Health Care archive- Page 3 of 6

Health Care Weekly: Corcept Seeks Dismissal of Off-Label Marketing Whistleblower Suit; Medicare ACCESS Program to Cover More Chronic Conditions; FDA Launches Accelerated Investigational Drug Review Program; Agencies Announce Fresh Steps to Curb Animal Testing; Abbott Settles Federal Claims of Formula Contamination

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • Corcept Therapeutics says alleged off-label drug promotion doesn’t...

Sep 23, 2026 Read Now >

Medline: Following FDA Warning Letter, Prior Inspections, and Recalls Related to Contamination, Company Receives FDA 483 Over Microbial Testing Practices at Mundelein Facility

In the wake of recent FDA scrutiny of microbial contamination in Medline (MDLN) products and several related recalls, FDA investigators found during a July inspection that the company has substandard processes for testing drug products for microbial contamination at its Mundelein,...

Sep 21, 2026 Read Now >

Chemed: Families of VITAS Patients Say The Company Mismanaged the Care of Their Loved Ones, Causing Physical and Emotional Pain; Former Employees Say VITAS Misrepresented Services When Marketing and Left Patients Alone in Crises; Company Has Been Cited Hundreds of Times by Regulators for Poor Care and Holds Medicare Ratings Well Below National Average Despite Higher-Than-Average Payments

In 2024, Vitas Healthcare, the largest hospice provider in the nation and a subsidiary of Chemed (CHE), was paid by Medicare roughly 26%, or $4,000, more per patient compared with the national average to provide end-of-life care, according to an analysis of Medicare claims data for that...

Sep 18, 2026 Read Now >

Capitol Forum Analysis of August MAUDE Data

The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports...

Sep 17, 2026 Read Now >

Health Care Weekly: FDA Leaders Open to Regulatory Flexibility on Psychedelics; House E&C Panel May Back Medicare Coverage for Respiratory Illness Care at Pharmacies; Patients, Plans Push for No Surprises Act Dispute Resolution Changes; CMS Can Better Screen for DME Fraud in Medicare Advantage, HHS-OIG Says

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • FDA officials say they’re open to regulatory flexibility on psychedelic...

Sep 16, 2026 Read Now >

The European Antitrust Agenda: Commission Ignores Chinese Blocking Orders; Brussels Hosts Digital Rulebook Meeting on Browsers

Welcome to The European Antitrust Agenda, our weekly overview of European tech and competition law developments. Key stories we’re following this week include: • Commission ignores Chinese blocking orders • Officials are bringing browsers together to tackle a longtime digital rule...

Sep 15, 2026 Read Now >

Health Care Weekly: Pharmacists Wary of Data Sharing in CVS Caremark Settlement; FTC Touts Success of OhioHealth Probe; FDA Seeks to Speed Botanical Drug Development; CMS Announces Fraud Crackdown as Comments Close for Home Health, Hospice, DME Rule

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • Independent pharmacies are concerned about FTC’s CVS Caremark settlement....

Sep 09, 2026 Read Now >

Insulet: Omnipod Users Report Persistent Leakage, Under-Delivery Problems with Insulin Devices Not Included in Prior Recall

In May, Insulet Corporation (PODD) issued a recall affecting millions of its Omnipod insulin delivery devices after some lots of the popular Omnipod 5 system, as well as the Omnipod DASH and Omnipod Eros, were found to have a small tear in the tubing just above the skin—a defect that...

Sep 08, 2026 Read Now >

Health Care Weekly: Florida AG Accuses PBMs of Price-Fixing; Acquisitions of Pending Pharma IP Should Face Antitrust Scrutiny, FTC Says; FDA Targets Online Peptide Sellers; Medicare DME Moratorium Ends; Dialysis Giants Comment on ESRD Proposal; Update on FDA Warnings About Clinical Trial Disclosures

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • Prime Therapeutics, Express Scripts engaged in price-fixing, Florida AG says....

Sep 02, 2026 Read Now >

Chemed: Vitas Healthcare Misdiagnosed Dementia Patients and ‘Fudged’ Evaluation Scores in Order to Admit Them into Hospice; Expert Who Reviewed Internal Documents Says They Warrant Federal Investigation

An ongoing Capitol Forum investigation of VITAS Healthcare, a subsidiary of Chemed (CHE) and the largest hospice provider in the nation, has found that the company is enrolling patients into hospice that do not meet Medicare guidelines and recording inaccurate diagnoses to avoid scrutiny...

Aug 26, 2026 Read Now >

Antibiotics Producer Warns ‘Buy European’ Rules Could Create Quasi-Monopoly

Dutch antibiotics producer Centrient is warning that a careless implementation of the “Buy European” criteria in the EU’s recently agreed Critical Medicines Act (CMA) could decrease competition in the antibiotics market, especially for...

Aug 25, 2026 Read Now >

Maude Monthly: Insulet Omnipod Lots Outside of Recall Appear to Be Showing Same Defects; Medline Reports Thousands of Backlogged Reports; ConvaTec Subsidiary Discloses Hundreds of Deaths but Little Investigation of Their Causes

Adverse-event reports for Insulet Corporation’s (PODD) Omnipod 5 insulin pump that describe the specific defect behind two recalls earlier this spring reached an all-time monthly high in July, according to a Capitol Forum analysis of the FDA’s Manufacturer and User Facility Device...

Aug 18, 2026 Read Now >

Capitol Forum Analysis of July MAUDE Data

The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports...

Aug 18, 2026 Read Now >

A Closer Look at FDA’s Next Steps Following Advisory Committee’s Recommendation to Legalize Compounding for Wellness Peptides

On July 23 and 24, an advisory committee voted to recommend that the Food and Drug Administration allow compounding pharmacies to work with six non-FDA-approved peptides— protein building blocks that proponents such as Health and Human Services Secretary Robert F. Kennedy Junior praise...

Aug 14, 2026 Read Now >

Chemed: Hospice Subsidiary VITAS Healthcare Overutilizing Intensive Services at Medicare’s Expense; Company Has Long History of Improper Billing Practices

As the Trump Administration continues its crackdown on hospice fraud, a Capitol Forum investigation has found that VITAS Healthcare, a subsidiary of Chemed (CHE) and the largest hospice operator in the country, may be systematically overbilling Medicare by tens of millions of dollars...

Aug 13, 2026 Read Now >

FDA’s Forthcoming Proposal Could Make Direct-to-Consumer Pharma Ads Prohibitively Long and Expensive to Run; Some Scenarios Could Make Some Current Ads Over Ten Minutes Long

An anticipated proposal from the Food and Drug Administration (FDA) could make direct-to- consumer (DTC) pharmaceutical ads so lengthy as to be cost-prohibitive, according to The Capitol Forum’s analysis and conversations with sources. In some scenarios, a stringent interpretation of...

Jul 30, 2026 Read Now >

Hims & Hers Health: FTC, Utah, and California Sue Hims & Hers Over Deceptive Billing and Privacy Practices

Today, the FTC, as well as regulators in California and Utah, filed a lawsuit against the telehealth provider Hims & Hers Health (HIMS), alleging that the company enrolled consumers in prescription subscriptions without their consent, obstructed cancellations, and shared sensitive...

Jul 29, 2026 Read Now >

Health Care Weekly: FDA Compounding Advisory Committee Votes Favorably on Six Peptides; Updates on CMS’ Implementation of SDP, Provider Tax Law; Judge Dismisses NSA Case Against HaloMD in GA; CVS Accused of 340B Spread Pricing; OpenAI Faces Unlicensed Practice of Medicine Suit; FDA 483s

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • FDA opens pathways for compounded peptides. • CMS receives comments on SDP...

Jul 29, 2026 Read Now >

Universal Health Services: Lawsuit Alleges Three Minors Were Sexually Assaulted While Patients at Missouri Psychiatric Hospital; One Allegation Relates to 2025 Assault, Potentially After Company Lost Insurance Coverage

A lawsuit filed in Vernon County, Missouri last month alleges that three minors were sexually assaulted during their stay at Heartland Behavioral Health, a psychiatric facility operated by Universal Health Services (UHS) in Nevada, Missouri. Importantly, one of the allegations of assault,...

Jul 23, 2026 Read Now >

Health Care Weekly: HHS Withholds More Medicaid Funds from CA and MN, Citing Suspected Fraud; House Dems Propose Bill Targeting Commercial Health Insurance Denials; Senate Votes Against Resolution to Scrap WISeR; Eli Lilly Buys Psychedelics-Focused Drugmaker; FDA Issues Letters, Asks for Input on Monitoring Infant Formula Industry; CMS Collects Public Comment on Implementing PBM Laws

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • HHS defers more than $1 billion in Medicaid payments to California and...

Jul 22, 2026 Read Now >

As Florida AG Investigates Caremark, Independent Pharmacists and Pharmacy Owners Say CVS Self-Preferences and Targets Independents with Unfair Rates and Audits

Last month, the Florida attorney general issued a subpoena to CVS (CVS) to determine whether its pharmacy benefit manager (PBM), Caremark, is harming independent pharmacists by steering patients to its own pharmacies, giving higher reimbursements to itself, and subjecting independent...

Jul 17, 2026 Read Now >

Proposed OPPS and ASC Rule May Curb Hospital Consolidation in Imaging Space, Drive Volume to Non-Hospital Settings

A proposed rule from the Center for Medicare and Medicaid Services (CMS) would disincentivize hospital ownership of outpatient imaging clinics—potentially driving down costs for patients and the government—and may push more services out of the hospital setting into ambulatory surgical...

Jul 15, 2026 Read Now >

Health Care Weekly: HHS OIG Requests Information on Direct-To-Consumer Drug Sales, Anti-Kickback Laws; CMS Seeks to Break AMA Monopoly on Coding and Payments; CMS to Propose Rule Loosening Conditions for Participation in Medicare, Medicaid; FTC Settles With Caremark; FDA to Defend Legal Authority to Publish CRLs; FDA Cracks Down on Online Ketamine Sales; FDA Issues Guidance, Schedules Hearing on Psychedelic Research and Usage

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • HHS OIG may seek to update anti-kickback regulations to accommodate DTC drug...

Jul 15, 2026 Read Now >

Capitol Forum Analysis of June MAUDE Data

The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports...

Jul 15, 2026 Read Now >

Maude Monthly: Abbott CGM Low Reading Problem Continues to Grow as Company Discloses Additional Death; Medline Reports Hundreds of Late Reports in Wake of FDA Scrutiny; MAUDE Data Reveals Additional Issue with Insulet Omnipod

The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports...

Jul 15, 2026 Read Now >

The European Antitrust Agenda: EU Plans Public Procurement Restrictions; Apple Appeal Loss Has Consequences for Future ‘Gatekeepers’

Welcome to The European Antitrust Agenda, our weekly overview of European tech and competition law developments. Key stories we’re following this week include: • Public procurement restrictions exclude China and India • Apple’s recent court loss has consequences beyond the iPhone...

Jul 14, 2026 Read Now >

Health Care Weekly: VA Suspends Harrow’s Out-of-State Compounding Licenses; CMS Reneges on Bone Growth Stimulator Payment Change; CMS Proposes Bundling Payment for Phosphate Binders into ESRD in 2027; OPPS Rule Includes Site Neutrality Measures, 340B Reimbursement Crackdown; CMS Seeks Stricter Enrollment Oversight for Home Health, DME; FDA 483s

The Health Care Weekly is a timely analysis of competition developments, policy changes and other updates that may affect medical and pharmaceutical markets. Key stories we’re following this week include: • Virginia suspends Harrow’s compounding licenses. • CMS walks back pricing...

Jul 08, 2026 Read Now >

The European Antitrust Agenda: EU Steel Curbs Complicate MMG Review; EC Seeks to Calm Merger Guideline Fears

Welcome to The European Antitrust Agenda, our weekly overview of European tech and competition law developments. Key stories we’re following this week include: • EU steel quota implications for MMG’s Anglo bid • EC calms worries for minority shareholdings under new merger...

Jul 07, 2026 Read Now >

Universal Health Services: Former Employee Accused of Sexual Assault in Washington Had Suspended Nursing License in Britain; Former Employees Raise Concerns Regarding Background Check Process

An ongoing Capitol Forum investigation of patient safety at psychiatric facilities operated by Universal Health Services (UHS) has found that a former employee accused of sexual assault of a patient at Fairfax Behavioral Health, a 157-bed inpatient psychiatric hospital in Washington...

Jul 01, 2026 Read Now >

The European Antitrust Agenda: European Commission Defends ‘Call-In’ Powers; EU Executive’s IT Department Breaking Up with Contentious Broadcom Unit

Welcome to The European Antitrust Agenda, our weekly overview of European tech and competition law developments. Key stories we’re following this week include: • European Commission defends call-ins • EU executive ditches controversial American...

Jun 30, 2026 Read Now >

EU Faces Pressure to Extend Probe to Protect Transformer Makers, Sources Say

The EU steel industry is pressing the European Commission to widen the scope of the bloc’s safeguard investigation into potentially harmful imports of grain-oriented electrical steel (GOES) to include material used in finished power transformers, according to three people familiar with...

Jun 23, 2026 Read Now >

The European Antitrust Agenda: Portugal Assesses Gun-Jumping Fine; Italy Tests Limited Member State Role in EU Digital Rules

Welcome to The European Antitrust Agenda, our weekly overview of European competition law developments. Key stories we’re following this week...

Jun 23, 2026 Read Now >

Acadia Healthcare: CMS Issues Immediate Jeopardy Citation to Youth Hospital Under Ongoing Federal Investigation and Facing Multiple Sexual Assault Lawsuits; Investigators Find 20 Girls Locked in Rooms for Several Days for No Reason and Abusive Staff Repeatedly Put Back on Floor with Patients

A Spring 2026 inspection of Lakeland Behavioral Health, a youth psychiatric facility in Missouri operated by Acadia Healthcare (ACHC), resulted in government investigators issuing an immediate jeopardy citation to the facility, the worst citation a facility can...

Jun 17, 2026 Read Now >

Use of AI in Drug Development Raises Novel Patentability Questions

With pharmaceutical companies and inventors increasingly using artificial intelligence (AI) for drug discovery and development, legal challenges to the validity of patents on drugs that were developed with assistance from AI may start emerging in the coming years, health care and...

Jun 17, 2026 Read Now >

Medline: Poor Quality of Nitrile Gloves May Exacerbate Possible Shortages and Price Increases

When Iran closed the Strait of Hormuz at the start of the conflict with the United States, industries around the globe that depended on petrochemical inputs, from fuel to fertilizer, saw shortages and price jumps due to the restrained trade. That shortage, however, has rippled out far...

Jun 17, 2026 Read Now >

Maude Monthly: Medline Reports Uptick in Malfunctions in Products Highlighted in Prior Capitol Forum Reporting; Abbott Backlog Indicates Company Knew of Freestyle Libre Problems for Years; ConvaTec Infusion Sets Breaking Reports Continue to Increase After Warning Letter

The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports...

Jun 12, 2026 Read Now >

Encompass Health: HHS OIG Report Highlights High Rate of Medicare Advantage Denials for IRF Stays

A report published today by the Health and Human Services Office of Inspector General (HHS OIG) indicates that the three largest Medicare Advantage Organizations (MAOs) are denying requests for stays at inpatient rehabilitation facilities (IRFs) at an outsized rate. The report raises...

Jun 11, 2026 Read Now >

Health Care Weekly: SCOTUS Sides with Generic Drugmaker in Skinny Labeling Case; FDA, Congress Aim to Speed Up Investigational New Drug Applications; OpenEvidence Says Doximity Misled Pharmaceutical Advertisers; CMS to Launch GLP-1 Bridge Program in July; FDA 483s

SCOTUS rules in favor of generic drugmaker in “skinny labeling” case. On June 4, the Supreme Court issued a unanimous opinion to reverse a previous Federal Circuit ruling in a patent case filed by drugmaker Amarin (AMRN) against its generic competitor Hikma, ruling that Hikma had not...

Jun 10, 2026 Read Now >

Four Years After OTC Hearing Aid Rule, Competition in Hearing Aid Market Remains Limited Due to Deep Vertical Integration, Sources Say

In 2022, the Food and Drug Administration finalized a rule expected to increase competition in the hearing aid market by giving patients with mild-to-moderate hearing loss access to over-the-counter hearing aids, a potentially cheaper alternative to expensive prescription...

Jun 05, 2026 Read Now >

Health Care Weekly: Whistleblower Suit Accuses Corcept of Off-Label Marketing; CMS Finalizes Long-Awaited Rule on NSA Dispute Process; Democrats Seek Congressional Disapproval of WISeR; FDA Publishes More Draft Guidance on Reducing Animal Testing; Optum Close to Settling FTC Insulin Case; MultiPlan, Insurers Face Price-Fixing Lawsuit in AZ; FDA 483s

Recently-unsealed whistleblower lawsuit accuses Corcept of off-label marketing. Originally filed in February 2017 on behalf of the United States of America, almost 30 states, and unnamed insurance policyholders, the just-unsealed lawsuit alleges that Corcept (CORT) engaged in off- label...

Jun 03, 2026 Read Now >

Medline: Company Receives Warning Letter from FDA Over Bacterial Contamination in Infant Surgical Wipes

Earlier today, the FDA published a warning letter that the agency sent to Medline (MDLN), citing the company for several systemic failures in how it has responded to bacterial contamination in its ReadyPrep Chlorhexidine Gluconate (CHG) antiseptic wipes, which are used to prepare...

Jun 02, 2026 Read Now >

The European Antitrust Agenda: Von der Leyen Urged to Greenlight Google Penalty; JD.com Stands Against FSR Probe

Welcome to The European Antitrust Agenda, brought to you by Europe Executive Editor Javier Espinoza and Senior Correspondents Lydia O’Neal, Barbara Pianese, Joanna Sopinska and Catherine Stupp. This week, we look at fresh pressure on the European Commission to move ahead with a fine...

Jun 02, 2026 Read Now >

Medline: FDA, Industry Experts Raise Concerns Over Company’s Oversight of Contract Manufacturers and Ability to Monitor Device Malfunctions

A Capitol Forum investigation has found that poor oversight of its suppliers and post-market surveillance practices by the medical device company Medline (MDLN) is leading to patient harm and delayed recalls of dangerous products. Over the last several years, FDA inspectors have...

Jun 01, 2026 Read Now >

Universal Health Services: Sexual Assaults and Runaways Persist at South Carolina Facility Despite Federal Sanction

This article contains descriptions of sexual assault. Last year, government inspectors placed multiple immediate jeopardies (IJs) on Three Rivers Behavioral Health, a psychiatric facility operated by Universal Health Services (UHS) in West Columbia, South Carolina, after finding the...

May 26, 2026 Read Now >

DOJ Launches Criminal Antitrust Probe into Claritev

DOJ’s antitrust division has launched a criminal price-fixing investigation into Claritev (CTEV), previously known as MultiPlan, a pricing intermediary that major health insurers use to set reimbursement rates for out-of-network medical claims, sources familiar with the matter...

May 14, 2026 Read Now >

The European Antitrust Agenda: Merger Guidelines Offer Clarity to Startup Buyers and Consider Workers’ Rights

Welcome to The European Antitrust Agenda, brought to you by Europe Executive Editor Javier Espinoza and Senior Correspondents Lydia O’Neal, Barbara Pianese, Joanna Sopinska and Catherine Stupp. This week, we look at the leaked draft of the EU’s forthcoming merger guidelines. A boon...

Apr 28, 2026 Read Now >

Medline: Company Apparently Did Not Disclose Systemic Problems Identified in Multiple FDA Inspections in Year Prior to IPO

Last December, Medline (MDLN), one of the largest suppliers of medical and surgical products in the country, went public in the biggest IPO of the year, raising over $6 billion. In the 12 months prior to the IPO, Medline received four Form 483 inspection...

Apr 16, 2026 Read Now >

CMS Policy: Proposed 0.09% Medicare Rate Appears More Likely to Climb Due to Technical Changes Than CMS Backing Down on Risk Adjustment Policies

Last week, the Centers for Medicare and Medicaid Services (CMS) published an advance notice proposing both technical and policy-related changes to the Medicare Advantage (MA) and Medicare Part D payment methodologies that would, on average, result in a nearly flat rate increase of 0.09%...

Feb 03, 2026 Read Now >

Oral Tirzepatide Ads Could Conflict with Meta’s Ad Policy, Raise Other Legal Questions

In December, the attorneys general of 35 U.S. states and territories wrote a letter calling on Meta to address “the surge of misleading marketing for weight loss products on Meta’s platforms,” particularly for compounded GLP-1 products, which do not have Food and Drug Administration...

Jan 20, 2026 Read Now >

Beta Bionics: iLet Insulin Pump’s Aggressive Algorithm is Pushing Some Users into Dangerous Hypoglycemic Events; FDA Data Shows High Rate of Hypoglycemia Relative to Competitors

A Capitol Forum investigation has found that the iLet Bionic Pancreas, an automated insulin delivery (AID) device produced by Beta Bionics (BBNX), is pushing some users into dangerous hypoglycemic events, with some patients ending up in the hospital and developing life-altering conditions...

Jan 13, 2026 Read Now >

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