2024
Medical Devices Applying for Outpatient Medicare Supplemental Payments
Moneer O, Johnston J, Rathi V, Ross J, Dhruva S. Medical Devices Applying for Outpatient Medicare Supplemental Payments. JAMA Health Forum 2024, 5: e244016. PMID: 39546305, PMCID: PMC11568453, DOI: 10.1001/jamahealthforum.2024.4016.Peer-Reviewed Original ResearchConceptsCenters for Medicare & Medicaid ServicesMedicare beneficiariesUS Centers for Medicare & Medicaid ServicesCross-sectional studyCross-sectional analysisPatient demographic characteristicsClinical decision-makingMedicaid ServicesMain OutcomesHispanic patientsClinical evidence requirementsPremarket clinical studyOutpatient settingOutpatient paymentsTraditional pathwaysMedicareSupplemental paymentsFiscal yearTransitional pass-through paymentsReimbursementDemographic dataEffectiveness end pointPathway applicationClinical studiesAuthorization pathways
2023
Unique Device Identifiers—Missing in Action
Rathi V, Ross J, Redberg R. Unique Device Identifiers—Missing in Action. JAMA Internal Medicine 2023, 183: 1049-1050. PMID: 37603363, DOI: 10.1001/jamainternmed.2023.3561.Commentaries, Editorials and LettersEquipment and SuppliesEquipment FailureFinancial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices
Lu A, Ji R, Ge A, Ross J, Ramachandran R, Redberg R, Dhruva S. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA 2023, 330: 1094-1096. PMID: 37589985, PMCID: PMC10436180, DOI: 10.1001/jama.2023.14414.Peer-Reviewed Original Research
2022
Medical Device User Fee Reauthorization — Back to Basics or Looking Ahead?
Rathi VK, Ross JS, Redberg RF, Dhruva SS. Medical Device User Fee Reauthorization — Back to Basics or Looking Ahead? New England Journal Of Medicine 2022, 387: 196-199. PMID: 35675195, DOI: 10.1056/nejmp2204947.Commentaries, Editorials and LettersRenewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersMeSH KeywordsDevice ApprovalEquipment and SuppliesEquipment SafetyHumansProduct Surveillance, PostmarketingRisk FactorsUnited StatesUnited States Food and Drug AdministrationConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2021
Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?
Rathi VK, Johnston JL, Ross JS, Dhruva SS. Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown? New England Journal Of Medicine 2021, 384: e43. PMID: 33691059, DOI: 10.1056/nejmp2101874.Commentaries, Editorials and Letters
2020
Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Internal Medicine 2020, 180: 1701-1703. PMID: 33044513, PMCID: PMC7551221, DOI: 10.1001/jamainternmed.2020.3214.Peer-Reviewed Original ResearchEarly experience with the FDA’s Breakthrough Devices program
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Early experience with the FDA’s Breakthrough Devices program. Nature Biotechnology 2020, 38: 933-938. PMID: 32704171, DOI: 10.1038/s41587-020-0636-7.Peer-Reviewed Original Research
2019
The Bleeding Edge
Pendyal A, Ross JS. The Bleeding Edge. JAMA 2019, 322: 190-192. PMID: 31310276, DOI: 10.1001/jama.2019.8147.Commentaries, Editorials and LettersConceptsRegulatory approval
2018
Fulfilling the Promise of Unique Device Identifiers.
Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Annals Of Internal Medicine 2018, 169: 183-185. PMID: 29868760, DOI: 10.7326/m18-0526.Commentaries, Editorials and Letters
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2014
The Shape of Things to Come: 3D Printing in Medicine
Michalski MH, Ross JS. The Shape of Things to Come: 3D Printing in Medicine. JAMA 2014, 312: 2213-2214. PMID: 25461994, DOI: 10.1001/jama.2014.9542.Commentaries, Editorials and Letters
2010
Physician Attitudes Toward Industry: A View Across the Specialties
Korenstein D, Keyhani S, Ross JS. Physician Attitudes Toward Industry: A View Across the Specialties. JAMA Surgery 2010, 145: 570-577. PMID: 20566978, PMCID: PMC2891545, DOI: 10.1001/archsurg.2010.75.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdultAttitude of Health PersonnelConflict of InterestCross-Sectional StudiesDrug IndustryEquipment and SuppliesEthics, MedicalFemaleGeneral SurgeryGift GivingHumansInterprofessional RelationsMaleMarketingMiddle AgedMultivariate AnalysisNew York CityPractice Patterns, Physicians'Surveys and QuestionnairesTotal Quality Management
2009
Appropriateness of Collaborations between Industry and the Medical Profession: Physicians' Perceptions
Ross JS, Keyhani S, Korenstein D. Appropriateness of Collaborations between Industry and the Medical Profession: Physicians' Perceptions. The American Journal Of Medicine 2009, 122: 955-960. PMID: 19786162, PMCID: PMC3020980, DOI: 10.1016/j.amjmed.2009.04.013.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAttitude of Health PersonnelChi-Square DistributionConflict of InterestCross-Sectional StudiesDelivery of Health CareDrug IndustryEquipment and SuppliesFemaleHospitals, UniversityHumansInternal MedicineInterprofessional RelationsMaleNew York CityPhysician's RolePrivate SectorProbabilitySurveys and QuestionnairesRelationships with the drug industry: More regulation, greater transparency
Krumholz HM, Ross JS. Relationships with the drug industry: More regulation, greater transparency. The BMJ 2009, 338: b211. PMID: 19193612, DOI: 10.1136/bmj.b211.Commentaries, Editorials and Letters