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on the table?
Knowing the rules empowers future decision making
Outpatient Payments in 2022: What’s on the Table
The payment calendar year (CY) for the outpatient setting is almost upon us. It begins Jan. 1, 2022, and encompasses all that we do in the outpatient and ambulatory surgery arenas, as well as setting payments covered by the physician fee schedule. These rules from the Centers for Medicare & Medicaid Services (CMS) reflect the agency’s payment philosophies, and they also take into consideration other programs or mandates that have been set, sometimes by external agencies. Although it might seem arduous to read through the explanations substantiating the decisions that CMS has reached, this background information can guide you through the decisions that your facility will be making going forward.
Common themes for 2022 include an emphasis on health equity and patient access, with the goal of creating a health care system that results in better accessibility, quality, affordability, empowerment and innovation. The approach of CMS to outpatient reimbursement also touches on multiple facets of health care, from requirements for price transparency to
“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered. Bonnie Kirschenbaum, MS, FASHP, FCSHP
SMOFLIPID (lipid injectable emulsion), for intravenous use BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR HEALTHCARE PROVIDERS
This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, including Boxed Warning for SMOFlipid (lipid injectable emulsion), for intravenous use at www.FreseniusKabiNutrition.com.
WARNING: DEATH IN PRETERM INFANTS
• Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature. • Autopsy findings included intravascular fat accumulation in the lungs. • Preterm infants and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
INDICATIONS AND USAGE
SMOFlipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of Use The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
DOSAGE AND ADMINISTRATION
The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion. Prior to administration, transfer to a separate PN container.
CONTRAINDICATIONS
Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients. Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 1,000 mg/dL.
WARNINGS AND PRECAUTIONS
• Death in Preterm Infants: (see BLACK BOX WARNING) • Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut oil. Signs or symptoms of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, or chills. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and undertake appropriate treatment and supportive measures. • Risk of Catheter-Related Infections: Lipid emulsions, such as SMOFlipid, can support microbial growth and is an independent risk factor for the development of catheter-related bloodstream infections. The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions or drugs. • Fat Overload Syndrome: This is a rare condition that has been reported with intravenous lipid emulsions. A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in a syndrome characterized by a sudden deterioration in the patient’s condition including fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, fatty liver infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). • Refeeding Syndrome: Reintroducing calories and protein to severely undernourished patients with PN may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. • Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum.
During prolonged PN administration in patients with renal impairment, the aluminum levels in the patient may reach toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral intakes of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of PN products. • Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD has been reported in patients who receive PN for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. Intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development of PNALD, although a causal relationship has not been established. If SMOFlipid-treated patients develop liver test abnormalities, consider discontinuation or dose reduction. • Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome. • Monitoring/Laboratory Tests: Routinely monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment.
Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. • Interference with Laboratory Tests: Content of vitamin K may counteract anticoagulant activity. The lipids contained in this emulsion may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream.
ADVERSE REACTIONS
Most common adverse drug reactions >1% of patients who received SMOFlipid from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia and device-related infection. Less common adverse reactions in 1% of patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis. The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Infections and Infestations: infection. Respiratory, Thoracic and Mediastinal Disorders: dyspnea.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters.
USE IN SPECIFIC POPULATIONS
• Pregnancy and Lactation: There are no available data on risks associated with
SMOFlipid when used in pregnant or lactating women. • Pediatric Use: The safety and effectiveness of SMOFlipid have not been established in pediatric patients. • Hepatic Impairment: Parenteral nutrition should be used with caution in patients with hepatic impairment. Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive PN, including cholestasis, hepatic steatosis, fibrosis and cirrhosis (PN associated liver disease), possibly leading to hepatic failure.
OVERDOSE
In the event of an overdose, fat overload syndrome may occur. Stop the SMOFlipid infusion until triglyceride levels have normalized. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from serum.
REFERENCE: 1. Deckelbaum RJ, et al. Biochemistry (Mosc). 1990;29(5):1136-1142. increased reimbursement rates for ambulatory surgery centers (ASCs) and a variety of efforts toward patient safety.
A Practical Example
A prevailing theme for the past few years, and again in CY 2022, is to continue to give beneficiaries more affordable choices on where to obtain care and potentially reduce out-of-pocket expenses. Although there had been pushback from hospitals and a reluctance to embrace site-of-care changes for a variety of reasons, the need to provide care in nonhospital settings during the pandemic showed that change indeed was possible.
Beginning in 2020 and continuing forward, there has been a move to shrink the inpatient-only list with some procedures now eligible for Medicare payment both in inpatient and outpatient settings as well as at ASCs. This change began with total hip arthroplasty, six spinal procedure and five anesthesia codes, grew rapidly in 2021, and has been retracted to a much smaller list for CY 2022.
Addressing the Opioid Crisis
At the same time, the march to reduce opioid use continues with the wellrecognized fact that the point of origin often is the surgical and/or dental setting. As a pharmacist, you are part of the team working diligently to mitigate this risk for opioid misuse and abuse. The Department of Health and Human Services continues to support science- and community-based efforts to combat the opioid crisis with a five-point strategy: 1) better prevention, treatment and recovery services; 2) better data; 3) better pain management; 4) better availability of overdose-reversing drugs; and 5) better research (bit.ly/3C6AAYr).
Beginning several years ago, CMS did its part by instituting a packaging policy for nonopioid pain management treatments that affected both hospital outpatient departments and ASCs. In the ASC setting, CMS continued to pay separately at average sales price ASP+6% for the cost of nonopioid pain management drugs that function as surgical supplies in the performance of
• J1745 billing unit is 10 mg paid at $85.811 per billing unit • Bill 10 billing units for a 100-mg dose • Total reimbursement is $858.11 ($85.811 x 10) • CMS pays you 80%: $686.49 ($858.11 x 0.8) • Patient copay of 20%: $171.62 • Sequestration deducts 2% from the CMS amount to pay: $672.76
a Example based on using the quarterly ASP tables, which publish the ASP+6% rate that applies to non-340B facilities.
surgical procedures. This payment was outside the surgical bundle payment and required the facility to bill for it separately. How did you ensure your revenue cycle department understood the nuances of the rule and actually made provisions for a separate payable line item to be included on the claim?
At the same time, hospital outpatient departments would continue to package payment for nonopioid pain management drugs that function as surgical supplies in the performance of surgical procedures with no separate reimbursement for any drug-related line items.
The CY 2022 packaging policy for nonopioid pain management treatments continues to pay separately at ASP+6% for nonopioid pain management drugs functioning as surgical supplies in the performance of surgical procedures only when performed at an ASC. Currently, there are two eligible products defined by CMS: Exparel (HCPCS [Healthcare Common Procedure Coding System] Code C9290, Injection, bupivacaine liposome, 1 mg) and Omidria (HCPCS Code J1097, phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml).
Sequestration Squabbles
Sequestration comes from the Latin word “sequestrare,” which means something that is locked away for safekeeping. When the ancient Romans couldn’t agree on who owned a piece of property, they gave it to a third party called the sequester, who held it until the two sides resolved their differences. In the present, sequestration applies to budget limits that Congress created in the Budget Control Act of 2011. At that time, there was a consensus to use sequester threats to force legislators to reach deficit limit agreements. Sadly, threats didn’t work, implementing the sequester to cut spending from 2013 to 2021. Subsequently, expiration dates continue to be extended into the future as each budget deficit looms larger (now into the 2030s).
How do past and present political squabbles affect your department? The sequestration payment cut implemented in 2013 reduced reimbursement by 2% for all government payments including those for health care. Remember this 2% reduction applies only to the 80% that Medicare reimburses and not the 20% patient copays.
The COVID-19 pandemic paused the sequestration of minus 2%, and this has been renewed several times. However, the proposed infrastructure bill discussions maintain an expiration date of Dec. 31, 2021, with no further extensions of the pause. (See box for how should this information be used when calculating impacts on the budget.)
Remember that sequestration applies to the 80% facility payment only, and applies whether or not your facility is part of the 340B program.
Update: Moderna and Janssen (J&J) Booster Shots
Effective Oct. 20, 2021, FDA amended the emergency use authorizations for the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines to allow for use of a single booster dose for certain populations. For more information on the most current list of billing codes, payment allowances and effective dates, visit go.cms.gov/3C9lzF5. ■
Evidence Matters.
Super-fast phenotypic MIC results and the evidence to back them up.
USP <797> Release
continued from page 1
of the revision on June 1, 2019, USP received appeals on several aspects of the chapter, primarily related to BUD.
In November 2019, the organization announced that the planned Dec. 1, 2019, implementation date for the Chapter <797> would be delayed indefinitely while it considered the various appeals filed by stakeholders. Some 22 months later, the revisions spurred by those appeals are finally in effect. Assuming your institution was preparing for implementation of the revised Chapter <797> as it stood in November 2019, you can continue with those same preparations, albeit with some special considerations for 503A compounders.
BUD Extended With Adequate Testing
The primary changes relate to BUD. In the currently official <797>, which was last revised in 2008, longer storage times are permitted if sterility testing is performed. “The BUD can be assigned based on professional experience and careful interpretation and application of stability and sterility considerations,” noted an informational document published alongside the latest proposed revisions (bit.ly/3FbQGSB). The 2019 proposed revisions limited BUDs based on concerns regarding stability, sterility, environmental monitoring and personnel monitoring—prompting the appeals that led to the implementation delay and the latest revision.
“The people who complained about the BUDs are the independent compounders, large and small, that are doing batch compounding and have CSPs [compounded sterile preparations] on their shelves and want a longer BUD than 14 days,” said Seth DePasquale, RPh, BCSCP, the senior director of hospital and health system services for Visante. “Those are the compounders who will primarily be affected by this revision.”
2 Key Categories
The 2019 proposed revision of <797> had two categories of CSPs. Category 1 CSPs, assigned a BUD of 12 hours or less at controlled room temperature, or 24 hours or less refrigerated, may be prepared in an unclassified segregated compounding area. Category 2 CSPs, assigned a BUD of greater than 12 hours at controlled room temperature or great-
er than 24 hours refrigerated, are given specific BUDs dictated by the method of sterilization, whether or not a sterility test is performed and passed, and the storage temperature of the preparation.
The new <797> also established a Category 3, which allows for longer BUDs than those established for Category 2 CSPs, up to a maximum of 180 days, with requirements that a compounding site must meet at all times to be permitted to employ these extended BUDs. The requirements include the use of stability-indicating analytical methods validated based on USP’s Chapter <1225> “Validation of Compendial Procedures”; heightened standards for personnel competency and garbing; increased environmental monitoring in all classified areas where Category 3 CSPs are compounded; and increased frequency of sporicidal disinfection.
“For the people who are only making sterile-to-sterile compounds and are not pursuing BUDs beyond even what’s listed in the current standards, there isn’t much difference between this and the original proposal,” said Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety at Cardinal Health. “That’s probably 98% of hospital-based sterile compounders. You can’t make something with extended BUDs one or two days a month and only follow the requirements on those days; you have to do all of it, all the time. The chapter is much more specific on what needs to be done and why it needs to be done.”
Category 2 compounders also have some additional changes to their BUDs, but the biggest changes in this category don’t apply to most hospital-based facilities, said Kristina Bryowsky, PharmD, the
pharmacy director at SSM Health, which operates more than two dozen hospitals and health centers in Wisconsin, Illinois, Oklahoma and Missouri, and became the first hospital-based system to register as a 503B in 2014. “Most hospitals and health systems still only get 10 days in the refrigerator and 45 days in the freezer. To get the 45 days at room temperature, 60 days refrigerated and 90 days in the freezer, you have to do terminal sterilization and pass sterility testing, which most institutions don’t do.”
Stronger Basis for USP Changes
“I’m glad that USP had the appeal and were put to the task to come up with scientific reasoning behind what they’re saying,” Mr. DePasquale said. “I’m confident that the changes in the chapter are there for very good reason, and they’ve come up with revisions that make a lot of sense and aren’t just doing things for the purpose of checking boxes.”
One set of modifications that does apply to compounding pharmacies at hospitals and health systems is a change in just how specific one has to be in identifying microorganisms recovered during surface and/or air sampling. For airborne sampling, if colony-forming units (CFUs) exceed 1 in an ISO Class 5 room, 10 in an ISO Class 7 room and 100 in an ISO Class 8 room, identification of the microorganism to the genus level must be attempted. For surface sampling, genus-level identification must be sought if CFUs are 3 or more in ISO Class 5, greater than 5 in ISO Class 7, or greater than 50 in ISO Class 8 rooms.
“This is different from evaluating the gloved fingertip/thumb samples. In those situations, you are looking to answer the question, is there growth or not?” Ms. Kienle explained. “Those issues were already incorporated in the 2019 revision, but the new revision offered the chance to reword the section to make it clearer.”
Check With Your State Board of Pharmacy
Dr. Bryowsky noted that some state boards of pharmacy may have different requirements and that it’s important for each institution to check before making any changes. “I do like how [USP has] changed the details around what does and does not need to be identified,” she said. “Historically, we’ve had to identify the genus of all detected microorganisms and then act on it if it’s highly pathogenic; now we only have to identify it if it’s above actionable levels. That’s a good element that gives compounders more flexibility in remaining open while we do remediation.” —Gina Shaw
—Kristina Bryowsky, PharmD
Ms. Kienle reported that she serves on the USP Compounding Expert Committee but did not speak in that capacity in her interview. The other sources reported no relevant fi nancial disclosures.
Compounding Resources
All of the details of the new Chapter <797>, and revisions to <795> for nonsterile compounding, can be found online at bit.ly/3mxprJN. In addition to the fully revised chapters, USP has provided documents detailing the scientific rationale for the proposed revisions.
Above and Beyond USP Chapters <795> and <797>
Aim for CGMP-like environmental monitoring standards in your 503A compounding pharmacy
If your hospital or health system has a compounding pharmacy, it’s almost certainly classified as a 503A facility, permitted to do small-batch compounding, primarily for individual prescriptions, and is governed by your state board of pharmacy and USP General Chapters <797> and <795>. Your environmental monitoring and other practices are not required to meet the much more rigorous Current Good Manufacturing Practice (CGMP) regulations demanded of largebatch 503B outsourcing compounding facilities. So, why would CGMP be relevant to environmental monitoring in your 503A facility?
“There are many reasons why you should design an environmental monitoring program for your 503A that exceeds USP <797>,” said Tenille Davis, PharmD, BCSCP, the pharmacist-in-charge at Civic Center Pharmacy, in Scottsdale, Ariz., during a session on “quality built in” at the 2021 Compounding Pharmacies Grand Salon, held virtually. “First, it improves patient safety; but also, it comes closer to what the FDA is looking for during inspections. Some observations on 483s issued by the FDA are beyond <797> requirements. Knowing what the FDA would like to see can help you build a more robust pro-
gram and give you more control of your space, which improves patient safety.”
One way to do that is by increasing the frequency of your surface and air sampling. The proposed revised USP Chapter <797>—released to much fanfare on Sept. 1 (see page 1)—requires only two sampling points per year for 503A compounders. (By comparison, 503Bs must sample at least once per shift.) “The chapter tells us that we have to trend data, but you can’t trend data with two air-sampling points a year,” said Abby Roth, the senior director of business operations for Critical Point LLC, who moderated the session. “If you are doing sterile-to-sterile compounding, we suggest that you do both air and surface sampling at least monthly.”
“Twice a year is not enough to trend anything,” Dr. Davis agreed. “If you’re only doing surface sampling every six months, it will take years and years to see trends. The more testing you can do, the more data points you have to trend your results and mitigate any sort of problems.”
Taking as much of your sampling and testing in-house as possible can help you conduct more testing without the added expense and delays of using an outside certification company. “Many 503As are outsourcing their testing to outside companies, which makes it difficult to react in a timely manner if you have an actionable exceeded level,” Ms. Roth said. “Sometimes the certifier can’t come in for another two weeks to resample, which means that depending on what the excursion was, that may mean you’re now operating at a reduced beyond-use date. It puts a lot of strain on your organization to not have control over the sampling.”
Once you’ve invested in your own air sampler, all you have to pay for on a regular basis are the sampling media, Dr. Davis said. “Those are really inexpensive, and it allows you to have more control of the process and get more data points.”
You can also improve your sampling procedures with guidance from supplemental resources, such as the Controlled Environmental Testing Association’s (CETA) Application Guide CAG-009, “Viable Environmental Monitoring for Sterile Compounding Facilities” (bit.
ly/3uNvddM); USP’s Chapter <1116>, “Microbiological Control and Monitoring of Aseptic Processing Environments” (bit.ly/3oGGkEn); and the FDA’s Aseptic Processing Guideline (bit.ly/3BlpSNt).
“USP <797> tells you what to do, while documents like these can help you with how to do it,” Ms. Roth said. “CAG-009 will provide information to fill in the gaps. For example, the chapter doesn’t talk about how to ship samples to a lab or get into specifics about control plates, or things an org might run into if they’re outsourcing the analysis of their samples to a lab. While <1116> focuses on the limitations of environmental monitoring, what it’s meant to do and things like what you should look for in air samplers.”
Once you have more environmental monitoring data and can actually look for trends, what information are you actually looking for? It shouldn’t just be whether or not action limits for viable microorganism colony-forming units are exceeded. “If there are increasing numbers of colonies over time, even if action levels aren’t exceeded, that should be a red flag,” Dr. Davis said. “Are you seeing continued growth in the same area? That tells you it’s a hot spot you need to monitor and develop
an action plan for what to do if those kinds of trends continue.”
What do you do if action levels are exceeded? “You need an out-ofspecification plan: How do you investigate your results; what do you do to remediate them; and how often do you retest?” Dr. Davis asked. “A lot of pharmacies are just checking boxes. They don’t want growth in the buffer room, so they clean the location three times with bleach and then retest. Maybe it doesn’t grow anything, but that doesn’t solve any underlying problems.”
Instead, Ms. Roth recommended repeating sampling for five days to determine whether the result is a trend or a one-off, while assessing other factors such as air pressure differentials and personnel involved. “If you have the same finding five days in a row, you have a clear problem you need to think about fixing,” she said. “Use data to figure out how to mitigate contributing factors so they don’t keep happening. Do you need to retrain people in handwashing and garbing, for example? Do you need to change up your cleaning products or increase fingertip testing?”
Ms. Roth cautioned that environmental monitoring has its limits. “It’s a snapshot in time. What’s here now might not be here 15 minutes from now or five days from now,” she said. “And it’s a tool, not a box check for chapter compliance. You can’t use environmental monitoring as a sterility test for your compounded sterile preparations. Just because you recover organisms in your buffer room, anteroom or even your ISO [International Organization for Standardization] 5 primary engineering control, that doesn’t mean that everything produced during that time is contaminated. The way you build quality into your operations is what gets to be important. Has your organization implemented a really good hand hygiene and garbing program? Does everybody comply? Does everybody know how to use the primary engineering controls? Do you have good material handling procedures? All those things will mitigate the risk that even if we do recover something in that space with environmental testing, it will reduce the chance that your compounded preparations were contaminated.”
—Tenille Davis, PharmD, BCSCP
‘Has your organization implemented a really good hand hygiene and garbing program? Does everybody comply? Does everybody know how to use the primary engineering controls? Do you have good material handling procedures? All those things will … reduce the chance that your compounded preparations were contaminated.’
—Abby Roth
—Gina Shaw
Pushback on COA Report
continued from page 1
provide significant discounts on outpatient drugs for qualifying institutions that serve high numbers of low-income and uninsured patients. DSH, which account for most 340B participating institutions, are supposed to receive a minimum 23.1% discount off the average sales price (ASP), but actual discounts are estimated to be upward of 34.7% on average.
The COA is calling for reform of the 340B program. The group says 340B pricing practices are driving up premiums for commercially insured individuals, and it questions why drug discounts aren’t being passed on to the patients served by safety net hospitals.
“Non-profit 340B hospitals charge both commercial payors and uninsured patients extraordinarily high prices and use an aggressive form of price discrimination between payors,” industry analyst and lead study author Aharon Gal, PhD, of the consultancy firm Moto Bioadvisors, said in a COA press release announcing the report (bit.ly/3Ec8SKo).
However, 340B advocates harshly criticized the report. 340B Health, an association of 340B hospitals and health systems, stated in a blog on its website that “the report is highly flawed and presents an inaccurate picture of the role 340B plays in America’s health care safety net.” Besides challenging the methods and conclusions of the study, 340BHealth said the authors misunderstood that the 340B program is designed to support a broad range of services for low-income patients using hospital savings from the lower drug prices (bit.ly/3Gl4vOV).
COA Seeks a More Informed Debate
The Centers for Medicare & Medicaid Services (CMS) enacted new transparency regulations this year, requiring all hospitals to report the actual drug prices they negotiate with each payor (go.cms.gov/3ntSRsE). COA saw access to these data as an opportunity to enable a more informed debate about the 340B program, which it has long criticized for causing competitive disadvantages for private practices. With this goal in mind, the organization commissioned the study to evaluate a sample of 340B hospitals for compliance with the new CMS regulations, and their contract prices for oncology drugs as reported in their own price transparency data.
As of this April, 876 of the 1,087 acute care 340B hospitals in the sample had a publicly accessible price transparency file on their website, most of which only reported the list prices (charge master data) required before this year. CMS has reported low compliance with the new transparency regulations across all hospital systems, and plans to increase what are now considered relatively minor penalties of $300 per day for facilities not meeting the new transparency standards (bit.ly/ 3bbMW5A). Of hospitals that did attempt to comply, 123 published individual drug prices negotiated with each payor. From these, the researchers analyzed more than 52,000 individual prices negotiated with mostly commercial payors (85%) for a roster of 59 oncology drugs, which accounted for the highest Medicare Part B drug costs in 2019.
The report’s key findings are that 340B hospitals: • charge a median of 3.8 times their acquisition costs for oncology drugs, ranging from markups of 240% (brentuximab vedotin; Adcetris, Seagen) to 1,100% (epoetin alfa; Epogen, Amgen); • fail to reduce drug prices for un insured or cash-paying patients, or when acquisition costs decline; • price drugs inconsistently between and within hospitals; and • prefer innovator biologics over lower-cost biosimilars. 340B Health noted that the report draws conclusions about 340B hospitals’ behavior with a very small sample of DSH (123 of more than 1,000) and without comparing it with non-340B hospitals. The group also criticized the report for overstating the value of the 340B discount. Rather than the difference between the acquisition and reimbursement costs, the discount’s real value is in the spread between the acquisition cost and what providers would have paid without the program, the group noted in its blog post.
Drug Pricing at Odds With 340B Mission?
A major contentious issue is COA’s allegation that the practice of charging similar prices whether patients are insured or paying out of pocket conflicts with the mission of 340B hospitals to provide affordable care to the uninsured population. “To the extent 340B institutions fulfill their mission of providing lower cost care, we are not seeing it reflected in their drug prices,” the authors wrote. COA argued that these pricing practices show 340B drug discount savings are not being directly passed on to patients.
The problem with this argument, 340B advocates say, is the 340B program was designed to allow participating hospitals to use the savings from drug discounts to fund community programs and services. “Lawmakers created the 340B program to allow savings from lower drug costs to support a broad range of services for patients with low
Q & A
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340B PUSHBACK
continued from page 26
incomes,” 340B Health wrote in its blog post. “In other words, 340B is working as intended. … [The] report fails to consider the many ways 340B hospitals are using the savings to provide uncompensated and unreimbursed care as well as vital services that cost more to deliver than the reimbursements they bring in, including trauma and burn care, HIV care, and inpatient mental health care.”
Preserving the Safety Net
Peggy Tighe, JD, and Barbara Williams, JD, health care attorneys with Powers Law, who represent 340B-covered entities, argued that Ryan White Clinics are a strong example of a safety net facility that depends on 340B drug discount savings to fund comprehensive clinical care and social services for low-income patients— in this case, half of all people living with HIV/AIDS in the United States.
According to a white paper released in October 2020, Ryan White Clinics detailed exactly where their 340B discount dollars go to benefit the patients they serve, which included funding for free or low-cost primary HIV/AIDs medical care; health insurance coverage counseling and copay assistance; and support services, such as medical transportation, respite care for caregivers, nonmedical case management, and housing and food assistance (bit.ly/3B8gonP).
“Without the 340B program, there’s really no way that Ryan White Clinics can do all that they do for the communities they serve,” Ms. Tighe said. “The reason is pretty simple: Not only did they get discounts on outpatient prescription drugs because they’re eligible to participate in the 340B program, they were able to invest the savings and additional insurance revenue in comprehensive care services. So those monies enable the Ryan White Clinics to do a lot more than just get discounted drugs.”
Ms. Williams noted that the language Congress used when it wrote the legislation that enacted the 340B program entrusted non-profit safety net providers to reinvest drug discount savings in the services needed by their particular communities. “Congress didn’t say you have to directly pass along the drug discount to the patient,” she said. “Most 340B-covered entities have financial assistance programs, so if a patient needs the discount, they can get it. But if a patient is privately insured, and they’re an eligible patient of that 340B-covered entity, then the savings goes back to that covered entity and is used to provide other community services.” is that 340B hospitals charge private insurers much higher rates than the reimbursement they receive from Medicare for the same drug. As an example, the report outlines how 340B hospitals would make 15 times as much profit from a commercially insured patient versus a Medicare patient prescribed the multiple myeloma drug
Figure. Part of the problem with the 340B Drug Pricing Program is a lack of pricing transparency from participating entities, despite new federal regulations requiring such transparency, according to a report from the Community Oncology Alliance. In this figure, the COA claims that only 123 of the 1,087 acute care 340B hospitals included in its analysis published individual negotiated payor price data for drugs.
Source: Community Oncology Alliance
Rapid on.
Byfavo® sedative that may be used across many procedures and adult patient types.
Rapid Onset
3.0–3.5 minutes to peak sedation after initial 5 mg dose Rapid
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Indication: Byfavo is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo. • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. • Byfavo has been associated with hypoxia, bradycardia, and hypotension.
Continuously monitor vital signs during sedation and through the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag/ valve/mask assisted ventilation must be immediately available during administration of Byfavo. • Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death.
The sedative effect of intravenous Byfavo can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Contraindication: Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Personnel and Equipment for Monitoring and Resuscitation: See Boxed Warning. Consider the potential for worsened cardiorespiratory depression prior to using Byfavo concomitantly with other drugs that have the same potential (eg, opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A during administration of Byfavo. Risks From Concomitant Use With Opioid Analgesics and Other SedativeHypnotics: See Boxed Warning. Hypersensitivity Reactions: Byfavo contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Neonatal Sedation: Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly. Pediatric Neurotoxicity: Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through
daratumumab (Darzalex, Janssen Oncology) ($213,696 vs. $14,259). COA suggested that the much higher value of commercial patients could motivate 340B hospitals to acquire younger, healthier, commercially insured patients instead of the underserved populations for which they are tasked with caring. But 340B Health says there is no evidence for this claim, and that findings from the Medicare Payment Advisory Commission and other studies show 340B hospitals are more likely to serve low-income, racially diverse and disabled patients.
“When these types of reports find their way into the public dialogue over the 340B program, they obscure the tremendous good the program does for the health care safety net and the patients it serves. Policymakers who understand the benefits and intent of the program will recognize the holes in these arguments,” 340B Health said.
Ms. Tighe said she suspects that calls for greater transparency by 340B hospitals from COA and other groups is really an attempt to gain access to information that can be used to reduce the size of the drug discount program—an ongoing effort among many stakeholders. As Pharmacy Practice News previously reported (bit.ly/3EivTeW), 340B hospitals are in litigation with drug manufacturers who have refused to provide drug discounts through 340B contract pharmacies.
“What we’ve said for a long time is transparency is a buzzword,” Ms. Tighe noted. “What’s really happening here is, increased transparency and reporting is really intended to diminish savings, and also consequently would diminish that freedom of local communities making these determinations about how these savings are used. I don’t think anybody should question why there is a hesitancy in the hospital community to hand over more information when the information they give away is used against them.” —Adam Leitenberger
Ms. Tighe and Ms. Williams reported that they represent a range of 340B institutions.
For more 340B coverage, see page 30.
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age in humans. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, Decisions regarding the timing of any elective procedures requiring anesthesia the potential risks. Adverse Reactions: of patients (N=630) receiving Byfavo 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. Pregnancy effects of Byfavo on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression. Lactation—Monitor infants exposed to Byfavo through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after Byfavo administration. Pediatric Use—Safety and effectiveness in pediatric patients have not been established. Byfavo should not be used in patients less than Geriatric Use—No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of Byfavo slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications. Hepatic Impairment—In patients with severe hepatic impairment, the dose of Byfavo should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications. Abuse and Dependence: Byfavo is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.
Please see the Brief Summary of Prescribing Information for Byfavo on next page. ASA=American Society of Anesthesiologists Physical Status. of Alertness/Sedation. 1. 2. Pastis NJ, et al. Chest 3. Rex DK, et al. Gastrointest Endosc 4. Data on File. Acacia Pharma Inc. 5. Pambianco D, Cash B. Tech Gastrointest Endosc.
Access to affordable medications a key focus
340B Program, PAPs Help Ensure Specialty Rx Success
Actively managing participation in the federal 340B Drug Pricing Program and other financial assistance and medication access efforts can help maximize savings and ensure the overall success of specialty pharmacy services, a panel of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually.
For example, when the FDA approved the pediatric cystic fibrosis medication elexacaftor-tezacaftor-ivacaftor (Trikafta, Vertex) in June, the specialty pharmacy team at Atrium Health Wake Forest Baptist, in Winston-Salem, N.C., worked with eligible patients and their families to ensure they were completing necessary lab tests and education counseling during clinic visits leading up to the approval so patients would be ready, said Regina Schomberg, PharmD, BCPS, the system director of pharmacy, retail and specialty pharmacy services. With the help of a medication access specialist, they were able to obtain prior authorization for 19 patients within one week of the FDA approval, and all patients were able to have their prescriptions sent either to the hospital’s internal specialty pharmacy or another specialty pharmacy within the first week. They also were able to use 340B savings to support pharmacy staff to continue providing personalized care to this vulnerable population.
Solid organ transplant patients
for Byfavo© • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo. • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. • Byfavo has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of Byfavo. Concomitant use of benzodiazepines, including Byfavo, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Hypnotics Pregnancy—Risk Summary:
340B disproportionate share hospitals provide 60%
of all unreimbursed and uncompensated care in the U.S., yet make up only 38%
of all acute care hospitals.
Source: 340BHealth.
also can benefit from ongoing specialty pharmacy care and 340B funding. “Financial assistance continues to be the largest barrier these patients experience,” Dr. Schomberg said. “You can imagine the severity of being overwhelmed with the desire to continue with their newly transplanted organ, and the need for finance assistance with medication payment.”
During a patient outreach call, one of her pharmacy technicians discovered that a patient had lost their job two months prior, was at risk for losing insurance coverage, and had been paying out of pocket for the medication. The patient shared that he or she went without medication because there was not enough money to pay for the new script. The pharmacy technician found a patient assistance program (PAP) and contacted the manufacturer for approval within a few days.
Year to date, Dr. Schomberg and her colleagues’s work on PAPs has garnered millions of dollars of medication savings. They also use a computerized system that allows searching for PAP, foundation or grant funding, and they keep track of the paperwork to assist patients. Their efforts to maximize 340B savings also have paid off. But Dr. Schomberg stressed that the program doesn’t just benefit patients; at her institution, 340B savings also are invested in staff, including two designated medication-access specialists fully devoted to PAPs.
UC Davis Approach
The UC Davis Health System in California also established specialty services to help solid organ transplant patients with medication access needs, said David Mitchell, PharmD, MBA, the health system’s pharmacist manager of specialty pharmacy operations. Dr. Mitchell’s team used 340B savings to hire and train staff to perform tasks such as billing Medicare B for immunosuppressants, supporting the prior authorization process and obtaining financial assistance when needed. They also established a meds-to-beds delivery system to provide prescriptions to patients before discharge. Technicians call patients every month to ensure they continue on therapy.
But those 340B savings don’t magically appear, Dr. Mitchell stressed. His specialty pharmacy has clinical pharmacists embedded in clinics who make sure that orders for specialty medications sent to the internal specialty pharmacy are eligible for 340B savings. They also are responsible for ensuring that orders patients choose to have filled at external pharmacies—or that payors mandate be sent to a specialty pharmacy—still remain in the health system’s contract pharmacy network.
Clinical pharmacists also guarantee that orders are eligible for 340B savings by ensuring patients are seen within a specified time frame. It not only makes for great patient care, Dr. Mitchell said, but guarantees that patient orders are issued from a qualified encounter.
He said pharmacy staff perform additional activities to optimize 340B savings, such as checking 340B accumulations before placing orders to maximize orders through the 340B account and minimize orders from the wholesale acquisition cost account. The 340B team also reviews orders that are not automatically qualified and manually qualifies them if initially rejected, if they meet certain criteria.
Clinical Considerations—Fetal/Neonatal Adverse Reactions Data— Human Data: Lactation—Risk Summary: Pediatric Use Geriatric Use Hepatic Impairment Clinical Presentation Management of Overdosage Alcohol and Current Medications— Pregnancy Lactation—Advise
—Karen Blum
FDA Grants Cyltezo Biosimilar ‘Interchangeable’ Status
The FDA expanded the designation of adalimumab-adbm (Cyltezo, Boehringer Ingelheim) to include interchangeable status—marking the second such approval to date.
The drug, which was initially approved in 2017, is now biosimilar to and interchangeable with adalimumab (Humira, AbbVie). Cyltezo is one of six biosimilar agents scheduled to reach the market by 2023, according to the Center for Biosimilars (bit. ly/2Z5TyAj).
“The interchangeable designation will allow pharmacists to substitute Cyltezo for the originator product without consulting with the prescribing physicians,” the group said. “This is expected to open doors to wider patient access, although all states have now enacted conditions that govern the interchangeable designation.”
Cyltezo is approved for the following indications in adults: • moderately to severely active Crohn’s disease; • moderately to severely active ulcerative colitis; • moderately to severely active rheumatoid arthritis; • active psoriatic arthritis; • active ankylosing spondylitis; and • moderate to severe chronic plaque psoriasis.
The drug also is indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, and children ages 6 years and older who have Crohn’s disease.
Cyltezo comes as a citrate-free, singledose, pre-filled glass syringe (40 mg/0.8 mL, 20 mg/0.4 mL) and is administered subcutaneously. The most common adverse events associated with use of the drug are upper respiratory and sinus infections, injection site reactions, headache and rash, according to the FDA. Malignancies also have been reported, among other severe reactions outlined in the drug’s boxed warning.
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FDA Expands Indication for Flucelvax Quadrivalent
The FDA expanded the indication for a cell-based quadrivalent influenza vaccination (QIVc; Flucelvax Quadrivalent, Seqirus) for children as young as 6 months old.
The expanded age indication is supported by a phase 3 clinical study demonstrating that QIVc was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children 6 months to 3 years of age during the U.S. 2019-2020 influenza season, according to data presented at the Pediatric Academic Society virtual annual meeting on May 1, 2021.
Safety profiles also were comparable between QIVc and QIV. The most common adverse events (AEs) were similar between vaccinated groups, and included tenderness, erythema at the injection site, irritability and sleepiness. The rate of serious AEs was less than 1% for each vaccine group.
Cell-based influenza vaccines are designed to produce an exact match to World Health Organization–selected influenza virus strains by avoiding eggadapted changes, and therefore may have the potential for greater effectiveness, according to the CDC.
Children younger than 5 years old, particularly those younger than 24 months, are at increased risk for developing serious influenza-related complications, including pneumonia, brain dysfunction, and in rare cases, even death. According to the CDC, almost 50,000 hospitalizations occurred in children during the 2019-2020 U.S. influenza season, and there were more than 486 influenzarelated deaths in this age group.
The CDC recommends everyone 6 months of age and older without contraindications receive an influenza vaccine annually.
Jakafi Approved To Treat Chronic GVHD In Adults and Children
ure of one or two lines of systemic therapy in adults and children ages 12 years and older.
“Nearly half of the people who develop chronic GVHD do not respond adequately to steroids—the current standard of care—making this life-threatening condition particularly challenging to treat,” noted Robert Zeiser, MD, the principal investigator of the REACH3 trial, on which the approval was based.
Dr. Zeiser called the approval “a significant advancement in the treatment of appropriate patients with chronic GVHD—for both the patients who face a poor prognosis and the health care providers who struggle to effectively treat them.”
The phase 3 REACH3 study compared ruxolitinib with best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. In the trial, investigators randomly assigned 329 patients to receive either ruxolitinib 10 mg twice daily or best available therapy. The major efficacy outcome used to support approval was overall response rate through week 24. Full results from the trial were published in The New England Journal of Medicine (2021;385[3]:228-238).
The overall response rate was 70% (95% CI, 63%-77%) for the ruxolitinib arm and 57% (95% CI, 49%-65%) for the best available therapy arm.
The most common hematologic adverse events (incidence >35%) were anemia and thrombocytopenia. The most common nonhematologic adverse events (incidence ≥20%) were infections (pathogen not specified) and viral infection.
For more information, see the complete prescribing information for ruxolitinib (bit.ly/3pm4Yuo).
Brukinsa Granted Accelerated Approval For R/R MZL Treatment
The FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20–based regimen.
The approval is based on the pivotal phase 2 MAGNOLIA (BGB-3111-214) trial (ClinicalTrials.gov Identifier: NCT03846427) and the phase 1/2 BGB-3111-AU-003 trial (NCT02343120). In both trials, zanubrutinib was administered orally at 160 mg twice daily or 320 mg once daily. The efficacy measures were overall response rate (ORR) and duration of response (DOR), as assessed by an independent review committee using the 2014 Lugano criteria.
In the MAGNOLIA trial, investigators evaluated 66 patients with relapsed or refractory MZL who received at least one anti-CD20–based regimen, including 26 with extranodal subtype, 26 with nodal subtype, 12 with splenic subtype and four with unknown subtype. The ORR was 56% (95% CI, 43%-68%) with a complete response (CR) rate of 20% based on assessment using CT and 67% (95% CI, 54%-78%) with a CR rate of 26% based on assessment-prioritizing PET/CT. The DOR was not reached at the median follow-up time of 8.3 months; 85% of responders still were in remission at 12 months (95% CI, 67%-93%). Responses were observed in all MZL subtypes.
In the BGB-3111-AU-003 trial, 20 patients were evaluated, including nine with extranodal subtype, five with nodal subtype and six with splenic subtype. The ORR was 80% (95% CI, 56%-94%), with a CR rate of 20%, based on assessment using CT. The median DOR was not reached at the median follow-up time of 31.4 months; 72% of responders still were in remission at 12 months (95% CI, 40%-88%).
The prescribing information (bit. ly/3E2BBS2) includes warnings and precautions for hemorrhage, infections, cytopenias, second primary malignancies and cardiac arrythmias.
The most common adverse reactions, including laboratory abnormalities (incidence, ≥30%), in the pooled safety population of 847 patients were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash and musculoskeletal pain. ■
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Profi ts and the Pandemic
continued from page 1
At Wellforce, a multiple-hospital network that includes Tufts Medical Center, in Massachusetts, adding pharmacists on the care team “not only [helps] with the bottom line, but ultimately, it will lower the total cost of care because we are going to be able to keep patients’ treatment within our system,” said chief pharmacy officer Keith B. Thomasset, PharmD, MBA.
In practical terms, “hospitals have had to get a lot more creative and innovative in finding programs and resources to replace lost revenue and margin,” Mr. Jorgenson said. “For the profession of pharmacy, that has been tremendous because for a lot of organizations, pharmacy has really been an undervalued, underutilized resource with a lot more to contribute. We have never been busier supporting the accelerated growth of high-performance pharmacy services and the associated contributions.”
Health-system pharmacy often has risen to meet challenges. One example is the University of California, San Francisco (UCSF). “With so much lost revenue early on in the pandemic, we had to think outside of the box to be more efficient and effective,” said Desi Kotis, PharmD, the chief pharmacy executive at UCSF. Thanks to that approach, UCSF’s financial statement for the fiscal year ended June 30 showed more than $80 million in medication management savings and increased pharmacy revenues.
Improvements ranged from relatively modest to very large. A focus on IV dose rounding, for instance, saved approximately $500,000; a specialty pharmacy push yielded an additional $31 million; and a focus on leveraging UCSF’s 340B purchasing program and managing drug wholesale acquisition cost together added $40 million more (box).
Savings Start at Home
Other health systems and hospitals are taking different paths to revenue building and saving costs. Norton Healthcare, a five-hospital, 1,800-bed health system covering Louisville, Ky., and southern Indiana, is weighing the financial benefit of launching a home infusion therapy program, according to Paul Allen, PharmD, the vice president for pharmacy services.
With more payors pushing home infusion because it is less expensive to deliver those services at home versus a hospital, such a program “would be another revenue generator for us,” Dr. Allen said. “It would also enhance our ability to take care of patients across the continuum of care, including when they go home from the hospital.”
Steve Rough, MS, RPh, a senior vice president at Visante, also sees a big financial upside for hospitals in the home infusion market. “Setting up home infusion therapy programs and separate home infusion suites can provide hospitals with additional venues for infusing drugs outside of the traditional hospital-based site of care,” he said.
Mr. Rough also is bullish on the growth potential for specialty and retail pharmacy programs, by “moving the needle on the capture rate for high-cost, highmargin drugs that patients need to get the best outcomes.”
Dr. Allen is on board with expanding both pharmacy areas. Norton already has “pretty robust specialty pharmacy and retail pharmacy programs,” he said, with revenues that provide “a significant net margin stream for the organization.” Specialty pharmacy alone, he noted, generates year-over-year growth of at least 10%, owing in large part to the health system’s ability to gain access “to more limiteddistribution products than in the past.”
Norton is looking to capitalize on those gains by improving the specialty pharmacy capture rate for patients coming out of its specialty clinics or discharged from its hospitals. Another goal is to build its medsto-beds program, “so we ensure patients have their discharge medications before they leave the hospital, and then we can capture additional pharmacy revenue.”
At Wellforce, a multiple-hospital health system including Tufts Medical Center, in Massachusetts, Keith B. Thomasset, PharmD, MBA, the chief pharmacy officer, said the aim is frictionless and total care and “to optimize the volume that we fill internally by having our pharmacists spend more time in our clinics, helping our providers. Not only is that going to help with the bottom line,” Dr. Thomasset said, “but ultimately, it will lower the total cost of care because we are going to be able to keep patients’ treatment within our system.”
Supply Chain Savings
Wellforce also has worked to leverage its size to optimize supply chain purchasing agreements. This year alone, he said, that effort saved the health system nearly $2.5 million. Wellforce’s 340B program also has helped. Specifically, he said with COVID-19 shifting a lot of care to the home, “we have tried to capitalize on our 340B potential” by targeting contract pharmacy agreements to a handful of high-use home infusion companies. Partway through this year, he noted, that approach has yielded nearly $150,000 in additional revenue.
Dr. Thomasset cited two additional drug initiatives that added more than a half-million dollars in savings. First, he said, by insourcing, rather than outsourcing, a specific sedative medication, Wellforce saved roughly $400,000 over the past year. Another $200,000, he added, was saved by switching from cephalosporin to an alternative antibiotic.
For other health systems, rising patient acuity levels driven largely by the pandemic have left little time for developing revenue-building pharmacy programs. That has been the case for the threehospital Baptist Health system in the Montgomery, Ala., area.
“I don’t know if we’ve done anything particularly innovative in reaction to the pandemic,” said Eric Morgan, PharmD, the CEO at Prattville Baptist Hospital, in Alabama, the smallest member of the group. “But we’re kind of the offensive line on the team,” he said, referring to pharmacy. “We keep our heads down doing what we do.” This means remaining “nimble” in the face of rising demand, reacting to FDA emergency use authorization guidelines and moving quickly to get new therapies approved by the system’s pharmacy and therapeutics committee and monitoring their use. It also has meant, he said, “proactively ordering stock of critical care drips and medications that have gone in and out of supply over the pandemic.”
Dr. Morgan said he didn’t know if any of the measures saved money. “Our pharmaceutical buyers are buying more than they ever have.” They’ve been judicious, he added, “but our pharmaceutical expenses are well above pre-pandemic levels.” —Bruce Buckley
An $80 Million Windfall
In May 2020, when Desi Kotis, PharmD, the chief pharmacy executive at University of California, San Francisco (UCSF), moved from Northwestern Medicine to join the UCSF executive team, she said one of the first things she was asked was, “What can we do to decrease expenses by being more efficient and effective?”
More than a year later, the health system’s financial picture has been brightened by more than $80 million in pharmacy revenue enhancements and savings. These are some of the year’s highlights: • drug use management of biosimilars: $7.7 million—$1.7 million above $6 million targeted; • dose rounding of injectable drugs, with a special focus on UCSF’s two pediatric hospitals: $500,000; • converting IV medications (including IV acetaminophen) to oral administration: $3.4 million; • partnering with the revenue cycle department to reverse authorization denials, especially for biosimilars: $1 million; and • improving billing practices, including use of the Medicare JW modifier to maximize payments for unused and discarded drugs and biologics in singleuse vials: $6 million. —B.B.
The Right Structure Is Key
How can pharmacy help to improve hospitals’ financial performance?
“You need the right pharmacy structure,” said Steve Rough, MS, RPh, a senior vice president at Visante. “You also need to empower your pharmacy leadership team to go after the opportunities in the face of limited resources and competing priorities.
“When you do that, it frees up additional margin for your organization to invest in the overall pharmacy enterprise in terms of patient care services,” he added. “That can give the organization the financial capacity, for example, to elevate pharmacy technicians’ salaries and positions to where they ought to be. You establish a model in which the best pharmacy practitioners want to work and want to practice, and where they are empowered to make a difference in optimizing patient quality outcomes and doing everything pharmacists are trained to do.”
—B.B.
