Clinical Insights: August 3, 2018

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Mulpleta® (lusutrombopag) – July 31, 2018 – The Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Read more.

    Azedra (iobenguane I 131) – July 30, 2018 – The U.S. Food and Drug Administration approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use. Read more.

    PerserisTM (risperidone) – July 27, 2018 – Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has approved PerserisTM, the first once monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of PerserisTM without use of a loading dose or any supplemental oral risperidone. Read more.

    OrilissaTM (elagolix) – July 23, 2018 – AbbVie a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc., announced that the U.S. Food and Drug Administration (FDA) approved OrilissaTM (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. The FDA approved OrilissaTMunder priority review. OrilissaTM represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade and is expected to be available in U.S. retail pharmacies in early August 2018. Read more.

    Krintafel (tafenoquine) – July 20, 2018 – GSK and Medicines for Malaria Venture (MMV) announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. Read more.

    Tibsovo® (ivosidenib) – July 20, 2018 – The U.S. Food and Drug Administration approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML. Read more.

    NivestymTM (filgrastim-aafi) – July 20, 2018 – Pfizer Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NivestymTM (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. Read more.


    New Formulation Approval

    Remodulin® (treprostinil) – July 31, 2018 – United Therapeutics Corporation, announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of Remodulin® (treprostinil) Injection in the Implantable System for Remodulin® (ISR). Read more.


    New Indication Approval

    Zomacton® (somatropin) – July 19, 2018 – Ferring Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Zomacton® (somatropin) for injection in four additional pediatric indications: Idiopathic short stature (ISS), Short stature associated with Turner syndrome, Short stature born small for gestational age (SGA) with no catch-up growth by two to four years and Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. Zomacton® was previously approved to treat growth failure in pediatric patients due to inadequate secretion of endogenous growth hormone (GH) and replacement of endogenous GH in adults with GH deficiency. Read more.


    New Drug Shortage

    August 1, 2018 

    July 31, 2018 

    July 30, 2018 

    July 24, 2018 


    New Drug Recall and Safety Alerts

    Piperacillin and Tazobactam for Injection, AuroMedics Pharma – New Drug Recall Alert – July 31, 2018 – AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. Read more.

    Ranier’s Rx Laboratory Issues Voluntary Recall – New Drug Recall Alert – July 28, 2018 – Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA. Read more.

    Valsartan-Containing Product Information – New Drug Recall Alert – July 27, 2018 – FDA is updating healthcare professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products. FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    Opioid Use Guidelines for Cancer Care in Need of Long-Term Data, Collaboration – August 2, 2018 – What are the inherent issues with basing opioid use guidelines mostly on expert consensus, rather than empirical research? The Centers for Disease Control and Prevention (CDC) opioid guidelines are not entirely based on expert consensus, but rather low-quality evidence. Speaking strictly about the evidence pertaining to cancer patients, it is essentially an “evidence-free zone.” Read more.

    Drugs for Heart Failure are Still Under-Prescribed, Years after Initial Study – August 2, 2018 – A new study found that many people with heart failure do not receive the medications recommended for them under guidelines set by the American College of Cardiology, American Heart Association and Heart Failure Society of America. Read more.

    Behavioral Nudges Lead to Striking Drop in Prescriptions of Potent Antipsychotic – August 1, 2018 – Letters targeting high prescribers of Seroquel (quetiapine), an antipsychotic with potentially harmful side effects in the elderly, significantly reduced the number of prescriptions for patients in Medicare. The results showed that peer comparison letters led to statistically meaningful, persistent decreases in quetiapine prescribing, with no detected negative effects on patients. Read more.

    FDA Guidance on 503B Provides Leeway – August 1, 2018 – Last May, Fairview Health Services, the Minnesota company with 13 hospitals and 36 pharmacy locations spread across the state, opened its new 503B outsourcing facility. IntegraDose, as the new, affiliated company is called, is housed in the same building as its 503A pharmacy but the two are completely segregated by a wall. The 503B facility has a separate address, separate entrance and separate passcodes. Fairview began considering opening a 503B facility three years ago when the Minnesota Pharmacy Board told the company it would not renew the 503A’s manufacturing license. Read more.

    Spending on Prescription Drugs in the U.S.: Where Does All the Money Go? – July 31, 2018 – President Donald Trump’s May 11 speech on lowering prescription drug prices, as well as many statements from the pharmaceutical industry, have stressed that supply chain intermediaries, or “middlemen,” are capturing much of the money that is often categorized as drug spending. A number of studies have attempted to quantify this by focusing on the gap between the list and net price. However, these analyses focus primarily on manufacturers’ rebates and do not account for revenues retained from other transaction costs and mark-ups. Read more.

    New Methods of Assessing Drug Benefits Can Help Cut Healthcare Costs – July 31, 2018 – With the cost of drugs a critical issue in healthcare, health insurance companies and government payers need to understand how new and existing drugs compare in terms of benefits and risks. But there’s a problem. When drugs are first approved, they have typically been compared in clinical trials to either a placebo or to one standard of care, which is an established treatment that has previously been widely accepted. Read more.

    Pfizer CEO Believes U.S. Will Eliminate Rebates on Prescription Drugs – July 31, 2018 – Chief Executive Ian Read said on Tuesday that he believes the Trump administration intends to eliminate rebates on prescription drug purchases, but he does not know how quickly such a policy could be implemented. Earlier this month, the administration proposed a rule that would scale back protections currently in place that allow rebates between drug manufacturers and insurers and pharmacy benefits managers. Read more.

    Pharmacy Copays, Out-of-Pocket Costs Rise as Spending on Medicare Drugs Soars – July 31, 2018 – The cost of Cuprimine (250-mg oral capsule), a drug used for rheumatoid arthritis and Wilson’s disease, increased 2,143 percent, from $6 in 2011 to $135 in 2015. In that same time period, the cost of Stelara (a solution of 45 mg per half millimeter), a drug used to treat autoimmune disorders, rose 93 percent, from $5,523 to $10,669. Only next to 2,143 percent would 93 percent—almost a doubling—seem moderate. Read more.

    Providers Ramp Up Preparation for Drug Shortages – July 31, 2018 -Cleveland Clinic’s pharmacists have standing weekly meetings with nurses, physicians, anesthesiologists, supply chain administrators and other staff to discuss how the system will address current and potential drug shortages. But after Hurricane Maria crippled the primary manufacturer of small-volume saline bags, that process hit overdrive as they convened daily, if not hourly. They brainstormed how they could repackage what they already had, potential substitutes and how to best ration their three-week supply of saline—one of the most widely used drugs in hospitals. Read more.

    Study: Adalimumab Monotherapy Provides Benefits up to 3 Years in RA – June 30, 2018 – Clinical guidelines recommend using conventional disease-modifying anti-rheumatic drugs, like methotrexate, as part of an initial treatment strategy for rheumatoid arthritis (RA). This approach can be followed by a biologic if treatment targets are not met, or if a patient has poor prognostic factors. Combination treatment with a biologic and methotrexate is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events (AEs) with methotrexate that make monotherapy with a biologic a desirable option. Read more.

    Justice Department Places Increased Scrutiny on Pharmacies, Pharmacists – July 30, 2018 – The United States Department of Justice (DOJ) has focused its attention on healthcare providers in the past decade with increased frequency. Almost weekly, the DOJ touts another splashy settlement or prosecution related to rogue physicians or inappropriate pharmaceutical kickbacks. But, increasingly, federal prosecutors are turning their attention to pharmacies and pharmacists. In this article, we detail some of the recent enforcement efforts, as well as outline some proactive strategies for compliance. The message is that, now more than ever, an ounce of prevention is worth a pound of cure. Read more.

    Value-Based Pricing is in Place, but Prices for a Single Drug Vary – July 29, 2018 – Value-based pricing has become an important topic of discussion in healthcare in the United States. Although value-based pricing is intended to regulate prices of drugs based on their actual value, prices for a single drug can still vary significantly. Authors Anna Kaltenboeck, MA, and Peter B. Bach, MD, both of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, suggested that value-based pricing has refined itself and now can initiate any change to traditional payment models for drugs, which does not necessarily consider the final price of the product. Read more.

    NASP Comments on The HHS Drug Pricing Blueprint – July 27, 2018 – The National Association of Specialty Pharmacy (NASP) recently issued its comments in response to the Department of Health and Human Services’ (HHS) request for information related to HHS’s Drug Pricing Blueprint. The Blueprint is part of the Trump Administration’s initiative to lower prescription drug prices. Center for Medicare and Medicaid Services (CMS) Administrator Seema Verma has said that “[l]owering drug prices is a top priority for the President and CMS, and the agency is committed to finding innovative ways to increase competition and lower out-of-pocket costs for consumers. Read more.

    As Amazon Lurks, Walgreens Launches Digital Marketplace Listing Providers and Prices – July 26, 2018 – Walgreens Boots Alliance is launching a new digital marketplace that will connect the pharmacy chain’s mobile visitors to its drugstores as well as local doctors and clinics across the U.S. The move comes as Walgreens, CVS Health, Walmart and other brick-and-mortar retailers with health services face the possibility online retailer Amazon will expand deeper into the healthcare business. Amazon grabbed headlines last month with its acquisition of the small retail pharmacy PillPack. But Walgreens is stressing ties to local healthcare providers, which Amazon doesn’t yet have. Read more.

    FDA to Hold Public Hearing on Biosimilar Action Plan – July 25, 2018 – In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan on September 4, 2018. The action plan addressed four key areas intended to improve biosimilar competition. Read more.

    Addressing Out-Of-Pocket Specialty Drug Costs in Medicare Part D: The Good, The Bad, The Ugly, And the Ignored – July 25, 2018 – The cost of prescription drugs in the United States has been a popular topic of debate in recent years, particularly when it comes to specialty drugs with very high price tags. High-profile proposals and reports—including this year’s President’s Budget; the National Academies of Science, Engineering, and Medicine’s report on making medicines affordable; the Medicare Payment Advisory Commission (MedPAC) annual report to Congress; and the recent Department of Health and Human Services (HHS) Blueprint to Lower Drug Prices and Out-of-Pocket Costs—have made a variety of recommendations, leading to a flurry of reactions from all segments of the healthcare industry. Read more.

    Déjà Voodoo: Pharma’s Promises to Curb Drug Prices have been Heard Before – July 25, 2018 – Prescription drug prices were soaring. Angry policymakers swore they’d take action. Pharma giant Merck responded by promising to address the problem voluntarily, vowing to keep price increases under the overall rate of inflation. “We believe these moderate increases are a responsible approach, which will help to contain costs,” the Merck CEO said at the annual shareholders meeting. That assurance wasn’t made last week when multiple drug companies offered similar pledges amid similar criticism. It was nearly three decades ago, in 1990. Read more.

    Several of the Biggest Pharma Giants are Freezing Drug Prices. Here’s How it will Affect You – July 25, 2018 – You may have been hearing a flurry of news about drug price freezes recently — but don’t start spending your windfall just yet. Bowing to political pressure from the White House, some of the biggest drug manufacturers have announced a series of temporary price freezes or even price cuts to their medications in recent weeks. Read more.

    New Guidelines for Treatment and Prevention of HIV Infection in Adults – July 24, 2018 – The International Antiviral Society-USA Panel has released updated recommendations for the treatment and prevention of HIV infection in adults, published in the Journal of the American Medical Association. Michael Saag, MD, director of the University of Alabama at Birmingham’s Center for AIDS Research, served as the article’s lead author. Read more.

    Generic Drugs could have Saved $3B for Medicare Part D Program – July 24, 2018 – Using generic drugs instead of their brand-name equivalents could have saved the Medicare Part D program approximately $3 billion in 2016 alone, according to new data from HHS. A relatively small number of brand-name therapies is responsible for significant spending, HHS found. Ninety percent of all prescriptions filled in the U.S. are already for generic medications, but shifting the remaining ten percent of prescriptions away from pricey brand-name options could have reduced spending by a third. Read more.

    Target Prices to Control Prescription Drug Spending, AHA Advises – July 23, 2018 – With prices, not utilization, driving prescription drug spending at hospitals and health systems, the American Hospital Association (AHA) recently called on policymakers to focus on controlling costs via average sales price (ASP) control. In a letter to the Medicare Payment Advisory Commission (MedPAC), the hospital group pushed for an ASP inflation cap for Medicare Part B-covered drugs to curb prescription drug spending for providers. Read more.

    New Clinical Guideline for Evaluating Alzheimer’s, Related Dementias – July 23, 2018 – Twenty recommendations have been developed by the Alzheimer’s Association workgroup to help clinicians evaluate Alzheimer disease and other dementias in the areas of primary and specialty care. The guidelines were presented at the 2018 Alzheimer’s Association International Conference, July 22-26, 2018 in Chicago, Illinois. Read more.

    Medicare Patients May Lower Drug Costs by Not Using Their Insurance – July 23, 2018 – Generic medicines for many common health problems like high blood pressure and diabetes may cost Medicare patients less when they pay cash instead of using their health insurance, a U.S. study suggests. Researchers compared out-of-pocket costs for 30-day supplies of 27 different medications for conditions related to cardiovascular disease. They looked at how often these prescriptions cost more than $4 – the amount charged by Wal-Mart’s drug discount program – when people used one of 622 different standalone Medicare drug plans or one of 1,533 different health insurance plans known as Medicare Advantage. Read more.

    Federal Working Group to Consider Importing Prescription Drugs – July 22, 2018 – Health and Human Services (HHS) Secretary Alex Azar, MD, asked FDA Commissioner Scott Gottlieb, MD, to establish a working group to examine how to safely import prescription generic drugs in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities. “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim [pyrimethamine, Vyera], we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent. Read more.

    Outrageous Prices of Orphan Drugs: A Call for Collaboration – July 20, 2018 – Few instances of a single act of legislation have shifted industrial policy in the pharmaceutical industry like the Orphan Drugs Act did when it was signed in the U.S.A. in 1983. The Act was written to facilitate the development of drugs for rare diseases and health conditions, 1 and the incentives provided by the Act, such as seven-year exclusivity, tax credits of up to 50 percent of research and development costs, and access to research and development grants, resulted in the U.S. Food and Drug Administration 2 (FDA) approving 575 drugs and biological products for rare diseases between 1983 and 2017—a real success. Read more.

    Polycystic Ovary Syndrome: World-First Plan to Improve Diagnosis, Treatment – July 19, 2018 – That was the blunt diagnosis doctors came up with for Sarah DeLozier as she desperately sought help for a condition that had plagued her since she was a teenager. It would take more than 10 years until an international expert visiting Queensland would finally confirm what Sarah had begun to suspect: she had polycystic ovary syndrome (PCOS). “I felt ignored because I knew there was something more wrong with me,” she said. Read more.

    ECRI Institute to Relaunch Clinical Guidelines Website in September on Subscription Basis – July 19, 2018 – ECRI Institute will bring back the National Guideline Clearinghouse database in September on a subscription basis after the Agency for Healthcare Research and Quality shut down the website July 16 due to a funding cut, a spokesperson for ECRI Institute confirmed to Becker’s Hospital Review. Until its shutdown, the NGC gave users free access to clinical practice guidelines, including standardized abstracts about each guideline and syntheses of guidelines covering similar topics. Read more.


    340B in the News

    340B Program Restatements and Refunds Navigate Current Requirements and Plan for the Future – July 31, 2018 – It is a time of change in the 340B Program. Manufacturers should closely monitor 340B program developments and prepare to respond promptly and effectively to changes in legal requirements. This may make it necessary to devote additional resources to 340B program compliance today. Please see full publication below for more information. Read more.

    Hospitals Say OPPS Proposed Rule will Harm Patient Access to Care – July 30, 2018 – Hospital associations across the country are speaking out against the recent CMS proposed Hospital Outpatient Prospective Payment System (OPPS) rule, stating that the rule will hinder patient access to care and increase out-of-pocket patient costs. The proposed rule included site-neutral payments, meaning hospital and physician clinics will receive equal payments for Medicare. CMS intends this change to encourage patients to receive care where they choose without the potential for high out-of-pocket co-pays. Read more.

    Vizient, Inc. Urges CMS to Reconsider 340B & “Site-Neutral” Policies in Proposed OPPS Rule – July 26, 2018 – Vizient, Inc. is disappointed with the recently released Centers for Medicare and Medicaid Services (CMS) annual outpatient prospective payment system (OPPS) proposed rule, specifically those policies related to the 340B Drug Pricing Program and “site-neutral” payments. The 340B program is critical to America’s safety net, allowing hospitals to provide lifesaving programs to the nation’s most vulnerable patients and communities. Read more.

    Proposed Site-Neutral Payment Policy Sets the Stage for Battle Royale Between CMS, Hospitals – July 26, 2018 – As the CMS charts a path to level pay for outpatient services, it’s also leading toward a head-to-head battle with powerful hospital lobbying groups as some providers win and lose with site-neutral payments. If the agency’s 2019 proposal to pay the same rate for services delivered at off-campus hospital outpatient departments and independent doctors’ offices is finalized, the CMS said it would save Medicare $610 million and patients about $150 million via lower co-payments. That represents about 1 percent of the around $75 billion hospitals receive a year from the CMS for outpatient services. Read more.

    Hospitals Condemn CMS Site Neutral Rule That Would Cut Payments to Off-Campus Clinics – July 26, 2018 – Hospital groups, particularly 340B providers, have condemned the Centers for Medicare and Medicaid Services’ prop­osed rule for site-neutral payments that would reduce the rate paid to outpatient off-campus hospital clinics to 40 percent of their current reimbursement. CMS’s proposed the rule Wednesday would pay these clinics at the lower physician fee schedule rate, instead of at their current and higher outpatient rate. Read more.

    CMS Rule Proposes Site Neutral Payments, Extends 340B Cuts – July 25, 2018 – CMS issued a proposed rule for the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Centers (ASC) for 2019 that would institute site-neutral payments and extend 340B payment cuts to previously exempt off-campus providers. The proposal would also remove a number of reporting requirements for OPPS and ASCs. CMS also issued a request for information (RFI) soliciting suggestions on how it can improve price transparency. Read more.

    CMS Proposes Slashing Clinic Visit Payments as Part Of Site-Neutral Policy – July 25, 2018 – In a massive outpatient payment rule, the CMS on Wednesday proposed expanding its site-neutral payment policy to clinic visits, a move that could save the agency hundreds of millions of dollars. Clinic visits, or checkups, are the most common service billed under the outpatient pay rule. The CMS often pays more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting. Read more.

    340B Hospitals Provided Similar Charity, More Uncompensated Care – July 25, 2018 – The debate over whether 340B hospitals truly use discounted prescription drug rates to improve care for vulnerable, low-income patients goes on with a new Government Accountability Office (GAO) report. GAO found that the median amount of charity care provided by hospitals in the 340B Drug Pricing Program was comparable to the amount of charity care rendered by non-participating hospitals in 2016. Read more.

    Congress Should Save this Program that Helps Provide Medicine to Low-Income Texans – July 23, 2018 – The list of government programs that provide free or low-cost care to millions of patients and don’t cost the taxpayers a dime is short. In fact, it may be one line long. Since being signed into law in 1992 by President George H.W. Bush, the 340B Drug Pricing Program has saved billions of dollars in drug costs for safety-net providers, allowing us to care for low-income and rural patients and communities. Read more.

    PAUSE Act a Responsible Approach Toward Reforming The 340B Drug Pricing Program – July 23, 2018 – With 340B being back in the news and with beneficial legislation in the works, I wanted to take the opportunity to reshare my thoughts. The 340B program, a well-intentioned program which, through bureaucratic tinkering, has gone off the rails, primarily due to a lack of oversight and transparency, is back in the news. Created in 1992, 340B was meant to serve as a safety net to ensure that uninsured and indigent patients have access to prescription medicines. Read more.

    340B Showdown: Big Pharma, Hospitals Squaring Off in Lobbying Fight – July 21, 2018 – In Washington, congressional aides waiting for the bus to take them to Capitol Hill stand by signs that picture a unicorn and ask: “What’s rarer than a unicorn? A lifesaving program that costs taxpayers nothing. Congress please:” A visit to the website, paid for by the AIDS Health Foundation in California, finds patient stories and the office phone numbers of lawmakers on the Senate Health, Education, Labor and Pensions Committee, where serious talks over whether the program needs an overhaul started a few months ago. Read more.

    340B Update: D.C. Court of Appeals Upholds Medicare Part B Reimbursement Cut – July 20, 2018 – On July 17, 2018, the U.S. Court of Appeals for the District of Columbia rendered a decision upholding the reimbursement cut that took effect on January 1, 2018. The reimbursement cut applies to drugs purchased under the 340B Drug Discount Program (“340B Program” or “340B”) that are reimbursed under the Medicare hospital Outpatient Prospective Payment System (“OPPS”). Accordingly, 340B covered entity hospitals will continue to absorb the financial impact of the 28.5  percent cut under the OPPS for the time being. Read more.

    Court Rejects AHA’s Attempt to Block 340B Hospital Payment Cuts – July 19, 2018 – A federal appellate court recently tossed the American Hospital Association’s (AHA) lawsuit against HHS, which attempted to block $1.6 billion in 340B hospital payment cuts. Three judges on the U.S. Court of Appeals for the District of Columbia Circuit unanimously agreed that a lower court appropriately decided to dismiss the lawsuit filed by the AHA and several other industry groups because the groups failed to meet the “presentment” threshold. Read more.

    Save the Safety Net Drug Program for Patients Who Need Help – July 19, 2018 – A poster on the side of a bus stop in downtown Washington D.C. read: “Let 340B,” clearly a sign of an organized campaign asking Congress not to interfere with the gravy train for some hospital systems that this obscure provision has become. The safety net drug program, usually referred to as 340B for the section authorizing it in the Public Health Service Act, was created by Congress in 1992 to require pharmaceutical companies participating in Medicaid to provide their drugs at deeply discounted prices to hospitals and other facilities that serve a disproportionate number of indigent and uninsured patients. Read more.

    GAO Finds 340B Hospitals are Mostly Rural or Qualify for DSH Payments – July 19, 2018 – A new Government Accountability Office report has found that the hospitals most likely to benefit from the 340B Drug Discount Program are those it set out to target: rural hospitals and those that serve larger numbers of low-income patients. The GAO report, which comes amid increased scrutiny of the 340B Drug Discount Program, offers a look into the characteristics of hospitals in the program. For instance, the report found that the 340B program has grown significantly in concert with the Affordable Care Act’s Medicaid expansions. The number of participating hospitals increased by 60 percent between 2011 and 2016, from 1,465 to 2,399. While GAO found that 340B participation by eligible acute care hospitals increased between 2012 and 2016 in expansion states, it didn’t increase in nonexpansion states. Read more.