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Clinical Insights: October 10, 2018

Posted on October 10, 2018 By RxStrategies, Inc. -

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

TegsediTM (inotersen) – October 5, 2018 – Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved TegsediTM (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Read more.

RevcoviTM (elapegademase-lvlr) – October 5, 2018 – Leadiant Biosciences, Inc. announced that the Food and Drug Administration (FDA) has granted approval to RevcoviTM (elapegademase-lvlr) injection in the U.S. RevcoviTM is a new enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. Read more.

NuzyraTM (omadacycline) – October 2, 2018 – Paratek Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NuzyraTM (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NuzyraTM, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The company plans on making NuzyraTM available in the first quarter 2019. Read more.

SeysaraTM (sarecycline) – October 2, 2018 – Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of therapies based upon tetracycline chemistry, announced that the U.S. Food and Drug Administration (FDA) has approved SeysaraTM (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older. Read more.

XyostedTM (testosterone enanthate) – October 1, 2018 – Antares Pharma, Inc. announced the approval of XyostedTM (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XyostedTM is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector. Read more.

Libtayo® (cemiplimab-rwlc) – September 28, 2018 – The U.S. Food and Drug Administration approved Libtayo® (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC. Read more.

Arikayce® (amikacin liposome inhalation suspension) – September 27, 2018 – The U.S. Food and Drug Administration approved a new drug, Arikayce® (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease). Read more.

Vizimpro® (dacomitinib) – September 27, 2018 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vizimpro® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Read more.

EmgalityTM (galcanezumab-gnlm) – September 27, 2018 – Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved EmgalityTM (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. EmgalityTM offers a once-monthly, self-administered, subcutaneous injection. EmgalityTM is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Read more.

Copiktra (duvelisib) – September 24, 2018 – Food and Drug Administration granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Read more.

AjovyTM (fremanezumab) – September 14, 2018 – Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved AjovyTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AjovyTM, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options. Read more.

XelprosTM (latanoprost) – September 14, 2018 – Sun Pharmaceutical Industries Ltd., “Sun Pharma” (including its subsidiaries and/or associate companies), and Sun Pharma Advanced Research Company Ltd. announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XelprosTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. Read more.

LumoxitiTM (moxetumomab pasudotox-tdfk) – Septebmer 13, 2108 – The U.S. Food and Drug Administration approved LumoxitiTM (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. LumoxitiTM is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL. Read more.

Cassipa® (buprenorphine and naloxone) – September 7, 2018 – The U.S. Food and Drug Administration approved Cassipa® (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. Read more.

TiglutikTM (riluzole) – September 6, 2018 – ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful medicines in therapeutic areas with unfulfilled needs, announced that the U.S. Food and Drug Administration (FDA) has approved TiglutikTM (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Read more.

PifeltroTM (doravirine) – August 30, 2018 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved a new HIV-1 medicine PifeltroTM (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. PifeltroTM is indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. Read more.

Jivi® (antihemophilic factor (recombinant), PEGylated-aucl) – August 30, 2018 – Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. Read more.

DelstrigoTM (doravirine, lamivudine and tenofovir disoproxil fumarate) – August 30, 2018 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved new HIV-1 medicine DelstrigoTM, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). DelstrigoTM is indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and is administered orally once daily with or without food. DelstrigoTM contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection. Read more.

XeravaTM (eravacycline) – August 27, 2018 – Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, announced that the U.S. Food and Drug Administration (FDA) has granted approval of XeravaTM (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). Read more.

 

New Formulation Approval

Xolair® (omalizumab) – September 28, 2018  – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. Read more.

Symjepi (epinephrine)TM – September 27, 2018 – Adamis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ lower dose version (0.15mg) of SymjepiTM for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Read more.

 

New Indication Approval

Gardasil® 9 (Human Papillomavirus (HPV) – New Expanded Indication Approval – October 5, 2018 – The U.S. Food and Drug Administration approved a supplemental application for Gardasil® 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil® 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. Read more.

Hemlibra® (emicizumab-kxwh) – New Indication Approval – October 4, 2018 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra® is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously (under the skin) and at multiple dosing options (once weekly, every two weeks or every four weeks). Read more.

Fycompa® (perampanel) – New Expanded Indication Approval – September 28, 2018 – Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients four years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both Fycompa® tablet and oral suspension formulations. Read more.

Coagadex® (coagulation Factor X [human]) – Updated and Expanded Indication Approval – September 26, 2018 – The Food and Drug Administration (FDA) has approved updated labeling for Coagadex® (coagulation factor X [human]; Bio Products Laboratory) to remove age restrictions for the currently approved indications and to add an indication for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. In addition, the FDA has approved an expanded indication for perioperative management of bleeding to include patients with moderate hereditary Factor X deficiency. Read more.

Actemra® (tocilizumab) – New Indication Approval – September 13, 2018 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with SJIA. Read more.

Imbruvica® (ibrutinib) – Expanded indication – August 27, 2018 – AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib) plus rituximab (Rituxan®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the Imbruvica® prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Read more.

 

New Drug Shortage

October 4, 2018 

October 2, 2018 

September 28, 2018 

September 26, 2018 

September 21, 2018 

 

New Drug Recall and Safety Alerts

Robaxin® (methocarbamol) – New Drug Recall Alert – September 28, 2018 – Endo International plc announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750 mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” Read more.

Pharm D Solutions, LLC Recall of all Sterile Compounded Drugs – New Drug Recall Alert – September 10, 2018 – Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician 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.

Furosemide, SCA Pharmaceuticals – New Drug Recall Alert – September 6, 2018 – SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate. Read more.

Montelukast, Camber Pharmaceuticals – New Drug Recall Alert – September 5, 2018 – Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10 mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10 mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10 mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50 mg. Read more.

Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitors – New Safety Alert – August 29, 2018 – The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. Read more.

 

New Generic Launch

Tadalafil (Cialis®) – Sep. 27, 2018 – Teva Pharmaceutical Industries Ltd. announced the exclusive first-to-file launch of a generic version of Cialis® (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the U.S. Read more.

Dalfampridine Ampyra® – September 21, 2018 – Mylan has launched its 10 mg Dalfampridine Extended-Release Tablets, an authorized generic version of Acorda’s Ampyra (dalfampridine). Dalfampridine, which is being marketed to to treat adult patients with multiple sclerosis (MS), is indicated to improve patients’ ability to walk and increase speed. Read more.

 

Clinical and Pharmacy News

How To Avoid Medication Errors In Hospitals – October 9, 2018 – The American Society of Health-System Pharmacists has released guidelines on preventing medication errors in hospitals. The guidelines, which are targeted at health system and hospital settings, are designed to give pharmacists ground rules and best practices to improve patient safety and avoid medication errors. Read more.

Improvement in Guidelines for Monitoring Patients Receiving Lithium Essential – October 9, 2018 – Improvement in the applicability of clinical practice guidelines on the use of lithium in the treatment of bipolar disorder and treatment-resistant depression is necessary, according to the results of a study published in Bipolar Disorders. Lithium is often used in the treatment of bipolar disorder and for the augmentation of therapy in patients with treatment-resistant depression. However, close monitoring of lithium therapy is essential to maintain lithium levels within a narrow therapeutic window. Read more.

Study Highlights Need To Enhance Glycemic Management For Older Adults – October 4, 2018 – A cross-sectional analysis published in the Journal of the American Geriatrics Society found that one-quarter of older adults with type 2 diabetes were tightly controlled and receiving glucose-lowering medications with high risk for hypoglycemia. Investigators examined 30,969 patients aged 75 and older who participated in The Diabetes Collaborative Registry between 2014 and 2016, then categorized them based on A1C and types of antihyperglycemic medications. Data suggested that the availability of safer treatment options and updated guideline statements had not improved antidiabetic management for older adults. Read more.

AGA Drafts New Recommendations for Opioid-Induced Constipation – October 4, 2018 – Draft guidelines from the American Gastroenterological Association recommend that only laxatives and peripherally acting mu-opioid receptor antagonists be used for the pharmaceutical treatment of opioid-induced constipation (OIC). The document, presented during the 2018 Digestive Disease Week, advises use of intestinal secretagogues and 5-HT agonists, but the guidelines panelists did not make a recommendation regarding use of these agents due to insufficient data, they said. Read more.

Trump Expected To Sign Opioids Package Passed By Congress – October 4, 2018 – By a vote of 98-1, the Senate approved a package of bills Wednesday to address the opioid crisis, sending the bill to President Trump, who is expected to sign it.”We have an urgent bipartisan consensus … to deal with the most urgent public health epidemic facing our country today in virtually every community,” said Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor, & Pensions Committee. “Including the appropriations bill passed in March and the bill approved last week, we’ll have directed $8.5 billion toward the opioid crisis. Read more.

Walgreens to Purchase Pharmacy Files of 185 Fred’s Stores – October 3, 2018 – Walgreens and Fred’s, Inc. have announced they have entered into a definitive asset purchase agreement, pursuant to which Walgreens will acquire pharmacy patient prescription files and related pharmacy inventory of 185 Fred’s stores located across 10 Southeastern states, according to a news release. Read more.

Why Health Systems Should Worry About Walgreens And CVS – October 2, 2018 – Even with Amazon threatening to compete with retail drugstore chains CVS Health and Walgreens with its own online pharmacy, these retailers aren’t giving up on brick-and-mortar as a way to attract more patients into their stores.And that’s bad news for the nation’s hospitals and health systems.There’s a building threat from the nation’s two retail drugstore giants to hospitals and health systems as medical care providers move away from fee-for-service medicine to value-based care and lower-cost outpatient services. Read more.

Do Price Spikes on Some Generic Drugs Indicate Problems in The Market? – October 2, 2018 – A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common.The study from the USC Schaeffer Center for Health Policy & Economics, published in the October issue of Health Affairs, shows that the portion of generic drugs that at least doubled in price year-over-year represents a small but growing share of the market: from 1 percent of all generic drugs in 2007 to 4.39 percent in 2013. Read more.

Do Price Spikes on Some Generic Drugs Indicate Problems in the Market? – October 1, 2018 – A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common. The study from the USC Schaeffer Center for Health Policy & Economics, published in the October issue of Health Affairs, shows that the portion of generic drugs that at least doubled in price year-over-year represents a small but growing share of the market: from 1 percent of all generic drugs in 2007 to 4.39 percent in 2013. Read more.

Nonprofit That Aims to Lower Drug Prices is ‘Disruption’ The Industry Needs, CHI Health Exec Says – October 1, 2018 – First hospitals had to hunt down or find work-arounds for certain types of IV fluids that were in short supply. More recently, some pain medications have been hard to get. To address shortages and high prices for some older drugs, a group of seven large health systems and three philanthropic groups recently launched a new nonprofit generic drug company called Civica Rx. Read more.

UnitedHealth Purchases Pharmacy Genoa Healthcare from Advent – September 27, 2018 -UnitedHealth Group Inc. bought pharmacy company Genoa Healthcare from private equity group Advent International. The price was about $2.5 billion, according to a person familiar with the transaction. UnitedHealth, the biggest U.S. health insurer, beat out other parties including drugstore chain Walgreens Boots Alliance, which was said to be interested in Genoa in August, according to the person, who requested anonymity because the talks were private. Read more.

House Passes Bills Prohibiting Pharmacy Gag Clauses on Drug Prices – September 27, 2018 – The U.S. House of Representatives unanimously passed two bills that would prevent pharmacy benefit managers from putting gag clauses into contracts with pharmacies. The gag clauses restrict the pharmacist from telling customers they could pay less for a prescription if they paid the full price of the drug out-of-pocket rather than using their insurance and paying the copay amount. Read more.

Physicians, Surgeons Ask Feds to Block CVS Health-Aetna Deal – September 26, 2018 – The Association of American Physicians and Surgeons expressed its opposition to CVS Health’s proposed $69 billion acquisition of Aetna in a Sept. 21 letter to the Department of Justice. In the letter, sent to Attorney General Jeff Sessions, AAPS’ President-elect Marilyn Singleton, MD, said: “CVS has demonstrated a pattern of anticompetitive behavior. Allowing this merger to proceed will hand the combined CVS/Aetna even more clout to drive up costs without any corresponding benefit to patients.” Read more.

Big Pharma Boosts Drug Prices as Supplies Run Low, Study Reveals – September 26, 2018 – Federal lawmakers have been griping about drug pricing for years, led most recently by President Donald Trump, who famously declared even before he was elected that the industry is “getting away with murder.” A new study could very well fuel those complaints. Researchers at the University of Pittsburgh and Harvard Medical School scoured the U.S. Food and Drug Administration’s drug-shortage database and compared the results to pricing data. They determined that prices increased twice as fast as expected for drugs that were in short supply in 2016. Read more.

Pharmacists May Soon Be Able to Tell You the Cheapest Way to Get Prescriptions – September 25, 2018 – A bill backed by President Donald Trump that will allow pharmacists to tell patients about the cheapest way to pay for prescription drugs at the counter won approval in the House of Representatives. The legislation, already passed by the Senate, bars insurers and pharmacy-benefit managers, or PBMs, from prohibiting pharmacists from telling patients they could potentially save money by paying cash instead of an insurance copayment. Read more.

Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab – September 24, 2018 -Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health. The study, published Sept. 24 in JAMA Internal Medicine, is the most comprehensive analysis of key drug trial costs to date, and suggests that these costs contribute only modestly to the overall costs of developing new drugs. The $19 million median figure represents less than one percent of the average total cost of developing a new drug, which in recent years has been estimated at between $2 to $3 billion. Read more.

 

340B in the News

340B Litigation Update: Both Ceiling Price Rule Delay and 340B Rate Cuts Face Legal Challenges – October 8, 2018 – On September 11, 2018, the American Hospital Association (AHA) and other major healthcare industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of Columbia force HHS to implement the long-delayed Ceiling Price Rule. The rule sets out the process for calculating the ceiling price of 340B drugs and allows HHS to bring monetary penalties against drug companies that overcharge for 340B drugs. Read more.

Hospital CEOs Urge Congress To Protect 340B – October 3, 2018 – CEOs representing more than 700 hospitals in the 340B Drug Pricing Program are urging Congress to protect their discounts. In a letter this week to U.S. House and Senate leaders, the CEOs said that recent proposals to cut back the 340B program would worsen the high prices charged for drugs.”We are concerned about recent regulatory actions that have reduced the reach of this vital program and by legislative proposals that would undo more than two decades of bipartisan work to preserve the healthcare safety net,” they said. Read more.

340B Advantage for Hospitals Starts to Erode – October 2, 2018 – A change this year to the 340B Drug Pricing Program improved the competitive standing for independent oncology practices, a gain that was solidified as legal challenges failed to overturn the payment policy change. However, the battle over 340B—specifically, to improve discounts for participating hospitals on outpatient drug purchases and tighten the charitable component of the program—continues in Congress, with multiple legislative initiatives. Read more.

Update: AHA Proposes Voluntary 340B Program Transparency Efforts – Septebmer 28, 2018 – On September 18, 2018, leaders from the American Hospital Association (“AHA”) formally announced a new initiative called the “Commitment to Good Stewardship Principles,” which requests certain voluntary public reporting of eligible hospitals related to the 340B Drug Discount Program (“340B Program” or “340B”). This grassroots initiative comes on the heels of recent debate in Washington, D.C., regarding policy changes to promote greater transparency in the 340B program. Read more.

340B Update: AHA Proposes Voluntary 340B Program Transparency Efforts – September 27, 2018 – On September 18, 2018, leaders from the American Hospital Association (“AHA”) formally announced a new initiative called the “Commitment to Good Stewardship Principles,” which requests certain voluntary public reporting of eligible hospitals related to the 340B Drug Discount Program (“340B Program” or “340B”). This grassroots initiative comes on the heels of recent debate in Washington, D.C., regarding policy changes to promote greater transparency in the 340B program. Read more.

AHA: Proposals in Outpatient Payment Rule ‘Run Afoul Of The Law – September 27, 2018 – The American Hospital Association is “deeply disappointed” in certain proposals in CMS’ Outpatient Prospective Payment System proposed rule for 2019, the group said in a comment on the proposed rule submitted Sept. 24. The AHA said some of the proposals in the proposed rule “run afoul of the law and rely on the most cursory of analyses and policy rationales.” Read more.

‘Deeply Disappointed’: Hospitals Urge Cms To Change Course On OPPS 2019 – September 25, 2018 – The deadline to comment on proposed changes to the Medicare outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system for next year passed Monday evening.Hospital groups did not pass up the opportunity to make their displeasure known, and they hinted that legal action to block the proposal could be warranted. Read more.