Centers for Medicare and Medicaid Services & Food and Drug Administration. Parallel review of medical products, available at <https://www.federalregister.gov/documents/2010/09/17/2010-23252/parallel-review-of-medical-products> (last accessed November 27, 2018.+(last+accessed+November+27,+2018.>Google Scholar

Kramer, D.B., Xu, S., and Kesselheim, A.S., “Regulation of Medical Devices in the United States and European Union,” New England Journal of Medicine 366, no. 9 (2012): 848–855.Google Scholar

US Food and Drug Administration, Premarket Application Review Process, available at <https://www.fda.gov/MedicalDevices/DeviceRegulationand-Guidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm> (last accessed November 27, 2018).+(last+accessed+November+27,+2018).>Google Scholar

U.S. FDA. Code of Federal Regulations. Title 21, Volume 8, Chapter I, Subchapter H, Part 860, available at <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7> (last visited November 27, 2018).+(last+visited+November+27,+2018).>Google Scholar

Dhruva, S.S., Bero, L.A., and Redberg, R.F., “Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices,” JAMA 302, no. 24 (2009): 2679–2685; V.K. Rathi, H.M. Krumholz, and F.A. Masoudi, J.S. Ross, “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 314, no. 6 (2015):604-612.Google Scholar

Chambers, J.D., May, K.E., and Neumann, P.J., “Medicare Covers the Majority of FDA-Approved Devices and Part B Drugs, but Restrictions and Discrepancies Remain,” Health Affairs (Mill-wood) 32, no. 6 (2013):1109–1115.Google Scholar

Tunis, S., Berenson, R., Phurrough, S., and Mohr, P., “Improving the Quality and Efficiency of the Medicare Program through Coverage Policy Issues,” Urban Institute (2011), available at <http://www.urban.org/sites/default/files/alfresco/publication-pdfs/412392-Improving-the-Quality-and-Efficiency-of-the-Medicare-Program-Through-Coverage-Policy.PDF> (last accessed November 27, 2018); P.J. Neumann and J.D. Chambers, “Medicare's Enduring Struggle to Define ‘Reasonable and Necessary’ Care, New England Journal of Medicine 367, no. 19 (2012): 1775-1777.+(last+accessed+November+27,+2018);+P.J.+Neumann+and+J.D.+Chambers,+“Medicare's+Enduring+Struggle+to+Define+‘Reasonable+and+Necessary’+Care,+New+England+Journal+of+Medicine+367,+no.+19+(2012):+1775-1777.>Google Scholar

Centers for Medicare and Medicaid Services. Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4), available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263> (last accessed November 27, 2018).+(last+accessed+November+27,+2018).>Google Scholar

Department of Health and Human Services, “Local Coverage Determinations Create Inconsistency in Medicare Coverage,” available at <https://oig.hhs.gov/oei/reports/oei-01-11-00500.pdf> (last accessed November 27, 2018).+(last+accessed+November+27,+2018).>Google Scholar

114th Congress. Public Law 114-255. 21st Century Cures Act. (last accessed August 30, 2018).Google Scholar

Neumann, P.J., Kamae, M.S., and Palmer, J.A., “Medicare's National Coverage Decisions for Technologies, 1999-2007, Health Affairs (Millwood) 27, no. 6 (2008):1620–1631.Google ScholarPubMed

Center for Medicaid and Medicare Services. Coverage with evidence development, available at <https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/> (last accessed November 27, 2018); see Tunis, supra note 7.+(last+accessed+November+27,+2018);+see+Tunis,+supra+note+7.>Google Scholar

Centers for Medicare and Medicaid Services, Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development, available at <https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27> (last accessed November 27, 2018).+(last+accessed+November+27,+2018).>Google Scholar

Krucoff, M.W., Brindis, R.G., Hodgson, P.K., Mack, Mj.J., and Holmes, Jr., “Medical Device Innovation: Prospective Solutions for an Ecosystem in Crisis. Adding a Professional Society Perspective,” JACC: Cardiovascular Interventions 5, no. 7 (2012):790–796; Lindor, R.A., Allocco, S.J., Cheatham, L., et al. “Regulatory and Reimbursement Innovation,” Science Translational Medicine 5, no. 176 (2013):176cm3.Google Scholar

Messner, D.R. and Tunis, S.R., “Current and Future State of FDA-CMS Parallel Reviews, Clinical Pharmacology & Therapeutics 91, no. 3 (2012): 383–385.Google Scholar

Ridge, J.R. and Statz, S., “Exact Sciences’ Experience with the FDA and CMS Parallel Review Program,” Expert Review of Molecular Diagnostics 15, no. 9 (2015):1117–1124.CrossRefGoogle Scholar

Centers for Medicare and Medicaid Services, Medicare Program Integrity Manual – Chapter 13 Local Coverage Determinations, available at <https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/…/pim83c13.pdf> (last accessed November 27, 2018).+(last+accessed+November+27,+2018).>Google Scholar

Memorandum of Understanding between United States Food and Drug Administration and Centers for Medicare & Medicaid Services In: Administration FaD, ed.2010.Google Scholar

Pilot Program for Parallel Review of Medical Products In: Administration CfMaMSFaD, ed.2011:62808-10; Services DoHaH. Medicare Program: Revised Process for Making National Coverage Determinations. In: Services CfMM, ed. Federal Register2003:55634-41.Google Scholar

Chambers, supra note 6; Basu, S. and Hassenplug, J.C., “Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes,” New England Journal of Medicine 367, no. 6 (2012):485–488.CrossRefGoogle Scholar

Chambers, J.D., Chenoweth, M., Thorat, T., and Neumann, P.J., “Private Payers Disagree with Medicare over Medical Device Coverage about Half the Time,” Health Affairs (Millwood) 34, no. 8 (2015):1376–1382.Google Scholar

Forman, D.E., Maurer, M.S., Boyd, C., et al., “Multimorbidity in Older Adults With Cardiovascular Disease,” Journal of the American College of Cardiology 71, no. 19 (2018): 2149–2161.Google Scholar

Dhruva, S.S., Mazure, C.M., Ross, J.S., Redberg, R.F., “Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices,” JAMA Internal Medicine 177, no. 9 (2017):1390–1391.CrossRefGoogle Scholar

National Academies of Sciences, Engineering, and Medicine, “Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials,” (Washington, DC: National Academies Press, August 24, 2016), available at <https://www.ncbi.nlm.nih.gov/pubmed/27606381> (last accessed November 27, 2018); US Food and Drug Administration, “FDA Report: Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products,” August 2013, available at <https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf> (last accessed November 27, 2018).+(last+accessed+November+27,+2018);+US+Food+and+Drug+Administration,+“FDA+Report:+Collection,+Analysis,+and+Availability+of+Demographic+Subgroup+Data+for+FDA-Approved+Medical+Products,”+August+2013,+available+at++(last+accessed+November+27,+2018).>Google Scholar

Richardson, E., “Health Policy Brief: Aligning FDA and CMS Review,” Health Affairs (2015), available at <https://www.healthaffairs.org/do/10.1377/hpb20150827.132391/full/> (last accessed December 12, 2018); F. Zannad, M.L.A. Alonso Garcia, and J.S. Borer, et al. “Role of Payers in the Development of Cardiovascular Therapeutics: Misalignment Between Approval and Reimbursement,” Journal of the American College of Cardiology 70, no. 22 (2017):2822-2830.Google Scholar

Rickard, J., Michtalik, H., Sharma, R., et al., “Use of Cardiac Resynchronization Therapy in the Medicare Population,” AHRQ Technology Assessment, Rockville, MD, 2015.Google Scholar

Kramer, D.B. and Steinhaus, D.A., “Cardiac Resynchronization Therapy in Older Patients: Age Is Just a Number, and Yet…,” Journal of Cardiac Failure 22, no. 12 (2016): 978–980; Elming, M.B., Nielsen, J.C., Haarbo, J., et al., “Age and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Nonischemic Systolic Heart Failure,” Circulation 136, no. 19 (2017):1772-1780.Google Scholar

US Food and Drug Administration, Medical Devices: Databases, 510(k) premarket notification, available at <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm> (last acessed November 27, 2018).+(last+acessed+November+27,+2018).>Google Scholar

Institute of Medicine, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC: National Academies Press, 2011; Ardaugh, B.M., Graves, S.E., and Redberg, R.F., “The 510(k) Ancestry of a Metal-on-Metal Hip Implant,” New England Journal of Medicine 368, no. 2 (2013): 97-100.Google Scholar

See Chambers, supra note 6.Google Scholar

Forman, supra note 22.Google Scholar

Dhruva, S.S. and Redberg, R.F., “Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence used for Medicare National Coverage Decisions,” Archives of Internal Medicine 168, no. 2 (2008):136–140.Google Scholar

Tisminetzky, M., Bayliss, E.A., Magaziner, J.S., et al., “Research Priorities to Advance the Health and Health Care of Older Adults with Multiple Chronic Conditions,” Journal of the American Geriatrics Society 65, no. 7 (2017):1549–1553; A.S. Bierman and M.E. Tinetti, “Precision Medicine to Precision Care: Managing Multimorbidity, Lancet 388, no. 10061 (issue number?)(2016): 2721-2723.Google Scholar

Department of Health and Human Services, Office of Inspector General, Local Coverage Determinations Create Inconsistency in Medicare Coverage, OEI-01-11-00500, January 2014.Google Scholar

Centers for Medicare and Medicaid Services, Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4), available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263> (last acessed November 27, 2018).+(last+acessed+November+27,+2018).>Google Scholar

Centers for Medicare and Medicaid Services, Decision Memo for Transcatheter Aortic Valve Replacement (CAG-00430N), available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAIAAA&> (last acessed November 27, 2018).+(last+acessed+November+27,+2018).>Google Scholar