US Healthcare System Overview-References

References 

US and World Population Clock. United States Census Bureau.  https://www.census.gov/popclock/. Accessed December 14, 2020. 

Nishtar S. Politics of health systems: WHO’s new frontier. Lancet. 2007;370:935-936 DOI: 10.1016/S0140-6736(07)61442-1. 

2019 Health Insurance Coverage of the Total Population. Kaiser Family Foundation Website. https://www.kff.org. Accessed June 23, 2020. 

Reinhardt UE. The Money Flow From Household to Health Care Providers. 2011. https://economix.blogs.nytimes.com/2011/09/30/the-money-flow-from-households-to-health-care-providers/. Accessed November 8, 2018. 

Davis E. What Is Diagnostic Related Grouping (DRG)? 2018. https://www.verywellhealth.com/drg-101-what-is-a-drg-how-does-it-work-3916755. Accessed November 12, 2018. 

National Health Expenditures 2019 Highlights. Center for Medicare and Medicaid Services. https://www.cms.gov/files/document/highlights.pdf . Accessed January 29, 2021 

Kamal R. How has U.S. spending on healthcare changed over time? Peterson-Kaiser Health System Tracker. https://www.healthsystemtracker.org/chart-collection/u-s-spending-healthcare-changed-time/ .  Accessed February 2, 2021. 

Tolbert J, Orgera, K. Key facts about the uninsured population. Kaiser Family Foundation. https://www.kff.org/uninsured/fact-sheet/key-facts-about-the-uninsured-population/. Accessed December 14, 2020. 

About HHS. US Department of Health & Human Services. https://www.hhs.gov/about/index.html. Accessed November 11, 2018. 

21st Century Cures Act. US Food and Drug Administration. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act. Accessed May 15, 2019. 

Kaplan S. Winners and losers of the 21st Century Cures Act. STAT News. https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/. Accessed May 15, 2019. 

Blumenthal D. The Affordable Care Act at 5 Years. 2015. N Engl J Med. 2015;372:2451-2458. DOI: 10.1056/NEJMhpr1503614. 

Summary of Coverage Provisions in the Patient Protection and Affordable Care Act. Kaiser Family Foundation. 2012. https://www.kff.org/health-costs/issue-brief/summary-of-coverage-provisions-in-the-patient/. Accessed November 14, 2018. 

About the ACA. US Department of Health & Human Services Website. https://www.hhs.gov/healthcare/about-the-aca/index.html. Accessed November 14, 2018.  

Status of State Action on the Medicaid Expansion Decision. Kaiser Family Foundation. https://www.kff.org/health-reform/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/?activeTab=map&currentTimeframe=0&selectedDistributions=current-status-of-medicaid-expansion-decision&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D. Accessed December 14, 2020. 

State Insurance Mandates and the ACA Essential Benefits Provisions. National Conference of State Legislatures Website. April 2018. http://www.ncsl.org/research/health/state-ins-mandates-and-aca-essential-benefits.aspx. Accessed November 14, 2018. 

Explaining health care reform: questions about health insurance subsidies. Kaiser Family Foundation. https://www.kff.org/health-reform/issue-brief/explaining-health-care-reform-questions-about-health-insurance-subsidies. Accessed December 14, 2020. 

The GOP tax bill repeals Obamacare’s Individual Mandate. here’s what that means for you. December 20, 2017. Fortune.com/2017/12/20/tax-bill-individual-mandate-obamacare/. Accessed June 23, 2020. 

Countries in the World by Population (2020). http://www.worldometers.info/world-population/population-by-country/. Worldometer. Accessed December 14, 2020. 

OECD Health Statistics 2019, WHO Global Health Expenditure Database. https://stats.oecd.org/Index.aspx?DataSetCode=SHA . Accessed December 14, 2020. 

An overview of the Medicare Part D Prescription Drug Benefit. Kaiser Family Foundation. https://www.kff.org/medicare/fact-sheet/an-overview-of-the-medicare-part-d-prescription-drug-benefit/. Accessed June 23, 2020. 

The Children’s Health Insurance Program (CHIP). Healthcare.gov. https://www.healthcare.gov/medicaid-chip/childrens-health-insurance-program/. Accessed November 24, 2018. 

Rovner J. VA and Military health care are separate, yet often confused. National Public Radio. https://www.npr.org/sections/health-shots/2014/05/30/317381276/va-and-military-health-care-are-separate-yet-often-confused. Accessed January 9, 2018. 

Kaiser Permanente. https://healthy.kaiserpermanente.org/. Accessed November 24, 2018. 

What is a patient-centered medical home? American College of Physicians.  https://www.acponline.org/practice-resources/business-resources/payment/delivery-and-payment-models/patient-centered-medical-home/understanding-the-patient-centered-medical-home/what-is-the-patient-centered-medical-home. Accessed January 9, 2018. 

Legal Information Institute – Federal Food, Drug, and Cosmetic Act. Cornell Law School. https://www.law.cornell.edu/uscode/text/21/chapter-9. Accessed November 24, 2018. 

New Drug Application (NDA). US Food and Drug Administration. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Accessed November 24 2018. 

Abbreviated New Drug Application (ANDA). US Food and Drug Administration. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm. Accessed November 24, 2018. 

Therapeutic Biologics Applications (BLA). US Food and Drug Administration. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/default.htm. Accessed November 24, 2018. 

Prescription Drug User Free Amendments. US Food and Drug Administration. https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm Accessed November 24, 2018. 

What Is a PDUFA Date? The Motley Fool. https://www.fool.com/knowledge-center/what-is-a-pdufa-date.aspx. Published July 7, 2016. Accessed November 24, 2018. 

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. US Food and Drug Administration. https://www.fda.gov/ForPatients/Approvals/Fast/default.htm. Accessed January 9, 2018. 

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions – Guidance for Industry. US Food and Drug Administration. https://www.fda.gov/media/120267/download. Accessed May 15, 2019. 

Eisenman T. FDA Reports on its progress advancing policies for developing next generation antibiotics. US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm595264.htm. Accessed January 9, 2018. 

Rare Pediatric Disease Priority Review Voucher Program. US Food and Drug Administration. https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. Accessed January 9, 2018. 

Designating an Orphan Product: Drugs and Biological Products. US Food and Drug Administration. https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm. Accessed January 9, 2018. 

Criteria for hospital participation in the 340B Drug Discount Program. 340B Health https://www.340bhealth.org/members/340b-program/criteria-for-hospital-participation/. Accessed June 23, 2020. 

Guide to pharmaceutical payment methods – AMCP. https://www.amcp.org/sites/default/files/2019-03/Full-Pharmaceutical-Guide-%283.0%29.pdf    Accessed June 23, 2020. 

Baghdadi R. Medicaid Best Price.  https://www.healthaffairs.org/do/10.1377/hpb20171008.000173/full/. Published August 10, 2017. Accessed November 26, 2018. 

Blumenthal D, Squires D. Drug Price Control: How Some Government Programs Do It. The Commonwealth Fund. https://www.commonwealthfund.org/blog/2016/drug-price-control-how-some-government-programs-do-it. Published May 10, 2016. Accessed January 12, 2018. 

The AMCP Format for Formulary Submissions Format 4.1.  https://www.amcp.org/sites/default/files/2019-12/AMCP_Format%204.1_1219_final.pdf . Published April 2020. Accessed February 16, 2021. 

Institute for Clinical and Economic Review. About. https://icer-review.org/about/ . Accessed November 26, 2018. 

Statement From FDA Commissioner Scott Gottlieb, MD and Jeff Shuren, MD, Director of the Center for Devices and Radiological Health, on FDA’s Updates to Medical Device Safety Action Plan to Enhance Post-market Safety. US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626286.htm. Accessed December 3, 2018. 

The Device Development Process. US Food and Drug Administration. https://www.fda.gov/ForPatients/Approvals/Devices/ucm405381.htm. Accessed December 3, 2018. 

Overview of IVD Regulation. US Food and Drug Administration. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm#1. Accessed December 3, 2018. 

Learn if a Medical Device Has Been Cleared by FDA for Marketing. US Food and Drug Administration. https://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm. Published December 29, 2017. Accessed January 15, 2018. 

De Novo Classification Request. US Food & Drug. https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request. Published December 7, 2018. Accessed June 2, 2019. 

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). US Food and Drug Administration. https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Accessed June 2, 2019. 

Theoret M. Biomarkers for PD-1/L1 Inhibitors: Regulatory Considerations. https://www.ema.europa.eu/en/documents/presentation/presentation-biomarkers-pd-1/l1-inhibitors-regulatory-considerations-marc-theoret-s31_en.pdf. Published February 4, 2016. Accessed June 2, 2019. 

Premarket Notification 510(k). US Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k . Accessed December 14, 2020. 

Regulatory Path for In Vitro Diagnostics. UL LLC. https://studylib.net/doc/18687152/regulatory-path-for-in-vitro-diagnostics. Accessed December 9, 2018. 

Humanitarian Device Exception. US Food and Drug Administration. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/humanitariandeviceexemption/default.htm. Accessed January 15 2018. 

Breakthrough Devices Program. US Food and Drug Administration. Available at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program. Accessed June 16, 2019. 

Planning for successful medical device reimbursement: so your device is cleared, now what? NAMSA. http://www.eimmedical.com/wp-content/uploads/2013/09/publications/Planning%20for%20Successful%20Medical%20Device%20Reimbursement%204122013.pdf. Accessed December 14, 2020. 

New medical services and new technologies. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-payment/AcuteInpatientPPS/newtech.html. Accessed June 3, 2019. 

Pass-Through Payment Status and New Technology Ambulatory Payment Classification (APC). Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-fee-for-service-payment/HospitalOutpatientPPS/passthrough_payment.html. Accessed June 3, 2019. 

Clark DP. From ‘Approved’ to ‘Covered’ – What Medical Device Companies Need to Know. Med Device Online. https://www.meddeviceonline.com/doc/from-approved-to-covered-what-medical-device-companies-need-to-know-0001 . Published May 31, 2017.  Accessed January 14, 2019. 

What Is a MAC. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.html . Accessed December 14, 2020. 

Durable Medical Equipment, Prosthetics/Orthotics & Supplies Fee Schedule. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/index.html. Accessed June 9, 2019. 

DEMPOS Competitive Bidding. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSCompetitiveBid/index.html. Accessed June 9, 2019. 

Investigational New Drug (IND) Application. US Food and Drug Administration. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm. Accessed December 9, 2018. 

510(k) Clearances. US Food and Drug Administration. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm. Accessed December 9, 2018. 

Premarket Approval (PMA). US Food and Drug Administration. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm. Accessed December 9, 2018. 

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers. US Food and Drug Administration. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf. Published June 2018. Accessed December 9, 2018.