Clearly, the way that home infusion is covered right now is very fractured.’ —Tyler Wilson

Infusion Confusion Most private and commercial insurers appreciate the distinction between the costs of services and supplies and those of drugs, and offer separate reimbursements for each, Mr. Wilson said. However, until recently, home infusion providers have not had much luck at making the distinction, and its significance, clear to legislators. This much is apparent from a report by the Office of the Inspector General of the U.S. Department of Health & Human Services that was released in 2013, and

reissued in 2015, pertaining to the DME benefit under Medicare Part B. The report stated that the Centers for Medicare & Medicaid Services could save tens of millions of dollars per year by basing reimbursements for home infusion drugs covered by the DME benefit on average sales prices (ASPs), rather than on average wholesale prices. “The problem is, if they do that and change that reimbursement structure, services will then go unreimbursed,” Mr. Van Pool said. “Right now the drug

reimbursement is basically picking up the services. “What we’ve always proposed, for years now,” he added, “is that if you’re going to change the reimbursements for Part B DME drugs, there has to be an acknowledgement via per diem payment for the services that are associated with those drugs.”

Reasons for Optimism Thus far, attempts to pass legislation in support of ASP pricing have

been unsuccessful. These attempts include two bills that were introduced to the House and Senate on Dec. 16 that contained the ASP pricing provision, S. 2409 and H.R. 4273, which were not acted upon. Following inaction on those two bills, another bill, S. 2425, was introduced on Dec. 18 by Sens. Rob Portman (R-Ohio) and Bob Casey (D-Pa.). This bill did not include the ASP pricing provision, and was passed into law on Dec. 28. “We are happy that the legislation did not include the ASP pricing provision,” Mr. Van Pool said. “We continue to urge Congress to not impose ASP pricing without consideration of the Medicare Home Infusion Site of Care Act of 2015. Through our efforts in December, we have called even more attention to the need to get the Medicare Home Infusion Site of Care Act

The Benefits of Home Infusion

y whatever metric is used—be it patient safety, quality of life or cost savings to the health care system—providing Medicare reimbursement for home infusion services simply makes good sense, according to Logan Davis, PharmD, a pharmacist with experience providing home infusion services and the director of Franchise Development at Vital Care Inc., a home infusion and specialty pharmacy company, in Meridian, Miss., that is on the board of the National Home Infusion Association. “With home infusion therapy, we can keep patients out of hospitals and nursing homes, and in a more cost-effective site of care, both for patients and for the health care system overall,” Dr. Davis said. He cited a report by Avalere Health, a health care consulting firm commissioned by the NHIA, which found that providing reimbursements for home infusion services under an NHIA-proposed framework would save Medicare nearly $80 million over 10 years. This figure is based on a comparison of current Medicare expenditures on infusion services across the available sites of care—hospital outpatient departments (HOPD), physicians’ offices, HOPD together with physicians’ offices and skilled nursing facilities—with calculated expenditures after the migration of a certain percentage of patients from each setting to the

home site of care. Specifically, the report anticipates that 50%, 10%, 20% and 23% of patients in each of these treatment settings, respectively, will migrate to home infusion therapy. Dr. Davis noted that the Avalere figure is likely to be a conservative estimate, because it includes only anti-infective drugs, which account for a fraction of all home infusion medications. Supporting these findings, another study, published in Pharmaceutical Commerce in 2009 (http://goo.gl/v7pgvf), cited the cost of infusion in the hospital setting as $1,500 to $2,500 per day, versus $150 to $200 per day at the home site of care. By moving more patients to home infusions, “we’d be able to reduce ER visits and hospital readmissions, and reduce patients’ length of stay in the hospital,” Dr. Davis said. Besides providing a cost benefit, that strategy also would protect patients against the risk for hospital-acquired infections. A 2009 report estimated that hospital-acquired infections cost the health care system anywhere between $28 and $45 billion per year, according to a 2009 report from the Centers for

Disease Control and Prevention (http://goo.gl/ nQwNrO). For elderly patients, the stakes are potentially even higher. As it stands now, Dr. Davis explained, the lack of reimbursement for home infusion services forces many patients to go to nursing homes for their care—a situation he called “an injustice to our seniors.” In many cases, he explained, “we don’t know what a patient’s situation is: They may have jobs to get back to, families to take care of,” all of which can be disrupted by an unplanned or unanticipated move to a longterm care facility. “The benefit of covering these services at home is that it opens up doors to our seniors that have been closed for such a long time,” Dr. Davis stressed. “In my mind, getting the math right is why this legislation hasn’t been passed in previous attempts,” he added. “With Medicare trying in other areas to move patients out of the hospital, I think this flows with a lot of other reforms we’re seeing. I think the time is right.” —A.R.

Specialty Pharmacy Continuum • January/February 2016

POLICY

of 2015 legislation passed.” Indeed, Mr. Van Pool added, “W We’re feeling quite positive with the appro oach we’re getting from Sens. Isaksson (R-Ga.) and Warner (D-Va.), an nd Reps. Engel (D-N.Y.) and Tiberi (R-Ohio). There’s an opportunity here to really get something done, and we feel that this larger solution really has some legs.”

The Road Ahead More good news for home infusion patients and providers came on o Dec. 18, with the passage of the fiscal year 2016 Omnibus Appropriattions bill, which did not include the ASP pricing provision. However, the staketake holders in this ongoing struggle “must remain vigilant,” emphasized Wayne Grau, the vice president of legislative affairs for Managed Health Care Associates (MHA) Inc., which has been working closely with the NHIA to assist with grassroots efforts to educate legislators on this issue. “Whenever a bill costs money, Congress has to determine a way to pay for it,” Mr. Grau said. “This money [the reported savings from the ASP pricing provision] is out there, so someone’s going to try to use it for something else.”

‘It’s not that Congress doesn’t care; it’s that Congress doesn’t know about home infusion.’ —Wayne Grau

Echoing comments made by Mr. Van Pool, Mr. Grau said the goal of MHA and the other stakeholders in this issue is to ensure that, when the ASP pricing is raised, it becomes part of the larger dis-

cussion about reimbursing home infusion providers for supplies and services. To that end, Mr. Grau said the Medicare Home Infusion Site of Care Act of 2015 is the best available solution

to this problem. At the moment, he noted, the bill is being reviewed by the Subcommittee on Health in both the House and the Senate, which reports to the Energy and Commerce and Ways and Means Committees in the House, as well as the Finance Committee in the Senate. Once the bill is voted on by each of these subcommittees, they will undergo a process of review by the larger committees; and then, once the Senate and the House vote on their individual bills to create a congruous version of the bills, the act will be ready to be signed or vetoed by the president, Mr. Grau explained. The most important thing for stakeholders to keep in mind, he added, is that legislators want to hear from them. “It’s not that Congress doesn’t care; it’s that Congress doesn’t know about home infusion,” he said. “They want to understand these issues. If we want them to understand the negative consequences, or even the positive consequences, of a piece of legislation, we have to reach out to them.” —Ajai Raj None of the sources reported any relevant ﬁnancial relationships beyond their stated places of business.

achc.org

ACCREDITATION IN YOUR FIELD SPECIALTY PHARMACY

ACHC offers a range of pharmacy compliance solutions that facilitate the highest level of patient safety through robust quality standards. ACHC Pharmacy accreditation includes: Comprehensive Offerings—Specialty, Community Retail, Long Term Care, Infusion, PCAB Compounding, and DMEPOS Broad Program Acceptance—Most US Third-Party Payors and Medicare in all 50 States Industry-Specific Surveyors—All pharmacy surveys are conducted by a licensed pharmacist

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Specialty Pharmacy Continuum • January/February 2016

POLICY

MAC PRICES

Generic Reimbursed Drugs Using MAC Pricinga 25

continued from page 1

$22.33 $20.58

Cost, $

Dr. Warnock and his team considered—and eliminated—the usual suspects: increasing costs of labor, goods, packaging or operations. They assumed it must be a problem with inventory; perhaps inventory managers weren’t buying correctly. “But as we got deeper in, we realized it was something we hadn’t seen before.” The team finally was able to identify the culprit when they began looking at their Medicare Part D billing. They found that the drug costs specified by the Centers for Medicare & Medicaid Services (CMS) “was not what our drug costs actually were,” Dr. Warnock said. “The MAC [Maximum Allowable Cost] prices were off dramatically for extended periods of time. We found a pattern: Generic drug prices would go up, but the MACs would not reflect that. It got to the point where every time we dispensed a generic drug, we were losing money, and the spreads kept getting larger.”

$23.23

$21.88

10 5 $1.30 0 $(0.90) –5

Q3, 2013

Q4, 2013

Q1, 2014

Total Revenueb (Per Rx)

Q3, 2014

Total Costc (Per Rx)

Q4, 2014

Q1, 2015

Margin

Average total revenue, total cost, and margin for all generic drugs reimbursed using MAC pricing, all Medicare Part D payors, 30-day supply, 2013-2015. b

Total revenue includes reimbursement for ingredient costs plus dispensing fees, but does not include manufacturer rebates (if any).

Total cost is cost of goods sold plus cost to dispense. This analysis uses a fixed $13.54 for cost to dispense. The value is the median cost to dispense a 30-day supply of a prescription as determined by researchers at Virginia Commonwealth University and Midwestern University. Source: J Manag Care Spec Pharm 2014;20(3):291-320. Source: Avalere report: MAC Pricing Analysis, Prepared for the Senior Care Pharmacy Coalition. http://goo.gl/vhND4U. MAC, Maximum Allowable Cost

March 2015—found that MAC prices paid for the same generic drug on the same day by different payors can vary considerably. Generic drugs reimbursed using MAC pricing now have negative margins,

‘It got to the point where every time we dispensed a generic drug, we were losing money, and the spreads kept getting larger.’ —Robert Warnock, PharmD As an increasing proportion of Pruitt’s prescriptions moved to generic, the situation became a “perfect storm” of getting paid less and less, more and more frequently. It turned out that Pruitt wasn’t alone. An Avalere analysis released in November, based on data from 18 LTC pharmacies— including some 21.4 million individual drug transactions from January 2012 to

Q2, 2014

the analysis concluded, because revenue has remained flat even as total cost has increased. Sometime around the first quarter of 2014, the analysis found, the curves crossed: Average total revenue for all generic drugs reimbursed using MAC pricing dipped below the average total cost, and stayed there. By the first quarter of 2015, average total revenue per drug was $22.33, vs. an average total cost—cost

of goods plus a fixed $13.54 for cost to dispense—of $23.23, for a negative margin of 90 cents per 30-day prescription (Figure). CMS has established additional MAC transparency requirements, effective Jan. 1. The new standards require pharmacy benefits managers (PBMs) to update MAC prices on a frequent basis in the Medicare Part D program—although other federal health care programs, such as Tricare, are not included. However, a coalition of LTC pharmacies called the Senior Care Pharmacy Coalition (SCPC), which sponsored the Avalere study, thinks the CMS measure will not be enough. “These new requirements do not go far enough to ensure that independent LTC pharmacies know what they’ll be paid, and the market-based reasons for pricing changes,” Alan Rosenbloom, the president and CEO of SCPC, told Specialty Pharmacy Continuum. The problem, he noted, is that transparency in and of itself might be insufficient to create a fair negotiating playing field between independent

LTC pharmacies and PBMs, because it does not necessarily lead to any actual change in pricing policies or practices. Long-term care pharmacies are not alone in dealing with MAC pricing challenges, but Mr. Rosenbloom said they face unique additional burdens that community-based pharmacies do not. “Additional regulatory requirements in these settings mean that packaging must be in a unit dose and individual to the patient, in a way that can be easily dispensed. The average nursing home patient takes seven or eight prescriptions in any given day, and 11 or 12 over the course of a month. The amount of medication and management requirements, and consultative clinical services, make the cost to dispense significantly higher than in the retail setting—about 30% to 35%.” Plus, LTC pharmacies don’t have the same offsets as community retail pharmacies. “For the most part, they have no other real sources of revenue—no sales of convenience items directly to consumers, for example,” Mr. Rosenbloom said. “MAC pricing variability, unpredictability and apparent disconnect from true market conditions make the situation even worse for independent LTC pharmacies.” Long-term care pharmacies aren’t opposed to MAC pricing, Dr. Warnock said. “We understand why MAC pricing is important. It makes us better and more conscientious purchasers. We’re not after a competitive advantage; we just want fairness. A universal MAC would be fine with us; a fair and open process for determining MAC would be fine with us; even understandingg the process would be fine with us. We’re fine with competing, but just let us compete.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

Drug Pricing Remains an Inexact Science Oncology drug manufacturers make a host of complex calculations when pricing new medications. Clinical indications at the time of FDA approval, changing definitions of cancers and discounts to stakeholders are among the many variables that have to be factored into the pricing equation, an industry expert said during the Association of Community Cancer Centers’ (ACCC) recent annual meeting. Drug costs have been criticized for well over a century, said Alex Bastian, MBA, a vice president for GfK Custom Research, in San Francisco, who specializes in pricing and evaluation of new drugs and technologies. But manufacturers do feel an ethical and professional responsibility when pricing drugs, and they conduct extensive research

to understand the effect that price will have on patients, insurers, clinicians and other stakeholders, he said. Given those efforts, Mr. Bastian cautioned against putting too much weight on media reports of selected cancer drugs launching at sky-high prices. Spending on cancer medications as a percentage of total health care spending, he noted,

by the

numbers Pricing trend: Cancer drug approvals based on the FDA’s Breakthrough Designation category are on the rise, raising questions about the optimal approach to pricing such agents.

Other 21.9% Cancer 43.8%

Rare inherited disorders 12.3% Infectious disease 17.8%

Designations announced by sponsors. Source: Friends of Cancer Research; www.focr.org/ breakthrough-therapies.

Cardiovascular 4.1%

Breakthrough Designation by therapeutic categorya

Specialty Pharmacy Continuum • January/February 2016

POLICY

tells a different story: It has remained constant—about 5% of total health care costs—over the past half-century, Mr. Bastian said, citing data from the National Institutes of Health ((NCI Cancer Trends Progress Report, 2011-2012; http://progressreport.cancer.gov). That spending trend can be explained, in part, by the way cancer drugs are priced at launch. The system, he noted, is not set up to reward value as the clinical data on cancer drugs evolve. For example, when gemcitabine was launched in 1997, it was FDA approved only for pancreatic cancer, and the data showed it produced a 1.1-month improvement in overall survival compared with fluorouracil ((J Clin Oncol 1997;15[6]:2403-2413). After a few years in the marketplace, gemcitabine demonstrated efficacy in lung cancer, and several years later, in breast cancer. By 2013, gemcitabine was found to increase five-year survival rate in pancreatic cancer by 10.3% as adjuvant post-surgery therapy. “It took almost 16 years to realize the full [clinical] value of this drug,” Mr. Bastian said. Yet during that time, although wholesale acquisition cost per unit rose from $55 in 1997 to $148 in 2010, the Medicare average sales price per unit actually dropped from $115 in 2005 to $8 in 2015.

Defense, Department of Veterans Affairs, Medicaid and particularly 340B participants. “You can have discounts of anywhere from 20% to 50% or 60% off the visible public drug price,” he said. In addition, site of care plays a role, with drug costs higher when treatment is given in an inpatient setting. Going forward, he noted, innovative pricing strategies, such as performance-based agreements or indication-based pricing models, have the potential to reduce costs to payors or health systems while providing access

to patients most likely to benefit. Other factors that could affect pricing include new oncology payment models under consideration by payors, such as bundled payments and shared savings programs, and new care delivery models such as accountable care organizations and patient-centered medical homes. Copay assistance for patients taking oncology drugs “is still a big deal,” and providers spend a lot of time on the issue, said Ernest R. Anderson Jr., MS, RPh, a past president of the ACCC, who attended the meeting. More patients are getting

insurance through the Affordable Care Act, but the selected coverage is often “bare bones; it’s still a dilemma.” —Karen Blum Mr. Bastian has worked with or provided professional consulting services to AbbVie, Alder Pharmaceuticals, Amgen, Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eisai, Eli Lilly, Genomic Health, Gilead, GlaxoSmithKline, Lundbeck, Milestone Pharmaceuticals, Novartis, Pﬁzer, Roche/Genentech, Teikoku and Ventana Medical Systems. Mr. Anderson reported no relevant ﬁnancial relationships.

Breakthrough Therapies Immature clinical data are a reality in cancer therapeutics, he said. To enable innovative drugs with such limited data to enter the market, the FDA created the Breakthrough Therapy category. As of May 29, 2015, the agency has given 24 approvals to drugs designated as Breakthrough Therapies. Nearly 44% of all the Breakthrough Designations granted by the FDA were in the cancer drug class, the report noted (Figure). This brings challenges when trying to price drugs based on limited data sets, Mr. Bastian said, adding, “We’re going to have to ask ourselves as a society, is a Phase II trial that looks at overall response rate really going to demonstrate [adequate] value?” Moreover, cancers have been parsed more finely and indications have become more precise, creating smaller, more targeted patient pools, he noted. In such cases, relatively high prices need to be set for manufacturers to recoup research and development costs, let alone make a profit.

Multiple Stakeholders Manufacturers also consider competitors’ prices, payors’ willingness to cover the medications, physicians’ willingness to prescribe the medications and patients’ willingness to pay out of pocket, he said. And payors have their own set of considerations to juggle when determining pricing and reimbursement, Mr. Bastian noted. For example, they have to include significant discounts to selected stakeholders, including the Department of

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Specialty Pharmacy Continuum • January/February 2016

OPERATIONS & MANAGEMENT

What Do Health Plans, Employers Want? If you’re trying to make your specialty pharmacy attractive to health plans that are assembling their in-network coverage, and to employers who are working with those health plans, at the top of your to-do list should be figuring out what those groups want from their specialty pharmacy partnerships. It should come as no surprise that their leading selection criteria are financial, said Angie Baughman, the senior director of pharmacy contracting and sales at Blue Cross and Blue Shield (BCBS) of South Carolina. “Dollars do matter,” Ms. Baughman said. “Health plans are looking for competitive discounts, utilization manage-

plan are also essential. “We sell customers on the fact that we provide a holistic approach to health care management. So it’s critical that the case manager at the pharmacy has regular interaction with my case managers.” Many health plans are now looking for specialty pharmacies that can work with them on strategic opportunities

‘We sell customers on the fact that we provide a holistic approach to health care management.’ —Angie Baughman

ment, product preferencing, rebates and price protection terms, so that if costs increase over time, the value of those rebates isn’t negated—because employers’ No. 1 question for those health plans is ‘how are you going to help me forecast how these new specialty drugs are going to impact my bottom line?’” But financial matters aren’t the final word, Ms. Baughman stressed. Equally important or nearly so, she said, are “all the things that bring the [specialty pharmacy] experience to life.” Those include operations: fulfillment, access and service; formulary and rebate management; and medical management and clinical programs. Health plans are looking for specialty pharmacies that have a sophisticated operations infrastructure that gives the prescriber and patient a seamless experience. “The last thing I want is for an employer to call me because one of their members called and said, ‘I can’t get my drug,’” Ms. Baughman pointed out. “I need to know that the specialty pharmacy I’ve partnered with has a state-of-the-art system for monitoring the life of the prescription, and gives members access to a wide range of products and convenient delivery options. I’m all about the member’s experience and my specialty pharmacy needs to be, too.” When it comes to medical management, Ms. Baughman said health plans want specialty pharmacy partners with the expertise and willingness to put together sets of criteria that are available on day 1 of a patient’s therapy. Open lines of communication between the specialty pharmacy and the health

for managing the specialty spend under the medical benefit. That, said Ms. Baughman, was one of the primary reasons that BCBS

leader for the National Employer Initiative on Biologics & Specialty Pharmacy through the MBGH. “But 96% either agree or strongly agree that they are concerned about the increasing costs of specialty drugs,” he said. Dr. Vogenberg pointed out that nearly half of all employers in the survey—48%—offer incentives to their employees for the use of specialty pharmacy, a strategy they say is effective. “Employers are trying to encourage the use of specialty pharmacies, and that wasn’t always the case,” he said. “This is a good thing. They’re placing high value on services, and on case management and care management.” Employers are focusing on a wide variety of cost management and patient outcome strategies, Dr. Vogenberg noted. They include alternative risk financing and actuarial design, restricted coverage under the medical benefit, exclusive or limited networks by setting of care, site-of-care opti-

say that new and innovative solutions are needed to manage specialty. For example, if we’re [assuming] risk as an employer plan sponsor, we want to see knowledgeable approaches to chronic disease management, particularly with the implementation of care pathways and guidelines that incorporate the use of specialty drugs.” Specialty pharmacies must plan ahead and anticipate some of the changes in care delivery that will be happening two or three years down the road. “Decisions about 2017 to 2018 networks and partnerships will be made starting by January 2016, so the time is now to think about where we’re going to be in a couple of years,” Dr. Vogenberg said. He pointed to one of the fastestgrowing trends: More and more major employers are putting in place on-site health clinics with closed networks. In a 2015 survey of major U.S. employers by Towers Watson, a professional services company, 105 of 137 employers offered employer-sponsored health centers, and another 15 are planning to add them by 2018. Half of those centers now offer some type of pharmacy services, a big jump from 38% in 2012. “Pharmacy services interest employers because they offer convenient access to prescription drugs for employees, encourage medication compliance, and help decrease overall medical and pharmacy spend,” said Allan Khoury, MD, PhD, a senior consultant at Towers Wat-

‘Employers are trying to encourage the use of specialty pharmacies, and that wasn’t always the case.’ of South Carolina returned to CVS Caremark as its specialty pharmacy partner as of Jan. 1, 2016, after three years with a different provider. With its acquisition of Novologix in 2014, CVS Caremark boasts that it now has “unmatched claims editing technology” that allows health plans to manage drugs paid under their medical benefit with the same level of precision that is expected for pharmacy benefit managers. On the employer side, there is strong agreement on the importance of specialty drugs: 82% of respondents to the 2015 Midwest Business Group on Health (MBGH) survey on specialty drugs called them either “valuable” or “highly valuable” in significantly improving chronic or life-threatening disease outcomes, noted managed care consultant Randy Vogenberg, PhD, RPh, a principal of the Institute for Integrated Healthcare in Greenville, S.C., and co-project

—Randy Vogenberg, PhD, RPh

mization strategies that steer patients to lower-cost options and day’s supply/ limitations messaging.

Using Data for Innovation Forecasting and innovation using actionable data are important to both health plans and the employers who contract with them, Dr. Vogenberg added. “Right now, employers are the largest purchasers of health care,” he pointed out. “They’ll be overtaken by the Centers for Medicare & Medicaid Services [CMS] within the next 10 years, but if you’re looking for real short-term innovation opportunities, that’s not going to happen at CMS. On the other hand, there is a lot of opportunity for innovative specialty pharmacies to partner with employers—90%

son, in a statement when the survey was released in May 2015. “The distribution of specialty drugs is evolving, and specialty pharmacies need to keep up and think more long term about how they fit into the rapidchanging marketplace,” Dr. Vogenberg said. “As hockey legend Wayne Gretzky said, ‘You have to focus on where the puck is going, not where it is right now.’” —Gina Shaw Dr. Vogenberg reported that he is a consultant to the National Employer Initiative on Biologics & Specialty Pharmacy managed by the Midwest Business Group on Health. This article is based in part on coverage of the 2015 National Association of Specialty Pharmacy’s Annual Meeting & Expo, in National Harbor, Md.

Specialty Pharmacy Continuum • January/February 2016

OPERATIONS & MANAGEMENT

The Push for Credentialed/Privileged Pharmacists Chicago—Specialty pharmacies often define themselves based, in part, on the patient care skills of their pharmacist providers. Now, there is a move afoot to qualify those skills via a standardized credentialing and privileging process that could also expand the scope of practice for the profession. The current push to broaden the pharmacists’ role is driven in part by pending federal legislation and recent papers from leading pharmacy groups, each emphasizing the potential benefits for both providers and patients. But there’s still a long way to go, experts say. “The pharmacy profession and many organizations are in the early steps in this process,” said Joel A. Hennenfent, PharmD, MBA, BCPS, FASHP, the system director of pharmacy services for Truman Medical Centers, in Kansas City,

Fargo, who was not involved in the presentation, underscored the importance of this move. “Provider status gives us more ability, and more visibility,” Dr. Miller said. Privileging pharmacists was a key component of the Practice Advancement Initiative (formerly known as the Pharmacy Practice Model Initiative) released in 2011 by the ASHP ((Am J Health Syst Pharm 2011;68[12]:11481152). The initiative has since prompted many organizations to “move for-

“We have a major shortage in physicians—especially for internal medicine and family practitioners—which means many patients aren’t able to be seen,” Dr. Hennenfent said. “If pharmacists obtain provider status, they can improve access to health care for patients.” Many states and organizations around the country aren’t waiting on passage of a federal bill to move forward on their own. Dr. Hennenfent highlighted examples such as the Department of Veterans Affairs (VA) Health System, where pharmacists can see patients in the clinic just as would a physician or nurse practitioner. The VA began the process back in the 1980s.

‘Pharmacists are gradually proving themselves as essential health care providers, and the momentum for recognition is continually increasing.’ —Donald Miller, PharmD, FASHP Mo. Dr. Hennenfent and his colleague, Todd Nesbit, PharmD, MBA, the director of pharmacy patient care services for Johns Hopkins Health System, in Baltimore, presented implementation essentials to some 300 pharmacist leaders in attendance at the recent American Society of Health-System Pharmacists (ASHP) Conference for Pharmacy Leaders, most of whom had just begun to explore how to open these doors for pharmacists in their own organizations. Credentialing, as they explained, refers to the process of obtaining, verifying and assessing the qualifications— from licenses to board certifications—of an applicant requesting privileges to do specific tasks in an organization. Such privileges for a pharmacist might include the ability to order laboratory tests, adjust or discontinue medications, or complete point-of-care testing. “Once credentialed and privileged by the medical staff, a practitioner can perform the requested privileges and patient care roles independently,” Dr. Hennenfent said. “This is a significant change,” he added. “The need for credentialing and privileging will be even more important as the pharmacy profession continues to pursue provider status including payment for patient care services.” Donald Miller, PharmD, FASHP, a professor in the School of Pharmacy at North Dakota State University, in

ward” with credentialing and privileging, according to Dr. Hennenfent.

Medicare Part B Payments Pending federal legislation also is helping the effort to extend pharmacists’ contributions past typical medication management duties. More specifically, if passed, the House and Senate proposals would amend the Social Security Act to make pharmacists eligible for payments under Medicare Part B, Dr. Miller explained. “The federal bill will put pharmacists on an equal footing in federal law with other medical providers,” he said. Of course, it remains unclear which way Congress will go, especially since passage would increase federal spending, Dr. Miller added. “But we’re getting closer all the time,” he said. “Pharmacists are gradually proving themselves as essential health care providers, and the momentum for recognition is continually increasing.” As of mid-January 2016, H.R. 592 has 262 bipartisan co-sponsors and S. 314 has 40. In addition to creating opportunities for pharmacists to be physician extenders, and to bill for services, Dr. Hennenfent noted that the legislation could justify additional pharmacists in the ambulatory care setting to fill an urgent provider gap.

Billing for Services What all these changes mean for individual pharmacists also could vary greatly, experts noted. “For some it will validate what they are already doing, solidify their role and allow them to bill for their services,” said Dorothy McCoy, PharmD, a clinical associate professor at the Ernest Mario School of Pharmacy, in Piscataway, N.J., and clinical infectious diseases pharmacist at Hackensack University Medical Center. “For others, it may be the push that is needed to move their practice into the future and allow them to do even more for their patients.” She pointed to antibiotic stewardship as a case in point. “These are programs set up to maximize the use of antibiotics while minimizing the risks associated with their use,” Dr. McCoy said. “They benefit the patients, as there is an additional layer of scrutiny over their antibiotic regimens in terms of appropriate indication, dose and duration of therapy. “Medication regimens are becoming more complex, and navigating through the multiple choices that exist for different disease states is also becoming more challenging,” she added. “This is where pharmacists can make a huge impact for the patient as well as for the health care systems.” For pharmacy leaders looking to help their team have an effect via credentialing and privileging, Dr. Hennenfent pointed to a 2014 resource

‘[Credentialling and privileging] may be the push that is needed to move [pharmacists’] practice into the future and allow them to do even more for their patients.’ —Dorothy McCoy, PharmD “There are others around the country that are also headed down that path,” he added, pointing to more leaders such as Johns Hopkins University, The Ohio State University and Kaiser Permanente. “All are at different levels of completing that process but have multiple pharmacists privileged by their medical staff.” In his own organization, Truman Medical Centers, pharmacists are recognized as providers and privileged by the medical staff, said Dr. Hennenfent. He also noted significant state-by-state variability. California and Wisconsin, for example, already have granted pharmacists provider status.

paper from the Council on Credentialing in Pharmacy ((Am J Health Syst Pharm 2014;71[21]:1891-1900), as well as an ASHP clinical resource center on the topic, as good starting points: www.ashp.org/menu/PracticePolicy/ ResourceCenters/Clinical-Specialistsand-Scientists/Credentialing. He added some advice: “Start now.” “It can take six months to a year to get things going,” he said, “and two to three years to get things in a real usable format.” —Lynne Peeples The sources reported no relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • January/February 2016

OPERATIONS & MANAGEMENT

Hospitals Break Through the LDN Class Ceiling In July 2014, only 15% of U.S. health-system pharmacies operated at least one in-house specialty pharmacy, according to industry estimates. A little over a year later, there are no updated figures, but “every health system in the United States either already has a specialty pharmacy or is working on developing one,” according to Fairview Pharmacy Services’ Tim Affeldt. But not all hospitals will take the same approach to building their specialty pharmacy services. Indeed, there are several models of hospital-based specialty pharmacies currently in play.

The Academic Vanderbilt University Hospital & Clinics initiated its specialty pharmacy operation in 2012. Prior to that time, although Vanderbilt had four retail pharmacies on its campus, they were not contracted to fill prescriptions for specialty medications. “Most of our specialty drug prescriptions were going outside the facility,” said Jim Hayman, MS, MBA, FASHP, Vanderbilt’s chief pharmacy officer. “This felt like a significant opportunity to capture revenue and enhance continuity of care.” In 2013, Vanderbilt launched a small demonstration specialty pharmacy project, serving only medical center employees and two pilot clinics, using existing space. In 2014, the initiative expanded to a seven-clinic pilot with central support hub and decentralized clinic staff. By fiscal year 2015, specialty pharmacy at Vanderbilt was serving eight different specialty clinics, Mr. Hayman noted. The financial impact of those efforts are evident in Vanderbilt’s financial report for 2015 (http://goo.gl/Idn1qa). According to the report, the university experienced a $203 million, or 7.8%, increase in healthcare services revenue in fiscal year (FY) 2015 versus 2014, “due largely to increases in hospital acuity, realization rate and increases in retail, specialty and contract managed pharmacy revenue.” And the scope of Vanderbilt’s specialty pharmacy service continues to grow. For FY2016, Mr. Hayman said, the service will have 80-plus full-time employees, with 30 of those directly embedded in clinics, and a large off-campus support services facility housing the hub and back office operation. The pharmacy serves about 11,000 specialty patients and about 3,000 transplant patients, and has a mail-order facility shipping medications to 15 states, with more to come. Vanderbilt has begun to merge its clinic appointment system with the medication system, to coordinate information about which patients will be in clinic on which days and what medications they’re taking. That move has enabled the specialty pharmacy to capture about 98% of new patients; of pre-existing specialty

patients, about 60% have been converted to the in-house specialty pharmacy. “We now have access to 90% of limit-

70 community retail pharmacies. Like Vanderbilt, it made its first foray into specialty in 2013, serving predominantly Aurora’s own patients. By 2015, it was filling approximately 30,000 specialty prescriptions per year and generating $100 million in revenue. (Both the retail and specialty pharmacies are for-profit subsidiaries of the nonprofit organization.) Aurora’s specialty pharmacy primarily focuses on the disease states most com-

‘We’re not looking to take on the world. We just want to provide the best possible care for our patients.’ —Tom Woller, MS

‘We now have access to 90% of limited-distribution drugs.’ —Jim Hayman, MS, MBA, FASHP

ed-distribution drugs,” Mr. Hayman said. “But there are a few poster-child drugs we haven’t been able to get yet.” He said hospitals with specialty pharmacies should pick their battles when it comes to these drugs. “Frankly, some of them aren’t worth the effort to acquire distribute [rights]. Look at where you have a strong physician base, bring them into the dialogue and have a compelling story to tell. We have very little leverage against big payors, so we just try to make the case for better care: If we’re managing everything for our patients here and they have to go outside of coordinated care for just one thing, that’s not good for them.”

The Wisconsin Nonprofit Aurora Health Care is a nonprofit heath system operating 15 hospitals and 185 clinics in eastern Wisconsin. Unlike Vanderbilt, before expanding into specialty pharmacy it already had a large retail pharmacy footprint, with more than

monly seen at its facilities: cancer, neurologic conditions, HIV/AIDS, hepatitis C, autoimmune diseases, inflammatory conditions, osteoporosis and transplant. “We’re not looking to take on the world,” said Tom Woller, MS, Aurora’s senior vice president of pharmacy services. “We just want to provide the best possible care for our patients.” Despite Aurora’s extensive experience in retail pharmacy, it found that major changes were needed when moving into specialty. “Fulfillment is different,” Mr. Woller said. “We already had mail order in place, but we needed all the cold chain shipping and additional monitoring. We needed additional staff and space and an IT [information technology] platform. On the clinical side, we needed to add expertise and full-time employees in order to ensure that we are hitting outcomes.” Investing in specialty has forced the often glacial decision-making process of

a large hospital system to become more nimble. “Big health systems like ours are not used to making [quick] decisions. They study for two years, think for awhile and then maybe budget for something,” he said. “You can’t do that in this space. I told our executive team that we need to be able to post a position today, hire in two weeks and have them operating in six. We’re not going to get to $300 million in revenue if we don’t behave in that way.”

The Network Premier Inc. is a national health care performance improvement alliance of 3,600 U.S. hospitals and 120,000 other providers. It’s best known as a group purchasing organization, but chief pharmacy officer Gaurang Gandhi, PharmD, said it does much more than that, providing integrated pharmacy solutions for its members for more than a decade. About five years ago, Premier took a giant step into specialty when it acquired Commcare, a Florida-based specialty pharmacy. Premier’s Commcare specialty pharmacy and care management program are now fully integrated into Premier’s pharmacy benefits manager, which focuses on benefit design, formulary management, specialty medication management, pharmacy provider networks, utilization management and optimizing the use of in-house pharmacies. “Commcare was already successful, but since the acquisition, our major focus has been on information technology, call center analytics and data,” Dr. Gandhi said. “We [can] reach out to about 100,000 pharmacists, but with a scale that big, to leverage education to them, we must focus on IT.” Interoperability in dispensing systems and case management systems is a high priority for Premier’s member health systems, he added, in order to avoid doing almost double the work. Indeed, all three organizations are placing a premium on technology. Mr. Hayman said informatics is the biggest challenge and the top priority for Vanderbilt. “We feel like the toolset we need is not there yet, and we’re working very hard to build a new platform.” Specialty pharmacy requires a level of passion for patients that Mr. Woller said is a natural fit for a hospital or health system. “We take it seriously—our ability to provide an entire suite of services for our patients—because especially with the advent of new payment models, we are responsible for their outcomes.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships. The article is based in part on a session at the 2015 National Association of Specialty Pharmacy Annual Meeting & Expo, in National Harbor, Md.

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