Clinical Insights: August 25, 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

    Kesimpta® (ofatumumab) Injection – New Drug Approval – August 20, 2020 – Novartis announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta® is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready® autoinjector pen. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    No new update.

    New Drug Shortage

    August 24, 2020 

    New Drug Recall and Safety Alerts

    Metformin Extended-Release (ER) Tablets by Bayshore Pharmaceuticals – New Drug Recall – August 19, 2020 – Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore. <Read More>

    Heparin Sodium Compounded Products by SCA Pharmaceuticals (SCA) – New Drug Recall –August 18, 2020 – SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46). <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Under Presidential Pressure, FDA Gives ‘Emergency Approval’ for COVID-19 Plasma Treatment – August 24, 2020 – Under pressure from President Donald Trump, the Food and Drug Administration on Sunday issued an emergency use authorization for “investigational convalescent plasma” treatment for COVID-19. This is not an outright approval — it is temporary pending more drug trial outcomes. The president said the FDA found the treatment to be “safe and very effective,” but that is not what FDA said. The FDA actually said, “This product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.” <Read More> 

    Pharmacy Groups Voice Support for Pharmacist-Provided Childhood Vaccines After AAP Opposition – August 24, 2020 – Soon after the American Academy of Pediatrics (AAP) expressed opposition to the policy allowing all pharmacists to administer childhood vaccinations, 12 pharmacy organizations banded together in support of the profession’s ability to vaccinate. “There are no greater public health priorities today than defeating the COVID-19 pandemic and protecting our nation from other vaccine-preventable diseases like the seasonal flu. We need all hands on deck to improve Americans’ access to life-saving vaccines during these difficult times,” APhA, NCPA, ASHP, and several other groups said in a joint statement. “For that reason, we celebrate the action by the US Department of Health and Human Services to expand pharmacists’ role in providing life-saving vaccines to children.” <Read More>

    Telehealth Improves Access to Pharmacists for Medically Underserved Patients – August 24, 2020 – An examination of how telehealth services for medically underserved patients in rural areas improve access to pharmacists for chronic care management. Through telehealth services, medically underserved patients in rural Florida have been able to effectively access ambulatory care pharmacists and student pharmacists during the pandemic, according to a commentary published in Preventing Chronic Disease. With the coronavirus disease 2019 (COVID-19) pandemic, health care professionals are tasked with finding alternative ways to deliver care to patients who may be vulnerable to poor health outcomes. As in-person interactions may be limited, the use of technologies such as telehealth through virtual and telephone medical therapy management (MTM) can help improve care for these vulnerable patients. <Read More> 

    ERISA Plan Participants Cannot Proceed as a Class in Challenging EpiPen Prices – August 24, 2020 – Four ERISA plan participants, who participated in four different ERISA plans, commenced an ERISA class action against four of the nation’s largest pharmacy benefit managers (PBMs), alleging that the PBMs breached their fiduciary duties by failing to ensure that the plaintiffs and other plan participants received the benefit of discounts that the PBMs had negotiated with Mylan Pharmaceuticals, a company that markets and sells EpiPens.  As a result of the alleged breaches, the plan participants argued that they were forced to pay excessive prices for EpiPens through their respective plans. In a blow to the plaintiffs’ case, a federal judge in Minnesota recently denied their motion for class certification of four nationwide classes—one class for each PBM. <Read More> 

    IDSA on Serology Testing: Better Results Come to Those Who Wait – August 22, 2020 – Waiting two weeks after symptom onset until performing a serological test to diagnose SARS-CoV-2 infection enables the body to develop antibodies and increases the performance of serology testing, according to new COVID-19 testing recommendations devised by the Infectious Diseases Society of America (IDSA). “We are recommending against using antibody testing in the first one or two weeks after exposure to infection because many patients haven’t developed antibodies yet, and they are not detectable. If you have a negative result from a patient who had compatible signs or symptoms [of COVID-19], you really cannot exclude the possibility that the patient could still have COVID-19,” explained Kimberly Hanson, MD, MHS, the chair of the IDSA COVID-19 Diagnostic Guidelines Expert Panel, during an IDSA press briefing. <Read More> 

    IDSA: Recommends Against Using Hydroxychloroquine for COVID-19 – August 21, 2020 – The Infectious Diseases of America treatment guidelines for COVID-19 were updated Friday afternoon. The panel recommended against the use of either hydroxychloroquine alone or in combination with azithromycin in the hospital setting. In assessing the current state of the literature, IDSA’s expert guidelines panel concluded that higher certainty benefits, such as a reduction in mortality, for the use of these treatments are now “highly unlikely even if additional high quality data would become available,” the society said a statement. <Read More> 

    Elevating Pharmacists Through Rx Pricing Stability – August 21, 2020 – I worked as a pharmacy intern and technician for six years in a large retail chain pharmacy. I admired the relationship the pharmacist I worked under, let’s call her Mary, had with her patients and the unbelievable amount of trust they put in her advice… I aspired to be a respected resource for my community when I entered pharmacy school, but by the time I graduated in the late 1990s, a major shift in the industry already had taken hold…Compounding this issue, the largest pharmacy benefit managers (PBMs) now exclude hundreds of products. Brand-name medications are particularly prone to such exclusions: Their removal increased by as much as 63% in 2020, according to CoverMyMeds’ 2020 Medication Access Report ( Moreover, nearly 70% of patients report having made personal or financial sacrifices to afford prescriptions, and 30% say they’ve had to abandon a prescription due to cost, the CoverMyMeds report noted. That abandonment rate is even higher when out-of-pocket costs exceed $100. <Read More> 

    Pharmacist Management of Hyperkalemia: A Focus on Improving Clinical Outcomes – August 21, 2020 – Treatment updates in hyperkalemia was a practical and informative topic discussed during the 2020 virtual Directions in Pharmacy® conference. Todd Brothers, PharmD, BCCCP, BCPS, presented a comprehensive overview of hyperkalemia to optimize patient care with the use of safe and effective pharmacotherapeutic agents. Dr. Brothers began his discussion by reviewing the basic physiology of potassium (an intracellular cation) homeostasis, which is primarily preserved by the kidneys (90%). Potassium homeostasis is maintained in a narrow range, and increased concentrations can vary from being inconsequential to life-threatening malignant arrhythmias associated with increased risk of all-cause mortality. There are multiple, typically multifactorial, etiologies for the development of hyperkalemia. Symptomatology often affects both the muscular and cardiac systems, manifesting as dyspnea, muscle weakness, ventricular arrhythmias, or asystole. <Read More> 

    AMA Opposes Expanding Pharmacists’ Ability to Provide Child Vaccinesn – August 21, 2020 – “The American Medical Association (AMA) opposes HHS’ new declaration that allows pharmacists and pharmacy interns to administer vaccines to children between the ages of 3 and 18. While we acknowledge that childhood vaccinations have significantly declined during the pandemic, preempting state licensing laws to expand pharmacists’ scope of practice is not the solution to vaccine hesitancy and will create additional problems. It will likely cause children to forgo holistic well-child exams and comprehensive preventive care, early diagnosis, optimal therapy, and ensured timely vaccinations that are necessary to safeguard children’s health, especially during a pandemic. <Read More> 

    Amgen, Coherus Pegfilgrastims Lose Formulary Placement – August 21, 2020 – In what a company spokesman described as a minor setback, Coherus BioSciences has seen its Udenyca® pegfilgrastim biosimilar dropped from the 2021 national preferred formulary list for the pharmacy benefit manager (PBM) Express Scripts, whose revenues in 2017, prior to its takeover by Cigna, amounted to over $100 billion. Amgen’s Neulasta® originator pegfilgrastim product was also switched to nonpreferred status on the 2021 formulary. “Less than 5% of the pegfilgrastim market by unit volume is reimbursed through the nonmedical/pharmacy benefit,” the Coherus BioSciences spokesman said. “Express Scripts represents only a fraction of the pharmacy benefit, so a fraction of the ~5% volume.” The spokesman said the company is mainly focused on moving Udenyca® through the medical benefit side, which applies to hospital and clinic administration of the drug. <Read More> 

    FDA Reassures on Biosimilar Progress as COVID-19 Applications Pile Up – August 20, 2020 – Is the FDA a little overworked during the coronavirus disease 2019 (COVID-19) pandemic? Consider that over 270 clinical trials specifically related to COVID-19 had been launched by July 31, 2020, and more than 570 additional clinical trials are in planning stages. But according to Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA, the federal agency can review these trials, resist the intense pressure to do things in a hurried or sloppy fashion, and get all of its normal work done as well, while still adhering to rigorous scientific and medical standards. <Read More>

    2021 Proposed Payment Rules: Implications for Pharmacy August 20, 2020 – This summer has seen the rollout of several payment rule sets, executive orders and additional health care legislation, some of which is related to the COVID-19 pandemic. This column concentrates on the proposed OPPS/ASC and PFS rule sets. The underlying message is that pharmacy needs to upgrade its reimbursement skill sets, become a player in the decisions that are being made, and recognize the implications of their decisions, especially if these are made in a silo without knowing their payors. <Read More> 

    Immune Checkpoint Inhibitor Therapies: Identifying and Managing Adverse Effects – August 20, 2020 – A new session at the 2020 virtual Directions in Pharmacy® conference was a discussion of immune checkpoint inhibitor therapies. Jacob Kettle, PharmD, BCOP, discussed managing immune-related adverse effects (AEs) associated with immune checkpoint inhibitor therapies. Dr. Kettle began his discussion on cancer immunotherapy and the clinical benefits for various malignancies with immunooncology (IO). In contrast to traditional cancer therapies, IO therapies typically involve the immune system to recognize and eradicate tumor cells. Immune checkpoint inhibitors have revolutionized treatment for patients with certain solid tumors targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA- 4), programmed death protein 1 (PD-1), and programmed deathligand 1 (PD-L1). <Read More> 

    ACP, AAFP Release Guidelines for Management of Acute Pain – August 20, 2020 – The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) developed a guideline of clinical recommendations on nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults. The organizations based the guideline on a systematic evidence review on the efficacy and safety of acute pain management in adults in the outpatient setting. <Read More> 

    National Kidney Foundation, Academy of Nutrition and Dietetics Release KDOQI Clinical Practice Guidelines on Nutrition – August 20, 2020 – The National Kidney Foundation (NKF) in collaboration with the Academy of Nutrition and Dietetics released the 2020 Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline on Nutrition in Chronic Kidney Disease that will guide health care practitioners who treat people with all stages of kidney disease. KDOQI, which pioneered evidence-based clinical practice guidelines for improving the diagnosis and treatment of kidney disease, first published guidelines on nutrition for patients with end-stage kidney disease in 2000. This comprehensive update has been expanded to include nutritional management of patients with stages 1-5 chronic kidney disease and patients with a functioning transplant. It addresses six primary areas: nutritional assessment; medical nutrition therapy; dietary protein and energy intake; nutritional supplementation; micronutrients; and electrolytes. <Read More>

    Express Scripts Axes Novartis’ Psoriasis Drug in Favor of Lilly’s as Discounting Takes Over: Analyst – August 20, 2020 – It’s that time of the year once again. The major pharmacy benefits managers are making changes to their formularies for 2021, and one of the biggest—Express Scripts—is sending a strong signal about just how much of a difference discounting can make. Express Scripts is axing three major drugs from its formulary for 2021, most notably Novartis’ psoriasis drug Cosentyx®. In its place is Eli Lilly’s rival Taltz®, which interestingly, the PBM had excluded from its 2020 version. Express Scripts also lists (PDF) AbbVie’s new psoriasis treatment Skyrizi® as a “preferred alternative” to Cosentyx®, along with several older anti-inflammatories. <Read More> 

    FDA Denies Approval for Gilead Sciences’ Potential Blockbuster Arthritis Drug – August 19, 2020 – The space for oral rheumatoid arthritis treatments won’t be getting crowded quite as quickly as some might have been expecting. Gilead Sciences (NASDAQ: GILD) told investors on Tuesday that the FDA has issued a complete response letter (CRL) denying approval for its drug candidate filgotinib — for now — and dealing a huge blow to the company’s cash flow projections. An FDA approval for filgotinib had been widely expected, and forecasts of its market potential suggested it would likely become a blockbuster. Sales had been expected to exceed $1 billion in 2022 and peak above $4 billion annually. <Read More> 

    Pharmacies Not Immune From Enforcement Action for Role in Patient Assistance Programs – August 19, 2020 – A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to patient assistance programs and charitable assistance foundations. Specifically, the government’s civil settlement with Advanced Care Scripts Inc. (ACS), a specialty pharmacy, announced on Aug. 13, 2020, highlights the risks to specialty pharmacies in direct interactions with co-pay assistance foundations. <Read More>

    Prosecutors Sue Teva’s U.S. Business Over Charitable Donations – August 19, 2020 – The Justice Department has lodged a lawsuit against the U.S. unit of Teva Pharmaceuticals, which allegedly used $300 million in charitable donations to insulate Medicare patients from escalating drug costs. The company referred users of its increasingly expensive multiple sclerosis drug to a specialty pharmacy, which arranged for copay help through Chronic Disease Fund and the Assistance Fund. Teva then used information from the foundations and from the specialty pharmacy to determine the size of donations to each charity. Federal prosecutors say the drugmaker’s actions, carried out from 2005 to at least 2015, represent a violation of anti-kickback laws. <Read More>

    Updates in the Management of Heart Failure and the Pharmacist’s Role in Patient Education – August 19, 2020 – Updates in heart failure (HF) was a topic of interest during the 2020 virtual Directions in Pharmacy® conference. Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPSAQ Cardiology, CACP, presented a comprehensive overview of new and emerging agents for HF management and the role of the pharmacist. Dr. Beavers began his discussion with a summary of the burden of HF, including a projected increase of 46% by the year 2030. There are approximately 1000 admissions annually and there were 80,480 deaths in 2017. HF is classified as HF with preserved ejection fraction (HFpEF), HF with mid-range ejection fraction (HFmEF), and HF with reduced ejection fraction (HFrEF). <Read More> 

    HHS Gives Pharmacists Ability to Deliver Childhood Vaccines, Upsetting AAP – August 19, 2020 – An attempt to increase access to childhood vaccines and decrease the risk of preventable outbreaks during the ongoing coronavirus disease 2019 (COVID-19) pandemic—by giving all state-licensed pharmacists and even pharmacy interns the ability to order and give pediatric vaccines—has drawn fire from the American Academy of Pediatrics (AAP). HHS Wednesday said that it was adding a third amendment to the March public health emergency that allows the change for patients aged 3 through 18 years, in response to a May CDC report that found a significant drop in routine childhood immunizations as a result of the crisis. This decrease is another threat to public health, HHS said in a statement. <Read More> 

    Polster Says Pharmacies Can’t Dismiss Opioid Claims – August 18, 2020 – U.S. District Judge Dan Polster, appointed by Bill Clinton and tasked with overseeing the federal opioid litigation in Cleveland, Ohio, has denied efforts by Rite Aid, Walmart, CVS, and other pharmacies to dismiss allegations that their opioid monitoring systems were unreliable and that their failure to prevents opioids from being obtained illegally created a public nuisance.  This means, the pharmacies will be subject to defending their potential role in contributing to the nationwide opioid epidemic. In his order, Polster found the plaintiff counties had shown sufficient evidence to support the allegations due largely to the fact that the pharmacies dispensed medication to the public, which Polster said “violated the Federal Controlled Substances Act and also Ohio controlled substance laws.”  Evidence cited to support the plaintiffs’ claims included that “CVS Health Corp.’s system for suspicious orders was makeshift, haphazard and ineffectual.”  Polster also stated “between 2006 and 2009, CVS had no formal written procedures to identify suspicious opioid orders and instead relied on employees’ gut feelings to identify orders that were too large” rather than properly monitoring shipments. <Read More> 

    National Comprehensive Cancer Network® Adds Monjuvi® (tafasitamab-cxix) to its Clinical Practice Guidelines in Oncology for B-cell Lymphomas – August 18, 2020 – MorphoSys AG and Incyte announced that Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for B-cell Lymphomas. Specifically, the NCCN Guidelines in the United States now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT). <Read More> 

    Updates for Influenza Vaccination Recommendations: Role of the Pharmacist – August 18, 2020 – Influenza disease prevention, identification, and vaccination was a topic discussed during the 2020 virtual Directions in Pharmacy® conference. Rupal Mansukhani, PharmD, FAPhA, CTTS, presented a comprehensive overview of influenza disease, including identifying at-risk patient populations, analyzing safety and efficacy data for vaccine preparations, and providing interventions to address influenza vaccination misconceptions. <Read More> 

    HIV and Immunotherapy: The Immune System Awakens – August 18, 2020 – Patients living with HIV (PLWH) must take daily medications to suppress the virus, despite significant advancements in antiretroviral therapy (ART). A major limitation of ART is that it is only effective against an actively replicating virus. Therefore, despite being successful in suppressing HIV RNA, ART cannot inhibit a nonreplicating virus. The latter is a contributing reason why HIV cannot be cured with ART alone. Contemporary efforts for therapy have focused on using the immune system to target HIV. One strategy being investigated to replace daily ART is to use broadly neutralizing antibodies (bNAbs). <Read More> 

    Role of Specialty Pharmacists in Treating Patients With HIV – August 18, 2020 – On February 5, 2019, in the State of the Union Address, President Donald Trump announced a goal to end the HIV epidemic in the United States within 10 years. The Ending the HIV Epidemic: A Plan for America initiative was created with the goal of reducing new HIV infections in the United States by 75% in 5 years and 90% by 2030. Collaboration among federal, state, and local health departments, and health care providers is needed to reach this target. Specialty pharmacists also have a role to play to help ensure that goal is reached, starting with understanding HIV guidelines and how specialty pharmacists can facilitate and optimize the care of HIV patients. <Read More> 

    Community Pharmacies Have an Even Bigger Role During COVID-19 – August 18, 2020 – Community pharmacists’ scope of practice is widening during COVID-19, with more patients seeking care from pharmacists and more pharmacies anticipating increased point-of-care testing and expanded immunization services. “We are getting more OTC questions than any other time in my 27 years as a pharmacist,” said Nadia Rasul, RPh, from Kroger Pharmacy in the Columbus, OH, area. She noted that community pharmacists are the new urgent care professional when patients are afraid to go to medical offices. “We counsel on which gauze to get, how to change a dressing, how to help a breastfeeding mom know if her symptoms are serious enough to go to the emergency department—and we help calm anxiety about COVID-19,” she said. “We also address concerns about buying ibuprofen after listening to the media, how to take a temperature. And we explain how soap is still a viable option when no sanitizer is available.” <Read More> 

    Pharmacy Deserts Are on the Horizon if PBMs Continue to Underpay Medicaid Reimbursements – August 17, 2020 – Independent pharmacies are being forced into bankruptcy due to underpayment for Medicaid reimbursements, which are managed by Pharmacy Benefit Managers (PBMs.) These small pharmacies are deciding to either turn away Medicaid patients, or to close their practices, creating pharmacy deserts in poor neighborhoods. A survey of 123 independent pharmacies in Florida found that over 60% “may be forced to discontinue taking Medicaid patients if changes are not made to the program that currently requires neighborhood pharmacies to sell most prescription drugs at a loss.” 93% declared having to turn away at least one Medicaid patient per month because dispensing to them would cause the pharmacy to lose money. <Read More>


    340B in the News

    Drugmakers Want to Rein in 340B Discounts. Here’s What You Need to Know. August 24, 2020 – At least five major drugmakers in the past several weeks have notified hospitals that they may no longer provide discounts to the providers under Medicare’s 340B Drug Discount Program, sparking the latest in a series of clashes over the long-controversial program. The 340B Drug Discount Program is one of the most contentious issues in health care. Its critics say it “hurts patients” and is being “abused” by hospitals, and a report issued earlier this year by the Government Accountability Office found that HHS was not adequately monitoring the 340B and Medicaid Drug Rebate Programs, which could increase the risk of pharmaceutical companies paying duplicate discounts for eligible drugs. The program’s defenders, however, say 340B is vital to the health of low-income patients and essential to helping safety-net hospitals care for their communities. <Read More> 

    Comment: Trump Order on Drug Prices Restricts Helpful Program August 23, 2020 – COVID-19 has put our country’s most vulnerable patient populations at further risk. The pandemic puts into perspective the critical role our safety-net health care providers play in ensuring all patients have access to lifesaving medications and quality health care. While community health centers and federally qualified health clinics pivot to respond to rapidly changing front-line needs, so too should federal health care programs pivot to better support that work. One of these programs, the 340B Drug Discount Program, recently targeted by an executive order issued by the Trump administration, needs to be protected so organizations such as Lifelong can continue using it to support better health outcomes for vulnerable patient populations. <Read More> 

    AHA has Sent Letters to Drug Companies Expressing ‘Profound Concern’ About Undermining 340B August 21, 2020 – On Friday, the American Hospital Association sent letters to the heads of U.S. operations for five large drug companies — Merck, Eli Lilly, Sanofi, Novartis and AstraZeneca — expressing “profound concern” over what the hospital group says are actions they are taking to limit the distribution of certain 340B drugs to hospitals and health systems. The AHA is asking them to “cease this conduct immediately.” The actions cited by AHA range from limiting the distribution of certain 340B drugs to demanding, on short notice, detailed reporting on 340B drugs distributed through hospitals’ contract pharmacies — reporting the AHA calls “superfluous.” <Read More> 

    CMS Proposes Quality Program Changes, Increased OPPS and ASC Medicare Payments for 2021 August 20, 2020 – On August 4, 2020, CMS proposed its annual rule adjusting the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System, as well as changes to quality reporting programs and other important policies described in detail below (the Proposed Rule). Overall, CMS proposes to increase OPPS and ASC payments by 2.6%, reflecting an increase of nearly $7.5 billion and $160 million, respectively, over CY 2020 figures. Comments are due to CMS by 5:00 p.m. EST on October 5, 2020…Following on the results of a hospital acquisition cost survey, the Proposed Rule also proposes to pay for drugs acquired under the 340B program at ASP minus 34.7%, plus an add-on of 6% of the product’s ASP, leading to a net payment rate of ASP minus 28.7%. CMS also proposes the alternative of continuing its current policy of paying ASP minus 22.5% for 340B-acquired drugs. <Read More>

    Drug Payment Cuts to 340B Hospitals Spur Debate on Best Path Forward August 20, 2020 – On August 3, a federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%, reversing an earlier ruling calling those cuts illegal. The 2-1 decision by the U.S. Court of Appeals for the District of Columbia Circuit essentially gives the Trump Administration and the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals. HHS Secretary Alex Azar said the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program. But providers, including the American Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals, said the 340B decision will hurt hospitals and patients in these vulnerable areas. <Read More> 

    DC Circuit Upholds 340B Cut – So CMS Cuts Deeper August 19, 2020 – The 340B Drug Pricing Program and the related Prime Vendor Program, or PVP, provides discounts on the purchase of outpatient drugs to certain providers. For many nonprofit and rural providers, the 340B program is a lifeline, providing drugs that are often given out to patients that can’t afford to pay their bill. It appears that Medicare’s big concern is that participating providers may benefit by buying the drugs at a discount, then benefit again when the drugs that are separately billable are paid by Medicare for Medicare patients. Here is a guide to which types of hospitals qualify for 340B:  Back in January 2018, Medicare slashed payments for certain drugs under the 340B program. Medicare specifically cut payments for “separately billable” drugs, from 6 percent over the standard average sales price (SASP) to 22.5 percent less than the SASP. The American Hospital Association (AHA) filed suit, and surprisingly won a rate-setting battle when a district court ruled that Medicare had exceeded its authority and made the cuts without underlying data to support the computation. On July 31, the District of Columbia Circuit Court of Appeals overturned the lower court ruling, allowing the cut from 2018 to stand. In the proposed rule for 2021, Medicare is driving the knife in deeper by further reducing the payment, from SASP minus 22.5 percent to SASP minus 28.7 percent. <Read More> 

    Patient Options Expand with OPPS Proposed Rule, as 340B Hospitals see Increased Cuts August 18, 2020 – Released Aug. 4, the Outpatient Prospective Payment System (OPPS) proposed rule for 2021 would eliminate the Medicare inpatient-only list of services while increasing the number of Ambulatory Service Center (ASC)-eligible procedures. The rule would also increase 340B payment cuts, and looks to overhaul the hospital star-rating system. The Centers for Medicare & Medicaid Services (CMS) has released new policies in Proposed Rule CMS-1736-P. Titled Protecting and Improving Medicare for Our Nation’s Seniors, the proposal was made with the intent to increase choice and lower patients’ out-of-pocket costs. These proposed changes further existing measures to increase patient choice by making Medicare payments available for more services in different sites of service and adopting policy changes under the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System. <Read More> 

    Safety Net Providers Launch “Protect the Safety Net” Campaign August 18, 2020 – The New York chapter of Ryan White Clinics for 340B Access (RWC-340B) announced the launch of the Protect the Safety Net campaign. The campaign, led by advocates and Medicaid patients, seeks to reverse a provision in the state budget that strips a critical federal benefit from health care providers and patients in New York State. This “carve out” provision harms all safety net providers in the federal 340B drug discount program. It further jeopardizes the health of some of New York’s most vulnerable Medicaid recipients in the middle of a global health pandemic and economic recession. <Read More> 

    AstraZeneca Slammed by Advocacy Group Over Drug Discount Denials August 18, 2020 – AstraZeneca decided it will begin denying the discounts it offers under the federal 340B drug pricing program to on-site hospital pharmacies on Oct. 1, according to a statement from the British drugmaker. The Aug. 17 statement did not disclose the reason for the upcoming discount denials, but detailed that all 340B pricing for on-site hospital pharmacies will be honored through Sept. 30. The following day, drug pricing organization 340B Health issued a statement on AstraZeneca’s decision to deny 340B discounts to on-site hospital pharmacies. “The action of AstraZeneca is a direct attack on the 340B drug pricing program that will hurt hospitals, health centers, and clinics as well as the low-income and rural Americans who rely on them for care,” the statement, attributed to 340B Health President and CEO Maureen Testoni, reads. “We believe that refusing to offer discounts that the 340B statute requires is a violation of federal law. We are calling on Health and Human Services Secretary Azar to exercise his authority to stop these overcharges before they cause permanent damage to the health care safety net.” <Read More>