138 matches.
- EventsACC Chicago Roundtable: Agency Action Challenges in the Second Trump Administration2 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
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration- 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 Uncertainty13 minute read
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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
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Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
- Media CoverageRobert Wanerman Quoted in “Health Regulators Likely to Tread Carefully Post-Chevron”2 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 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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Entrepreneurship in Biotech: Growing Your Business
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Chevron Deference: Is It Time for Change?
- 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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Industry Implications of AI: Thought Leaders in Health Law Video Series
- 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