150 matches.
- BlogsThe Largest Sunshine Act Penalty in History - Pharmaceutical Company Settles False Claims Act, Anti-Kickback Statute and Sunshine Act Allegations4 minute read
- BlogsThe Sixth Circuit Revives the Medicare Waiver of Liability for Overpayments and Appeals5 minute read
Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202711 minute read- Media CoverageEpstein Becker Green Featured in Litigator of the Week Series2 minute read
- Media CoverageEpstein Becker Green Featured in Legal Lions of the Week Series2 minute read
- EventsAHLA Institute on Medicare and Medicaid Payment Issues 2026March 18 - 20, 20262 minute read
- Media CoverageEpstein Becker Green Secures Preliminary Injunction in AAP v. Kennedy, Blocking Changes to Childhood Vaccine Schedule6 minute read
- Media CoverageRobert Wanerman Quoted in "Inside HHS’ Anti-Fraud Efforts: An Aggressive Crackdown Sweeps Up Mainly Democratic-Led States"2 minute read
PublicationsCMS Seeks to Ban Hospitals from Providing Gender-Affirming Care to Minors17 minute read- BlogsCMS Attempts to Use Medicare and Medicaid Conditions of Participation to Ban Hospitals from Providing Gender-Affirming Care to Minors8 minute read
- BlogsOIRA Memo on Agency Deregulation: Implications for Health Care7 minute read
- EventsACC Chicago Roundtable: Agency Action Challenges in the Second Trump Administration2 minute read
- BlogsSimilar Language But a Different Outcome: Medicare DSH Payments after Advocate Christ Medical Center v. Kennedy4 minute read
- Media CoverageRob Wanerman Quoted in “HHS Reorganization Raises Questions for Claims Appeals Process”1 minute read
- Media CoverageRob Wanerman Quoted in “Payers to Lose Clear Communication Channel with Repeal of HHS Public Comment Period”2 minute read
- Media CoverageEpstein Becker Green's Health Law Advisor Cited in “Old Laws, Supreme Court May Stymie HHS Plan to Fast-Track Policy”2 minute read
- Media CoverageKate Heffernan, Robert Wanerman Quoted in “HHS Comment Reversal Sets Stage for Quick Policy Changes”2 minute read
- BlogsHHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking7 minute read
Videos & Podcasts- BlogsThe NIH IDC – Where Are We Now6 minute read
- BlogsNavigating Executive Orders: Insights and What Lies Ahead5 minute read
- BlogsA Primer on Executive Orders and a Preview of the Road Ahead5 minute read
- BlogsPost-Chevron, Agency Challenges Aren’t Always a Slam Dunk5 minute read
- PublicationsSupreme Court Alters the Administrative State: Loper and Relentless Decision Shifts Authority from Administrative Agencies and Creates Uncertainty12 minute read
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Videos & Podcasts
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Videos & Podcasts
- Media CoverageRobert Wanerman Quoted in “Health Regulators Likely to Tread Carefully Post-Chevron”2 minute read
Videos & Podcasts- 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 CoverageStuart Gerson, Rob Wanerman Quoted in “No Red Herring: Fisheries’ Legal Arguments About Chevron Deference Could Scramble Federal Healthcare Regulation”2 minute read
- PublicationsStriking a Balance: The Supreme Court and the Future of Chevron Deference27 minute read
- Media CoverageRobert Wanerman Quoted in “Fight Over Medicare Pay Hinges on Primary Care”4 minute read
- Media CoverageRobert Wanerman Quoted in “Hospitals Push Back on Safety-Net Payment Cuts”3 minute read
- BlogsHRSA Initiates Audits and Requires Return of Provider Relief Funds6 minute read
- PublicationsHRSA Initiates Audits and Requires Return of Provider Relief Funds3 minute read
- Media CoverageRobert Wanerman Quoted in Decoding Medicare: 10 Key Decisions and How They’re Made4 minute read
- Media CoverageRobert Wanerman Discusses How the Supreme Court's EPA Ruling Impacts Health Care Regulations3 minute read
- PublicationsDistrict Court Upholds Medicare Beneficiary’s Challenge to Local Coverage Determination4 minute read
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Videos & PodcastsApril 14, 2022
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Videos & Podcasts
- BlogsCMS “Splits the Baby” on Aduhelm—Medicare Coverage but Only with Evidence Development for Now5 minute read
- Media CoverageEpstein Becker Green Insight on CMS Proposal to Repeal Medicare Coverage of Breakthrough Devices Featured in Orthopedics This Week3 minute read
- Media CoverageHealthPlanMarkets Features Epstein Becker Green Insight on HHS Proposal to Repeal Rules on Guidance Documents2 minute read
- PublicationsHHS Proposes to Repeal Rules on Guidance Documents11 minute read
- BlogsPRRB Updates Its Rules and Mandates Electronic Filing4 minute read
- BlogsCMS Proposes to Reverse Course and Repeal Its Final Rule Expediting Medicare Coverage of Breakthrough Devices and Defining the Medicare “Reasonable and Necessary” Coverage Standard5 minute read
- EventsResolving Coding Disputes: Analyzing Agreements, Identifying Code Standards, Leveraging Expert Opinions2 minute read
- BlogsDistrict Court Invalidates Medicare GME Regulation and Orders CMS to Recalculate Hospitals’ Medicare Reimbursement4 minute read
- PublicationsHHS Limits Use of Guidance Documents in Civil Enforcement Actions and Issues First Good Guidance Practices Petition Response9 minute read
- PublicationsHHS Limits the Use of Guidance Documents in the Good Guidance Practices Rule and Advisory Opinion 20-0511 minute read
- PublicationsOIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework39 minute read
- PublicationsHow Health-Care Regulatory Issues May Unfold in a Biden Administration2 minute read
- PublicationsCMS Proposes to Expand the Scope of Medicare Coverage Determinations9 minute read
- PublicationsDACA Ruling Raises Bar for Assertions of Agency Deference3 minute read
- PublicationsChapter 33, "Biotechnology Product Coverage, Coding, and Reimbursement Strategies"2 minute read
- PublicationsChapter 29, "Artificial Intelligence in Biotechnology: A Framework for Commercialization"2 minute read
- PublicationsMedicare Expands Access to Genetic Diagnostic Tests for Certain Ovarian and Breast Cancers10 minute read
- Media CoverageRobert Wanerman Quoted in "HHS Attys Say High Court Ruling Curbs Billing Enforcement"2 minute read
- PublicationsMedicare’s Proposed National Coverage Determination: Expanding Access to Genetic Screening Tests for Certain Ovarian and Breast Cancers12 minute read
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 minute read
- EventsAI Applications for Drug Discovery and Development: Innovator Meets Regulator - the Challenge for AI in Biotech1 minute read
- PublicationsUncertainty On Hospital Disproportionate Share Pay Eligibility2 minute read
- PublicationsSupreme Court Expands the Scope of Public Participation in Medicare Policymaking7 minute read
- EventsBIO 15th Annual Biotechnology Entrepreneurship Boot Camp: Reimbursement & Pricing Strategies1 minute read
- Media CoverageRobert Wanerman Quoted in "CMS Floats New Add-On Payment Route for Breakthrough Devices"2 minute read
- BlogsGenetic Testing Company Agrees to Pay $1.99 Million to Resolve Allegations that it Violated the False Claims Act By Billing for Tests Not Covered Under Local Coverage Determinations3 minute read
- Media CoverageRobert Wanerman Quoted in "Supreme Court to Hear Arguments in DSH Formula Case"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
- PublicationsCMS's New Process for Issuing Local Coverage Determinations11 minute read
- PublicationsTo What Extent Can CMS Informally Issue Interpretive Rules?3 minute read
- Media CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 minute read
- PublicationsCMS Proposes to Revamp Medicare Reimbursement for Evaluation and Management Services: Trading One Controversy for Another?11 minute read
- Media CoverageRobert Wanerman Quoted in "Device Makers Praise Bipartisan Device Coverage Bill, But Issues Remain"3 minute read
- EventsBIO 14th Annual Biotechnology Entrepreneurship Boot Camp: Reimbursement & Pricing Strategies1 minute read
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Videos & Podcasts
- Firm AnnouncementsAttorneys from Epstein Becker Green's Washington, DC, Office Recognized for Pro Bono Service2 minute read
- BlogsA New Remedy for an Old Problem: Fifth Circuit Rules That Providers May Seek Injunctive Relief While Waiting For a Delayed Medicare Hearing5 minute read
- PublicationsObstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for Precision Medicine11 minute read
- PublicationsCMS Coverage Decision May Raise Barriers to Precision Cancer Medicine and Reduce Incentives for Evidence Development2 minute read
- EventsMedicare Enrollment Revocations Webinar: The Government Enforcement Initiative You May Not Know About2 minute read
- BlogsMedicare Secondary Payer Compliance: Payer FCA Litigation (Part VII)7 minute read
- BlogsMedicare Secondary Payer Compliance: The False Claims Act (FCA) for Providers (Part VI)6 minute read
- BlogsMedicare Secondary Payer Compliance: Providers (Part V)5 minute read
- BlogsMedicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)8 minute read
- BlogsMedicare Secondary Payer Compliance: Group Health Plans (Part III)6 minute read
- BlogsMedicare Secondary Payer Compliance: Conditional Payments (Part II)6 minute read
- BlogsMedicare Secondary Payer Compliance: An Introduction (Part I)6 minute read
- Media CoverageRobert Wanerman Quoted in "Human Research Office Needs More Independence, Transparency"1 minute read
- Events2017 BIO International Convention: Coverage and Reimbursement Strategies for Biotech Products1 minute read
- PublicationsSix Key Changes to the Common Rule13 minute read
- Firm AnnouncementsAttorneys from Epstein Becker Green's Washington, DC, Office Recognized for Pro Bono Service1 minute read
- BlogsCongress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts?7 minute read
- Media CoverageRobert Wanerman Quoted in "Doctors Argue Leadless Pacemakers Deserve Broader Medicare Coverage"1 minute read
- BlogsParallel Review – Forcing Manufacturers to Go All In5 minute read
- Media CoverageRobert Wanerman Quoted in "Program to Speed Medical Device Coverage Now Permanent"2 minute read
- Blogs"Good Faith" Off-Label Promotions Saved Ex-Acclarent Execs from Felony Misbranding Indictments4 minute read
- Media CoverageRobert Wanerman's Theranos Analysis Showcased in General Counsel News2 minute read
- BlogsDisruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos4 minute read
- PublicationsSupreme Court Rejects Government's Expansive View of FCA Liability but Endorses Implied Certification Theory (with Limits)6 minute read
- Media CoverageRobert Wanerman Quoted in "Feds Reverse Hospital Pay Cut to Avoid More Court Losses"1 minute read
- PublicationsSuccess of Opioid Addiction Bill Would Rely On Funding2 minute read
- BlogsHas Chevron Deference Run Out of Gas?3 minute read
- BlogsPursuing Medicare Appeals Is Not for the Impatient3 minute read
- Media CoverageRobert Wanerman Quoted in "Common Rule Update Expected to Dominate Regulatory Landscape in 2016"2 minute read
- PublicationsPharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition1 minute read
- EventsAUTM Business Development Course: Medical Devices - Clinical and Regulatory Phase and Legal Issues2 minute read
- Media CoverageRobert Wanerman Quoted in "Hospital Groups Call for More Two-Midnight Changes"1 minute read
- Media CoverageRobert Wanerman Quoted in "Benefits, Risks Seen with Medicare Device Pay Rule"1 minute read
- PublicationsSupreme Court Rules That Providers and Suppliers Cannot Challenge Medicaid Reimbursement Rates in Federal Court5 minute read
- PublicationsSupreme Court Removes a Major Hurdle for Administrative Agency Rulemaking8 minute read
- Media CoverageRobert Wanerman Quoted in "CMS Can Order Trials Before OKing Payment for New Tech"1 minute read
- PublicationsNew CMS Guidance for Biotech Industry on Coverage with Evidence Development: It's All About the Outcomes1 minute read
- PublicationsNIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations42 minute read
- PublicationsCMS Publishes Additional (but Limited) Guidance on the Coverage with Evidence Development Process8 minute read
- EventsAUTM Business Development Course: Medical Devices – Clinical and Regulatory Phase2 minute read
- EventsMAGI Clinical Research Conference: Master Class: Billing Compliance1 minute read
- PublicationsOMHA's Second Medicare Appellant Forum Reveals Some Forward Momentum but No Simple or Quick Solutions for Medicare Administrative Appeals Backlog11 minute read
- EventsSeton Hall U.S. Healthcare Compliance Certification Program: An Overview of Federal Health Care Programs for Drug & Device Manufacturers1 minute read
- EventsTherapy Utilization: Evolving Rules and Enforcement – Post-Acute Care in Transition Webinar Series2 minute read
- Events2014 BIO International Convention: Coverage and Reimbursement Strategies for Biotech Products1 minute read
- PublicationsCMS Requests Comments on the Dispute Resolution Process Associated with the Physician Payment Sunshine Act8 minute read
- PublicationsD.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations, in Bloomberg BNA's Medicare Report1 minute read
- PublicationsD.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations10 minute read
- PublicationsBiotechnology Product Coverage, Coding, and Reimbursement Strategies, in Biotechnology Entrepreneurship1 minute read
- PublicationsOMHA's Medicare Appellant Forum Offers Few Meaningful Answers for Frustrated Medicare Providers and Suppliers11 minute read
- Media CoverageRobert Wanerman Quoted in Article, "House GOP Floats New Details of SGR Reform Plan"2 minute read
- PublicationsSupreme Court Opinion in Sebelius v. Auburn Regional Medical CenterRejects a Challenge by Hospitals to Medicare's SSI Fraction Calculation7 minute read
- Firm AnnouncementsEpstein Becker Green Promotes 13 Attorneys in Four Practices - Health Care and Life Sciences, Labor and Employment, Litigation, and Corporate Services3 minute read
- PublicationsFederal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices, in Pharmaceutical and Medical Device Compliance Manual2 minute read
- BlogsThe Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare2 minute read
- PublicationsOverhauling the Medicare Coverage with Evidence Development Guidance Policy? Comments Requested by CMS6 minute read
- EventsHot Compliance Topics in the Medicare Programs: Webinar Sponsored by Epstein Becker Green and Marsh's Clinical HealthCare Consulting Practice3 minute read
- PublicationsMassachusetts Division of Insurance Rate Disapprovals Show Mixed Results; Implications for National Health Reform16 minute read
- EventsBIO General Counsels Committee Meeting1 minute read
- EventsMAGI Clinical Research Conference - East1 minute read
- PublicationsD.C. Circuit Rules That Medicare Coverage Determinations Cannot Set Reimbursement Rates6 minute read
- PublicationsEpstein Becker Green Giving Back – Fall 20091 minute read
- Media CoverageWanerman Quoted on Booming Interest in Israeli Start-Ups2 minute read
- EventsThe 8th National Life Sciences & Technology Week1 minute read
- PublicationsAmerican Health Lawyers Association, Fifty State Survey of Certificate of Need and Licensure: Nursing Homes, Assisted Living, Home Health and Hospice (New York Chapter)1 minute read
- PublicationsMassachusetts Department of Public Health Publishes Final Regulations on Pharmaceutical and Medical Device Manufacturer Conduct11 minute read
- PublicationsCongressional Activity on hESC Research, as appeared in BNA Medical Research Law & Policy Report3 minute read
- PublicationsAdvaMed Revises Code of Conduct37 minute read
- PublicationsFederal Court Enjoins CMS From Applying the "Least Costly Alternative" Payment Policy to Covered Medicare Part B Pharmaceuticals4 minute read
- Firm AnnouncementsTop U.S. Health Officials/Epstein Becker & Green Attorneys to attend Biomed Israel 20083 minute read
- Media CoverageModern Healthcare Quotes Wanerman on Medicare Competitive Bidding Project1 minute read
- Firm AnnouncementsPharmaceutical Law: Regulation of Research, Development and Marketing2 minute read
- PublicationsSPECIAL ALERT: CMS Announces Revisions to Clinical Trial Policy3 minute read
- PublicationsCMS Publishes Proposed Revisions to Clinical Trial Coverage Policy6 minute read
- PublicationsIt Ain't Over Till It's Over: Rights and Obligations When a Clinical Trial Ends as appeared in BNA's Medical Research Law & Policy Report