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Clinical Insights: March 23, 2022

Posted on March 23, 2022 By RxStrategies, Inc. -

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

New Drug Approval

Ztalmy® (ganaxolone) Oral Suspension – New Drug Approval – March 18, 2022 – FDA has approved Ztalmy® (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. CDD is a rare developmental epileptic encephalopathy (dysfunction of the brain) caused by CDKL5 gene mutations. The CDKL5 gene is responsible for making proteins that are important for normal brain functioning and development…The effectiveness of Ztalmy® to treat seizures associated with CDD in patients 2 years of age and older was established in a double-blind, randomized, placebo-controlled study in participants aged 2 to 19 years of age. <Read More>

Adlarity® (donepezil) Transdermal System – New Drug Approval – March 11, 2022 – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced the U.S. Food and Drug Administration (FDA) has approved Corium’s Adlarity® (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type. Adlarity® is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil. Adlarity® is the first approved prescription drug product using Corium’s proprietary Corplex™ transdermal technology, which has been used for years in consumer products. <Read More>

New Indication/Dosage/Formulation Approval

Nasonex® 24HR Allergy (mometasone furoate monohydrate) Nasal Spray – New OTC Drug Approval – March 17, 2022 – Perrigo Company plc, a leading provider of Quality, Affordable Self-Care Products, announced that it has received final approval from the U.S. Food and Drug Administration for the over-the-counter use of Nasonex® 24HR Allergy (mometasone furoate monohydrate 50mcg). This approval marks the first branded Rx-to-OTC switch for the Company and paves the way for Nasonex® to enter the OTC marketplace. Perrigo expects to begin offering Nasonex® 24HR Allergy later this year. <Read More>
Rinvoq® (upadacitinib) ER Tablets – New Approved Indication – March 16, 2022 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for Rinvoq® in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. <Read More>

New/Updated Drug Shortage

March 22, 2022

March 18, 2022

March 17, 2022

March 16, 2022

March 14, 2022

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) – New Generic Approval – March 16, 2022 – Viatris Inc. and Kindeva Drug Delivery L.P. announced that, Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), the first approved generic version of AstraZeneca’s Symbicort®.  Breyna™, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths. <Read More>

Clinical and Pharmacy News

Test to Treat, DIR Fees Top Legislative Issues at APhA – March 21, 2022 – APhA priorities include pharmacist reimbursement, PBMs, and DIR fees. Improving President Biden’s Test to Treat initiative, doing away with direct and indirect renumeration (DIR) fees, and pharmacist reimbursement for provided services remain top legislative and regulatory priorities for the American Pharmacists Association (APhA), the organization’s leaders said at the APhA 2022 Annual Meeting & Exposition in San Antonio, Texas. While the COVID-19 pandemic has brought about the “largest expansion of scope of practice” in 5 years, said Michael Baxter, senior director of Regulatory Affairs for APhA, the organization is working to make the temporary emergency use authorities granted by the Department of Health and Human Services permanent. <Read More>

The Pharmacist’s Role in Bleeding Disorders – March 21, 2022 – Pharmacists are an important part of the care team for patients with bleeding disorders, providing services such as medication counseling and reconciliation. March is Bleeding Disorders Awareness Month, which gives pharmacists the opportunity to advocate for and honor patients with bleeding disorders. Having a bleeding disorder can put a patient at risk of a hemorrhage and death…One of the most important roles a pharmacist can play in the treatment of patients with bleeding disorders is counseling on the symptoms of bleeding, which include but are not limited to easy bruising, bleeding gums, heavy bleeding from small cuts, and nosebleeds. Making sure patients are aware of these signs can be lifesaving. <Read More>

What Are the Advantages of Social Media for Pharmacy Professionals? – March 21, 2022 – As the profession moves more toward the internet, it is helpful to know how to best use the various platforms. Social media platforms are constantly changing and it is important to keep up with their evolution to optimize usage. Sometimes it is difficult to start. Many individuals only have personal Facebook accounts. What should you post and how often? Should you tweet or retweet? Share an article on LinkedIn or just like a post? When social media started, it was mostly just for fun, but this is no longer the case. The pharmacy world is no exception, as it is becoming more internet-based, with many professionals using social media platforms to advertise and market products and services. Social media is now a critical part of our way of life, used by colleges, corporations, governments, and pharmacies to make announcements and share ideas. Social media enables pharmacists to bring attention to their brand and work and allows the profession to highlight and showcase its value. It also allows pharmacists to connect with one another. <Read More>

The Impact of Social Determinants of Health on Patients With Diabetes – March 20, 2022 – Factors such as economic stability and education access can be categorized into social determinants of health. It is crucial for pharmacy teams to identify and address social determinants of health (SDOH) in the care of patients with diabetes to improve their outcomes, according to a session presented at the American Pharmacists Association 2022 Annual Meeting and Exposition. Erin E. Pauling, PharmD, BCACP, assistant dean for Academic Affairs and clinical assistant professor of Ambulatory Care at Binghamton University School of Pharmacy and Pharmaceutical Sciences, discussed the multiple different frameworks that exist in SDOH, which she defined as “conditions in the environments where people are born, live, work, play, worship, and age.” <Read More>

Just Culture Safety Science Framework Can Help Reduce Medication Errors – March 20, 2022 – Just culture framework helps to balance safety and accountability in medication error by identifying the root cause without blaming an individual. The use of a just culture safety science framework can be a valuable tool for pharmacists and pharmacy technicians to help reduce medication errors, according to a session at the American Pharmacists Association 2022 Annual Meeting and Exposition. The framework helps to balance safety and accountability in preventing medication error by identifying the root cause and avoiding blaming and shaming the individual. “When you have a closed system, it’s something that you work all the processes to try to figure out how to keep things as safe as possible, how you can reduce the liability for your organization,” Jennifer Adams, PharmD, EdD, FAPhA, FNAP, associate dean for Academic Affairs and associate professor at the Idaho State University College of Pharmacy, said during the session. “Just culture is one of those frameworks that our health system colleagues use pretty consistently.” <Read More>

Hormone Replacement Therapy Can Benefit Some Patients with Gynecologic Cancers ­– March 19, 2022 – Hormone replacement therapy can improve quality of life without necessarily increasing the risk of recurrence. Despite significant concerns for some patients with cancer, such as those who are BRCA-positive, treatment with hormone therapies can have significant benefits, according to an expert panel at the Society of Gynecologic Oncology 2022 Annual Meeting on Women’s Cancer. During the session titled “Bring Back That Loving Feeling…But Not Your Cancer: HRT in Gynecologic Cancer,” panelists noted that hormone replacement therapy (HRT) can improve quality of life without necessarily increasing the risk of recurrence. Panelist Melissa Gerardi Fairbairn, PA-C, Yale New Haven Hospital-Smilow Cancer Center, discussed the various uses of HRT. <Read More>

Outgoing APhA President Leal Commends Pharmacy for Commitment to Advocacy – March 19, 2022 – In her 2021 inaugural address as the 166th president of the American Pharmacy Association (APhA), Sandra Leal, MD, MPH, FAPhA, CDCES, asked her audience to use their voices to speak and to act. In her final address at the APhA 2022 Annual Meeting and Exposition, Leal acknowledged the tireless work of the pharmacists who have done just that. “Our teams are stressed and stretched,” said Leal. “Workforce shortages exist across the country and across all practice settings. We are dealing with a crisis…where advocacy efforts can seem insufficiently responsive to the demands of pharmacy practice.” As pharmacists have faced professional challenges ranging from vaccine misinformation, doubt, and mistrust to rapid changes in practice guidelines, they have remained “committed to serving [their] patients and communities,” said Leal. <Read More>

Pharmacists Can Help Educate Patients on the Implications of Cannabis Products – March 19, 2022 – Opening the door for communication in a nonjudgmental manner is essential for pharmacists to counsel patients on cannabis use. In recent years, medical cannabis use has been rapidly gaining traction, so it is critical for pharmacists to understand the clinical and pharmacologic uses and different products to better assist their patients interested in using them.“The regulations are changing and it is really important, for us, as pharmacists, to know how its regulated in our states,” Kam Capoccia, PharmD, BCPS, CDCES, clinical professor of community care at the Western New England University College of Pharmacy and Health Sciences, said during a presentation at the American Pharmacists Association Annual Meeting 2022. <Read More>

Evaluating Pharmacist Attitudes Toward, Understanding of Biosimilars – March 19, 2022 – Gaps exist in knowledge about interchangeability and substitutions. Although data have been reported for health care providers and patients, comprehensive, quantitative data are lacking on pharmacist attitudes toward and understanding of biosimilar medications, according to a poster presented at the APhA 2022 Annual Meeting & Exposition. Researchers set out to evaluate pharmacist understanding of biosimilars, including understanding of biosimilar interchangeability. Survey participants included self-identified pharmacists and certified pharmacist technicians. The 36-item questionnaire assessed knowledge of and attitudes toward biosimilars, including concepts related to FDA approval, interchangeability, substitutions, state pharmacy law, biosimilar naming, and patient involvement. <Read More>

As Use Increases, Understanding Marijuana is Essential for Pharmacists – March 19, 2022 – Patients should start low, go slow, and track their own dosing and effects. As a pharmacist, some of your patients are likely using marijuana—be it bud, concentrates, edibles, extracts, tinctures, or topicals. All marijuana formulations have documented interactions with drugs and foods, and none have the kind of randomized controlled trial data that pharmacists usually turn to for counseling. “We need to open the door for communication about these products with our patients,” said Kam Capoccia, PharmD, BCPS, CDCES, Clinical Professor of Community Care, Western New England University College of Pharmacy and Health Sciences. “Whenever we take a history, we include medical and recreational marijuana along with tobacco, medications, and health history. If you ask, you will learn.” <Read More>

Pharmacy Professionals Need to Prioritize Their Own Mental Health to Help Patients – March 19, 2022 – Pharmacy leadership remaining mindful, connected, and engaged is crucial to support the mental health needs of their staff. The COVID-19 pandemic placed pharmacies in a vital role on the frontlines of care, but the increased demands for their services also caused a subsequent rise in burnout among pharmacy staff. As such, it is just as essential for pharmacy professionals to prioritize their own mental health as it is for them to help their patients.“There is a difference between when you’re feeling stressed and when you are ultimately feeling burnt out,” Alex Varkey, PharmD, MS, FAPhA, director of pharmacy services at Houston Methodist Hospital, said during a session at the American Pharmacists Association Annual Meeting 2022. “From a self-assessment standpoint, understanding ‘okay, hey am I just feeling stressed out? Is this kind of based on one particular incidence or…I’m starting to feel burnt out?’” Vakey said. <Read More>

Gauging Pharmacists’ Comfort Immunizing Young Children – March 18, 2022 – Recent changes in regulations mean that pharmacists are able to administer vaccines to children as young as 3. In recent years, regulations have been changed to allow pharmacists to provide vaccinations to children as young as 3 years of age. However, some may be hesitant to do so, according to a poster presented at the APhA 2022 Annual Meeting & Exposition, held in San Antonio, Texas, that assessed the perception and satisfaction with administering immunizations to young children.Investigators created a 17-question questionnaire that was emailed to pharmacists in the Pharmacist Moms Facebook group, the Arkansas Pharmacists State organization, and the Pediatric Pharmacy Association National Organization. Respondents had a 21-day period to respond. <Read More>

Breaking the Stigma Against Naloxone Communication, Distribution in the Pharmacy – March 18, 2022 – Session at the American Pharmacists Association Annual Meeting discusses the importance of naloxone in reducing the burden of the opioid epidemic. To lead the change and create more patient-centric communication in the pharmacy regarding naloxone, it is essential to educate pharmacists and pharmacy technicians on their role in the process, according to a session at the American Pharmacists Association Annual Meeting and Exposition 2022. Thomas Franko, PhD, associate professor of pharmacy practice at Wilkes University, discussed how the health care landscape is currently shifting from an opioid epidemic to a holistic substance use epidemic, which has caused an increase in stimulant use, such as cocaine and methamphetamine. <Read More>

Lifesaving COVID drugs are Sitting Unused on Pharmacy Shelves, HHS Data Shows – March 18, 2022 – Even as this winter’s omicron surge recedes, more than 2,000 people in the U.S. still get hospitalized with COVID-19 each day. This population is largely unvaccinated, with medical conditions that increase their risks. Some of these hospitalizations could have been prevented with early COVID treatments, such as pills and monoclonal antibodies, purchased and distributed for free by the government. But data on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. <Read More>

Creating Opportunities for Collaboration Between Community, Health System Pharmacy – March 18, 2022 – Cross-practice collaboration is one of the best ways to improve patient outcomes. Sarah Martin is a 45-year-old White woman who, 6 months after being hospitalized and receiving a type 2 diabetes diagnosis, goes to her community pharmacy to attend a diabetes education class. Before the class, she asks the pharmacist to check her blood sugar, which typically range from 250 mg/dL to 280 mg/dL and average 200 mg/dL while fasting. When speaker Tamara A. McCants, PharmD, an assistant professor at Howard University asked the audience at an APhA 2022 session what opportunities for collaboration between community and health-systems pharmacy might look like when caring for Martin, suggestions began to fly. <Read More>

Ask an Adviser: How can we cut Specialty Pharmacy Costs? – March 18, 2022 – This week, we asked Michael Baldzicki, executive vice president of growth and strategy for AscellaHealth, to weigh in on the following:  How can we cut specialty pharmacy costs? Employers should consider carving out prescription medical and/or pharmacy benefits from their major pharmacy benefits management plan to contract directly with a specialty pharmacy services provider. Carve-out plans give employers better control over specialty pharmacy benefit costs, which is a crucial consideration as costs continue to rise. They give employers greater transparency into their benefit claims and allow them to gain greater understanding and control of specialty pharmacy spending by rethinking contractual partners. Another advantage is an ability to negotiate better deals by understanding the data and medical Rx claims. This strategy ensures clinical and financial programs perform as promised, while it’s also important to adopt employer-to-employee communication to drive specialty drug cost containment and medication compliance. <Read More>

COVID-19 Vaccines Continue to Protect Against Hospitalization and Death Among Adults – March 18, 2022 – COVID-19 vaccination continues to help protect adults against severe illness with COVID-19, including hospitalizations and death, according to two reports released in MMWR. During Omicron, COVID-19-associated hospitalization rates increased for all adults, regardless of vaccination status, but rates were 12 times higher among adults who were unvaccinated compared to adults who received a booster or additional doses. Hospitalization rates were also highest among non-Hispanic Black adults and nearly 4 times as high among Black adults than White adults during the peak of Omicron. <Read More>

TRICARE Pharmacy’s Home Delivery Offers Safe, Convenient Option to Get Medicines – March 17, 2022 – Are you regularly filling a prescription for a medical condition? If you are, choosing the right pharmacy option can save you a great deal of time and money. For many TRICARE beneficiaries, the cheapest, most convenient option is TRICARE Pharmacy Home Delivery. “Home delivery is a smart option for people who take maintenance drugs,” said Air Force Lt. Col. Melissa Yates, a pharmacist with the Defense Health Agency’s Pharmacy Operations Division. “Maintenance medications are drugs you take regularly for chronic conditions, like high blood pressure. Other short-term use drugs should be obtained from a military or retail network pharmacy. This way, you can begin therapy as soon as possible.” <Read More>

Pharmacy Groups to Biden: Expand Pharmacists’ Ability to Order COVID-19 Antivirals – March 17, 2022 – Fourteen national pharmacy organizations have called on President Joe Biden’s administration to remove barriers that prevent pharmacists from ordering oral COVID-19 antivirals, which they said would allow all patients to receive treatment immediately after a positive test. “Despite your statement during the State of the Union, Americans who test positive at a pharmacy will only be able to access time-sensitive oral antivirals, on the spot, from a limited number of pharmacies with in-house access to non-pharmacist prescribers, primarily in metropolitan areas,” the letter dated March 9 said. “Unfortunately, rural and underserved communities are less likely to benefit from your test to treat approach because of this limitation.” <Read More>

Iowa Senator Pushes for PBM Investigation – March 17, 2022 – Iowa Senator Chuck Grassley is pushing the FTC to investigate PBM practices. The Federal Trade Commission should examine how the business practices of pharmacy benefit managers (PBMs) determine prices for prescription drugs, says Sen. Chuck Grassley. In February, the Federal Trade Commission (FTC) split 2-2 on a vote to study the business practices of PBMs. Grassley, a Republican from Iowa, asked FTC Chair Lina Khan to find consensus and move forward with the review. Consolidation between PBMs and insurance companies has resulted in vertical integration with a small number of companies now managing “the vast majority of prescription drug benefits,” Grassley said in a March 9 letter to the FTC. <Read More>

U.S. Adult Tobacco Product Use Decreased From 2019 to 2020 – March 17, 2022 – Findings from a Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report show decreases in the use of commercial tobacco products overall, combustible tobacco products, cigarettes, e-cigarettes, and two or more tobacco products among U.S. adults from 2019 to 2020. Yet nearly 1 in 5 adults (an estimated 47.1 million) reported current (every day or some days) tobacco product use in 2020, including 30.8 million who smoked cigarettes. <Read More>

Revised CDC Opioid Guidance Marked by Pivot Away From Hard Prescribing Caps, Embrace of Clinical Judgment – March 16, 2022 – The update to the 2016 “CDC Guideline for Prescribing Opioids for Chronic Pain” continues the agency’s stance that opioids are not a first-line therapy for chronic pain, or even acute pain in some cases. Nonopioid and nonpharmacologic treatments are advocated for in more overt language. The revised guideline can be commented on through April 11. But the addition of language recognizing that clinical judgment should be relied upon more strongly and removal of recommended limits on opioid prescribing have earned the document the most attention. While the CDC maintained that the prescribing limits in the original guideline were voluntary, the consensus from pain clinicians was the limits were often misinterpreted as hard caps, leading to severe unintended consequences in the form of an undertreatment of pain that, in some cases, left legitimate pain patients in such distress they contemplated death or died by suicide. <Read More>

Hazardous Drugs Lists: Where to Look? – March 16, 2022 – One of the most important steps in handling hazardous drugs (HDs) is a seemingly simple one—knowing which drugs are in fact hazardous, according to Patricia C. Kienle, MPA, BCSCP, FASHP, the director of accreditation and medication safety for Cardinal Health. Unfortunately, it may be unclear to some practitioners where to find the most updated and reliable sources for that information. In identifying HDs, USP <800> Hazardous Drugs – Handling in Healthcare Settings requires use of the most current version of the list of such drugs maintained by the CDC’s National Institute for Occupational Safety and Health (NIOSH). NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. That means the 2016 list, which includes drugs assessed through 2015, is many years out-of-date. <Read More>

Survey Reveals Severe Shortage of Pharmacy Technicians in Hospitals and Health Systems – March 15, 2022 – Hospitals and health systems are experiencing severe shortages of pharmacy technicians, with a majority of pharmacy administrators in a recent survey reporting turnover rates of at least 21% in 2021, and nearly 1 in 10 noting they had lost 41% or more of their technicians…A separate ASHP survey conducted late last year and completed by more than 5,000 technicians shed light on what is needed to recruit and retain pharmacy technicians. Three-quarters of technicians who responded to the survey said higher pay would help retain technicians, nearly a third would like to see employers offer retention bonuses, and 25% desire a career ladder with clear pathways to promotion. <Read More>

Top 15 Pharmacies by Prescription Revenue – March 15, 2022 – CVS Health had the highest total prescription revenues of all U.S. pharmacies in 2021, according to estimates the Drug Channels Institute released March 8. Overall, prescription dispensing revenues hit a record $501 billion last year, the institute found. The estimates represent data for calendar year 2021 and may differ from other publicly available sources, as many companies either don’t report prescription revenues or report figures based on fiscal years. The figures also exclude revenues from COVID-19 vaccine administration to allow for more accurate comparison to previous years’ figures, the institute said. Fifteen largest pharmacies by total prescription-dispensing revenue in 2021:  1) CVS Health — $122.6 billion, 2) Walgreens Boots Alliance — $90.3 billion, 3) Evernorth/Express Scripts — $54.4 billion… <Read More>

Why the FTC Should Reconsider its Vote on Probing Pharmacy Benefit Managers – March 15, 2022 – More than one-third of retail pharmacies in the country are independently owned community pharmacies. There are roughly 20,000 of these small businesses across the country and nearly 500 in Tennessee. In many communities, especially in rural areas, they are the only accessible providers. That makes them essential health care providers, not just indispensable to their communities, but to our entire national healthcare system. According to the Centers for Disease Control and Prevention (CDC), pharmacies working with the federal government have administered 230 million doses of COVID-19 vaccines. Tens of millions were administered by independent pharmacies, many serving vulnerable populations. There’s no doubt we would have suffered a great deal more without our network of independent pharmacies. <Read More>

340B in the News

J&J to Restrict 340B Discounts for 29 Drugs – March 22, 2022 – Johnson & Johnson will stop offering 340B discounts to safety-net hospitals effective May 2 if providers do not submit certain patient claims data, the drugmaker said March 21. “We believe that this policy will also improve 340B program integrity and compliance,” Johnson & Johnson said in its announcement. “Unfortunately, despite years of efforts by Johnson & Johnson Health Care Systems and other stakeholders to address 340B program integrity and compliance concerns, the program has been seriously challenged by contract pharmacy transactions that are not required by or consistent with the statute.” <Read More>

Health Systems Should Better Integrate Pharmacy Arrangements – March 21, 2022 – Nine in 10 large hospitals operate a specialty pharmacy, and most of these pharmacies also participate in the federal 340B drug pricing program.1,2 Health system pharmacies participating in the program often use external contract arrangements to expand the reach of their offerings. Thirty-thousand pharmacy locations—nearly half the US pharmacy industry—participate as 340B contract pharmacies.3 Health systems often initiate these arrangements to expand access to payer contracts and increase the number of covered individuals who can participate in 340B programs. Focusing on contracts is an important consideration for health systems that expand the reach of some or all of their pharmacy services in this way. Nevertheless, focusing exclusively on payer contracts may cause health systems to miss opportunities for improving patient engagement and outcomes and for enhancing 340B compliance. Let’s review considerations beyond insurance contracts for 340B contract pharmacy partners and examine how health systems can better integrate their pharmacy arrangements to address criticism of the 340B program, improve patient outcomes, and increase 340B compliance. <Read More>

Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals – March 17, 2022 – In a move welcomed by the growing number of hospitals forced out of the 340B Program due to falling disproportionate share hospital (DSH) adjustment percentages, Congress has passed a measure offering a chance to rejoin. Tucked away in the 2022 Consolidated Appropriations Act signed into law March 15, 2022, the bill provides a temporary re-enrollment path for hospitals that lost their 340B eligibility during the COVID-19 pandemic due to falling below the minimum DSH threshold required by the 340B statute (11.75% for DSH, free-standing cancer (CAN), and children’s (PEDS) hospitals, 8% for sole community (SCH) and rural referral center (RRC) hospitals). <Read More>

Gilead to Limit 340B Discounts for Hepatitis C Drugs – March 16, 2022 – Gilead will stop offering 340B discounts to safety-net hospitals effective May 2 if providers do not submit certain patient claims data, the drugmaker said March 15. “We are making this change across our branded hepatitis C products because of the acute impact of duplicate discounts and diversion,” Gilead said in its announcement. “The claims level data being requested is similar to the data Gilead receives from other purchasers and payers and is tailored to minimize burdens on covered entities while mitigating duplicate discount and diversion concerns.” <Read More>

Omnibus Spending Bill Passed by Congress Includes Healthcare Provisions – March 16, 2022 – On March 10, 2022, the Senate passed a $1.5 trillion omnibus appropriations bill (the Omnibus Bill) to fund the federal government for fiscal year 2022 (FY 2022) that contained significant healthcare-related provisions impacting hospitals and health systems. The Senate’s vote followed passage by the House on March 9, 2022. The measure will be sent to President Biden, who is expected to sign the Omnibus Bill before March 15, 2022, when current federal government funding expires. Some of the most significant healthcare-related provisions relate to 340B eligibility, telehealth, maternal health, and increased healthcare appropriations. However, noticeably missing from the package was $15 billion in additional COVID-19 relief, which was pulled from the Omnibus Bill before it was passed by the House. Highlights of the Omnibus Bill’s healthcare-related provisions are described below. <Read More>

Gilead Implements Contract Pharmacy Integrity Initiative for Branded Hepatitis C Products – March 15, 2022 – Gilead Sciences, Inc. announced the company will launch a Contract Pharmacy Integrity Program that aims to improve transparency in the 340B Federal Drug Pricing Program and address duplicate discounts and diversion. Gilead recognizes the important role of the 340B program in providing medicines for individuals with low incomes. The 340B program has grown rapidly in recent years, and a well-documented lack of program oversight has elevated concerns among stakeholders about the program’s integrity and sustainability. Over time, Gilead has seen duplicate discounts and diversion of its hepatitis C products distributed through contract pharmacies with increased frequency. This means multiple discounts have been improperly applied to the same single bottle of Gilead medicine, and/or discounts are being claimed on bottles dispensed to individuals who are not patients of a 340B covered entity. <Read More>