Clinical Insights: August 11, 2020

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval 

    OlinvykTM (oliceridine) Injection – New Drug Approval – August 7, 2020 – The U.S. Food and Drug Administration approved OlinvykTM (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. OlinvykTM is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use. <Read More> 

    EvrysdiTM (risdiplam) – New Drug Approval – August 7, 2020 – The U.S. Food and Drug Administration approved EvrysdiTM (risdiplam) to treat patients two months of age and older with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. This is the second drug and the first oral drug approved to treat this disease. <Read More> 

    Lampit® (nifurtimox) Tablets – New Drug Approval – August 7, 2020 – Bayer announced that the United States Food and Drug Administration (FDA) has approved Lampit® (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi). Lampit®, an antiprotozoal medication will be available in a new, dividable tablet that can be split on the scored lines by hand. According to prescribing instructions, the tablet is specially formulated to disperse in water, which can aid in the dosing and administration to pediatric patients who may have difficulty swallowing whole or half tablets. <Read More> 

    BlenrepTM (belantamab mafodotin-blmf) Injection – New Drug Approval – August 6, 2020 – GlaxoSmithKline plc announced the US Food and Drug Administration (FDA) has approved BlenrepTM (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BlenrepTM is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Spravato® (esketamine) Nasal Spray – New Expanded Indication – August 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Spravato® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Spravato® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours, providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect. <Read More>

    New Drug Shortage

    August 04, 2020

    New Drug Recall and Safety Alerts

    Desmopressin Nasal Spray Products by Ferring US – New Drug Recall – August 5, 2020 –  Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and Stimate® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Psoriasis Guidelines Focus on Treatment of Adults – August 10, 2020 – Topical agents, alternative medicine, and disease severity assessment are the subjects of the latest updated set of guidelines for the management and treatment of psoriasis issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation. The guidelines, published in the Journal of the American Academy of Dermatology, focus on treatment for adults, and follow the release of other AAD-NPF guidelines on biologics for psoriasis, psoriasis-related comorbidities, pediatric psoriasis, and phototherapy in 2019, and earlier this year, guidelines for systemic nonbiologic treatments. <Read More>

    Antidepressants Can be Better Than Painkillers for Chronic Pain, Suggests NICE – August 10, 2020 – In draft guidance published in August, NICE said paracetamol, non-steroidal anti-inflammatory drugs (which include aspirin and ibuprofen), benzodiazepines or opioids should not be offered to those suffering from chronic primary pain…The guidance, which is being consulted upon until the middle of September, recommended that, instead, some antidepressants should be considered for people with chronic primary pain. <Read More> 

    The Next Generation of PBMs: New Technology, Simpler Business Model and More Transparency – August 10, 2020 – The COVID-19 pandemic has had a deep and profound impact on American businesses both large and small. As the country inches back to a “new normal,” business leaders have to deal with the cost of healthcare as a significant issue to their bottom line. Managing pharmaceutical costs will continue to be a major priority for employers. During the last few years, employers, patients, pharmacies, pharmaceutical companies and the government have become “fed up” with the PBM cartel that exists in the marketplace. The “old guard” PBMs have been reinventing themselves through mergers and acquisitions. Promises of lowering drug costs have not materialized. New PBM entrants have emerged to bring new technology, a simpler business model, and more transparency. I propose to lay out a road map of where we are today and a guide to the market dynamics in the making. <Read More> 

    Hospital Pharmacies Pushing for Use of New Vancomycin Guidelines Despite COVID-19 – August 10, 2020 – In March 2020, the new guidelines for vancomycin dosing were released, with the major changes including the transition from a trough-based monitoring process to area under the curve (AUC)-based dosing strategies. A survey conducted between March 30 and April 6 by InsightRx found that implementing the new vancomycin guidelines into the pharmacy community is as important as coronavirus disease 2019 (COVID-19) in the health care system. Further, a second survey was conducted by Sage Growth Partners in April 2020 to assess pharmacists’ sentiments regarding newly released vancomycin dosing guidelines and related precision dosing topics. <Read More> 

    APhA Collaborates with Walmart to Provide Free Comprehensive Opioids Training Program for All U.S. Pharmacists and Pharmacy Technicians Nationwide – August 10, 2020 – As part of ongoing efforts to help curb our nation’s opioid epidemic, the American Pharmacists Association (APhA) has collaborated with Walmart to offer a free online training program on opioid stewardship to all pharmacists and pharmacy technicians around the country.  The new resource for pharmacists is being launched at a time when parts of the country are experiencing increased opioid-related overdoses as access to social and treatment networks are disrupted by the Covid-19 pandemic. The customized pharmacist program contains 6.5 hours of training and education, including a pain management curriculum. <Read More> 

    Barriers Shown to Decrease Uptake of Vaccines Administered in Community Pharmacy – August 10, 2020 – Many Americans, especially older adults, suffer each year due to vaccine-preventable diseases, such as influenza, pneumococcal disease, and shingles. Currently, low immunization rates prompt a combined effort to vaccinate more people. Pharmacists, due to their accessible locations, can help the immunization effort by supporting and giving vaccines. More than 90% of American live within 2 miles of community pharmacies. The CDC found that in 2017, pharmacies alone administered 28.2% of total flu shots in the United States…In the study, pharmacists who gave vaccines say competing tasks are the most significant barrier to increasing their vaccination metrics. <Read More> 

    Hydroxychloroquine: Where Pharmacy, Medicine and Politics Intersect – August 8, 2020 – The debate over the merits of hydroxychloroquine or chloroquine for COVID-19 is raising questions about the responsibilities of pharmacists, who are trying to use good science and data to guide their recommendations, even though not everyone agrees with them. Are they coming between a doctor and a patient? <Read More> 

    Acute Treatment of Migraine in Children And Adolescents: AAN Guidelines – August 7, 2020 – The Academy of Neurology (AAN) supported by the American Headache Society, have recently laid down a revised set of guidelines on the Acute management of Migraine in Children and Adolescents which have been published in the prestigious JAMA Pediatrics. It serves as an update to the AAN’s 2004 guidelines on short-term treatment in new and established patients with migraine… The revised guidelines, which conforms to Institute of Medicine standards in its development and evidence base, was initiated and funded by the American Academy of Neurology (AAN)with support from the American Headache Society. <Read More>

    Participating in Intervention Resources are More Likely to Follow Chronic Opioid Therapy Guidelines – August 7, 2020 – Results of a new study find that providers participating in an intervention with education and resources to help manage chronic opioid therapy for patients with HIV and chronic pain are more likely to adhere to national chronic opioid therapy guidelines compared to providers who do not take part. The intervention resources include a nurse care manager to work with physicians and nurse practitioners who are the primary care providers for such patients, and access to addiction medicine specialists. <Read More>

    A Coalition of Patients Urges Congress to Recognize the Importance of Pharmacists During the COVID-19 Pandemic – August 7, 2020 – The National Association of Chain Drug Stores (NACDS) shared a coalition release from the National Forum for Heart Disease & Stroke Prevention and 20 other groups asking Congress to take the necessary action required to allow pharmacies to accelerate patients’ access to coronavirus disease 2019 (COVID-19) testing and prepare for the administration of a COVID-19 vaccine upon its availability. Although pharmacists are authorized to order and administer COVID-19 tests, they are still not able to be reliably paid for their services. If Congress were to address and ameliorate this issue, more Americans would have access to testing across the country, according to the coalition. <Read More> 

    New Clinical Practice Guidelines on Acute Myeloid Leukemia in Older Adults – August 6, 2020 – ASH published new guidelines to help older adults with acute myeloid leukemia (AML) and their health care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice care. Each year, nearly 20,000 people receive a diagnosis of AML. The disease generally develops in older people; the median age of diagnosis is 68. As the “baby boomer” generation ages and the average demographic age in the United States increases, evidence-based recommendations for the optimal treatment of older adults with AML take on greater urgency and importance. <Read More> 

    Oncology Practices Adapt to COVID-19 – August 6, 2020 – Agility. Flexibility. A can-do attitude to adapt to the unexpected. These are some attributes community oncology practices have needed to survive during the COVID-19 pandemic, which has put renewed emphasis on the importance of nimble and responsive leadership in dealing with crises, according to medical experts who were panelists on the virtual 2020 Community Oncology Alliance Conference’s Cancer v. COVID session. <Read More> 

    Pharmacists Society Forms Diversity Task Force – August 6, 2020 – The American Society of Health-Systems Pharmacists named 18 of its members to a task force on racial diversity, equity and inclusion Aug. 6. The task force is assigned to take inventory of the society’s efforts on racial diversity, equity and inclusion on issues facing Black Americans and make recommendations on new or enhanced efforts the group can take… <Read More> 

    The Power of Medication Packaging Automation During COVID-19 – August 6, 2020 – Coronavirus disease 2019 (COVID-19) has kept the US health care industry on its toes since the first case was identified on our shores in January 2020. In a matter of months, cases skyrocketed from single digits to millions, requiring health care facilities and pharmacies to adapt quickly during a time in which labor, money, and resources grew scarce…During a time in which “contactless” and “touch-free” have become household phrases, multi-dose medication packaging machines do exactly that. Packaging and verification of medication is done automatically through these machines, verifying the size, color, shape, and amount of each pill in every pouch to check them quickly, accurately, and safely. <Read More> 

    New Guidelines Aim to Reduce Obesity Stigma in Health Care – August 6, 2020 – The 2019 report from Canada’s Chief Public Health Officer Dr. Theresa Tam focused on addressing different forms of stigma. Included in the report was one form of stigma—obesity or weight stigma—that has proven remarkably difficult to overcome. We are hoping to change that. As a team of researchers from across Canada, we have previously written about the harm that weight bias causes. Now, and for the first time, we are ensuring that the newly updated Canadian Clinical Practice Guidelines for obesity management include explicit guidance to reduce weight bias and obesity stigma among health professionals and policy-makers. <Read More>

    Hospital-Acquired Pneumonia Possibly Linked to Worse Outcomes Among Patients With Acute Heart Failure – August 6, 2020 – Prevention and early screening efforts need to be stepped up for patients with acute heart failure (AHF) who develop hospital-acquired pneumonia (HAP) for their condition, due to clinical outcomes that include an increase in all-cause death both during and after their hospital stay and worsening heart failure, reported study results in Journal of Clinical Medicine. <Read More>

    New TKI May be a Game Changer for Breast Cancer – August 6, 2020 – Advances in therapy have improved overall survival for patients with HER2-positive metastatic breast cancer, but for those with brain metastases—as much as 50% of that population—the outlook has remained grim…Now a new oral oncology drug may change that picture. In April, the FDA approved the novel tyrosine kinase inhibitor tucatinib (Tukysa, Seattle Genetics), in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases who received one or more prior anti-HER2–based regimens in the metastatic setting. <Read More> 

    Large Study Sheds Light on Pneumonitis in NSCLC – August 6, 2020 – A history of pneumonitis increases the risk that patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy or immune checkpoint inhibitors (ICIs) will develop treatment-associated pneumonitis (TAP), according to a study of real-world and clinical trial data presented at the American Association for Cancer Research (AACR) 2020 virtual annual meeting. The study investigators also found a higher incidence of TAP among patients receiving ICIs with or without chemotherapy compared with those receiving chemotherapy alone. <Read More> 

    Online PharmD Programs are Becoming More Common, Presenting Unique Opportunities for Students – August 6, 2020 – As the number of pharmacy schools grow across the United States, there is also a notable rise in online PharmD programs, which present unique opportunities and challenges, according to a presentation at the American Association of Colleges of Pharmacy Annual Meeting and Expo. The presentation, titled, “A Discussion of Current Online PharmD Degree Programs,” examined the challenges of developing a virtual PharmD degree program, how to covert a face-to-face program to an online environment, and opportunities for developing such a program. <Read More> 

    Pharmacies See Continued Growth as Primary Care Hubs – August 6, 2020 – Healthcare consumers are embracing primary care in retail pharmacies with the rising use of consultation kiosks, exam rooms, and walk-in clinics, according to the J.D. Power 2020 U.S. Pharmacy Study. James Beem, managing director of healthcare intelligence at J.D. Power, said the major drug store chains are reaping the fruits of a strategy they’ve laid out over the past several years “to become the center of gravity for consumer healthcare.” <Read More> 

    New Guidelines Emphasize Biomarker & Genetic Testing  – August 5, 2020 – In its latest guidelines for the treatment of patients with metastatic pancreatic cancer, the American Society of Clinical Oncology (ASCO) emphasized the importance of patients undergoing biomarker and genetic testing. Published in the Journal of Clinical Oncology, the updates were prepared by a clinical guidelines committee that includes the Pancreatic Cancer Action Network’s (PanCAN) associate director of Scientific and Medical Affairs, Cassadie Moravek. <Read More> 

    A Safe Environment is Critical When Discussing a Patient’s Use of CBD, Kratom as Pain Relief Alternatives – August 5, 2020 – With a growing number of products containing cannabidiol (CBD) and kratom available in the marketplace, many pharmacists and pharmacy students are increasingly being asked to discuss the use of these products, especially in relation to pain relief. In order to support this process of engagement, presenters at the American Association of Colleges of Pharmacies’ Virtual Pharmacy Education 2020 conference discussed some educational strategies for the pharmacy curriculum that can support a comprehensive approach to student practice-readiness in answering questions regarding patient use of CBD and kratom products. <Read More> 

    FDA Guidance for Health Care Professionals When Prescribing Treatment for Opioid Use Disorder – August 5, 2020 – The opioid epidemic affects millions of Americans every year. To address this public health crisis, in a recent statement, the FDA provided some guidelines for health care professionals when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). In the statement, the FDA noted that it is important for health care professionals to routinely discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD. Additionally, it may also be important to consider prescribing naloxone to patients who have been prescribed medicine to treat OUD previously or patients who may be at an increased risk of opioid overdose. <Read More> 

    Pharmacy Technicians Contribute to Positive Outcomes for Patients Using Opioids by Avoiding Stigma – August 5, 2020 – …The opioid epidemic continues to affect American communities at staggering rates. Since 1999, the opioid epidemic has been an increasingly constant headline in newspapers, social media, and on television with approximately a half-million opioid-related deaths (CDC, 2018; CDC, 2019; Wilson, 2020). Perhaps no other health care worker has been exposed to this epidemic more frequently than pharmacy technicians and pharmacists…Because of the frequency of these encounters, pharmacists and pharmacy technicians often suffer from something known as “compassion fatigue.” This is a phenomenon in which a care provider experiences secondary trauma from caring for another, which can result in turnover, decreased morale and job satisfaction, and reduced empathy toward patients (Winstanley, 2020). <Read More> 

    Tip of the Week: Minimizing Pharmacy Workflow Interruptions – August 5, 2020 – Wouldn’t it be nice to have all day to perform the tasks one sets out to do during their work day and not be interrupted by anyone at anytime? Can you imagine how much work you could get done? Can you imagine the stress reduction? Well, those sorts of conditions are rarely, if ever, applicable for anyone’s job. In fact, so-called interruptions are a large part of pharmacists’ jobs and involve a considerable amount of their communication activities. However, workflow and job descriptions can be designed to minimize the impact of these disruptions and even leverage them to promote higher quality of work while minimizing their deleterious impact on work life. <Read More> 

    Pharmacies are Playing a Bigger Role in Local Retail During the Pandemic – August 5, 2020 – The role of the pharmacy store, especially in areas where there aren’t a lot of other retail outlets, is changing during the pandemic. Pharmacies are rarely just pharmacies these days. They’re one-stop shops, convenient for consumers who want to consolidate their shopping trips. <Read More> 

    The Evolution of Specialty Medicine – August 4, 2020 – In recent years, specialty pharmacy has branched out from representing a small subset of pharmacies to become its own industry. Specialty pharmacy originated nearly 50 years ago and was an area of medicine that was designed to serve patients who needed specific therapies for various conditions. Originally, these therapies mainly consisted of infusions to treat diseases such as hemophilia, cancer, and malnutrition. An industry that originally dispensed medications to treat a small number of conditions has now transformed into a conglomerate that serves a population of patients with more than 6800 rare diseases that are treated by more 450 specialty medications. <Read More> 

    Preparing Future Pharmacists to Recognize a Mental Health Crisis and Take Action – August 4, 2020 – Mental health first aid (MHFA) is increasingly becoming a part of pharmacy education, and training more pharmacists to recognize patients in crisis may be critical for saving lives. A session of the American Association of Colleges of Pharmacy (AACP) Annual Meeting’s Virtual Pharmacy Education 2020, July 13-31, provided data on mental health in the United States and Australia, and offered insights into training programs for pharmacy students to apply mental health first aid. <Read More> 

    Women are the Majority of Pharmacy School Graduates, So Why is There Still a Gender Gap? – August 4, 2020 – Although women comprise the majority of pharmacy school graduates, gender gaps still exist in pharmacy ownership, school deanships, and other leadership positions, according to a panel presentation at the American Association of Colleges of Pharmacy Annual Meeting. The presentation, titled “Women Leading Big Change,” discussed how the role of women in the pharmacy industry is growing but still needs to evolve in order to achieve equity. <Read More> 

    Forecast Predicts 3.29% Drug Spend Increase in Health Systems – August 4, 2020 – A drug pricing forecast predicts a 3.29% increase for pharmaceutical purchases by health systems in 2021, driven by ongoing disruptions due to the coronavirus disease 2019 (COVID-19) pandemic and enduring market trends, according to a press release. The report said that the COVID-19 pandemic has created many uncertainties, including variations in medication use trends and the impact of total expenditures, which could have a significant effect in the coming year. “One of the things that makes this year’s forecast particularly more variable is that utilization—the medications that are utilized and the volumes that are prescribed, could be very different depending on how COVID continues this year and into the beginning of next year,” said Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, in an interview with Pharmacy Times. <Read More> 

    To Save Money and Lives, Involve Pharmacists in Cardiovascular Disease Prevention Efforts, Group Says – August 4, 2020 – The Community Preventive Services Task Force (CPSTF) released a recommendation that the health care system incorporate tailored pharmacy-based interventions for cardiovascular disease (CVD) prevention into overall prevention efforts. Interventions delivered by community and health-system pharmacists is cost-effective and keeps patients adherent to their medication regimen, CPSTF found. <Read More>

    World Federation of Hemophilia (WFH) publishes “The WFH Guidelines for the Management of Hemophilia, 3rd edition” – August 4, 2020 – Led by content leads, Alok Srivastava, MD, and Glenn Pierce, MD, PhD, WFH Vice-President, Medical, this 3rd edition of the World Federation of Hemophilia (WFH) Guidelines for the Management of Hemophilia offers up-to-date guidance and practical recommendations on the diagnosis and management of hemophilia, including the management of musculoskeletal complications and inhibitors, updates to laboratory diagnosis and genetic assessments, as well as new recommendations on outcome assessments. Informed by the best available evidence and supplemented with expert opinion and patient preference, the more than 300 practical recommendations in these guidelines were developed by consensus using the “Trustworthy Consensus-Based Statement” process to ensure reliable guidance. <Read More> 

    CareSource Launches Pharmacist Provider Status Pilot – August 4, 2020 – CareSource, a leading multi-state managed care plan, announced a six-month pilot program reimbursing pharmacists for clinical services provided to Medicaid patients in Ohio. The Pharmacist Provider Status Pilot program includes two sites near Dayton, Ohio: an independent pharmacy in a rural community, Camden Village Pharmacy, and an inner-city independent pharmacy, ZIKS Pharmacy. “The pilot program is a win-win for the Greater Dayton community because it improves health outcomes and will decrease hospitalizations and unnecessary ER visits for patients with chronic diseases,” said Nnodum Iheme, owner of ZIKS Family Pharmacy. “Pharmacists are in a position to greatly impact better health outcomes by increasing patient access to care. We are grateful to CareSource for giving us the opportunity to serve our community by promoting optimal health.” <Read More> 

    National Association of Specialty Pharmacy Annual Meeting and Expo to Offer Unique Virtual Experience – August 4, 2020 – The National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo will take place between September 14 and 18, 2020, and will be held within a unique virtual environment. Although the coronavirus disease 2019 (COVID-19) pandemic prevents an in-person expo this year, a virtual experience will allow attendees to earn required continuing pharmacy education (CPE) credits, share best practices, enhance their knowledge, and even wander a virtual convention hall with an array of poster presentations. The meeting will have a shortened daily schedule with a later start time in order to allow participants from all over the country to participate, even those in different time zones. <Read More> 

    Study: Medicare Beneficiaries Visit Pharmacies Much More Often than Primary Care Offices – August 3, 2020 – Among more than 681,000 active Medicare beneficiaries evaluated in a nationwide study, investigators found that the median number of visits to community pharmacies was significantly higher than encounters with primary care physicians, suggesting that community pharmacists have frequent opportunities to deliver preventive care and chronic disease management services. <Read More>

    Low Vitamin K Levels Associated With Greater Risk of Death in Older Adults – August 3, 2020 – Older adults with low vitamin K levels are more likely to die within 13 years compared with those who have adequate vitamin K levels, according to a study published in The American Journal of Clinical Nutrition. Vitamin K is found in leafy greens and vegetable oils such as soybean and canola. It is important for maintaining healthy blood vessels and may also have protective health benefits, according to the study authors. The study, which was led by researchers at the Jean Mayer USDA Human Nutrition Center on Aging at Tufts University and Tufts Medical Center, was composed of nearly 4000 Americans between the ages of 54 and 76 years. The data were a meta-analysis of 3 different ongoing studies: The Health, Aging, and Body Composition Study, The Multi-Ethnic Study of Atherosclerosis, and the Framingham Heart Study. <Read More> 

    Pharmacy Compliance:  Will Your Pharmacy’s Policies and Protocols Withstand a DEA or PBM Audit? – August 3, 2020 – Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) as well as private payors, and it is true for all pharmacies regardless of their size, location, and the patients they serve. What does it mean for a pharmacy to be compliant? As with pharmacy practice itself, there is no one-size-fits-all approach. While pharmacies face the same general compliance obligations based on the types of medications they dispense, pharmacy compliance programs need to be custom-tailored in order to ensure that they will be effective in terms of both (i) protecting patients and providers from mistakes; and, (ii) avoiding liability in the event of an audit, inspection, or investigation. <Read More>

    340B in the News

    CMS Boosts Outpatient Payment By 2.6% While Making Further Cuts to 340B Hospitals – August 5, 2020 – The Centers for Medicare and Medicaid Services is proposing a 2.6% payment increase for ambulatory surgical centers in an update to the Outpatient Prospective Payment System released Monday. This proposed change would also help promote site neutrality between hospitals and ambulatory surgical centers and encourage the migration of services from the hospital setting to the lower-cost ASC setting, CMS said. Under the proposed rule, 340B hospitals take another reimbursement hit as CMS has proposed a 28.7% cut to their drug payments. <Read More> 

    Trump Administration Announces Executive Action Intended to Reshape the Economics of the Prescription Drug Distribution Chain in the United States – August 4, 2020 – On July 24, 2020, one day after Department of Health and Human Services (HHS) Secretary Alex Azar renewed the COVID-19 public health emergency declaration for an additional 90 days, President Trump announced a series of three executive orders and one anticipated executive order aimed at addressing the perception of high-cost prescription drugs in the United States. Two of the announced orders would obligate certain clinics to pass along 340B program discounts to patients and effectively eliminate the Anti-Kickback Statute’s safe harbor for drug manufacturer rebates specifically offered to pharmacy benefits managers (PBMs). The Administration’s public advocacy of these goals has been evident since May 2018 at the time of the release of the HHS’ Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, which debuted a number of the policy changes reflected in these executive orders, including changes directed at specific pharmaceutical products, such as insulin and epinephrine.[1] These policies, if enacted, are likely to have a substantial impact on prices of FDA-approved drugs in the U.S. market. <Read More>

    Hospitals Vow to Fight Court of Appeals 340B Ruling – August 3, 2020 – Reimbursements that HHS imposed for certain medications administered in outpatient clinics of 340B hospitals were based on a “reasonable interpretation of the Medicare statute” and can remain, a 3-judge panel of the US Court of Appeals for the District of Columbia ruled July 31, 2020. The 2-1 reverses a District Court level ruling that HHS, through CMS, exceeded its authority when it imposed a 28.5% rate cut for a category of outpatient drugs used by hospitals enrolled in the discount program, which was created to support safety net hospitals serving Medicaid patients. <Read More>