Clinical Insights: December 15, 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

    OrladeyoTM (berotralstat) Capsules – New Orphan Drug Approval – December 3, 2020 – BioCryst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-daily Orladeyo™ (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. “OrladeyoTM offers people with HAE and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents an important and welcome step in making more treatment options available to physicians and patients,” said Anthony J. Castaldo, president and chief executive officer of the US Hereditary Angioedema Association (HAEA). <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Saxenda® (liraglutide) Injection – New Approved Indication – December 4, 2020 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda® (liraglutide) injection 3 mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to reduced-calorie meals and increased physical activity. Saxenda® was approved in 2014 for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased physical activity. <Read More>

    New/Updated Drug Shortage

    December 14, 2020

    December 11, 2020

    December 10, 2020

    December 09, 2020

    December 08, 2020

    December 7, 2020

    New Drug Recall and Safety Alerts

    Sildenafil and Trazodone Tablets by AvKare – New Voluntary Recall – December 9, 2020 – AvKARE is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues… To date, AvKARE has not received any reports of adverse events. <Read More> 

    Anagrelide Capsules by Torrent Pharmaceuticals Limited – New Voluntary Recall – December 9, 2020 – Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide could increase the risk of clotting (blood coagulation) and clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    HIV Medicine Association Issues New HIV Treatment Guidelines – December 12, 2020 – The HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America has issued an update to its 2013 guideline for providing comprehensive, evidenced-based primary care to people living with HIV. The guidelines were published in Clinical Infectious Diseases. As effective combination antiretroviral treatment, as well as other improvements to the care and treatment of people with HIV, have allowed this population to steadily age, these individuals encounter new health challenges associated with getting older. Even people with well-treated HIV have an elevated risk of various health conditions associated with aging, including cardiovascular disease, various cancers, kidney disease, cognitive decline and bone density loss. <Read More>

    Facing up to Long COVID – December 12, 2020 – Multiorgan symptoms after COVID-19 are being reported by increasing numbers of patients. They range from cough and shortness of breath, to fatigue, headache, palpitations, chest pain, joint pain, physical limitations, depression, and insomnia, and affect people of varying ages. At the Lancet–Chinese Academy of Medical Sciences conference on Nov 23, Bin Cao presented data (in press at The Lancet) on the long-term consequences of COVID-19 for patients in Wuhan, and warned that dysfunctions and complications could persist in some discharged patients for at least 6 months. So-called long COVID is a burgeoning health concern and action is needed now to address it. <Read More>

    Choose the Most Appropriate Therapy to Fight Influenza – December 11, 2020 – Just as each influenza season is different, the effectiveness of annual influenza vaccines is never the same from year to year. Influenza vaccine components are chosen each year based on the predicted predominant strains. Since the choices are made based on predictions, no vaccine reaches 100% effectiveness in preventing seasonal influenza. A vaccine effectiveness of 19% to 60% is historically consistent. The Centers for Disease Control and Prevention (CDC) reported an early start to the 2019-2020 influenza season during the week of November 9, 2019.2 Influenza B predominated early in the season, with influenza A cases increasing during the remainder of the season. The US Influenza Vaccine Effectiveness Network assessed patients aged 6 months or older who were seen for respiratory illness in the outpatient setting across 5 study sites.3 As of February 2020, among 6879 patients who tested positive for influenza, 37% had received an influenza vaccine. Vaccine effectiveness was 50% against influenza B, 37% against influenza A, and 45% for both types combined. <Read More>

    FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine – December 11, 2020 – The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S…The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information. <Read More>

    FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting – December 11, 2020 – Following the recent positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution. <Read More> 

    Three Challenges in Medication Adherence That Can Be Overcome by Pharmacists – December 11, 2020 – Prescribed medications are at the forefront of treating many chronic health conditions, and managing existing conditions is essential to overall health. Medication nonadherence results in greater health care spending and poorer patient health outcomes. One study in the Annals of Long-Term Care reported nonadherent diabetes patients were twice as likely to be hospitalized. Plus, medication adherence challenges are likely to worsen as patients continue to postpone routine health care visits. The CDC reports that certain chronic conditions, including diabetes, kidney disease, chronic obstructive pulmonary disease, and sickle cell disease, can place patients at high risk of serious illness from coronavirus disease 2019, making medication adherence even more critical. Increased medication nonadherence could have lasting consequences for population health. This article will discuss challenges in medication adherence and strategies pharmacists can use to help patients overcome them and improve their health. <Read More>

    Pharmacy Groups React to Supreme Court Ruling on State Regulation of Controversial PBMs – December 10, 2020 – The Supreme Court of the United States issued its landmark ruling in Rutledge v. Pharmaceutical Care Management Association (PCMA), determining whether community pharmacies are protected from abusive payment practices. The unanimous (8 to 0) decision ruled in favor of the interests of patients and community pharmacies, who have been fighting for years to regulate pharmacy benefit managers (PBMs), the controversial middlemen that manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. With this ruling, states will have greater authority to protect their local businesses and their patients from PBM overreach. “This is a historic victory for independent pharmacies and their patients. And it confirms the rights of states to enact reasonable regulations in the name of fair competition and public health,” said National Community Pharmacists Association CEO B. Douglas Hoey, pharmacist, MBA. “This is a great day for pharmacists and their patients,” said Scott J. Knoer, executive vice president and CEO of the American Pharmacists Association. “For years, PBMs have threatened the sacrosanct relationship between pharmacists and their patients and have never been forced to answer to any authority for their actions. This opinion redresses that imbalance and returns the power to protect the interests of patients to the states and other local authorities, where it belongs.” <Read More>

    Medication Safety: The Key to an American Health Crisis – December 10, 2020 – With the convergence of COVID-19 and the flu, the need for an equipped and accessible healthcare provider within the community has never been greater. Pharmacists, as frontline clinicians, have stepped up to the challenge and have demonstrated a remarkable ability to serve as a beacon of information, services, and care for millions of patients during an especially confusing and turbulent time…As a pharmacist, an industry advocate, and the American Pharmacists Association (APhA) President-elect, I believe pharmacy is the profession most exposed to the risks and implications of ADEs, and pharmacists are the most well-positioned providers to identify and resolve them. <Read More>

    Supreme Court Rules That States Can Regulate Pharmacy Benefit Managers – December 10, 2020 – The Supreme Court ruled unanimously Thursday that states can regulate pharmacy benefit managers, the prescription drug “middlemen” whose actions affect 250 million Americans. The ruling is a victory for 45 states, led by Arkansas, and independent pharmacies that sought to stop so-called PBMs, which process prescription drug claims and then reimburse pharmacies, from keeping reimbursement rates low for generic drugs. That has caused thousands of independent pharmacies to close, particularly in rural areas. <Read More>

    Pharmacy Technician Certification Board (PTCB) Rolls Out Advanced Certification for Experienced Pharmacy Technicians Who Have Comprehensive Knowledge and Skills – December 10, 2020 – The Pharmacy Technician Certification Board (PTCB), the nation’s leading credentialing organization for pharmacy technicians, has launched its Advanced Certified Pharmacy Technician (CPhT-Adv) credential. Certified Pharmacy Technicians (CPhTs) can earn the new certification when they complete four of PTCB’s specialty assessment-based certificate programs, or three certificate programs plus PTCB’s Compounded Sterile Preparation Technician® (CSPT®) Certification, and have 3 years of pharmacy work experience. <Read More>

    Unfounded Preventions, Treatments for COVID-19 and the Pharmacist Role in Educating the Public – December 10, 2020 – Recommendations from reputable medical groups, such as the CDC, should serve as the primary source for individuals to protect themselves, according to a poster presented at the American Society of Health-System Pharmacists’ (ASHP) virtual 2020 ASHP Midyear Clinical Meeting and Exhibition. The objective of the study was to increase awareness among pharmacists about products for which unfounded claims have been made regarding prevention of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infections. <Read More>

    Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data – December 10, 2020 – For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of hundreds of thousands of Americans…The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, is meeting to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH. <Read More>

    Fauci Warns Pharmacists of Challenging Months Ahead During Session at ASHP – December 9, 2020 – Pharmacists should be prepared for a challenging few months ahead until the majority of the public can be vaccinated against coronavirus disease 2019 (COVID-19), warned Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a session Wednesday at the American Society of Health-System Pharmacists 2020 Meeting. Fauci said he was first introduced to health care at his father’s pharmacy in Brooklyn, where Fauci would frequently deliver prescriptions. Although his initial aspirations were to be on the teaching faculty at Weill Cornell Medicine, Fauci became director of NIAID in 1986 and got involved in emerging diseases, including Zika, Ebola, and HIV/AIDS. “Now, I’m totally consumed with the work we’re doing with COVID-19,” Fauci said. <Read More>

    ADA Releases 2021 Standards of Medical Care in Diabetes Centered on Evolving Evidence, Technology, and Individualized Care – December 9, 2020 – The American Diabetes Association® released the 2021 Standards of Medical Care in Diabetes. The 2021 Standards of Care is now live online in Diabetes Care. Based upon the latest scientific diabetes research and clinical trials, the Standards of Care includes new and updated recommendations and guidelines to care for people with diabetes. The Standards of Medical Care in Diabetes—2021 provides the latest in comprehensive, evidence-based recommendations for the diagnosis and treatment of children and adults with type 1, type 2, or gestational diabetes; strategies for the prevention or delay of type 2 diabetes; and therapeutic approaches that can reduce complications, mitigate cardiovascular and renal risk, and improve health outcomes. <Read More>

    Skip the Clopidogrel? TAVR Patients Benefit From Antiplatelet Therapy That Includes Aspirin Only  – December 9, 2020 – Single antiplatelet therapy (SAPT) is recommended over dual antiplatelet therapy (DAPT) for transcatheter aortic valve replacement (TAVR) patients with no indications for anticoagulation, according to a new study published in the American Journal of Cardiology. “Current practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel for three to six months followed by lifelong aspirin after transcatheter aortic valve implantation,” wrote Agam Bansal, MD, of the Cleveland Clinic’s Heart and Vascular Institute, and colleagues. “However, recently published POPular TAVI trial and other trials that have compared DAPT with SAPT have shown decreased bleeding events and non-inferiority with respect to ischemic stroke, all-cause mortality, and myocardial infarction amongst patients receiving SAPT.” <Read More>

    Advancing Pharmacy Practice in a Rural Area – December 9, 2020 – An analysis of the Northern Navajo Medical Center (NNMC) found that although opportunities grew due to provider shortages, pharmacists practicing at the top of their license have the ability to significantly improve access to care, particularly in areas revolving around medication management, according to a poster presented at the American Society of Health-System Pharmacists’ (ASHP) virtual 2020 ASHP Midyear Clinical Meeting and Exhibition. The NNMC is 1 of 5 facilities located within the Shiprock Service Unit, which is the largest service unit on the Navajo Nation, offering inpatient and ambulatory care services. Pharmacist involvement in ambulatory patient care includes anticoagulation, chronic care, epilepsy, and rheumatology, according to the study authors. <Read More>

    CDC Expands Local Area Health Estimates to Include Data for the Entire U.S. NEW PLACES Data Help Inform Local Health Decisions – December 9, 2020 – The Centers for Disease Control and Prevention (CDC) has announced the expansion of the 500 Cities Project, a 2016 initiative to provide city- and neighborhood-level health estimates for a large portion of the nation’s population. The project is being renamed PLACES, and now provides Population Level Analysis and Community Estimates to the entire United States to show the prevalence of chronic diseases and the health impacts on underserved communities. Many Americans face health-related challenges like chronic respiratory diseases, heart disease, diabetes, and obesity that put them at increased risk for severe illness from diseases such as COVID-19. The critical information in PLACES can help local and state health departments and community organizations decide where best to target resources to address these health challenges. <Read More>

    New Guidelines for Treating the Complications of Brain Tumours – December 9, 2020 – The brain can be affected by a number of different types of tumour and this leads to serious complications such as epileptic attacks, brain edema, hemorrhage, or thrombosis. Hitherto, there have been no uniform standards available for the diagnosis and treatment of these common symptoms. An international team of researchers comprising experts from the leading oncology societies ESMO (European Society for Medical Oncology) and EANO (European Association of Neuro-Oncology) has now compiled international guidelines and standards for the treatment of these complications, and these have been published in the top journal Annals of Oncology (Impact Factor: 18.2). As EANO President, Matthias Preusser, Head of the Division of Oncology (MedUni Vienna’s Department of Medicine I) initiated these international guidelines and has played a leading role in coordinating them in his capacity as last author. <Read More>

    Antidepressant Utilisation and Risk of Suicide in Young People – December 9, 2020 – The Therapeutic Goods Administration (TGA) undertook this safety investigation in response to concerns that increased antidepressant prescribing had resulted in an increased rate of suicide in young people in Australia. The review commenced in June 2020 and concluded in December 2020…The investigation found that while the increasing use of antidepressants in young people was a concern, the strength of the current evidence available was insufficient to conclude that a causal relationship existed between prescribing of antidepressants and rates of youth suicide. <Read More>

    FDA’s New Draft Guidance Regarding Biosimilarity and Interchangeability – December 9, 2020 – On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for interchangeable biosimilar products. 85 FR 74345 (“Draft Guidance”). The Q&As in the Draft Guidance will be finalized by adding them as a revision to the final guidance document, Questions and Answers on Biosimilar Development and the BPCI Act. <Read More>

    Ability to Predict C-Diff Mortality Nearly Doubled With New Guidelines – December 9, 2020 – Clostridioides difficile infection (CDI) is the most common health care-associated infection in the United States, causing an estimated 12,800 deaths each year. The deadly and notoriously stubborn superbug, C. diff has been hard to spot and harder to stop. In 2017, two organizations leading the war on C. diff updated their guidelines for assessing patients and the severity of their infections. Now a University of Houston team, led by Kevin Garey, professor of pharmacy practice and chair of the UH College of Pharmacy Department of Pharmacy Practice and Translational Research, has proven that specific updates were well advised. Garey is reporting his findings in the journal Open Forum Infectious Diseases. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System – December 9, 2020 – The U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. <Read More>

    Standardized Practices Address Challenges With Germline Genetic Testing in Prostate Cancer – December 8, 2020 – Although updated guidelines and targeted therapies have led to the routine recommendation of germline genetic testing for patients with prostate cancer, increasing demand for tests and limited access to genetics providers have created an unmet need, according to a review performed by the Germline Genetics Working Group of the Prostate Cancer Clinical Trials Consortium that was published in the Journal of Clinical Oncology. Despite the inclusion of this testing in multiple guidelines, practitioners still find challenges in implementing it on a clinical level. In order to help bring the field closer to an actualized version of precision medicine, the review touched on existing germline testing guidelines, challenges, possible solutions, and the current benefits and limitations of testing. <Read More>

    New Guidelines for Emerging Tick-borne Disease – December 8, 2020 – Babesiosis is a rapidly emerging tick-borne disease that threatens unsuspecting victims with moderate to severe illness. How this infection will be diagnosed and treated by medical professionals in the years to come is outlined in a new Babesiosis Guideline issued by the Infectious Diseases Society of America (IDSA). This guideline is widely disseminated and is the go-to source for health workers and patients alike throughout the United States and beyond seeking the latest medical information. <Read More>

    Duration of Vancomycin Reduced Through Education of Prescribers, Utilization of MRSA PCR Nasal Swab – December 8, 2020 – A study on the de-escalation of vancomycin for pneumonia treatment found that there are opportunities to improve the use of the methicillin-resistant S. aureus (MRSA) PCR nasal swab upon diagnosis to further guide antibiotic prescribing for pneumonia, according to a poster presentation at the American Society of Health-System Pharmacists’ virtual 2020 ASHP Midyear Clinical Meeting and Exhibition. The objective of the study was to develop a method for de-escalation of intravenous (IV) vancomycin in patients receiving vancomycin with at least 1 other antibiotic appropriate for the treatment of community-acquired pneumonia (CAP). <Read More>

    Clinical Pathways for Patients With Giant Cell Arteritis During the COVID-19 Pandemic: An International Perspective – December 8, 2020 – Giant cell arteritis, a common primary systemic vasculitis affecting older people, presents acutely as a medical emergency and requires rapid specialist assessment and treatment to prevent irreversible vision loss. Disruption of the health-care system caused by the COVID-19 pandemic exposed weak points in clinical pathways for diagnosis and treatment of giant cell arteritis, but has also permitted innovative solutions. The essential roles played by all professionals, including general practitioners and surgeons, in treating these patients have become evident. Patients must also be involved in the reshaping of clinical services. As an international group of authors involved in the care of patients with giant cell arteritis, we reflect in this Viewpoint on rapid service adaptations during the first peak of COVID-19, evaluate challenges, and consider implications for the future. <Read More>

    Increased Use of Maintenance Therapy Following Transplantation for MM in US Clinical Practice – December 8, 2020 – Maintenance therapy use following autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (MM) has increased in routine clinical practice in the US since 2011-2013 and is associated with longer time to next myeloma treatment (TNTT), according to study results presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. <Read More>

    NCCN Adds Oral Decitabine, Cedazuridine Combo to MDS Guidelines – December 8, 2020 – The National Comprehensive Cancer Network recently updated its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes (MDS) to include the combination of decitabine and cedazuridine as a category 2a recommendation for the treatment of adult patients with intermediate- and high-risk MDS. Cedazuridine is an orally administered, fixed-dose combination of the DNA hypomethylating agent, decitabine, and cedazuridine, an inhibitor of cytidine deaminase. <Read More>

    Special Pharmacy Carve-Out a Dominant Trend for 2021: AscellaHealth Cites Benefits of Coordinated Medical Rx Strategy to Lower Total Cost of Care for Employers – December 7, 2020 – AscellaHealth, a national specialty pharmacy benefit manager (SPBMTM) serving commercial, Medicare and Medicaid segments, forecasts the overriding trend in 2021 among employers, third party administrators and payers will be the adoption of a specialty pharmacy Rx and/or medical benefit carve-out program that designates one vendor management model across the medical and/or pharmacy benefit channel. As a departure from the traditional pharmacy benefit management approach, a coordinated specialty medical Rx strategy that addresses the complexities of high-cost specialty claims enables a holistic view of member behavior that prevents unsafe or overly complex prescribing, which is crucial to lowering the total cost of care. <Read More> 

    2020 Pharmacy Salary Survey Results: Salaries Stabilize as Stress and Job Dissatisfaction Soar – December 7, 2020 – Each year, Drug Topics® surveys pharmacists on important workplace issues—from compensation encompassing salary, wages, and raises to stress levels and overall job satisfaction. As far as compensation goes, pharmacists are still largely making close to what they made in previous years. Salary versus hourly pay was nearly evenly split between respondents, with 50.4% of pharmacists reporting an annual salary and 49.57% receiving compensation on an hourly basis. In 2020, the majority of pharmacists who responded to the survey reported earning a salary of more than $120,000 or an hourly wage more than $61. The number of pharmacists with salaries in the $100,000 to $130,000 range in 2020 seems to be closely aligned with that from 2019: 38% reported making that amount in 2020, compared with 40% in 2019. However, a total of 39% of pharmacists in 2020 reported earning more than $130,000 per year, compared with 50% in 2019. <Read More> 

    340B in the News

    Attorneys General Ask HHS to Punish 340B Program Bilkers — But Pharma Claims It’s Fighting ‘Waste And Abuse’ – December 14, 2020 – Imagined as a benefit for low-income patients, the government’s 340B scheme requires participating drugmakers to sell their drugs at significant discounts to play ball in Medicare and Medicaid. But some pharmas are now loudly refusing to follow the rules after citing “waste and abuse” — and state prosecutors are demanding an intervention. In a Monday letter to HHS Secretary Alex Azar, a group of attorneys general from 28 states and the District of Columbia called on the agency to impose civil penalties on a group of Big Pharma players it claims have either stopped or plan to stop honoring discounts under the government’s 340B program. <Read More> 

    HRSA Publishes Long-Awaited (and Long-Overdue) 340B Program Alternative Dispute Resolution Process Final Rule – December 14, 2020 – On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative Dispute Resolution (ADR) Final Rule. The Final Rule was issued more than 10 years after the Affordable Care Act (ACA) amended the 340B statute to require the Secretary of HHS to promulgate regulations establishing and implementing a binding ADR process to resolve certain disputes between covered entities and manufacturers. <Read More> 

    Hospitals Allege HHS Let Pharmas Evade 340B Drug Discount Rules – December 14, 2020 – Six provider groups including the American Hospital Association on Friday filed a federal lawsuit against HHS, alleging the department failed to enforce 340B drug pricing program requirements and allowed actions from drug companies that undermined the program. Three 340B hospitals also joined the suit, alleging they had been harmed by drugmakers’ refusal to discount prescription drugs at community-based pharmacies as the program requires. HHS could not be reached for comment on the suit by time of publication. The plaintiffs want the department to force drug companies into compliance and issue refunds to hospitals that didn’t receive discounts. They’re also asking for an order requiring HHS to pinpoint which drug companies are responsible for the violations, and refer them to the Office of Inspector General to assess penalties. <Read More>

    McDermottPlus Check-Up – December 11, 2020 – President-elect Biden announced key healthcare officials, and Congress passed a short-term measure to avert a government shutdown as negotiations continue on a comprehensive funding package. The Food and Drug Administration (FDA) is expected to issue an Emergency Use Authorization for the first coronavirus (COVID-19) vaccine within days…The long-awaited 340B Administrative Dispute Resolution (ADR) Rule, which was required by the ACA, allows 340B covered entities and drug manufacturers to bring claims before an HHS panel (“ADR Panel”) to resolve disputes involving 340B overcharges and duplicate discounts or diversion. Decisions of the ADR Panel will be “final agency decisions,” eligible for judicial appeal. The ADR Panel decisions will also be made public and considered precedential. In general, covered entities and drug manufacturers must bring claims for review by the ADR Panel within three years of the date of the conduct giving rise to the dispute. Consistent with the underlying statutory provisions, drug manufacturers must first conduct a formal audit of a covered entity before bringing a claim to the ADR Panel, while covered entities do not have such a requirement. Both covered entities and drug manufacturers are expected to engage in “good faith” efforts to resolve disputes before bringing them to the ADR Panel. <Read More> 

    HHS Finalizes Dispute Resolution for 340B Program – December 11, 2020 – HHS’ Health and Resources Administration has finalized a rule aimed at providing additional stability to the 340B drug program, allowing for a dispute resolution mechanism for hospitals that contend that drug companies overcharged them for medications. Any claim involving an overcharge of $25,000 or more may be submitted for dispute resolution. Drug companies also have the ability to file an appeal if they believed participating hospitals, clinics and other providers received duplicative discounts. The installation of the dispute resolution mechanism has been a decadelong journey. The Affordable Care Act contained language calling on HHS to handle disputes in 2010. Although a rule is now in place, it was not received warmly by hospital groups. <Read More> 

    The Fate of the Trump Administration’s Controversial Most Favored Nation Drug Pricing Model is Unclear Given Mounting Legal Challenges – December 10, 2020 – On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive in similar countries.[1] CMS utilized its purported authority under the Affordable Care Act (ACA) to implement a pricing model via its Center for Medicare and Medicaid Innovation (CMMI)…CMS estimates that the MFN Drug Payment Amount may result in a reimbursement reduction of 65% (as it relates to ASP) by year 4. By way of comparison, CMS currently reimburses all separately payable Part B drugs, except for 340B drugs, at ASP plus 6% . The payment rate for 340B drugs is currently ASP minus 22.5%. For 340B drug claims, which must be submitted with the JG modifier, the reimbursement rate under the MFN model will be capped at the lesser of the phased in MFN price or the existing non-MFN payment (i.e., ASP minus 22.5%).[13] CMS expects that 340B entity pricing will remain consistent with ASP minus 22.5% in 2021, with 3% reductions in each following year based on CMS’s predictions concerning future international price increases by manufacturers. As a result, CMS is relying heavily on 340B entities to provide products and services to patients who seek care in alternative venues if and when the patients’ current providers are unwilling or unable to continue offering products subject to MFN model pricing. Time will tell if this holds true. <Read More> 

    AHF Blasts Amgen Over Drug Restrictions; Asks Biden Administration to Sanction It and Others – December 10, 2020 – AIDS Healthcare Foundation (AHF) strongly condemns Amgen for its announced refusal to sell “orphaned” drugs at reduced prices to non-profit providers who are covered entities under the 340B Drug Discount Program. The U.S. government already gives special favors to drug companies to produce expensive “orphaned drugs” for rare diseases that would otherwise be unaffordable. Amgen has joined eight other companies who have declared they will no longer offer drugs at the reduced 340B price to covered entities’ contract pharmacies as required by section 340B of the U.S. Health Services Act. This announcement is a serious blow to many rural hospitals and non-profit community health centers overwhelmed with the current COVID-19 crisis. They depend on the savings from the 340B program to keep open to stretch existing federally funded health care programs. Many of these small providers can’t afford to open and run their own pharmacies and use contract pharmacies to maximize their participation in the 340B program. <Read More> 

    CMS Releases 2021 OPPS and ASC Payment System Final Rule | Insights – December 9, 2020 – The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. Note that the incoming Biden Administration may wish to revise or reverse course on some provisions. Among notable changes, CMS abandoned a proposal to pay Average Sales Price (ASP) minus 28.7 percent for 340B drugs, changed the expansion exception process for a subset of physician-owned hospitals, expanded the prior authorization process to include two new categories of services reimbursed under the OPPS and eliminated the Inpatient Only (IPO) list. <Read More> 

    Conn. Health Providers Say Drug Maker Restrictions on Discount Program Will Leave Patients Stranded – December 8, 2020 – Shortly before his 24th birthday, Jesus Morales Sanchez of New Haven was diagnosed with Type 1 diabetes, a chronic illness that requires him to take insulin for the rest of his life. But at the time, he was in between jobs and didn’t have health insurance, so the medication would cost him several hundred dollars that he didn’t have. That’s when Sanchez was able to get insulin at a low price through the federal 340B Drug Pricing Program. “340B literally saved my life and was able to give me a stepping stone so that I could go back into my daily life,” he said…But this fall, several drug makers that provide a large bulk of chronic disease medications in the United States put restrictions on the types of health sites they will service and the kinds of medications they will provide as they demand stricter program oversight and additional claims data. <Read More> 

    Novo Nordisk to End 340B Discounts on Drugs Dispensed at Community Pharmacies – December 8, 2020 – Novo Nordisk has sent a notice to 340B member hospitals saying that starting Jan. 1 it will no longer give 340B discounts to contract pharmacies. If hospitals don’t have an in-house pharmacy to dispense 340B-covered drugs, they can designate one contract pharmacy to receive all of its drugs covered under the program. Novo Nordisk is the sixth drugmaker to put such a restriction on 340B drugs, following the likes of Eli Lilly, AstraZeneca, Merck, Sanofi and Novartis. The drugmakers have said that allowing hospitals to receive 340B drugs through contract pharmacies forces the drugmakers to pay duplicate discounts on the drugs, costing them money. <Read More> 

    Progressive Care Announces October Growth in Net Revenues as COVID-19 Testing Ramps Up – December 7, 2020 – Progressive Care Inc., a personalized healthcare services and technology company, is pleased to announce performance data for the month of October, which featured a strong jump in operating margins, significant sequential monthly growth in net revenues, and the establishment of sales growth related to rapid results COVID-19 testing: 1) Consolidated net sales across all locations during October 2020 totaled $3,3M, representing a 7% sequential monthly growth 2) October margins increased to 27%, helping to drive a 53% sequential monthly jump in cash on hand 3) Prescriptions filled during October grew 1% on a sequential monthly basis 4) 340B pharmacy dispensing fees grew 119% in October on a year-over-year basis 4) The Company booked nearly $100K in revenues related to rapid results COVID-19 testing in October. <Read More>