Regulação dos cuidados de saúde nos Estados Unidos: complexidade, confrontação e compromisso
Resumo
Os Estados Unidos têm o maior sistema de saúde do mundo, e a regulação que o supervisiona é imenso e complicado. A estrutura federal do Governo americano que divide os poderes entre o Governo federal e os Estados, potencia essa complexidade. Maior complexidade é acrescentada pela supervisão privada, incluindo a autorregulação de importantes aspetos do sistema. Esta teia de autoridades regulatórias cria um terreno fértil para a competição e confrontação entre várias entidades regulatórias, tal como está refletido na reestruturação regulatória para sectores chave. Os médicos são regulados por leis estatais de licenciamento, mas a profissão detém uma influência considerável sobre esse processo, tal como sobre outros aspetos da formação e prática médica. A regulação hospitalar é dominada por uma organização privada controlada pela indústria. Os seguros de saúde são primordialmente regulados pelos Estados. Medicamentos e dispositivos médicos são primordialmente regulados pelo Governo federal. Apesar deste sub-contexto de complexidade e competição, o sistema de saúde pode ser visto como uma simbiose na qual os sectores privado e público se juntam numa colaboração implícita que tem permitido que o sistema de saúde americano tenha crescido e florescido.
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Referências
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42 - McCarran-Ferguson Act, 15 U.S.C. § 1011-1015 (1945).
43 - Health Maintenance Organization Act of 1973, 42 U.S.C. §300e (Pub. L. 93-222).
44 - Employee Retirement Income Security Act of 1974, Pub. L. 93-406, 88 Stat. 829.
45 - Fronstin P. Self-insured health plans: recent trends by firm size, 1996-2015. Employee Benefits Res Inst Notes. 2016;37(7).
46 - Summary of the Affordable Care Act. Kaiser Family Foundation website. http://www.kff.org/health-reform/fact-sheet/summary-of-the-affordable-care-act/. Published April 25, 2013. Accessed August 23, 2017.
47 - NCQA website. http://www.ncqa.org/. Accessed August 23, 2017.
48 - Hilts P. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Knopf; 2003.
49 - Furey K, Wilkins K. Prescribing ‘off-label’: what should a physician disclose? AMA J Ethics. 2016;18(6):587-593.
50 - Federal Trade Commission Act, 15 U.S.C. § 45, 21 U.S.C. §334 (1914).
51 - Buc NL, Hofkin LA. FTC regulation of health care advertising: when providers deceive. Healthspan. 1992;9(9):3-6.
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56 - Research Involving Human Subjects. National Institutes of Health website. https://humansubjects.nih.gov/. Accessed August 23, 2017.
57 - Gutpa H, Kumar S, Roy SK, Gaud RS. Patent protection strategies. J Pharm BioAllied Sci. 2010;2(1):2-7.
58 - Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act), Pub. L. 98-417, 98 Stat. 1585 (codified as amended in scattered sections of 21 and 35 U.S.C.).
59 - Danzis SD. The Hatch-Waxman Act: history, structure, and legacy. Antitrust Law Journal. 2003;71(2):585-608.
60 - Regnier SA. How does drug coverage vary by insurance type? Analysis of drug formularies in the United States. Am J Managed Care. 2014;20(4):322-331.
61 - Atlas RF. The role of PBMs in implementing the Medicare prescription drug benefit. Health Aff. October 2004;W4-504–W4-515. doi: 10.1377/hlthaff.w4.504.
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65 - Snapshots: Health Care Spending in the United States and Selected OECD Countries. Kaiser Family Foundation website. http://www.kff.org/health-costs/issue-brief/snapshots-health-care-spending-in-the-united-states-selected-oecd-countries/. Published April 12, 2011. Accessed August 28, 2017.
66 - Ro S. Here are the profit margins for every sector in the S&P 500. Business Insider. August 16, 2012, http://www.businessinsider.com/sector-profit-margins-sp-500-2012-8. Accessed August 28, 2017.
67 - Igelhard JK. The uncertain future of Medicare and graduate medical education. New Engl J Med. 2011;365(14):1340-1345.
68 - 2016 CMS Statistics. U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services, Office of Enterprise Data and Analytics; March 2017. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Statistics-Reference-Booklet/Downloads/2016_CMS_Stats.pdf. Accessed August 28, 2017.
69 - Field R. Mother of Invention: How the Government Created ‘Free-Market’ Health Care. New York: Oxford University Press; 2014:109-117.
70 - Health, United States, 2011. Hyattsville, MD: National Center for Health Statistics; 2012:357, table 116. https://www.cdc.gov/nchs/data/hus/hus11.pdf. Accessed August 28, 2017.
71 - Angell M. Excess in the pharmaceutical industry. CMAJ. 2004;171(12):1451-1453.
72 - Research and Development in the Pharmaceutical Industry. Congressional Budget Office; October 2006:11. CBO pub. no. 2589.
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74 - Torpey E. Healthcare: millions of jobs now and in the future. Occupational Outlook Quarterly. Spring 2004. https://www.bls.gov/careeroutlook/2014/spring/art03.pdf. Accessed August 28, 2017.
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gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/
nhe-fact-sheet.html Updated June 14, 2017. Accessed August 22, 2017.
2 - OECD (2017). Health spending (indicator). doi: 10.1787/8643de7e-en.
3 - U.S. Const. art. I & II.
4 - AMA History. American Medical Association website. https://www.ama-assn.org/ama-history Accessed: August 22, 2017.
5 - Starr P. The Social Transformation of American Medicine. New York: Basic Books; 1982:102-104.
6 - Field R. Health Care Regulation in America: Complexity, Confrontation and Compromise. New York: Oxford University Press; 2007: 21.
7 - Flexner A. Medical Education in the United States and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching. New York: Carnegie Foundation for the Advancement of Teaching; 1910.
8 - Dower C. Health Policy Brief: Graduate Medical Education. Health Affairs website. http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=75. Updated August 31, 2012. Accessed August 22, 2017.
9 - McCormack LA, Burge, RT. Diffusion of Medicare’s RBRVS and related physician payment policies. Health Care Finance Rev. 1994;16(2):159-173.
10 - EHR Incentives & Certification: Meaningful Use Definition & Objectives. HealthIT.gov website. https://www.healthit.gov/providers-professionals/meaningful-use-definitionobjectives. Updated February 6, 2015. Accessed August 22, 2017.
11 - Blumstein JF. The fraud and abuse statute in an evolving health care marketplace: life in the health care speakeasy. Am J Law Med. 1996;22(2):213.
12 - Abrams MK, Nuzum R, Zezza MA, et al. The Affordable Care Act and Delivery System Reforms: A Progress Report at Five Years. The Commonwealth Fund website. http://www.commonwealthfund.org/publications/issue-briefs/2015/may/aca-payment-anddelivery-system-reforms-at-5-years. Published May 7, 2015. Accessed August 22, 2017.
13 - About HRSA. Health Resources & Services Administration website. https://www.hrsa.gov/about/index.html. Updated May 2017. Accessed August 22, 2017. 14 - 45 C.F.R. § 164.
15 - Annas GJ. HIPAA regulations: a new era of medical-record privacy? N Engl J Med. 2003;348(15):11486-11490.
16 - Igelhart JK. The American health care system: community hospitals. N Engl J Med. 1993;329(5):372-376.
17 - Weeks EA. The new economic credentialing: protecting hospitals from competition by medical staff members. J Health Law. 2003;36(2):247-300.
18 - Robinson JC, Yelgin JM. Medical management after managed care. Health Aff. 2004;W4:269-280. doi: 10.1377/hlthaff.w4.269
19 - Roberts JS, Coale JG, Redman RR. A History of the Joint Commission on Accreditation of Hospitals. JAMA. 1987;258(6):936-940.
20 - Cauchi R, Noble A. CON-Certificate of Need State Laws. National Conference of State Legislatures website. http://www.ncsl.org/research/health/con-certificate-of-needstate-laws.aspx. Published August 25, 2016. Accessed August 22, 2017.
21 - Transparency and Disclosure of Health Costs and Provider Payments: State Actions. National Conference of State Legislatures website. http://www.ncsl.org/research/health/transparency-and-disclosure-health-costs.aspx#Legislation. Updated March 2017. Accessed August 22, 2017.
22 - Weinberg J, Hilborne LH, Nguyen AT. Regulation of health policy: patient safety and the states. In: Henriksen K, Battles JB, Marks ES, et al., eds. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005(1).
23 - Hill-Burton Act, 42 U.S.C. § 291 et seq. (1946).
24 - Hospitals hit a revenue crunch. Healthcare Finance. April 25, 2014. http://www.healthcarefinancenews.
com/news/hospitals-hit-revenue-crunch. Accessed August 22, 2017.
25 - Baker JJ. Medicare payment system for hospital inpatients: diagnosis-related groups. J Health Care Finance. 2002;28(3):1-13.
26 - Lave JR, Frank RG. Effect of the structure of hospital payment on length of stay. HSR: Health Services Res. 1990;25(2):327-347.
27 - Schactman D. Specialty hospitals, ambulatory surgery centers, and general hospitals: charting a wise public policy course. Health Aff. 2005;24(3):868-873.
28 - The Emergency Medical Treatment and Active Labor Act, 42 U.S.C. § 1395dd (1986).
29 - Zibulewsky J. The Emergency Medical Treatment and Active Labor Act (EMTALA): what it is and what it means for physicians. Proc Baylor University Med Cent. 2001;14(4):339-346.
30 - Clinical Laboratory Improvement Act (CLIA). Centers for Medicare & Medicaid Services website. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Updated April 5, 2017. Accessed August 22, 2017.
31 - Blumenthal D, Abrams M, Nuzum R. The Affordable Care Act at 5 years. N Engl J Med. 2015;372:2451-2458.
32 - Exemption Requirements – 501(c)(3) Organizations. Internal Revenue Service website. https://www.irs.gov/charities-non-profits/charitable-organizations/exemptionrequirements-section-501-c-3-organizations. Updated January 26, 2017. Accessed August 22, 2017.
33 - Americans with Disabilities Act of 1990, 42 U.S.C. § 12101 et seq.
34 - Civil Rights Act of 1964, 42 U.S.C. § 2000d et seq.
35 - Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936.
36 - Mays GP, Claxton G, White J. Managed care rebound? Recent changes in health plans’ cost containment strategies. Health Aff. August 2004;W4-427–W4-436. doi: 10.1377/hlthaff.w4.427.
37 - State Health Facts: Total Number of Medicare Beneficiaries (2015). Kaiser Family Foundation website. http://www.kff.org/medicare/state-indicator/total-medicare-beneficiaries/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort
%22:%22asc%22%7D. Published March 2016. Accessed August 23, 2017.
38 - State Health Facts: Total Monthly Medicaid and CHIP Enrollment (May 2017). Kaiser Family Foundation website. http://www.kff.org/health-reform/state-indicator/totalmonthly-medicaid-and-chip-enrollment/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D. Published July 27, 2017. Accessed August 23, 2017.
39 - Affordable Care Act Medicaid Expansion. National Conference of State Legislatures website. http://www.ncsl.org/research/health/affordable-care-act-expansion.aspx. Published June 1, 2017. Accessed August 23, 2017.
40 - Weil A. Chipping away at the uninsured. Health Aff. 2004;23(5):153-154.
41 - State Health Facts: Health Insurance Coverage of the Total Population (2015). Kaiser Family Foundation website. http://www.kff.org/other/state-indicator/total-population/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22
:%22asc%22%7D. Accessed August 23, 2017.
42 - McCarran-Ferguson Act, 15 U.S.C. § 1011-1015 (1945).
43 - Health Maintenance Organization Act of 1973, 42 U.S.C. §300e (Pub. L. 93-222).
44 - Employee Retirement Income Security Act of 1974, Pub. L. 93-406, 88 Stat. 829.
45 - Fronstin P. Self-insured health plans: recent trends by firm size, 1996-2015. Employee Benefits Res Inst Notes. 2016;37(7).
46 - Summary of the Affordable Care Act. Kaiser Family Foundation website. http://www.kff.org/health-reform/fact-sheet/summary-of-the-affordable-care-act/. Published April 25, 2013. Accessed August 23, 2017.
47 - NCQA website. http://www.ncqa.org/. Accessed August 23, 2017.
48 - Hilts P. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Knopf; 2003.
49 - Furey K, Wilkins K. Prescribing ‘off-label’: what should a physician disclose? AMA J Ethics. 2016;18(6):587-593.
50 - Federal Trade Commission Act, 15 U.S.C. § 45, 21 U.S.C. §334 (1914).
51 - Buc NL, Hofkin LA. FTC regulation of health care advertising: when providers deceive. Healthspan. 1992;9(9):3-6.
52 - DEA History. Drug Enforcement Administration website. https://www.dea.gov/about/history.shtml. Accessed August 23, 2017.
53 - What We Do: Budget. National Institutes of Health website. https://www.nih.gov/about-nih/what-we-do/budget. Updated March 6, 2017. Accessed August 23, 2017.
54 - Impact of NIH Research: Our Health. National Institutes of Health website. https://www.nih.gov/about-nih/what-we-do/impact-nih-research/our-health. Updated March 17, 2016. Accessed August 23, 2017.
55 - National Academies (US) Committee on Measuring Economic and Other Returns on Federal Research Investments. Measuring the Impacts of Federal Investments in Research: A Workshop Summary. Washington, DC: National Academies Press, 2011.
56 - Research Involving Human Subjects. National Institutes of Health website. https://humansubjects.nih.gov/. Accessed August 23, 2017.
57 - Gutpa H, Kumar S, Roy SK, Gaud RS. Patent protection strategies. J Pharm BioAllied Sci. 2010;2(1):2-7.
58 - Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act), Pub. L. 98-417, 98 Stat. 1585 (codified as amended in scattered sections of 21 and 35 U.S.C.).
59 - Danzis SD. The Hatch-Waxman Act: history, structure, and legacy. Antitrust Law Journal. 2003;71(2):585-608.
60 - Regnier SA. How does drug coverage vary by insurance type? Analysis of drug formularies in the United States. Am J Managed Care. 2014;20(4):322-331.
61 - Atlas RF. The role of PBMs in implementing the Medicare prescription drug benefit. Health Aff. October 2004;W4-504–W4-515. doi: 10.1377/hlthaff.w4.504.
62 - An unhealthy burden: America’s health-care market is not as unfettered as it seems. The Economist. June 28, 2007. http://www.economist.com/node/9407716. Accessed August 23, 2017.
63 - Health, United States, 2010: With Special Feature on Death and Dying. Hyattsville, MD: National Center for Health Statistics; 2010:table 122. https://www.cdc.gov/nchs/data/hus/hus10.pdf. Published February 2011. Accessed August 28, 2017.
64 - OECD. Health at a Glance 2011: OECD Indicators. Paris, France: OECD Publishing; 2011:table 7.2.2. http://dx.doi.org/10.1787/health_glance-2011-en.
65 - Snapshots: Health Care Spending in the United States and Selected OECD Countries. Kaiser Family Foundation website. http://www.kff.org/health-costs/issue-brief/snapshots-health-care-spending-in-the-united-states-selected-oecd-countries/. Published April 12, 2011. Accessed August 28, 2017.
66 - Ro S. Here are the profit margins for every sector in the S&P 500. Business Insider. August 16, 2012, http://www.businessinsider.com/sector-profit-margins-sp-500-2012-8. Accessed August 28, 2017.
67 - Igelhard JK. The uncertain future of Medicare and graduate medical education. New Engl J Med. 2011;365(14):1340-1345.
68 - 2016 CMS Statistics. U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services, Office of Enterprise Data and Analytics; March 2017. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Statistics-Reference-Booklet/Downloads/2016_CMS_Stats.pdf. Accessed August 28, 2017.
69 - Field R. Mother of Invention: How the Government Created ‘Free-Market’ Health Care. New York: Oxford University Press; 2014:109-117.
70 - Health, United States, 2011. Hyattsville, MD: National Center for Health Statistics; 2012:357, table 116. https://www.cdc.gov/nchs/data/hus/hus11.pdf. Accessed August 28, 2017.
71 - Angell M. Excess in the pharmaceutical industry. CMAJ. 2004;171(12):1451-1453.
72 - Research and Development in the Pharmaceutical Industry. Congressional Budget Office; October 2006:11. CBO pub. no. 2589.
73 - Spotlight on Statistics: Health Care. Bureau of Labor Statistics website. https://www.bls.gov/spotlight/2009/health_care/. Published November 2009. Accessed August 28, 2017.
74 - Torpey E. Healthcare: millions of jobs now and in the future. Occupational Outlook Quarterly. Spring 2004. https://www.bls.gov/careeroutlook/2014/spring/art03.pdf. Accessed August 28, 2017.
75 - Top Lobbying Industries in the United States in 2016, but Total Lobbying Spending (in Million U.S. Dollars). Statista website. https://www.statista.com/statistics/257364/toplobbying-industries-in-the-us/. Published March 2017. Accessed August 28, 2017.
Publicado
2017-06-30
Como Citar
1.
I. Field R. Regulação dos cuidados de saúde nos Estados Unidos: complexidade, confrontação e compromisso. ihmt [Internet]. 30Jun.2017 [citado 23Dez.2024];16:61-0. Available from: https://anaisihmt.com/index.php/ihmt/article/view/45
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