Skip to content

Clinical Insights: January 5, 2021

Posted on January 5, 2021 By RxStrategies, Inc. - ,

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

No new update.

New Formulation Approval

No new update.

New Indication/Dosage Approval

No new update.

New/Updated Drug Shortage

December 31, 2020

December 30, 2020

December 29, 2020

New Drug Recall and Safety Alerts

Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL by Precision Dose, Inc. – Voluntary Drug Recall – December 31, 2020 – Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata. From information provided by the manufacturer, Sunstar Americas, Inc., use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such pneumonia and bacteremia. To date, no adverse events have been reported to Precision Dose, Inc. related to this recall. <Read More>

New Generic/Biosimilar Approval and Launch

Glucagon Injection USP, 1 mg/vial – New Generic Approval – December 28, 2020 – The U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous. “Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until now, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” said Sally Choe, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. <Read More>

Clinical and Pharmacy News

Let Pharmacy Chains Vaccinate the General Public Now, Former FDA Commissioner Urges – January 4, 2021 – Large retail pharmacy chains like CVS and Walgreens should be allowed to give COVID-19 vaccines to the general public now to help speed up the vaccination campaign and improve public health, former FDA commissioner Scott Gottlieb, MD, wrote in an opinion column published in The Wall Street Journal Jan. 3. According to Dr. Gottlieb, the federal government is currently withholding up to 55 percent of vaccine doses available to make sure there is enough supply to give everyone receiving the first round of shots a second dose. While sticking to the dosing schedule is essential, the supply of vaccines is expanding, and more of the available shots should be given now, he wrote. <Read More>

Prevention of Thrombosis in Covid-19 Patients: Only a Small Number of Ongoing US Trials Investigating Noacs in the Outpatient Setting – January 4, 2021 – The prevention of venous thromboembolism is one of many priorities in managing Covid-19 patients, but there are several complex considerations, especially when examining preventive strategies for those being managed as outpatients. General considerations include the dose of anticoagulant, anticoagulant drug/drug class choice, and treatment duration, as well as to whom and when to administer anticoagulation along the disease spectrum. According to GlobalData’s Pharma Intelligence Center Clinical Trials Database, as of 23 December, there were only two clinical trials in the US investigating the use of novel oral anticoagulants (NOACs) in Covid-19 outpatients with the goal of preventing thrombosis events. Data readouts from these trials have the potential to affect the anticoagulant landscape. If the results are notable, NOACs will have the opportunity to be integrated into Covid-19 outpatient management strategies. <Read More> 

List Prices for 589 Drugs Increase in the 1st Days of 2021 – January 4, 2021 – So far in January, a total of 589 drugs have seen list prices increase by an average of 4.2 percent, according to data from GoodRx, an online drug pricing platform. As of Jan. 2, list prices for 582 brand-name drugs were increased by an average of 4.2 percent. List prices for seven generic drugs were increased by an average of 2.7 percent. In January 2020, a total of 639 drugs increased in price by an average of 6 percent. In 2019, 486 drugs increased in price by an average of 5.2 percent. <Read More>

Allergic Reactions to COVID-19 Vaccines Shouldn’t Stop Vaccinations – January 4, 2021 – COVID-19 vaccines currently approved for emergency use by the U.S. Food and Drug Administration (FDA) are safe even among people with food or medication allergies, according to allergists from Massachusetts General Hospital. A review of all relevant information was published in the Journal of Allergy and Clinical Immunology: In Practice on December 31. To provide reassurance and support for vaccination across the U.S., the team of allergists sought to provide clear guidance to patients in accordance with recommendations by U.S. regulatory agencies. <Read More> 

Moderna Increases Expected Number of Vaccine Doses for 2021 by 20% – January 4, 2021 – Moderna increased the minimum number of COVID-19 vaccines it expects to produce in 2021 by 20 percent to 600 million, the drugmaker said Jan. 4. Moderna said it’s continuing to invest and add staff to increase production, and its goal is to deliver as many as 1 billion doses of the vaccine this year. It previously estimated it would produce at least 500 million doses this year. About 18 million doses have been supplied to the U.S. so far. The country is on track to get 100 million doses of the vaccine by the end of March and 100 million more by June, according to CNBC. <Read More>

The Impact of COVID-19 on Recent Pharmacy School Graduates – January 4, 2021 – Pharmacy students, particularly the graduating class of 2020, have been uniquely affected by the coronavirus disease 2019 (COVID-19) pandemic. Students raised concerns about the potential impact on their professional career due to the unforeseen schedule changes. In March 2020, universities were faced with the decision of transitioning to remote learning to protect students and their families from COVID-19. Approximately 69,000 US schools closed, affecting 36 million students, and New York quickly became the epicenter of the pandemic in the United States. Across the globe, 56 countries closed schools, impacting more than 516 million students worldwide.1 Finding the safest solution for experiential pharmacy students to finish their advanced pharmacy practice experiences (APPEs) was the main priority, which led to online didactic classes and virtual/remote APPEs being created to keep students on track with their education. <Read More>

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine – January 4, 2021 – Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years. <Read More> 

Utilizing Companion Diagnostics to Drive Clinical Decisions – January 1, 2021 – Precision oncology originates from the discovery of relevant, unique molecular abnormalities associated with specific cancers. It focuses on the selection of a specific anticancer therapy based upon the presence of an actionable target and disrupting that target’s role in driving cancer growth, thereby optimizing clinical benefit to the patient. Fundamental to the practice of precision oncology is the ability to accurately detect clinically relevant mutations, interpret test results, and apply the genomic information to the selection of the most appropriate agent. <Read More>

CDC Issues COVID-19 Vaccine Guidance for Americans with HIV, Guillain-Barré and Other Underlying Conditions – January 1, 2021 – People with certain underlying conditions can receive a COVID-19 vaccine as long as they haven’t had a severe allergic reaction to any of the vaccine’s ingredients, the Centers for Disease Control and Prevention said in recently released guidance. “Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the agency noted in recommendations posted Saturday. <Read More>

American Pharmacists Association Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule – January 1, 2021 – Ilisa B.G. Bernstein, senior vice president for pharmacy practice and government affairs at the American Pharmacists Association, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled “Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards”. The comment was written on Dec. 30, 2020, and posted on Dec. 31, 2020…APhA urges HHS/CMS to ensure transparency by requiring disclosure of pharmaceutical benefit manager (PBM) information submitted from the plans under Section 1150A to the states and providing clear guardrails for submitted data to prevent manipulation or misleading information by PBMs. <Read More>

Why Did the Flu Almost Disappear This Year? – January 1, 2021 – What happened to the flu this year? Public health authorities warned us that a bad influenza outbreak on top of COVID-19 would be too much for the health care system to handle. That’s why the Centers for Disease Control and Prevention urged Americans to get their flu shots early. So far, though, masks and social distancing in effect against COVID-19 transmission seem to be slowing the spread of flu. This should not be a big surprise. In countries like Australia, New Zealand, South Africa, Argentina and Chile, there was very little flu from May through September. That is winter in the Southern Hemisphere. <Read More>

FDA Tightens Regulation of Fentanyl Medication – December 31, 2020 – Illicit fentanyl may be a deadly scourge on the black market, but for thousands of Americans in severe cancer pain, prescription fentanyl is an essential medicine. And for some, the potent synthetic opioid may soon be harder to obtain.  The U.S. Food and Drug Administration recently announced plans to tighten its Risk Evaluation and Mitigation (REMS) program for transmucosal immediate-release fentanyl (TIRF) products. TIRF medicines such as Actiq and Subsys are approved for breakthrough pain in cancer patients, who regularly take other opioids around-the-clock and are considered “opioid tolerant.” <Read More>

Early Treatment Can Stem the Tide of COVID-19 Hospitalizations and Deaths, States the Association of American Physicians & Surgeons (AAPS) – December 31, 2020 – A peer-reviewed updated summary of COVID-19 early-treatment best practices was published Wednesday morning, in Reviews in Cardiovascular Medicine, an interdisciplinary scientific, open access journal…The early stage of viral replication provides a therapeutic window of tremendous opportunity to potentially reduce the risk of more severe sequelae in high risk patients. Precious time is squandered with a ‘wait and see’ approach … resulting in unnecessary hospitalization, morbidity, and death.… In newly diagnosed, high-risk, symptomatic patients with COVID-19, SMDT has a reasonable chance of therapeutic gain with an acceptable benefit-to-risk profile. <Read More>

State Law Regulating PBMs Not Pre-Empted by ERISA – December 31, 2020 – The Supreme Court recently held that the Employee Retirement Income Security Act (“ERISA”) does not preempt an Arkansas law regulating Pharmacy Benefit Managers (“PBMs”). PBMs generally act as intermediaries between health plans and pharmacies, providing services such as claims processing, negotiating rebates from drug manufacturers, and setting pharmacy reimbursement rates. Arkansas passed a law regulating the PBMs’ pharmacy reimbursement rates. Under this state law, a PBM could not set a reimbursement rate lower than the pharmacy’s acquisition cost. <Read More> 

Drugmakers to Hike Prices for 2021 Amid COVID, Political Pressures – December 31, 2020 – Drugmakers including Pfizer, Sanofi, and GlaxoSmithKline plan to raise US prices on more than 300 drugs in the United States on Jan. 1, according to drugmakers and data analyzed by healthcare research firm 3 Axis Advisors. The hikes come as drugmakers are reeling from effects of the COVID-19 pandemic, which has reduced doctor visits and demand for some drugs. They are also fighting new drug price cutting rules from the Trump administration, which would reduce the industry’s profitability. <Read More>

HMS Study Finds Mask-Wearing, Social Distancing Reduce Covid-19 Infections by 87% on College Campuses – December 31, 2020 – Harvard Medical School researchers found that a combination of wearing masks and practicing social distancing can reduce student and faculty Covid-19 infections on college campuses by roughly 87 percent, according to a peer-reviewed study published last week. The study, which was published on Dec. 21 in the Annals of Internal Medicine, used a dynamic microsimulation model to project the clinical and economic outcomes of different intervention strategies over the course of one semester, or 105 days. <Read More>

Pharmacists Play a Vital Role in Diabetes Management – December 31, 2020 – Based on 2018 data, about 34.2 million individuals have diabetes, representing 10.5% of the US population, according to the CDC’s National Diabetes Statistics Report, 2020. Just 19.2% of US adults 18 years or older with diagnosed diabetes met the following goals from 2013 to 2016: glycated hemoglobin A1C (HbA1C) value less than 7%; being a nonsmoker; blood pressure less than 140/90 mmHg; and non–high-density lipoprotein cholesterol less than 130 mg/dL. The results of a systematic review of 44 studies showed that medication therapy management (MTM) services improved drug regimen adherence and appropriateness. Long-term complications can be prevented when patients have well-controlled diabetes, and pharmacists can play a critical role through MTM. <Read More>

Centene Completes Acquisition of Specialty Pharmacy Pantherx – December 31, 2020 – Centene completed its purchase of Pantherx, a Pittsburgh-based pharmacy specializing in drugs to treat rare diseases, the insurer said Dec. 30. Under the deal, Pantherx and its management team will operate independently as a part of Centene’s Envolve Pharmacy Solutions. Envolve is Centene’s drug management program that provides pharmacy benefit manager services and specialty pharmacy solutions to millions of members in the U.S. <Read More>

Pharmacists are Moderately Satisfied with Compensation, Job Satisfaction, Survey Shows (Part 1) – December 31, 2020 – Pharmacists are moderately happy with both their compensation and jobs, according to the results of the 2020 Pharmacy Times Salary and Job Satisfaction Survey. When asked to rate their satisfaction with their annual total compensation on a scale of 1 to 7 (with 1 being “not at all” and 7 being “extremely”), the average response of the 292 respondents to that question was 4.85. Further, when asked to rate their overall job satisfaction on the same scale, the average was 4.53 compared with 4.23 in 2019. <Read More>

U of Missouri Settles Suit Against Former Pharmacy Professor Accused of Selling Student Research – December 30, 2020 – The University of Missouri has reached a settlement with a former pharmacy professor who was accused of stealing and selling student research, ABC News reported. The university sued Ashim Mitra in 2019, alleging he received $1.5 million and the potential to make millions more in royalties after selling a student’s research without permission. The research was done by Kishore Cholkar, a student who developed a more effective way to deliver drugs to the eye, ABC News reported. The university claims the money belongs to it because the research was completed while the student was working as a graduate research assistant at the University of Missouri-Kansas City. <Read More>

Consider Impact of Certain Medications on Brain Function – December 30, 2020 – The CDC’s healthy brain initiative aims to improve “understanding of brain health as a central part of public health practice” through education to health care providers and patients. The Pharmacy Times® Cognitive Health Focus series offers pharmacists information to help them actively participate as members of the health care team in addressing brain health. The previous article in the series discussed how pharmacists can help optimize patients’ modifiable risk factors, including nutrition and physical activity, to improve cognitive health. This article highlights medications that both cause and treat cognitive issues and summarizes the use of brain health supplements. <Read More> 

Redefining the Management of Anemia in Patients With Cancer – December 30, 2020 – It is estimated between 30% and 90% of patients with cancer develop anemia related to chemotherapy, radiation, bleeding, hemolysis, neoplastic bone marrow infiltration, renal or hepatic failure, or even in the absence of these factors. Anemia may contribute to fatigue, lethargy, dyspnea, anorexia, and difficulty concentrating, and is a negative prognostic indicator for disease progression, survival, and overall risk of death. Correction of anemia is associated with improvement in health-related quality of life and fatigue. Syeda Saba Kareem, PharmD, BCOP, shared her insights on the management of anemia in the 2020 Directions in Oncology Pharmacy® conference in a session titled The Relationship Between Anemia and Cancer: Opportunities for Pharmacists to Improve Patient Outcomes. <Read More> 

Tip of the Week: Managing Professional Identity in Pharmacy Personnel – December 30, 2020 – Everyone has a self-identity, and professionals also have a professional identity. Professional identity is a type of social identification and is the sense of oneness individuals have with a profession and the degree to which individuals define themselves as profession members. Professional identity consists of the individual’s alignment of roles, responsibilities, values, and ethical standards to be consistent with practices accepted by their specific profession. <Read More>

Building the Case for Integrated Care With Specialty Pharmacy in Health Systems – December 30, 2020 – Cancer is an indiscriminate, tenacious foe, making health care treatment more costly and complex. An 18% increase in new diagnoses from 2002 to 2017 has fueled a market determined to eradicate this disease.1 This has led to more than 40 oncology-related drug applications filed in 2020. Specialty pharmacies have become the primary providers of oncology-related medication therapy. Health system-owned or -integrated delivery networks are increasing. Health system specialty pharmacies have grown from 7.8% in 2015 to 26.4% in 2019.3 Their value proposition, in many respects, resembles that of a typical specialty pharmacy. However, characteristics unique to health system specialty pharmacies are essential for optimal patient care. <Read More>

Experts: Telehealth Will Play an Important Post-Pandemic Role in Pharmacy Practice – December 30, 2020 – Virtual health services, also known as telehealth, can be just as effective as in-person visits if used by pharmacists properly, according to a presentation at The American Society of Health-System Pharmacists virtual 2020 Midyear Clinical Meeting & Exhibition…According to the presenters, telehealth offers patients an interactive, cost-effective way of seeing a health care provider remotely using video and audio technology, and the coronavirus disease 2019 (COVID-19) pandemic has made telehealth an invaluable service. Before the pandemic, telehealth was seen as optional and primarily used during special circumstances. However, telehealth now offers patients a safe way to speak to their health care providers. <Read More>

Aetna Pharmacy Network Change Affects 400,000 Illinois Medicaid Members – December 30, 2020 – Aetna Better Health of Illinois excluded Walgreens from its pharmacy network Dec. 1, a change that affected roughly 400,000 Medicaid members in Illinois, according to the Chicago Tribune. Aetna said the change was reviewed by the Illinois Department of Healthcare and Family Services and determined to be equitable. However, lawmakers and physicians argue the exclusion hits poor and majority-Black neighborhoods that have increasingly few choices for pharmacies. In a written statement to the Chicago Tribune, Aetna said it has almost 2,000 pharmacies in Illinois that are considered in-network for Medicaid members, including Walmart, Jewel-Osco and independent pharmacies. <Read More>

Updated Insomnia Guidelines Support Behavioral, Psychological Treatments – December 29, 2020 – A new clinical practice guideline from the American Academy of Sleep Medicine (AASM) supports the use of behavioral and psychological treatments for chronic insomnia disorder in adults, with a combination of cognitive therapy strategies and education about sleep regulation. The guideline was developed by an expert task force and approved by the AASM board of directors. The strongest recommendation encourages the use of cognitive behavioral therapy for insomnia, combining 1 or more cognitive therapy strategies with education about sleep regulation and behavioral strategies such as stimulus control instructions and sleep restriction therapy. Treatment typically involves between 4 and 8 sessions. <Read More>

Guidance Provided for Antibiotic Stewardship in Pediatrics – December 29, 2020 – In an American Academy of Pediatrics policy statement, published online Dec. 28 in Pediatrics, guidance is provided for inpatient and outpatient antibiotic stewardship. Jeffrey S. Gerber, M.D., Ph.D., from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues discuss inpatient and outpatient antibiotic stewardship programs (ASPs) in pediatrics, including essential personnel, infrastructure, and activities needed. <Read More>

Pharmacist-Led Telemonitoring of Patients With HBP Reduces Heart Attack, Stroke Incidence – December 29, 2020 – Patients enrolled in a pharmacist led telemonitoring program to control high blood pressure (HBP) were about half as likely to experience a heart attack or stroke as patients receiving routine primary care, according to the results of a new study. Uncontrolled hypertension is the largest modifiable risk factor contributing to death from all causes in the United States, with nearly half of American adults having received a diagnosis of HBP, according to the study authors, who noted that most adults do not have their numbers under control. <Read More>

Peer Exchange: The Diagnosis, Treatment, and Standard of Care for Immune Thrombocytopenia – December 29, 2020 – Medical history and a physical exam remain care providers’ best tools when diagnosing cases of immune thrombocytopenia (ITP); however, challenges remain. In a recent episode of the Pharmacy Times® Peer Exchange live event series, experts discussed challenges in diagnosing, treating, and managing ITP, and current standards of care. The discussion was moderated by Bhavesh Shah, RPh, BCOP, senior director of specialty and hematology/oncology pharmacy, Boston Medical Center Health System, Boston, Massachusetts. Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator of hematology/ oncology, University of Arizona Cancer Center, and clinical assistant professor, University of Arizona College of Pharmacy, both in Tucson, Arizona, said that because ITP is a blood disorder characterized by decreased platelets, the condition doesn’t just affect the patient, but also daily living. <Read More>

Select High-Alert Medications Require Caution – December 29, 2020 – Searching by generic name for rapid-acting insulins may cause prescribing or dispensing errors. Medication errors have been reported because of mix-ups between Novo Nordisk’s FiaspTM and NovoLogTM, as well as the company’s authorized generic for NovoLogTM, all of which are insulin aspart. However, FiaspTM has niacinamide in the formulation, which makes it even faster acting than NovoLog. We warned about such errors in the April 2020 issue of Pharmacy Times®. Now the same problem exists with Eli Lilly and Company’s newly marketed LyumjevTM, HumalogTM, and the company’s authorized generic for HumalogTM, all of which are insulin lispro. LyumjevTM (pronounced LOOM jehv), which officially is insulin lispro-aabc (a 4-letter suffix is given to newly approved biologicals), contains treprostinil and other ingredients that make the product faster acting than HumalogTM. <Read More>

Pharmacists’ Roles in Addressing Oncology Biosimilar Challenges – December 29, 2020 – In a virtual symposium titled Adopting Oncology Biosimilars Into Clinical Practice: How Pharmacists Can Help Pave the Way, two expert speakers shared strategies for addressing challenges in the implementation and use of biosimilars in patients with cancer. As of September 2020, the FDA had approved 16 biosimilars for oncology-related indications, including supportive care and treatment uses. However, adoption of biosimilars in the United States has been slow. This symposium provided critical information, given the use of biosimilars is estimated to reduce biologic acquisition costs by 10% to 40%. <Read More> 

NHA Creates Partnership, Path for Accredited Immunization Training for Pharmacy Technicians Ahead of New Vaccines – December 29, 2020 – National Healthcareer Association (NHA) is now partnering with CEimpact to offer pharmacy technicians an ACPE-accredited immunization training option, helping them qualify to administer vaccinations according to the U.S. Department of Health and Human Services’ (HHS) Public Readiness and Emergency Preparedness (PREP) Act. CEimpact, a leader in pharmacy training and education, will provide both immunization training and technician-specific continuing education courses to NHA’s educational and employer partners, along with pharmacy technicians. The immunization training is open to all state-licensed pharmacy technicians, regardless of whether they are nationally certified. <Read More>

340B in the News 

HHS Guidance Clarifies Use of Contract Pharmacies in 340B Program – January 4, 2021 – New guidance from HHS has clarified that hospitals and other covered entities in the 340B Drug Pricing Program are entitled to discounts for covered outpatient drugs even if they use contract pharmacies to distribute the drugs to patients. Drug manufacturers are “obligated to deliver its covered outpatient drugs to” contract pharmacies acting as agents of a covered entity, and the manufacturers cannot charge more than the 340B ceiling price for the drugs, according to the guidance released on Dec. 30. The guidance comes after five national hospital organizations, including the American Hospital Association, and the leading hospital pharmacist organization filed a lawsuit against HHS after the department failed to address the refusal of several major drug manufacturers to discount the prices of covered outpatient drugs because hospitals used contract pharmacies. <Read More> 

Attorney General Tong Leads Coalition of Attorneys General in Important Win on Prescription Drugs – December 31, 2020 – (Hartford, CT) — Attorney General William Tong issued the below statement following an advisory opinion from the Health and Human Services Department (HHS) that concludes drug manufacturers are required to deliver discounts under the 340B Drug pricing Program on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. “This is a powerful statement from HHS that puts a tremendous amount of pressure on drug companies to do the right thing,” Attorney General Tong said. “It is very encouraging to see HHS affirm Congress’s plain intent for the 340B Drug Pricing Program, and is consistent with the continuing efforts of this office to protect vulnerable patients from the unlawful and unacceptable actions of these drug manufacturers.” <Read More> 

HHS General Counsel Opinion Says 340B Discounts Apply to Contract Pharmacies – December 31, 2020 – The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities…Although advisory opinions do not carry the force of law, they set out the agency’s current views on issues. Those views may be reflected in the various regulatory, enforcement, and oversight powers the federal government has to run the 340B Program, the HHS noted. <Read More> 

Opinion: Feds Aren’t Enforcing Lifesaving Drug Discount Program – December 30, 2020 – A federal program created in the 1990s that requires drug manufacturers to distribute significantly discounted medications to health care providers and pharmacies serving low-income patients is under attack. Several of those manufacturers are refusing to ship critically important, life-saving drugs to pharmacies. This means that patients served by safety-net providers, like our community health centers, can’t get affordable medications…We strongly urge the federal government to enforce the drug discounts of this essential program. Action must be taken before further harm falls on people who cannot access the vital medications they need to survive. <Read More> 

AHF Thanks HHS for Clarifying Rules on 340B Drug Pricing; Blasts Pharma’s Greed – December 30, 2020 – AIDS Healthcare Foundation (AHF) welcomed and praised an advisory opinion issued by the Office of the General Counsel for the United States Health and Human Services Department (HHS) which concluded that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. (HHS press release). The opinion came on the heels of widespread public pressure on HHS by safety net providers after nine rogue drug companies including Amgen, AstraZeneca, Eli Lilly, Merck, Novartis and Sanofi-Aventis, among others, announced they planned to refuse to continue to provide certain drugs at the legally required ‘340B price’ as required by section 340B of the U.S. Public Health Services Act. In addition, 28 U.S. state attorneys general recently drew a line in the sand trying to protect this essential part of the healthcare safety net against the seemingly limitless greed of the drug industry. In a December 14 letter, the bipartisan group of elected attorneys general demanded that U.S. Health and Human Services Secretary Alex Azar take immediate steps to enforce the law “to address drug companies’ unlawful refusal to provide critical drug discounts to covered entities such as community health centers under the 340B Drug Pricing Program.” <Read More> 

Report on Medicare Compliance Volume 29, Number 45. News Briefs: December 2020 #2 – December 29, 2020 – The American Hospital Association (AHA), Association of American Medical Colleges and other groups said Dec. 14 they have filed a lawsuit against HHS, alleging it failed to enforce the requirements of the 340B drug discount program. “This lawsuit will require the department to take actions that we’ve long called for against drug companies that are disregarding the law by limiting the distribution of certain 340B drugs to eligible hospitals. It’s time to stop these illegal actions from drug companies and protect vulnerable patients and communities,” said AHA President and CEO Rick Pollack. <Read More>