Health Care archive - The Capitol Forum

Inspire Medical Systems: Following Other MACs, WPS Removes Lucrative Billing Code for Hypoglossal Nerve Stimulation

The Medicare Administrative Contractor (MAC) WPS removed the CPT code 64568 from its list of approved billing codes for Hypoglossal Nerve Stimulation (HGNS), according to an update posted today on the MAC’s website. The move follows the recent updates by the MACs Noridian and CGS that...

Dec 29, 2025 Read Now >

Inspire Medical Systems: Medicare Administrative Contractors Working on ‘Consensus Approach’ to Resolve Billing Issue

At least three Medicare Administrative Contractors (MACs) are working on a “consensus approach” to resolving a billing dispute that could see some MACs paying much more than other MACs for hypoglossal nerve stimulation (HGNS) procedures, The Capitol Forum has learned. The rest of this...

Dec 15, 2025 Read Now >

MAUDE Monthly: Beta Bionics Reports Remain High; Dexcom Says It Has Fixed Sensor Issues; FDA Warns Patients Against RF Microneedling; Pyxis Problems Persist Despite Over a Dozen Recalls; Boston Scientific Spinal Implants Breaking During Surgery; Update on Dentsply Sirona Class Action

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...

Nov 13, 2025 Read Now >

Ski Gear Maker Tecnica Confirms EU Antitrust Raid of Austrian Facility

Tecnica Group, the Italian owner of the Rollerblade inline skates brand, was among the companies raided by the European Commission as part of a cartel investigation into the ski equipment sector yesterday, a company spokesperson told The Capitol Forum. Commission representatives visited...

Oct 21, 2025 Read Now >

Health Care Policy: Analysis of Potential Policy Outcomes, Industry Effects of MAHA’s Efforts to Target Direct-to-Consumer Pharma Ads

The White House’s Make America Healthy Again (MAHA) Commission, led by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., is expected to release a “Make Our Children Healthy Again” policy plan tomorrow. The strategy may include a crackdown on...

Sep 08, 2025 Read Now >

Caris Life Sciences: A Closer Look at Opportunities, Roadblocks for Widespread Adoption of AI-Based Precision Oncology Tools

Caris Life Sciences (CAI) earned Food and Drug Administration (FDA) approval for MI Cancer Seek, a tool that runs genetic sequencing on tumor tissue, for use as a companion diagnostic—atest that helps identify the best course of treatment for a patient—in November 2024. Since then,...

Sep 02, 2025 Read Now >

Dozens of Federal Judges Attended Antitrust Seminars Hosted by Big Tech-Funded Group, Records Show

Dozens of federal judges attended seminars in idyllic locales like Hawaii and Portugal held by a George Mason University (GMU) law school organization that received Big Tech funding, a Capitol Forum review of public records found. The university’s Antonin Scalia Law School, one of the...

Aug 13, 2025 Read Now >

Encompass Health: Facilities Across the Country Misusing Neurological Diagnosis to Increase Medicare Payments; Conduct Echoes Those Highlighted in 2019 DOJ Settlement

In 2019, Encompass Health (EHC), the country’s largest operator of inpatient rehabilitation facilities (IRF), entered into a settlement with the Department of Justice for $48 million to resolve allegations that its hospitals falsely diagnosed patients to increase Medicare payments and...

Jul 25, 2025 Read Now >

HPE/Juniper: As Fight Between DOJ Leadership and Antitrust Division Broils, Tunney Act Proceeding Looms

After DOJ’s suit to block HPE’s (HPE) $14 billion acquisition of Juniper Networks (JNPR) culminated in a highly unusual settlement, the consent decree faces one last barrier to becoming final: Tunney Act review by U.S. District Judge Casey Pitts. That’s typically a rubber stamp....

Jul 24, 2025 Read Now >

Novo Nordisk: Company Did Not Report or Investigate Deaths Potentially Caused by Ozempic

Novo Nordisk (NVO) did not report multiple deaths that may have been caused by its blockbuster weight loss drug Ozempic to the FDA, according to an agency inspection report obtained by The Capitol Forum through a Freedom of Information Act request… The rest of this article is...

Jul 15, 2025 Read Now >

Prestige Consumer Healthcare: Subsidiary Kept Mold-Contaminated Enemas on Market and Declined to Investigate Source of Outbreak, According to FDA Inspection

Between 2023 and 2025, Fleet, a subsidiary of Prestige Consumer Healthcare (PBH) that manufactures enemas and suppositories, received several complaints that its adult and pediatric enemas were being shipped to customers with visible signs of mold. Despite these complaints, however, the...

Jul 11, 2025 Read Now >

Inspire: Company Files Patent Lawsuit Seemingly to Delay Competition; A Closer Look at the Patents at Issue and Potential Paths Forward

Nyxoah, a Belgian company whose implantable sleep apnea device, Genio, has been on the market in Europe since 2020, plans on launching its device in the U.S. upon earning final approval from the Food and Drug Administration (FDA)—a decision company executives say is...

Jul 11, 2025 Read Now >

Merger Monthly: After Novel Omnicom/Interpublic, HPE/Juniper Remedies, is Everything Settleable?; Outlook for Key Transactions Including Getty/Shutterstock, Mars/Kellanova, and UnitedHealth/Amedisys

In the months after Inauguration Day, the Trump administration’s merger policy appeared to be slowly but surely rounding into form: To wit, meaningful continuity from the Biden administration (retaining the 2023 Merger Guidelines and updated HSR Form), coupled with substantive pull back...

Jul 10, 2025 Read Now >

Medicaid Policy: Approval Timeline for Tennessee’s 1115 Waiver Amendment Remains Uncertain, Could Be Complicated by Forthcoming Legislative Changes

Tennessee is waiting on the Centers for Medicare and Medicaid Services (CMS) to approve an amendment to its Medicaid managed care program, TennCare III, that would authorize additional payments to hospitals that meet certain access and quality improvement benchmarks. While it remains...

Jun 27, 2025 Read Now >

Universal Health Services: Problematic Hospital in California Did Not Consistently Report Patient Abuse to Regulators Because It ‘Would Be Reporting All the Time,’ Administrators Told State

Del Amo Behavioral Health, a psychiatric hospital in Torrance, California, owned by Universal Health Services (UHS), is not reporting severe physical and sexual assault of patients in its care, a Capitol Forum investigation has...

Jun 25, 2025 Read Now >

Influential Conservative Think Tank’s President Touts Legislation Targeting ACA, Medicaid Enrollment and Spending at House Hearing, Says Expansion Match Rate is Still a Problem

Brian Blase, the president of a conservative health policy group with links to the Trump administration, called on Congress at a June 25 House Budget Committee hearing to crack down on enrollments in the Affordable Care Act (ACA) Marketplace, de-incentivize states from expanding their...

Jun 25, 2025 Read Now >

FTC Advertising Collusion CIDs Target Nonprofits, Raising Jurisdictional Questions

The FTC Bureau of Competition’s move last month to issue lengthy civil investigative demands (CIDs) to more than a dozen media tracking and advertising organizations—many organized as nonprofits—raises a host of important...

Jun 10, 2025 Read Now >

UnitedHealth/Amedisys: DOJ, Parties Engaging in Serious Talks to Settle Case; Number of Divestitures Under Discussion

Prospects are brightening for UnitedHealth Group’s proposed takeover of Amedisys as DOJ and the parties’ representatives engage in serious negotiations to settle the department’s suit to block the $3.3 billion deal, sources familiar with the matter...

Jun 10, 2025 Read Now >

The Asia Antitrust Agenda: SAMR Fines Pharma Suppliers for Price-Fixing; ACCC Kicks Off Omnicom/IPG Review; China’s Regulators Warn Food-Delivery Platforms Over Competition Concerns; Indian Supreme Court Issues Landmark Ruling in Abuse of Dominance Case

SAMR fines four pharmaceutical suppliers 354 million yuan for price-fixing. The Tianjin branch of China’s State Administration for Market Regulation (SAMR) announced on May 9 that it had levied a total of 354 million yuan ($49 million) in penalties on four pharmaceutical suppliers for...

May 19, 2025 Read Now >

The Trade Desk: Adtech’s Persistent Identifier Can Be Tied to Potentially Sensitive Information as Lawsuits Allege Unfair Data Collection Practices

Adtech company The Trade Desk (TTD) enables advertisers to target millions of individuals based on unique persistent identifiers that can potentially be associated with a host of sensitive information, from precise geolocation to data capable of inferring a consumer’s gender, ethnicity,...

May 12, 2025 Read Now >

Roper Technologies’ Strata’s Information Sharing Practices, Tools for Health Care Providers, Could Bring Antitrust Scrutiny

Health care providers can access rivals’ detailed output data and receive customized pricing recommendations through Roper Technologies subsidiary Strata Decision Technology’s software tools, according to company marketing materials reviewed by The Capitol...

May 01, 2025 Read Now >

FDA’s Plan to Reduce Drug Testing on Animals May Take Longer Than Three to Five Years, But Lays Out Clear Blueprint for Phasing in Alternative Technologies, Scientists Say

In line with an ongoing, bipartisan push in Congress to reduce the pharmaceutical industry’s reliance on animal testing, the Food and Drug Administration (FDA) published a roadmap on April 10 laying out policy steps to transition drugmakers to non-animal methods for testing drug...

Apr 17, 2025 Read Now >

GTCR/Surmodics: Judge’s Record of Holding Companies Accountable Favors FTC; Agency, Companies Will Need to Focus on Details

After a legal career filled with civil and voting rights cases, U.S. District Judge Jeffrey Cummings has moved into antitrust law in a big way. He’s presiding over the FTC’s suit to block GTCR’s proposed buyout of medical-device coatings maker Surmodics (SRDX) and private litigation...

Apr 11, 2025 Read Now >

Universal Health Services: Hospital System Could Be at Risk if Congress, States Curb Supplemental Medicaid Payments

Universal Health Services (UHS), a health care management company that runs acute care and behavioral health facilities, could face financial risk if proposed policies targeting Medicaid supplemental payments—state reimbursements to hospitals that exceed the baseline Medicaid...

Apr 09, 2025 Read Now >

LiveRamp: Company Hosts Marketplace Selling Datasets that Target Millions of Americans Based on Sensitive Information, Military Status

Data broker LiveRamp Holdings, Inc. (RAMP) operates a vast digital marketplace that exchanges the personal information of hundreds of millions of individuals grouped into highly specific audience “segments”—many of which include potentially sensitive information denoting...

Apr 09, 2025 Read Now >

LiveRamp: Company Hosts Marketplace Selling Datasets that Target Millions of Americans Based on Sensitive Information, Military Status

Data broker LiveRamp Holdings, Inc. (RAMP) operates a vast digital marketplace that exchanges the personal information of hundreds of millions of individuals grouped into highly specific audience “segments”—many of which include potentially sensitive information denoting everything...

Apr 08, 2025 Read Now >

FTC’s Ferguson, DOJ’s Slater Signal Less Aggressive Merger Approach Than Biden Predecessors, Openness to Remedies

FTC Chairman Andrew Ferguson and DOJ antitrust chief Gail Slater today indicated they would take a less aggressive approach to merger enforcement than their Biden administration predecessors and be more willing to entertain remedies. “Healthy pro-competitive M&A that allows American...

Apr 02, 2025 Read Now >

Universal Health Services: Review of State Inspection Records Finds Conduct That Could Result in Additional Lawsuits Against the Company, Potentially Resulting in Large Judgments

Last year, a jury awarded $535 million in damages to the family of a 13-year-old girl that was sexually assaulted during a 2020 stay at the Pavillion Behavioral Health System, an Illinois residential treatment program owned and operated by Universal Health Services...

Mar 25, 2025 Read Now >

Dexcom: FDA Warning Letter States Company Made Changes to Continuous Glucose Monitors Without Necessary Approval from Agency; Letter States Company Commits to Ceasing Distribution of Sensors with Design Changes that Caused ‘Higher Risks for Users’

The FDA has published a warning letter it sent to Dexcom (DXCM) earlier this month regarding issues with the manufacturing and validation of its continuous glucose monitors (CGMs) that affected their accuracy. The warning letter states that Dexcom failed to gain necessary approvals for...

Mar 25, 2025 Read Now >

Teva: Drugmaker Requests Delisting of Inhaler Patents from Orange Book in Response to Court Order; Boehringer Ingelheim, Novo Nordisk Have Also Asked FDA to Pull Disputed Drug-Device Patents

Teva (TEVA), the drugmaker at the center of the Federal Trade Commission’s efforts to curb the improper listing of patents in the Food and Drug Administration’s Orange Book, has asked the FDA to delist five patents associated with its asthma inhaler, ProAir HFA, in response to a...

Mar 24, 2025 Read Now >

Labor Thursday: Litigation Tracker Updates; Labor Board Member Finds Receptive Judge in Termination Case Against Trump, Teeing Up Appeal

Labor Thursday is a weekly overview of competition and labor market issues and includes our analysis of the timing and priorities of the key agencies overseeing enforcement and rulemaking, including the Federal Trade Commission, Justice Department, and National Labor Relations Board. This...

Mar 06, 2025 Read Now >

GTCR/Surmodics: Facing Potential FTC Suit, Companies Allow Brief Review Extension to Early Next Month

Facing a potential FTC suit against GTCR’s planned $627 million Surmodics (SRDX) buyout, the companies have agreed to extend the antitrust review into early next month and continue discussions with the agency, sources familiar with the matter...

Feb 27, 2025 Read Now >

Hims & Hers Health: Questions Remain About Compounding Viability Post Resolution of Semaglutide Shortage

The Food and Drug Administration announced on Feb. 21 that the years-long shortage of semaglutide, the active ingredient in Novo Nordisk’s blockbuster weight-loss injections Ozempic and Wegovy, had been...

Feb 21, 2025 Read Now >

Johnson & Johnson/Intra-Cellular: Depression Overlap Poised to Draw FTC Questions, but Clinical Differentiation, Other Factors, Point to Abbreviated Review

Johnson & Johnson’s proposed $14.6 billion acquisition of Intra-Cellular Therapies is poised to draw FTC questions over whether the tie-up might affect competition in markets for drugs used to treat major depressive disorder (MDD), according to a Capitol Forum...

Feb 19, 2025 Read Now >

MAUDE Monthly: Byte Continues Working Through Backlog of Reports as Dentists Increasingly Advise Patients to Stop Treatment; Mentor Breast Implants Increasingly Rupturing Inside of Patients; Procept Biorobotics Reports Increases in Patient Bleeding from Aquablation Procedure; Update on Medtronic ICDs

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...

Feb 19, 2025 Read Now >

GTCR/Surmodics: FTC Staff Raises Concerns About Deal Creating Dominant Maker of Coatings for Medical Devices

GTCR’s attempted $627 million takeover of Surmodics (SRDX) could be in jeopardy as FTC staff raises concerns that the deal would transform the acquirer into the dominant maker of coatings for a number of medical devices, sources familiar with the matter...

Jan 28, 2025 Read Now >

Dexcom: FDA Staff Observe Several Potential Regulatory Violations During Recent Inspection; Practices Could Negatively Affect Accuracy of CGMs

FDA inspectors at the San Diego headquarters of Dexcom, a manufacturer of continuous glucose monitors (CGMs), observed several quality control and process issues at the facility, according to an inspection report obtained by The Capitol Forum via a Freedom of Information Act...

Jan 23, 2025 Read Now >

Health Care Antitrust Weekly: TCF Launches Monthly Litigation and Investigations Tracker; Judge Rules in Teva Patent Case; Corcept at Risk of Losing Market Share, Per 2025 Formulary Design Changes

The Federal Trade Commission publishes second report on PBMs, focusing on how the Big Three PBMs markup specialty generic drug prices. The PBMs enjoyed excess revenues of $7.3 billion, the FTC wrote in its report, comparing revenues to the National Average Drug Acquisition Cost (NADAC),...

Jan 15, 2025 Read Now >

Harrow: VEVYE Excluded from Stand-Alone Part D Plans in 2025, Amid Company’s Claims of ‘Market Access Win’ in Medicare

VEVYE, a dry eye disease drug marketed by Harrow (HROW), doesn’t appear to be covered by any Medicare Part D prescription drug plans in 2025, despite the ophthalmic health care company advertising that the drug was slated to get coverage in that market, a Capitol Forum investigation has...

Jan 14, 2025 Read Now >

Medicare Formularies Shift to Covering Generic Mifepristone Instead of Branded Korlym for 2025

Corcept’s (CORT) flagship product Korlym (mifepristone) has been removed from the preferred drug lists, or formularies, of nine out of 12 national prescription drug plans under Medicare Part D in 2025, a Capitol Forum investigation has found. Korlym, which treats a type of Cushing’s...

Jan 10, 2025 Read Now >

Labor Thursday: FTC Continues No-Hire Crackdown, Boosting Workers’ Union Campaign at Planned Companies; Commission Tees Up Vote on Expanding Clayton Act Labor Exemption to Independent Contractors; UnitedHealth Moves to Dismiss DOJ Case

FTC finds building services contractors’ no-hire agreement unlawful. The commissioners voted unanimously on Monday to order Planned Companies to cease its policies prohibiting building owners from hiring workers employed by Planned. The contractor’s no-hire rules are a violation of...

Jan 09, 2025 Read Now >

Novo/Catalent: Buyer Negotiating Contract Extensions with Complaining Drugmakers

Novo Holdings is negotiating contract extensions with drugmakers complaining to antitrust enforcers about its proposed $16.5 billion acquisition of pharmaceutical contract manufacturer Catalent (CTLT), sources familiar with the matter...

Dec 03, 2024 Read Now >

BrightSpring Health: Former Employees and Regulators Raise Concern Regarding Medical Care and Oversight of Patients

Some intellectually-disabled residents at group homes and facilities operated by ResCare, a subsidiary of BrightSpring Health (BTSG), are not receiving proper levels of medical care from staff, according to an ongoing Capitol Forum investigation of the...

Nov 26, 2024 Read Now >

UnitedHealth/Amedisys: DOJ Leans Toward Suing to Block Deal as Early as This Week

DOJ is leaning toward suing to block UnitedHealth Group’s (UHG) proposed $3.3 billion acquisition of home health care rival Amedisys (AMED) as soon as this week, sources familiar with the matter...

Nov 11, 2024 Read Now >

Dentsply Sirona: Internal Company Email Discloses That Sales of Byte Aligners Will Not Resume in Near Term; Company to Conduct Layoffs

An internal email sent to staff of at-home dental aligner company Byte, a subsidiary of Dentsply Sirona (XRAY), indicates that the company does not intend to market its products to new customers in the near term and will conduct layoffs to sales, marketing, and production...

Nov 07, 2024 Read Now >

Aveanna: Inspectors Find Home Health Company Providing Insufficient Services for High-Need Patients; Fort Wayne Location Sanctioned for Neglect of Patient

Home health company Aveanna (AVAH) provides in-home healthcare to some of the most “medically complex, high-cost patient populations,” according to the company’s SEC filings. Those patients often require round-the-clock nursing care and help with activities such as bathing and...

Oct 25, 2024 Read Now >

Dentsply Sirona: Company Suspends Worldwide Sales of Byte Aligners, Citing Potential for Patient Injuries and Discussions With the FDA

Dentsply Sirona (XRAY), the parent company of at-home orthodontic treatment Byte, announced yesterday that it was voluntarily suspending the sales of Byte aligners and impression kits. On a phone call this morning, Dentsply Sirona CEO Simon Campion told investors that the suspension was...

Oct 25, 2024 Read Now >

“Not Medically Necessary”: Inside the Company Helping America’s Biggest Health Insurers Deny Coverage for Care

“Not Medically Necessary”: Inside the Company Helping America’s Biggest Health Insurers Deny Coverage for Care This article is being published in collaboration with ProPublica. Every day, patients across America crack open envelopes with bad news. Yet another health insurer...

Oct 24, 2024 Read Now >

Health Care Antitrust Weekly: Powerful Republican Senator Excoriates FDA Over Orange Book Inaction; Democratic Senators Urge FTC to Scrutinize New PBM Vertical Integration Play; Surescripts Deal with PE Alarms Pharmacists

HELP Committee ranking member lambasts FDA Commissioner for inaction on clarifying patent listing requirements on the FDA Orange Book. Echoing concerns raised by industry stakeholders, Bill Cassidy (R-LA) wrote a letter to the FDA saying the agency’s reticence has resulted in the FTC...

Oct 09, 2024 Read Now >

BIOSECURE Act Could Aid U.S. Contract Research Organizations Hurt by Monkey Supply Chain Disruption; Supporters Target Passage in Must-Pass Defense Bill

U.S. drug development companies known as contract research organizations (CROs) continue to be stymied by supply chain issues for the monkeys used in pharmaceutical testing, after having lost access to two major sources of these animals in recent...

Oct 03, 2024 Read Now >

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