References

US and World Population Clock. United States Census Bureau. https://www.census.gov/popclock/.
Accessed November 16, 2023.

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

2022 Health Insurance Coverage of the Total Population. KFF Website. https://www.kff.org.
Accessed March 27, 2024.

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.

American Medical Association & American Medical Association. (2023). Trends in health care spending. American Medical Association. https://www.ama-assn. org/about/research/trends-health-care-spending.
Accessed April 11, 2024.

Out-of-pocket spending - Peterson-KFF Health System Tracker. (2024). Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org.
Accessed April 11, 2024.

Tolbert J, Orgera, K. Key facts about the uninsured population. KFF. https://www.kff.org/uninsured/fact-sheet/key-facts-about-the-uninsured-population/.
Accessed December 18, 2023.

Cohen RA, Cha AE. Health insurance coverage: Early release of estimates from the National Health Interview Survey, 2022. National Center for Health Statistics. May 2023. DOI: https://dx.doi. org/10.15620/cdc:127055.
Accessed April 11, 2024.

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. N Engl J Med. 2015;372:2451-2458. DOI: 10.1056/ NEJMhpr1503614.

Summary of Coverage Provisions in the Patient Protection and Affordable Care Act. KFF. 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. KFF. https://www.kff.org/affordable-care- act/issue-brief/status-of-state-medicaid-expansion- decisions-interactive-map/.
Accessed March 20, 2024.

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. KFF. 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.

CMS. NHE Fact Sheet. https://www.cms.gov/data- research/statistics-trends-and-reports/national- health-expenditure-data/nhe-fact-sheet.
Accessed April 11, 2024.

OECD, Health Spending. https://data.oecd.org/ healthres/health-spending.htm.
Accessed April 11, 2024.

Peterson-KFF Health System Tracker. How does health spending in the U.S. compare to other countries? - Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/chart- collection/health-spending-u-s-compare- countries/#Health%20expenditures%20per%20 capita,%20U.S.%20dollars,%20PPP%20adjusted,%20 2022.
Accessed January 23, 2024.

American Medical Association & American Medical Association. Trends in health care spending. American Medical Association. https://www.ama-assn.org/ about/research/trends-health-care-spending.
Accessed March 20, 2024.

An overview of the Medicare Part D Prescription Drug Benefit. KFF. https://www.kff.org/medicare/ fact-sheet/an-overview-of-the-medicare-part-d- prescription-drug-benefit/.
Accessed October 23, 2023.

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

Veterans Affairs. Veterans Health Administration. https://www.va.gov/health/ aboutvha.asp#:~:text=The%20Veterans%20Health %20Administration%20(VHA,Veterans%20enrolled %20in%20the%20VA.
Accessed April 11, 2024.

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/AbbreviatedNewDrug ApplicationANDAGenerics/default.htm.
Accessed November 24, 2018.

Therapeutic Biologics Applications (BLA). US Food and Drug Administration. https://www. fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/Approval Applications/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.

Office of the Commissioner. Rare Pediatric Disease Designation and Priority Review Voucher Programs. US Food And Drug Administration. https://www.fda. gov/industry/medical-products-rare-diseases-and- conditions/rare-pediatric-disease-designation-and- priority-review-voucher-programs.
Accessed March 26, 2024.

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.

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.

Cubanski J, Neuman T, Freed M. Explaining the prescription drug provisions in the Inflation Reduction Act. KFF. https://www.kff.org/medicare/issue-brief/ explaining-the-prescription-drug-provisions-in-the- inflation-reduction-act/.
Accessed March 6, 2024.

Centers for Medicare and Medicaid Services. Inflation Reduction Act and Medicare. https://www.cms.gov/ inflation-reduction-act-and-medicare.
Accessed March 24, 2024.

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.

Hernandez I, Hung A. A primer on brand-name prescription drug reimbursement in the United States. J Manag Care Spec Pharm. 2024;30(1):99-106.

AMCP Format for Formulary Submissions 5.0. J Manag Care Spec Pharm. 2024 Apr;30(4-b Suppl):1-64.

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.

BMP Medical. What’s the difference between the FDA medical device classes? https://bmpmedical.com/ whats-difference-fda-medical-device-classes-2/.
Accessed April 11, 2024.

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.

Office of the Commissioner. Step 3: Pathway to approval. US Food And Drug Administration. https:// www.fda.gov/patients/device-development-process/ step-3-pathway-approval.
Accessed on April 11, 2024.

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 April 4, 2024.

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.

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%20 Medical%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.

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.

DMEPOS 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/investigationalnewdrug indapplication/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.