2024
Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program
Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA 2024, 332 PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.Peer-Reviewed Original ResearchFunding of evidence included within public comments submitted to inform Medicare national coverage determinations
Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.Peer-Reviewed Original ResearchCenters for Medicare & Medicaid ServicesScientific journal articlesNational Coverage DeterminationPublic commentsCoverage determinationCross-sectional studyMedicare national coverage determinationsJournal articlesMedicare coverage decisionsCoverage of itemsMedicaid ServicesMedicare beneficiariesCommentsMedicare coverageGreater fundingMedicareAuthor disclosuresArticleCoverage decisionsEvaluation of benefitsFunding statementsSupport research
2022
Medicare’s National Coverage Determination for Aducanumab — A One-Off or a Pragmatic Path Forward?
Dhruva SS, Ramachandran R, Ross JS. Medicare’s National Coverage Determination for Aducanumab — A One-Off or a Pragmatic Path Forward? New England Journal Of Medicine 2022, 387: 1539-1541. PMID: 36301560, DOI: 10.1056/nejmp2210198.Commentaries, Editorials and LettersConceptsNational Coverage DeterminationMedicare National Coverage DeterminationCoverage determinationAducanumab
2018
Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016
Roginiel AC, Dhruva SS, Ross JS. Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016. Medicine 2018, 97: e12715. PMID: 30290675, PMCID: PMC6200488, DOI: 10.1097/md.0000000000012715.Peer-Reviewed Original ResearchConceptsOriginal clinical trialsCMS national coverage determinationsNational Coverage DeterminationClinical trialsFDA approvalControl armFDA approval documentsQuality of trialsCross-sectional studySignificant differencesCoverage determinationMedian ageMedian timePivotal trialsQuantity of evidenceInclusion criteriaTrial participantsMedicare populationCMS coverageDrug AdministrationStudy sizeNovel therapeuticsMedicaid ServicesMarketing approvalTrials