103 matches.
- EventsMAGI@home 2024: Collaboration Over Confrontation - CTA Negotiation Tips & Tricks1 minute read
- EventsBreaking Barriers Toward Inclusive Health Care: New ADA Title II Regulations Require Accessible Medical Diagnostic Equipment2 minute read
- BlogsUnited States’ Complaint-in-Intervention Highlights Continuing Effort to Use the False Claims Act to Pursue Alleged Cybersecurity Violations5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Convergence: Experts Offer Advice on Leveraging AI in Regulatory”3 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- PublicationsSumming Up the FDA's Long-Anticipated Draft Guidance on Diversity Action Plans3 minute read
- EventsNational Association of Chain Drug Stores Total Store Expo Pharmacy Compliance Roundtable1 minute read
- PublicationsCMS Issues Mandatory “TEAM Model” for Acute Care Hospitals to Improve Episode-Based Alternative Payments and Advance Accountable Care Relationships17 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
The DEA Is Knocking at Your Door . . . Are You Prepared?- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
- Media CoverageMandated Coverage of Biomarker Testing: Q&A with Robert Hearn4 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 minute read
- EventsBCBS Association: The World of Emerging Therapies and Alternative Substances in Healthcare2 minute read
FDA Releases Laboratory-Developed Tests Final Rule- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived8 minute read
- Media CoverageEpstein Becker Green Attorneys Elected to Law360’s 2024 Editorial Advisory Boards3 minute read
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants9 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- PublicationsSponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement13 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom”2 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
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Game-Changing IRA: Revolutionizing Prescription Drug Pricing and Medicare Benefits
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct7 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
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Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
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Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now?
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- EventsWhat's Nyoo! 30 Years of Women in Clinical Research - What It Means for You2 minute read
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Post-Dobbs: One Year Later
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- Media CoverageRobert Hearn Quoted in “Surveying Laboratory Tests from a Health IT Perspective”3 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
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Managing Trade Secrets and Restrictive Covenants in Health Care M&A Deals
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
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The End of the Public Health Emergency – What’s to Come?
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Direct Access Laboratory Testing: Reimbursement & Compliance
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
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Unpacking FDA's Final Clinical Decision Support Guidance
- EventsAdvanced Topics in Clinical Research2 minute read
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Post-Dobbs: Considerations for Clinical Trials and Research
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- EventsTrade Secrets, Restrictive Covenants, and No-Poach Agreements in Health Care2 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- Media CoverageEpstein Becker Green Expands “From Roe to Dobbs” Resource Center for Employers and Health Care / Life Sciences Professionals1 minute read
- EventsOhio Hospital Association: Impact of Dobbs Decision on Ohio Hospitals1 minute read
- BlogsDOJ Announces Enforcement Action Involving “Largest and Most Wide-Ranging” COVID-19 Fraud Detected to Date4 minute read
- BlogsUnpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA13 minute read
- BlogsVideo: Record-Shattering Year for FCA Recoveries in Health Care - Thought Leaders in Health Law3 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
- EventsAHLA Academic Medical Centers and Teaching Hospitals Law Institute 2022: Precision Medicine Studies—A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and ResearchFebruary 2, 20222 minute read
- Media CoverageNJBiz Features Glenn Prives in “Health Care Attorney Joins Epstein Becker Green”2 minute read
- Firm AnnouncementsHealth Care & Corporate Law Attorney Glenn P. Prives Joins Epstein Becker Green4 minute read
- EventsMaking Sense of the No Surprises Act and Interim Final RulesNovember 9, 20212 minute read
- BlogsFlorida Joins a Growing Number of States Requiring Licensure of Genetic Counselors6 minute read
- PublicationsThe No Surprises Act: New and Surprising Challenges for Clinical Laboratories3 minute read
- PublicationsMore Surprises on Surprise Billing: Will Federal or State Law Control?11 minute read
- EventsValue-Based Arrangements Under the Stark Law and Anti-Kickback Statute: New Rules, New Challenges, New Opportunities2 minute read
- Firm AnnouncementsFour Epstein Becker Green Attorneys Elected to Law360’s 2021 Editorial Advisory Boards4 minute read
- EventsOIG and CMS Voluntary Self Disclosures: Risks and Rewards of Self-Reporting, Implications of Stark Law Changes2 minute read
- Firm AnnouncementsHealth Care Attorney & Commercial Litigator Robert R. Hearn Joins Epstein Becker Green3 minute read
- BlogsDOJ False Claims Act Statistics 2020: Over 80% of All Recoveries Came from the Health Care Industry4 minute read
- PublicationsThe No Surprises Act: Implications for Health Plans, Health Care Facilities, and Health Care Providers19 minute read
- PublicationsStark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for Value-Based Arrangements26 minute read
- PublicationsOIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework39 minute read
- Media CoverageJames Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”3 minute read
- PublicationsFederal Court's Rejection of Some DOL FFCRA Rules May Affect Your Pandemic Leave Policies14 minute read
- PublicationsINSIGHT: Labs Must Follow Two Kickback Laws During Covid-192 minute read
- PublicationsOIG Offers an Alternative to Advisory Opinions for Emergency Arrangements During the Public Health Emergency7 minute read
- PublicationsHow Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?3 minute read
- BlogsFDA Authorizes the First Home Collection of Specimens to Be Tested for COVID-192 minute read
- PublicationsMedicare Expands Access to Genetic Diagnostic Tests for Certain Ovarian and Breast Cancers10 minute read
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Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
- PublicationsMedicare’s Proposed National Coverage Determination: Expanding Access to Genetic Screening Tests for Certain Ovarian and Breast Cancers12 minute read
- PublicationsHHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules34 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Media CoverageAnjali Downs Quoted in "Evolution of Healthcare Industry Poses New and Ongoing Compliance Risks in 2019"4 minute read
- Media CoverageVictoria Vaskov Sheridan Featured in "On the Move"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips"3 minute read
- PublicationsThe SUPPORT for Patients and Communities Act: Part 1: New Federal Anti-Kickback Law – Eliminating Kickbacks in Recovery Act of 201813 minute read
- BlogsSales and Marketing Compliance: New Federal Anti-Kickback Law May Alter How Clinical Laboratories Compensate Sales Personnel7 minute read
- EventsPathology Webinars: The New CMS White Paper on Healthcare Fraud Prevention – What You Need to Know, How You Can Avoid Its Consequences, and What to Do If You Are a Target of This Enforcement1 minute read
- Media CoverageJames Boiani Quoted in "The Ins and Outs of Lab-Developed Tests"4 minute read
- Media CoverageMelissa Jampol Featured in "Clinical Laboratory Compliance Practices Under Pressure as Federal Spotlight Is Aimed at Common Fraud and Abuse Schemes; Penalties for Violations Surge"3 minute read
- PublicationsHealthcare Fraud Prevention Partnership Issues a Review of Clinical Laboratory Services11 minute read
- BlogsFlorida Will No Longer Require State Laboratory Licensure2 minute read
- PublicationsObstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for Precision Medicine11 minute read
- Media CoverageJames Boiani Quoted in "Labs Hopeful for Less Severe Penalties for Referral Mishaps"2 minute read
- PublicationsD.C. District Court Clarifies Standard for Laboratory Determination of Medical Necessity9 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Outlook 2018: Pharma/Life Sciences Law and Policy"2 minute read
- EventsFDA Workshop – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Asserts Regulatory Authority Over Laboratory Developed Tests"2 minute read
