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date: 17 November 2018

(p. 1135) Index

(p. 1135) Index

Figures and tables are indicated by “f” and “t” following page numbers.

AAA (Area Agencies on Aging), 1055–1056
AAFP (American Academy of Family Physicians), 672
AARP, 1063
ABA (American Bar Association), 1030
Abbreviated New Drug Application (ANDA), 639, 643–644, 643n26, 646
Abigail Alliance v. Eschenbach (2007), 30, 33, 38–39, 46–47, 299, 302
Abortion
bioethics and, 29, 32–33, 37, 39–40
genomics and, 351–353, 379–380
history of, 333–334, 336–338
informed consent and, 214, 231, 236–237, 239
legal framework, 338–346
medical privacy and, 272
personhood movement and, 349–351
refusals of care and, 361–364, 366–368, 372–374
Absence of science claim, 956–957
Absolute scarcity, 916–917
Academic medical centers (AMCs), 530–531, 547, 604–605
Access to healthcare, 119–190
ACA and. See Affordable Care Act
Canada Health Act (CHA), 88–89
conscientious refusals of care, 362–366
dimensions of, 120–124
disability and, 391–397
federal laws, 124–142
foreign, 1084–1085
health insurance, 147–166. See also Health insurance
hospitals and health professionals, 119–146. See also Healthcare professionals; Hospitals
immigration and, 120, 139, 141–142, 144, 1034, 1039–1046
innovation and, 660
insurance market reform, 134–135
international law and, 142–145
Medicaid and. See Medicaid
Medicare. See Medicare
Penchansky-Thomas model of, 121–124, 121t
physician-patient contract, 126–128
Public Health Service Act (PHSA), 136–138
rationing and, 894–896, 895f, 904, 904n41, 909–910
retail clinics as, 664–665
as social determinant, 1099, 1105–1106
social inequality and, 120
state laws, 125–133
tort reform and, 558
Veterans Health Administration, 138–139
Accident insurance, 723, 729
Accidents, risk of, 720–721, 723, 723n8
Accountability principle, 1027
Accountable care organizations (ACOs)
as ACA initiative, 631–632, 634
access to healthcare and, 124
for aging population, 1055
antitrust regulation of, 615, 626–627
conflicts of interest disclosure and, 242–244, 243–244, 251–252, 254–255, 254–257, 264
as cost and care management strategy, 829–831, 839
as delivery system innovation, 667–669, 673–677, 678
discrimination and, 182
healthcare reform and, 61–62
health policy and, 10, 26–27, 55, 61–63, 662
hospital-physician relationship, model for, 515, 518, 532–533
integration of, 866, 867
medical liability and malpractice, 422, 432, 437–441, 437–442
as Medicare initiative, 760, 764
Accreditation
for healthcare facilities, 492–493
of multinational hospitals, 1082–1084
Accreditation Canada International, 1082
Accuracy of healthcare payments, 844–845, 847
Accutane (drug), 654–655
ACS (American College of Surgeons) Minimum Hospital Standards Statement, 513
Actavis, FTC v. (2012), 628–629
Active Design Guidelines (New York City), 1003
Active supervision of licensing boards, 627–628
Active treatment controls, 640
Activities of daily living (ADLs), 1054–1057, 1062–1063
Activity-based payments, 837–838, 839–841
ACTN3 gene, 1127–1128
Actuarially-based pricing model, 789
Acute care hospitals, 512, 513, 516, 521, 682
ADLs (activities of daily living), 1054–1057, 1062–1063
Administrative Procedure Act, 785
Admission of proof, 1072
Adult Protective Services (APS), 1064–1067
Advair (drug), 657
Advanced directives (AD), 1061–1062
Advanced nurse practitioners (ANPs), 504–506, 508–509, 515, 522, 664–666
Adventist Health International, 1081
Adverse events, 423. See also Medical liability and malpractice
Adverse selection principle, 706–707, 727
Advertising
for pharmaceuticals, 640–641, 640n14
regulation of, 943, 986–987, 990–993
Affordable Care Act of 2010 (ACA)
access to healthcare, 123, 135, 161–163, 1109
ACO development, 829
aging population and, 1065, 1073
Canada Health Act (CHA) compared, 79–89
chronic disease management, 955
Community Health Center Fund, 137
competition oversight by, 606–607, 631–632, 633–634
conflict of interest disclosures, 260–261
coordination of care, 854, 869
core provisions of, 709–711
coverage expansion, 634
on data exchange, 1106
delivery system reforms, 61–63, 659, 662–667, 669–672, 674–675
disability and access to care, 393–397
discrimination in healthcare and, 187–188
on drug costs, 635
employment based coverage and, 703, 705
EMTALA and, 141
enrollment goals of, 734, 736–737, 739, 739n44, 747, 782–784, 783–784n118
ERISA and, 714–715
federalism and, 59–60, 106–111
fraud provisions of, 855–856, 858–859, 871
on genomic testing and discrimination, 1124–1125, 1131
goals of, 6, 21, 54–55
hospital-physician relationship transformation, 512, 513–514, 516
immigrants and, 1039, 1040, 1041, 1043, 1044–1046, 1052
individual markets, 711–713, 788, 800–801
mandated benefits, 716–718
market-based ideology and, 56–58
Medicaid expansion, 800–801, 888–890, 943
Medicaid’s disability coverage by, 774
medical liability and malpractice, 426–427
Medicare and, 743, 759–760, 761, 763, 764, 799
mental and behavioral health services, 328
on menu labeling, 954, 989
nonprofit health organizations and, 536, 539–540, 542, 544, 554–555
overview, 517–518
on patented technology, 635
on payment system innovation, 851
physician payments sunshine provision, 260–261
political history and context, 50–54
population health improvement and, 532–534
preventive medicine, 887
private market reforms, 56–58
public and private coverage, 801–804, 805–807
quality measures of, 682, 684, 688, 689–690
rationing of healthcare, 912
reimbursement models of, 521
on RVU review, 840–841
on scope-of-practice regulations, 505
signing of, 1033
social determinants addressed by, 1105–1109
on underwriting practices, 620
universal coverage goal, 888–890
African Americans
access to healthcare, 134
ART and, 336
discrimination in healthcare, 171–173, 179
eugenics movement against, 1114–1115
healthcare discrimination and, 171–173
inequalityand, 1102, 1104
Medicaid expansion and, 772
noncommunicable diseases of, 952
pharmacogenomics and, 1126
Aga Khan Health Services, 1081
Age and aging population, 1053–1074
best practices in clinical geriatrics, 1069–1070
dangers posed by others, 1064–1066
dangers posed to others, 1067–1068
demographic background, 1053
epidemiology of, 1054
family issues of, 1057–1058
financial concerns and structural implications for, 1055–1057
healthcare professional shortage, 1079
impaired decisional capacity of, 1058–1062
laws on medical decision-making, 1059–1062
long-term services and supports, 1054–1055, 1062–1064
as rationing healthcare consideration, 905–906, 1072–1073
in risk pooling, 801–802
self-imposed dangers for, 1066–1067
standard of care for, 1071–1073
Age Discrimination Act of 1967, 188
Agency for Health Care Policy and Research (AHCPR), 672
Agency for Healthcare Research and Quality (AHRQ), 269, 284, 322–323, 425, 681, 699
Aggregation-disaggregation of payments, 834, 841–844, 843n30, 848–849, 848–849n53
Aggregation problem of CEAs, 930–931
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 1087
Agriculture Department, 602–603, 995
Agriculture, subsidies and deregulation of, 995
AGS (American Geriatrics Society), 1069–1070
AIDS. See HIV/AIDS
Aid to Families with Dependent Children (AFDC), 771, 771n37, 773–774. See also Temporary Assistance for Needy Families (TANF)
Alcohol
advertising, 991
retailer outlet density, 998
taxation on, 994
use of, 983, 983n3
Alexander, Leo, 215
Alexander v. Choate (1985), 185
(p. 1138) Alexander v. Sandoval (2001), 184
Alito, Samuel, 451
Allergenic extracts, 645
Allman, David, 745
Allocative efficiency, 917, 917n9, 918–919
Allocation of healthcare. See Rationing healthcare
All-of-government strategy for public health, 952–953
All-Patient Refined DRGs (APR-DRGs), 519
All-Payer Claims Databases (APCDs), 630
All-payer systems, 833
Almaraz, Rudolph, 235
Alternative dispute resolution, 431–432
Alternative payment systems, 618, 661–662
Ambulatory surgery centers (ASCs), 516, 528, 661
AMDA (American Medical Directors Association), 1070
American Academy of Family Physicians (AAFP), 672
American Academy of Pediatrics, 672
American Bar Association (ABA), 1030
American College of Obstetricians and Gynecologists (ACOG), 356, 362–363, 372, 425
American College of Surgeons (ACS) Minimum Hospital Standards Statement, 513
American Community Survey on uninsured immigrants, 1039
American Geriatrics Society (AGS), 1069–1070
American Hospital Association (AHA)
on access to healthcare, 125, 126–127, 156
consumer complaints to, 482
on cost controls, 828
disability law and, 380
globalization issues, 1082
on hospital-physician relationship, 531
medical liability and malpractice, 433
on Medicare, 745
American Medical Association (AMA)
access to healthcare and, 126–127
assistive reproductive technologies and, 333–334
on bundled payments, 520
on capitation, 826–827, 827n34
discrimination in healthcare and, 183
federalism and, 94, 102–105, 108
on health disparities, 183
on health plan ratings of physicians, 694
health policy and, 19, 57, 61
on hospital-physician relationships, 828
informed consent and, 215, 219, 234–235
on insurance mergers, 619
on mandatory driving hazard reporting, 1068
Medicare and, 105
on multinational hospitals, 1082
on multispecialty group practices, 825
on national health insurance, 744, 745, 748
on physician employment by hospitals, 528
on quality measures, 689
refusals of care and, 356, 363–364
socialized medicine opposed by, 25
on tort reform, 559
American Medical Directors Association (AMDA), 1070
American Public Health Association (APHA), 1013
American Recovery and Reinvestment Act of 2009 (ARRA), 674, 783, 1073
American Society for Reproductive Medicine (ASRM), 331, 336, 345, 351, 625
American Society of Anesthesiologists (ASA), 562
Americans with Disabilities Act of 1990 (ADA)
access to healthcare, 140, 385–389, 391–392, 397
compliance, 1019–1020
genomics and, 1130
health policy and, 11
medical privacy and, 273, 276
mental and behavioral health services, 317–318, 321, 324, 325–326
American Telemedicine Association, 1091
America’s Essential Hospitals (trade association), 133
Ancillary care providers. See Nonphysician healthcare professionals
(p. 1139) Angel Island, 1035
Angie’s List, 684
Animal and Plant Health Inspection Service (APHIS), 602–603
Animals
antibiotic use in, 949, 975–977
research on, 602–603, 949
Animal Welfare Act of 1966, 602
Annas, George J., 1014–1015
Annuities, 729
Anthrax, 950–951, 1009, 1010, 1011, 1013, 1014
Antibiotic resistance, 949–950, 973–978
Anti-Bloomberg Bill, 1001
Anticompetitive conduct
antitrust laws and, 495
cartelization, 613, 617, 621, 623, 624–625, 628, 636
clinical integration, 621–622
contracts referencing rivals, 623
defragmentation, 621
most-favored-customer clauses, 622–623
mutual advantage, 624
professional ethics of, 625–626
scope-of-practice regulation context, 505–506
Antidiscrimination provisions, 739. See also Discrimination in healthcare
Anti-kickback statute, 667, 668, 856, 858–859, 860, 862–863, 864
Antitoxins, 645
Antitrust Division of Department of Justice (DOJ), 612
Antitrust immunity, 611
Antitrust laws, 606–636
accountable care organizations, 626–627
analytical framework for, 609–612
bioethics and, 625–626
clinical integration, 621–622
competition policy and, 632–634
conduct and, 621–626
contracts referencing rivals and, 623
controversies of, 613–629
coordinated care models and, 668, 669
defenses, 611
defragmentation, 621
future implications for, 629–636
hospital mergers and, 614–616
hospital-physician relationship and, 828
insurer consolidation, 619–621
joint ventures and, 868
key statutes, 607–609
market division or trademark protection, 624–625
most-favored-customer clauses, 622–623
MSOs and, 523–525
mutual advantage, 624
nonprofit healthcare organizations and, 544–546
overview, 606–607
per se conduct, 610, 621, 625
pharmaceuticals, patents, and generic competition, 628–629
physician practice mergers and acquisitions, 616–619
private enforcement of, 613
professionalism and, 630–631
public enforcement of, 612–613
regulatory interface of, 626–629, 631–632
rule of reason and merger analysis, 610–611
self-regulation and “active supervision” of licensing boards, 627–628
status quo and, 634–636
APCDs (All-Payer Claims Databases), 630
APHA (American Public Health Association), 1013
Appropriations, 876, 876n12, 879–880
APR-DRGs (All-Patient Refined DRGs), 519
Area Agencies on Aging (AAA), 1055–1056
Arizona
Medicaid participation by, 769
preemption bills in, 1001
stem cell research in, 602
Arizona State University, 1116
Arkansas
charitable immunity, 548
Medicaid eligibility expansion and, 781–782, 784
as Medicaid privatization model, 805–806
Armstrong v. Exceptional Child Center, Inc. (2015), 112, 785
Arnold, Keri, 444
Arras, John, 42
Arrow, Kenneth, 631
ASA (American Society of Anesthesiologists), 562
Assisted reproductive technologies (ART)
conscientious refusals of care and, 373
genomics and, 351–353
history of, 332–333, 335–336
legal framework, 338–346
personhood movement and, 349–351
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), 603
Association for Molecular Pathology v. Myriad Genetics (2013), 1121
Association of American Medical Colleges, 236
Association of State and Territorial Health Officials (ASTHO), 967, 1013
Assurance behaviors, 564–565, 566–569
ASTHO (Association of State and Territorial Health Officials), 967
Astrue v. Capato (2012), 340
AT&T Mobility LLC v. Concepcion (2011), 431
Atwood, Margaret, 1132
Australian Council on Healthcare Standards International (ACHSI), 1082
Australian Institute of Sport, 1127–1128
Authorized Testing and Certification Bodies (ATCBs), 205
Autism spectrum disorders, 948, 969–970
The Autocrat of the Breakfast Table (Holmes), 92
Autonomy
clinical, 677–678, 826, 1093
decisional autonomy in psychiatric institutions, 313–316
disability and, 384
end-of-life care and, 399–417
experimental therapies and, 297–299, 301–302, 308–309
health policy and, 4–15, 60–61
mental and behavioral health services and, 312–318
of physicians, 63, 80, 361
Avastin (biologic), 657
Avoidance behaviors, 565, 569–570, 571, 574–575
Avraham, Ronen, 573
Baicker, Katherine, 573
Baker, Dean, 1104
Balanced Budget Amendments of 1997 (BBA), 756–757
Ball, Robert, 746
Barnes, Mark, 585
Baselines for budget processes, 878–879
Base rate of overutilization, 575
Basic Health Program option, 784
BasicPlus Health Insurance, 1084
Batalden, Paul, 828
Baucus, Max, 53
Bauer, Ursula, 951–958
Baxter v. State (2009), 33
Bayer, Ronald, 966–967, 1015
Bayh-Dole Act of 1980, 604
BBA (Balanced Budget Amendments of 1997), 756–757
Beauchamp, Tom L., 30, 36, 46
Beckett, Katie, 774, 774n56
Behavioral health services. See also Mental health services
ACA and, 328
ADA and, 325–326
autonomy and right to choose/refuse treatment, 312–318
community care, 318–321
decisional autonomy in psychiatric institutions, 313–316
deinstitutionalization, 318
federal parity laws, 326–327
integrated care, 321–325
involuntary outpatient commitment, 316–318
state parity laws, 326
Belmont Report (1979), 586, 586n1, 1115
Belous, People v. (1969), 32
Benefit aggregation, 902–903, 902–903n32
Benefit design, 812–813
(p. 1141) Benefits (insurance)
COBRA, 739, 739n46
cost-effectiveness analysis of, 920
covered, 754
designed benefit approach, 712–713
direct government, 789
for disabled people, 767–768n15
mandated, 716–718, 735n22, 739, 739n45, 803
Medicaid, 791–792
Medicare prescription drug, 654, 656n82, 657, 755, 757–760, 790, 798–799
of self-insured employment, 706, 714–715
Berenson, Robert, 698–699
Berger, John, 41
Berg, Paul, 1119
Berman, Allen, 225
Berman v. Hutchinson Cancer Center (2002), 225–226
Berra, Yogi, 582
Berwick, Donald, 12, 19
Best practices, 1027, 1069–1070, 1092
Betancourt, Joseph, 181
Biased Care Model, 181
Bilateral monopoly, 620
Biobanks, 1116, 1117
Bioethics, 29–48
antitrust enforcement and, 625–626
future of, 41–48
legal analysis, 38–41
libertarian, 46–48
literature review, 30–38
population-level, 42–45
Biologics Act of 1992, 644–645, 644n31
Biologics and biological products
defined, 638
Herceptin, 650–651, 652
intellectual property and statutory exclusivity for, 646–647, 651
product approval scheme for, 644–645
risk evaluation and mitigation strategy (REMS) for, 655
Biologics License Application (BLA), 644–645, 644n31, 646
Biomarker data, 651
Biomedical research enterprise, 585–605
animal research requirements, 602–603
clinical trial registration and data transparency, 594–596
Common Rule for, 585–588, 590–591
Common Rule, proposed changes to, 588–590
federal funding for, 603–605
federal grant principles, 603–604
financial disclosure requirements for, 597–598
globalization of, 1086–1087
HIPAA and, 592–594
human subject, defined, 587
human subject protections, 585–592
human subject research regulations by FDA, 590–591
informed consent for, 591–592
overview, 585
research defined, 586–587
research limitations, 601–602
research misconduct and, 598–601
state privacy law requirements, 594
technology transfer considerations, 604–605
Biosecurity, 950–951
Biosimilarity, 646–647, 652
Biosimilars Price Competition and Innovation Act of 2010, 646–647
Biospecimens, research use of, 588n13, 589–590, 591–592, 593–594
Bipartisan Policy Center, on long-term support services financing, 1063
Birth weights, 884, 1100, 1103–1104, 1107
Bittker, Boris, 877
Blockbuster pharmaceutical or device, 651
Block grants, 780
Blood products, 645
Bloomberg, Michael, 956–957
Blue Cross Blue Shield organizations
class actions against, 624–625
as competition, 633
consolidation of, 619
conversions of, 552–553
history of, 623, 624
on Medicare, 745
as nonprofit healthcare organizations, 542
risk pooling and, 834–836
(p. 1142) Blue Cross Blue Shield, United States v. (2011), 623
Blue Cross Blue Shield Antitrust Litigation, In re (2014), 625
Blue Ribbon Physician Recognition Program, 694–695
Blum, John D., 512
Blumstein, James F., 545
Board certification, 493. See also Licensure and licensure boards
Bobinski, Mary Anne, 31, 32–33
Bolton, Doe v. (1973), 341
Borgmann, Caitlin, 343
Botox, 1127
BPCI (Bundled Payments for Care Improvement) program, 22
Bradshaw, Howard, 216
Brain drain of healthcare workers, 1079, 1091
Brandeis, Louis, 267
Braveman, Paula, 1099–1100, 1109
Breast cancer treatment and screenings, 650–651, 955
Breaux, John, 757
Brewer, Jan, 1046
Breyer, Stephen, 186
British Columbia
healthcare payment system in, 846–847, 847n48
Medicare Protection Act, 90
British National Health Service, 895
Brock, Dan, 42
Bronze level coverage, 717–718, 717n42
Brooklyn Center for Independence v. Bloomberg (2012), 1020
Brown, Scott, 54n31
Brown v. Superior Court (1988), 446
Buck v. Bell (1927), 1114, 1129
Buckman Co. v. Plaintiffs’ Legal Committee (2001), 449
Bucy, Pamela, 870
Budget Act of 1974, 874, 878, 878n18
Budget process. See Federal budget
Buettgens, Matthew, 1045
Built environment alterations
land use, zoning, and design guidelines, 1002–1003
New York city as model for, 955, 956–958, 1003
noncommunicable disease prevention and, 1002–1005
public health law and, 943–944, 945t
as social determinant, 1099, 1109
Bundled payments
abuse of, 866
ACOs as transition to, 675
competition and, 634
for coordinated care models, 668
as cost and care management strategy, 814, 831
hospital-physician relationship and, 520–521, 532–533, 673
Inpatient Prospective Payment System (IPPS) and, 842
integration of healthcare and, 854
Medicare and, 760, 831
Bundled Payments for Care Improvement (BPCI) program, 22
Burger, Warren, 304
Burnet, Frank MacFarlane, 946, 947
Burris, Scott, 1097
Burwell v. Hobby Lobby (2014), 64–67
Bush v. Dake (1989), 248
Bush, George H. W., 52, 753
Bush, George W., 52, 601, 757–758, 759, 799, 877, 995
Butler, United States v. (1936), 99
Butterworth Health Corp., FTC v. (1997), 544–546
Cadillac health plans, 85, 705
California
antitrust enforcement in, 612
on Blue Cross Blue Shield conversion, 552
Confidentiality of Medical Information Act, 278
conflicts of interest disclosure in, 257
on corporate practice of medicine, 547–548
cross-border insurance in, 1084
duty to protect, 1068
on egg donor compensation, 625
genetic testing in, 591n30
immigrants’ access to healthcare in, 1040
informed consent in, 217, 232, 236
Medical Board, 62
medical privacy in, 278
Medi-Cal program, 20, 255 (p. 1143)
on MSOs self-governance, 524
on nonconforming practices, 501
physician licensure in, 23
Supreme Court, 216–217, 232, 253, 261, 380, 446, 458
tobacco education campaign, 987
on unauthorized practice of medicine, 504
vaccination law in, 949
California Endowment, 552
California HealthCare Foundation, 552
California Med. Ass’n v. Blue Shield of Cal. Life & Health Ins. Co. (2011), 694–695
California Medical Association, 694–695
Callahan, Daniel, 894–895
Call obligations for physicians, 519–520
CAM (complementary and alternative medicine), 499–501, 503–504
Cambie Surgical Corporation, 90
Canada
access to healthcare in, 77–78, 154, 156, 164
ART in, 345
Canada Health Act. See Canada Health Act
Charter of Rights and Freedoms, 83, 90
cost of healthcare in, 75–77, 91–92
disability law in, 378
division of powers in healthcare system, 74
healthcare payment system in British Columbia, 846–847, 847n48
healthcare system development in, 28, 71–73
health outcomes in, 78–79
life expectancy in, 79
oncomouse patent, 1120, 1120n41
Patented Medicine Prices and Review Board, 75
perspective on U.S. healthcare and ACA, 70–92
risk pooling in, 834
universal programs in, 74, 89–92, 743
wait times in, 78
Canada Health Act (CHA)
ACA compared, 79–89
access to healthcare under, 88–89
comprehensiveness of, 85–87
passage of, 72
portability provisions, 87–88
public administration and, 80–82
universality criterion, 82–85
Canadian Institute for Health Information, 75, 78
Canadian Medicare, 834
Cancer
incidence of, 171–172
informed consent and, 227
off-label use of drugs for, 461–462
privacy rights and, 274
treatment of, 216
Cannon v. University of Chicago (1979), 185
Canterbury, Jerry, 219–220
Canterbury v. Spence (1972), 32, 36, 218, 219–220, 222
Capio (hospital), 1081
Capitation
economic credentialing and, 526
as financial integration model, 814, 816, 826–827, 866
fraud and abuse, 870
for integrated healthcare delivery systems, 830–831
of Medicaid, 800
overview, 826–827, 826n33, 827n35
Caplan, Arthur, 1035
Capron, A.M., 37, 892
Caps on damages, 556, 573, 577–578, 580–581
Caps on discretionary spending, 880
Cardozo, Benjamin, 213
Care and cost management of insured population, 811–831. See also Managed care
benefit design, 812–813
capitation, 826–827
care management, defined, 812n3
hospital-physician relationship, 827–828
hypertension case study, 817–821
insurer/payer actions for, 813–814
Kaiser Permanente, 815–828. See also Kaiser Permanente
mechanisms of, 812–815
multispecialty group practice, 617, 816, 825–826
overview, 811
pharmaceutical cost management study, 821–823
policy issues for, 828–831
population, defined, 811n1
provider actions for, 814–815
social contract, 812
(p. 1144) Caregiver Advise, Record, Enable Act of 2014 (CARE), 1063–1064
Caronia, United States v. (2012), 653–654
Carrier, Emily R., 567–569
Cartelization, 613, 617, 621, 623, 624–625, 628, 636
Carter, James, 751
Case finding for communicable disease control, 965, 967
Case management, 813
Casualty insurance. See Liability insurance
Catastrophic coverage, 754–755, 779
Causal role of inequality in health, 1102–1105
CDRH (Center for Devices and Radiological Health), 638, 652
Cellular products, 645
Census Bureau, on immigrant demographics, 1036
Center for Biologics Evaluation and Research (CBER), 638, 645, 652
Center for Democracy and Technology, 207
Center for Devices and Radiological Health (CDRH), 638, 652
Center for Drug Evaluation and Research (CDER), 638, 645, 652
Center for Medicare and Medicaid Innovation (CMMI), 21, 55, 676, 829
Centers for Disease Control and Prevention (CDC)
on ART, 335
biosecurity at, 950–951
budget processes and, 876, 883
on community services, 1108
for emergency preparedness, 1013
on emergency preparedness, 1011
on foodborne disease, 962
on health-care associated infections, 947
on immunizations, 968–969
quarantine power of, 961
Centers for Law and the Public’s Health, 1013
Centers for Medicare and Medicaid Services (CMS)
accreditation of healthcare facilities, 492–493, 496
on ACOs, 669
on antibiotic stewardship, 975
antitrust enforcement of, 612
on best practices for elders, 1069
on bundled payments, 520–521
Chronic Condition Data Warehouse, 269–270
on clinical genomic testing, 1122
conflicts of interest disclosure and, 251
on cost and care management strategies, 829
on EMTALA, 520
federalism and, 112
on fraud prevention, 855–856
on health-care associated infections, 947
on MSOs, 522–523
on off-label drug use, 657
on payment system innovation, 851
on quality measures, 689
on RVUs, 840–841
Central Hudson Gas & Electric Co. v. Public Service Commission of New York (1980), 986–987, 990, 991
Certificates of need, 661, 899
Certification of invalidity or noninfringement, 643
Certification of need laws, 634
CFBAI (Children’s Food and Beverage Advertising Initiative), 992
Chaoulli v. Quebec (2005, Canada), 83, 90, 91
Charge-based reimbursement, 835
Charitable immunity, 548–549
Charitable trust law, 540
Charities
ACA requirements for hospitals as, 542
antitrust law and, 614–615
defined, 536–537, 543
Cheeseburger Bills, 993, 1001
Chelation therapy, 502
Chernew, Michael, 925
Chicago School antitrust theory, 634
(p. 1145) Childbirth
healthcare providers for, 510–511
tort reform and, 573
Children
advertising restrictions and, 992
vaccination of, 968–969
Children of Choice (Robertson), 339
Children’s Food and Beverage Advertising Initiative (CFBAI), 992
Children’s Health Insurance Program (CHIP), 155, 770, 791–792, 797–798, 798n33, 881, 1042
Children’s Health Insurance Program Reauthorization Act of 2009, 142, 1042
Childress, James F., 46
Choosing Wisely program, 1069
Chorionic villus sampling (CVS), 352
Chronic Condition Data Warehouse, 269–270
Chronic disease management
of aging population, 1054
bundled pricing for, 634
cost-sharing mechanisms for, 924–925
delivery system innovations, 665, 667–668
delivery system problems for, 661–662
for immigrants, 1039, 1048–1049
as noncommunicable disease, 952, 956
scope-of-practice regulations and, 504–506
social determinants for, 1100
telemedicine and, 533
Churning (insurance), 783–784, 929
Cigarettes. See Tobacco use
CIOMS (Council for International Organizations of Medical Sciences), 296, 1089
Civil litigation, 944–946
Civil monetary provisions (CMPs), 666–667, 671, 858
Civil Rights Act of 1964, 167, 749, 904n39
Title VI, 167–168, 174, 183–184, 749
Title IX, 185
CLASS program, 890–891
Clayton Act of 1915, 608, 611, 615, 618, 623
Clearance scheme for medical devices, 647–649
Clinical autonomy of physicians, 677–678
Clinical hold, 640
Clinical integration, 621–622, 677–678, 868
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 1117, 1122
Clinical practice guidelines for elderly, 1072
ClinicalTrials.gov, 595
Clinical trials registration, 594–595
Clinton, Bill
budget processes and, 882
employment-based health coverage and, 703
on healthcare fraud and abuse, 870
healthcare reform and, 18, 51–52
on health policy, 20
Medicaid and, 778, 780
Medicare and, 755–757
Clinton, Hillary, 52, 53
Closed malpractice claims, mining of, 562–563
COBRA (Consolidated Omnibus Budget Reconciliation Act of 1985), 739, 739n46
CODIS (Combined DNA Index System), 1128
Coercive measures, 963, 970–973, 1085
Cognitive changes. See Impaired decisional capacity
Cohen, Alan, 894
Cohen, I. Glenn, 29
Cohen, Neil B., 696–697
Cohen, Wilbur, 749–750
Coinsurance, 149–150, 165, 725, 862, 924
Colacicco v. Apotex (2008), 449, 450
Colgrove, James, 1015
Collective bargaining power
antitrust laws and, 633–634
clinical integration for, 621–622
foreign healthcare pricing and, 845
health insurer mergers and, 619–620
hospital mergers and, 615
most-favored-customer clauses for, 622–623
provider networks and, 926
Colorado
emergency preparedness in, 1016
human right to health in, 145
unauthorized practice of medicine in, 504
(p. 1146) Co-management service agreements, 528
Combination products, 652
Combined DNA Index System (CODIS), 1128
Commerce Clause, 47, 64–65, 100
Commercial speech restrictions, 986–987
Commission on Hospital Services, 156
Committee on Aging, 858
Common good, defined, 939–940
Common Rule
genomics research and, 1115–1116
informed consent requirement, 588
institutional review board (IRB) requirement, 587
proposed changes to, 588–590
on research misconduct, 599–600
state laws and, 591–592
Common Sense Consumption Acts, 993
Commonwealth Fund, 684, 868
Communal rights, 1015
Communicable disease control law, 959–982
antibiotic resistance, 973–978
disease surveillance data, 978–981
federal quarantine power, 961
federal vs. state public health powers, 960–962
immigrants and, 1034, 1035, 1038
intellectual property, 961
interstate commerce regulation, 961–962
law defined, 960
medical countermeasures, 965–970
overview, 959–960
personal control measures for, 970–973
police power, scope and limits of, 963–964
public health law and, 952
public health system and, 962–964
state health codes, 964–973
taxing and spending provisions, 962
voluntary and coercive measures, 962–963
Communitarianism, 940–941
Communities Actively Living Independent and Free (CALIF) v. City of Los Angeles (2011), 1019–1020
Community-based services for aging population, 1056
Community benefit test, 541–545, 551
Community care, 318–321
Community Health Center Fund, 137
Community health centers (CHCs), 89, 136–138, 775, 777, 1106–1108
Community immunity, 948
Community Mental Health Centers Act of 1963, 318
Community Preventive Services Task Force annual report (2011), on physical activity needs, 1108–1109
Community-rated premiums, 710, 836
Comorbidities, 905
Companion Global Healthcare, 1084
Comparative effectiveness research (CER)
ACA and, 61, 671, 672, 674, 678, 1073
defined, 270
EHRs and, 210–211
overview, 663–664
Comparative efficacy, 640, 640n14
Compelled commercial speech, 987
Compensating variation (CV), 932–933
Compensation for negligence, 580
Competition advocacy, 612, 632
Competition policy
agency, information, and professionalism in, 630–631
antitrust laws and, 606–636. See also Antitrust laws
ethics and, 625–626
global, 1094
in healthcare markets, 515–517, 629–636
as regulatory interface, 631–632
status quo in, 634–636
Complaints to professional and regulatory bodies, 465–484
consumer reviews, 482–483
disciplinary authority, 468–469, 475–476
federal regulations, 474–481
private organizations and professional associations, 481–482
procedures for complaints, investigations, and discipline, 469–471, 476–477
professional licensing boards, 467–474
state regulations, 467–474
Complementary and alternative medicine (CAM), 499–501, 503–504
Complete-lives analysis, 908–909
Comprehensive Care for Joint Replacement, 22
Concierge medicine, 900
(p. 1147) Conditional funding, 943
Conditions of Participation (CoP) for Medicare and Medicaid, 496, 531, 533–534, 975
Conflicts of interest (COIs), 240–266
ACA sunshine provision for physician payments, 260–261
clinical medicine advocacy, 254–257
clinical medicine disclosure mandates, 251–254
disclosure and advocacy, 247–250
FDA disclosure regulations, 259–260
financial incentives in healthcare delivery, 242–244
financial incentives in human subjects research, 244–247
HHS disclosure regulations, 258–259
human subjects research, 258–263
legal framework for, 250–263
reform proposals, 263–266
Congressional Budget and Impoundments Control Act of 1974. See Budget Act of 1974
Congressional Budget Office (CBO)
on ACA coverage rates, 83–84, 88, 135
on access to healthcare, 135
on baselines, 878–879
budget process role of, 875
on drug product liability, 458–459
on health reform, 68
on information security, 204
for Medicaid eligibility expansion, 888–890
scorekeeping by, 881–882, 883–885, 886, 888–889
on sustainable growth rate formula, 886–887
on tort reform, 572
Connecticut
behavioral health services in, 322
communicable disease regulations of, 966
nonprofit healthcare organization tax exemptions in, 543
Conscientious refusals of care, 354–374
access to care and, 362–366
anti-discrimination laws and, 373–374
corporate conscience and, 369–371
history of, 356–360
scholarly debates over, 360–366
scientific evidence, 372–373
sincerity of, 366–367
Consent-based alternative to restrictive standards, 501–502. See also Informed consent
Consequentialism, 902–903
Conservatism, 761
Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), 739, 739n46
Consolidation. See Mergers and acquisitions
Constitution. See also specific Amendments
Commerce Clause, 47, 64–65, 100
communicable disease law and, 961–962
Due Process Clause, 125, 314, 341
Equal Protection Clause, 1035, 1043, 1114
Establishment and Free Exercise Clauses, 949
federal power, limitations of, 960–961
police power, 964
power to alter built environment, 943–944, 945t
power to alter informational environment, 943, 945t
power to alter socioeconomic environment, 944, 945t
Supremacy Clause, 785
tax and spend power, 943, 945t
Consumerism, 16–19, 27
Consumer protection, 612, 856
Consumer-Purchaser Disclosure Project, 202
Consumers’ perspective on risk management, 724–726
Consumers Union, 684
Consumer welfare, 632
Contact tracing of communicable diseases, 966, 967–968
Contemporary Issues in Bioethics (Beauchamp & Walters), 30
Continuation coverage, 739, 739n46
Contraception, 33, 37, 340–341, 354–355, 357–359, 367, 371, 373
Contracting for shared use, 1003–1004
Contracting vehicles for patient reviews, 693–694
Contracts and antitrust considerations. See Antitrust laws
Controlled substances, 654, 654n73. See also Pharmaceuticals
(p. 1148) Controlled Substances Act of 1970, 654n73
Controls for drug trials, 640
Convention on the Rights of Persons with Disabilities (CRPD), 378, 383
Convergence
as globalization driver, 1077–1078
healthcare professional migration and, 1079
multinational hospitals and, 1082–1083
Conversions of healthcare organizations, 549–553
Cooper, Lisa, 180
Coordinated care models, 667–670, 674. See also Accountable care organizations (ACOs)
Coordinated interaction, 611
Coordination of coverage terms between public and private plans, 796
Copayments
in Canada, 82
as cost-sharing, 897–898
defined, 149
for drugs, 925
employment-based plans and, 165, 393
managed care plans and, 150
for Medicare, 393, 791
as out-of-pocket spending, 813
for preventive services and immunizations, 77, 85, 87
uniformity of, 84
Corn, Ruth, 215–216
Corn v. French (1955), 215–216
Corporate negligence, 434–436
Corporate practice of medicine, 547–548
Corrective justice, 580
Cortez, Nathan, 276, 1044, 1075
Cost-based reimbursement, 835, 844–845
Cost-benefit analysis, 918–919, 922, 932–933
Cost-containment strategies, 778
The Cost Conundrum (Gawande), 675
Cost-effectiveness analysis, 919–931
analytical challenges of, 928–930
application challenges of, 930–931
of covered services, 923
demand-side initiatives, 924–925
example of, 920–921, 922t
measurement challenges of, 927–928
overview, 919–920
of provider networks, 925–927
Cost of health insurance and healthcare
aging population and, 1055–1057
antitrust laws on, 614–615
in Canada, 75–77, 91–92
CHCs offsetting, 1107
cross-border insurance and, 1084–1085
defensive medicine practice and, 564–575, 580–581. See also Defensive medicine
delivery system innovation and, 664–665, 666–667, 668
as delivery system problem, 661–662
fraud law and, 855
globally, 1076
healthcare-associated infections, 947–948
for immigrants, 1042, 1048–1049
innovation and, 660
Medicaid spending, 734, 765, 765n2, 768–770, 777
of medical products and trials, 637, 642, 656–657, 656n80
Medicare Advantage plans, 798–800
of Medicare hospitalizations, 791
Medicare spending, 739, 750–753, 756, 762–764, 839–840
of noncommunicable diseases, 984
of pharmaceuticals, 643–644, 821–823
population health and, 941
rationing and. See Rationing healthcare
telemedicine in, 1090
Cost-sharing
ACOs and, 854
individual market subsidies, 802
for Medicaid, 768–769, 773, 792, 805
for Medicare, 791
overview, 150–151
for public health insurance, 789
rationing and, 897–898, 924–925, 926
Cost-shifting
food industry antibiotic use as, 976
healthcare professional migration as, 1079
Medicaid and, 806
Medicare and, 797, 836, 843
by providers, 788
(p. 1149) Costs of medical liability. See Medical liability and malpractice
Council for International Organizations of Medical Sciences (CIOMS), 296, 1089
Council of Advisors on Science and Technology, 974
Counseling for communicable disease diagnoses, 964
Counterfeit drugs and devices, 1088
Covered services, 923
Covert rationing, 895–896, 895f, 897, 899, 899n21, 900
Coyne, Andrew, 80
Credentialing process
economic, 519, 525–526, 525n65
as internal quality control, 493–494
Medicare’s influence on, 796
MSOs and, 522, 523–525, 523n57
self-regulation and, 628
Crick, Francis, 1113, 1115
Crisis standards of care, 1028
Crop insurance, 734n33, 741
Cross-border insurance, 1084–1085
Crossing the Quality Chasm (IOM), 559, 561, 681
Crosson, Francis J., 811
Cross-subsidization
employment-based health coverage, 708
globalization and, 1094–1095
by multinational hospitals, 1083
within risk groups. See Cost-shifting
Crowding-out of private coverage, 797–798, 798n33
CRPD (Convention on the Rights of Persons with Disabilities), 378, 383
Cruz v. Central Iowa Hospital (2012), 1047–1048
Cruzan v. Director, Missouri Department of Health (1990), 301, 302
Culbertson, Patty Jo, 218–219
Culbertson v. Mernitz (1992), 218–219
Cultural norms, 1005–1006, 1100, 1110
Culture of health, 1005–1006, 1110
Cuomo, Andrew, 201
Cutler, John, 223
CV (compensating variation), 932–933
CVS (chorionic villus sampling), 352
Cystic fibrosis, 1124
Daar, Judith, 330
Dafny, Leemore, 573
DALYs (disability-adjusted life years), 920, 920n17
Damages
caps on, 556, 573, 577–578, 580–581
noneconomic, 572–573, 574, 575, 578, 581, 716
PAYGO requirement, 880
Daniels, Norman, 907, 908, 909–910
DARTNet (Distributed Network for Ambulatory Research in Therapeutics), 284
Data capture
on antibiotic resistance and use, 974–975
for biomedical research, 589–590
comparative-effectiveness research (CER). See Comparative-effectiveness research
as delivery system problem, 662
for disease surveillance, 963, 965–967, 978–981
EHRs for, 687–688
for Kaiser Permanente case studies, 818–819, 823, 824
Medicaid-mandated, 630, 1106
for provider networks, 926
public-private repository approach to, 688
for quality measures reports, 681, 683–684
quality of, 691–692
Data exclusivity for pioneer drugs, 643
Data matching across surveillance systems, 980
Data transparency, 595–596, 596n53
Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993), 424
Day, Brian, 90
DEA licenses, 496, 654n73
Death
accidental death rate, 723n8
aging population and, 1054
from foodborne diseases, 962
from healthcare-associated infections, 947–948
Medicaid’s impact on rates of, 778–779
medical errors as cause of, 557–558 (p. 1150)
from noncommunicable diseases, 983, 983nn1–2
physician-assisted, 413–416
quality reporting of, 683
reporting of, 683
social isolation as predictor of, 1101
Death panels, 671, 893, 893n4
Declaration of Helsinki, 1089
deCode project (Iceland), 1117
Deductibles
as cost management mechanism, 813
as cost-sharing, 897–898
for Medicare, 791
Deemed status for healthcare facilities, 492, 521
De facto price regulation, 806–807
Defamation suits, 693–694
Defensive medicine, 564–575, 580–581
assurance behaviors, 564–565, 566–569
avoidance behaviors, 565, 569–570, 571, 574–575
base rate of overutilization and, 575
medical liability and malpractice, 569–570
opinion surveys on, 570–572
physician rationality, 566–570
practice-based studies on, 572–573
tort reform and, 558, 565–566, 574–575, 580–581
Deficit Reduction Act of 2005, 144
Defined benefit approach, 712–713
Defined contribution approach, 712–713
Defragmentation of healthcare, 621, 631, 635–636, 667–670. See also Accountable care organizations
De-identification of human subjects, 589
Deinstitutionalization, 46, 318
De jure segregation, 1101
Demand-side initiatives, 924–925
Denormalization of social norms, 1005–1006
Density of retailers, 996
Descartes, Rene, 846
Desegregation of hospitals, 749
DeShaney v. Winnebago County Department of Social Services (1989), 125
Designated health services (DHS), 859–860, 1017, 1021
Design guidelines for built environments, 1002–1003
Deterrence for negligence, 580
Dhankhar, Praveen, 573
Diabetes, 984
Diagnosis-Related Groups (DRGs)
for cost and care management, 20, 813–814
Medicare payments based on, 753
for prospective payment system, 518–519
for standardized unit of payment, 838–839, 842, 846, 849
Dialysis coverage, 1048–1049
Diamond v. Chakrabarty (1980), 1120
Dickey-Wicker Amendment, 39, 601
Dietary consumption, 983, 983n1, 983n3
Direct costs of medical liability, 564
Direct entry midwives, 510–511
Direct government benefits, 789
Direct health benefits, 929
Directive on Patients’ Rights in Cross-Border Healthcare, 1094, 1095
Directly observed therapy (DOT), 970, 973
Direct rationing, 895–897, 895n11, 898, 900–901
Direct spending, 875, 876n12, 877, 880, 883
Direct to customer (DTC) genomic testing, 1121–1122
Disability, 375–398
ACA and, 393–397
access to healthcare and, 391–397
in aging population, 1054
“Baby Doe” regulations, 380–382
condition-based definitions of disability, 390–391
discrimination laws, 1019–1020
emergency planning requirements for, 1019–1020
end-of-life decision-making and, 382–386
informed consent and, 377–379
legal framework, 386–391
Medicaid and, 773–774
Medicare and, 392–393
prenatal testing and, 379–380
provider-patient relationship and, 376–386
rationing of healthcare and, 903, 903n35, 920, 920n17, 927–928
reproductive liberty and, 379–380
(p. 1151) Disability-adjusted life years (DALYs), 920, 920n17
Disability insurance
defined, 729
Medicare as, 742, 751
subsidization of, 735–736, 735n35
Disability Rights New Jersey, Inc. v. Velez (2015), 314, 315–316
Disaggregation of payments. See Aggregation-disaggregation of payments
Disclosure mandates, 987, 988–990
Discretionary adjustment factor, 848
Discretionary spending, 876, 876n12, 879–880
Discrimination in healthcare
clinical level, 178–181
conscientious refusals of care, 373–374
federal laws on, 174–189
genomics and, 1130–1131
history of, 169–171
implicit bias of physicians, 177–178
organizational level, 181–183
public health and, 1019–1020
racial and ethnic, 171–174
social determinants of health and, 1101–1102, 1116
systemic level, 181–183
Disease management, 813
Disease surveillance data, 963, 965–967, 978–981
Disproportionate Share Hospital (DSH), 775–776, 1045, 1049
Disruptive innovations, 660–661, 667
Distributed Network for Ambulatory Research in Therapeutics (DARTNet), 284
District of Columbia, newborn genomic screening program in, 1122
Diversification for risk reduction, 725
Diversion analysis, 611
Divisible rationing, 900–901
DNA. See Genomics
Dobbs, Lou, 1035
Doctor-patient relationship, 671, 825, 949
Doctors. See Physicians
Doe v. See name of opposing party
Domenici, Pete, 326
Donabedian, Avedis, 682
Doolan v. IVF America, Inc. (2000), 1124
DOT (directly observed therapy), 970, 973
Douglas, Tommy, 71–72
Douglas, William O., 338, 341
DPOA (Durable power of attorney), 1060
DREAMers, 1044
Dresser, Rebecca, 399
DRG creep, 839
Driving hazard reporting, 1068
Drug Enforcement Administration (DEA), 496, 654n73
Drug formularies, 656–657, 657n86, 822–823, 824, 898, 898n17
Drug Price Competition and Patent Term Restoration Act of 1984, 628, 643–644, 643n26, 646–647
Drug product liability, 444–464
deference to prescriber decisions, 456–461
design-defect claims, 453–456
FDA approval and surveillance process, 447–448
off-label uses, 461–464
preemption and, 448–452
regulatory deference model, 445–447
Drug resistance. See Antibiotic resistance
Drugs. See Pharmaceuticals
DSH (Disproportionate Share Hospital), 775–776, 1045, 1049
DTC (direct to customer) genomic testing, 1121–1122
Dual emergency declaration dilemma, 1021–1024, 1022–1023t
Dual use research of concern (DURC), 951
Dubner, Stephen J., 872
Due process, 125, 314, 341, 495, 695, 1060
Durable power of attorney (DPOA), 1060
Duty of care, 1027, 1124
Duty to protect, 1067–1068
Dynamic allocation decisions, 917, 917n6
Dynamic cost-shifting, 797
Earned income tax credit (EITC), 1104
Ebola, 942, 971
Economic competitive landmarks, 632–634
Economic credentialing, 519, 525–526, 525n65
(p. 1152) Economic incentives, 661–662
ACOs and, 667
for clinical autonomy, 678
for crowding out of private coverage, 797–798, 798n33
for electronic health records (EHR), 687
gainsharing and, 666
for insurance coverage purchase, 802
for Kaiser Permanente physicians, 816
medical homes and, 668
quality-measures based, 686
Economic inequality, 1102–1105
Economics of healthcare rationing. See Rationing healthcare
Economies of scale, 706, 708–709
Educational qualifications, 497
Education as social determinant, 1099–1100, 1104
Edwards, Robert, 333
Efficacy
of biologics, 646
comparative-effectiveness research on, 663–664, 671, 672
cost-benefit and -effective analyses, 918–920
of drugs, 639–641, 643–644
limited networks and, 926
of medical devices, 647–648
of treatments, 662
Egalitarianism, 904–911
Egg-donor compensation, 625–626
Eisenstadt v. Baird (1972), 304, 341
EITC (earned income tax credit), 1104
EJA (Elder Justice Act), 1065
ELA (establishment license application), 645
Elder Abuse, Neglect, and Exploitation Forensic Centers, 1065
Elder Justice Act (EJA), 1065
Elder Justice Coordinating Council, 1065
Elder mistreatment, 1064–1066, 1067
Electronic cigarettes, 953, 1005
Electronic claims processing systems, 796
Electronic health records (EHR)
for data capture, 630
federal law, 203–209
hospital-physician reform efforts and, 517
medical liability and malpractice and, 441
practice alerts in, 820
as quality measure, 687–688, 691
Electronic Medical Records and Genomics Network (e-MERGE), 270
Elicited utility preferences, 927, 927n44
Eligibility age for Medicare, 763
Eligibility expansion of Medicaid
budget process and, 888–890
impact of, 769–772, 781–782, 791, 1046
overview, 800–801
premium assistance model and, 805–806
Emanuel, Ezekiel J., 703, 908–909
e-MERGE (Electronic Medical Records and Genomics Network), 270
Emergency declarations, 1012, 1021–1024, 1022–1023t
Emergency Management Assistance Compact (EMAC), 1029
Emergency Medicaid program, 1041, 1043, 1049, 1052
Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA)
access to healthcare, 140–142, 1012, 1105
call obligations of, 519–520
end-of-life care and, 409
healthcare rationing and, 899n21
hospital-physician relationship, 514
immigrants’ coverage, 1040, 1047, 1052
as public coverage, 792n18
refusals of care and, 356, 365
Emergency preparedness, 1008–1030
dual declaration dilemmas, 1021–1024, 1022–1023t
emergency powers balance, 1014–1016
federal roles in, 1011–1012
history of, 1009–1010
interjurisdictional coordination and responsibilities, 1010–1017
legal triage during crisis standards of care, 1024–1025
liability debate, 1028–1030
overview, 1008–1009
planning for, 1017–1020
real-time practice challenges, 1020–1030
scarce resource allocation, 1025–1028
state and local roles in, 1013–1014
Emergency use authorizations (EUAs), 1011
Emergency waivers, 1012
(p. 1153) Empire Blue Cross Blue Shield conversion, 552–553
Employee Retirement Income Security Act of 1974 (ERISA)
access to healthcare, 157
conflicts of interest disclosure and, 248, 252–253
on employee health plans, 57n45
federalism and, 106–107
genomics and, 1130
healthcare quality oversight and, 697
health policy and, 17, 57, 66–67
medical liability and malpractice, 437, 439
mental and behavioral health services and, 326
preemption doctrine and, 66n112
Employer mandates, 710–711, 710n24
Employer-sponsored insurance (ESI). See also Benefits (insurance)
access to care and, 148–149
federalism and, 103–104, 106–107, 112
healthcare reform and, 51
Employment as social determinant of health, 1099–1100, 1101, 1110
Employment-based health coverage, 703–719
ACA core provisions for, 709–711
ACA mandated benefits, 716–718
agency failure of, 630
Clinton health reform plan and, 755
complexities and controversies of, 713–718
covered benefits of, 754
crowding out of, 797–798, 798n33
as dominant form of health care, 704–709
economic reasons for, 706–709
ERISA preemption and self-insurance, 705–706, 714–715
future of, 709–713, 716–718
HMO option for, 674
HRAs and HSAs, 713–714
legal reasons for, 704–706
managed care liability, 715–716
overview, 703, 794–795
as path dependence example of healthcare delivery, 673
as private coverage option, 794–795
private exchanges and defined contributions, 711–713
tax subsidies for, 734–735, 735n35
tort reform and premiums for, 573
End-of-life care options
aging population and, 1061–1062
autonomy and, 399–417
capacity to make medical decisions, 401–402
children, 405–406
competent adults, 399–401
death determination, 406–407
delivery system innovation and, 671
disability and, 382–386
futile treatment, 408–410
incompetent adults, 402–405, 410–413
life-sustaining treatment decisions, 399–407
physician-assisted death, 413–416
rationing healthcare and, 893–894, 893–894nn6–7, 893n4
End-stage renal disease patients, 751, 893, 1048–1049
Enforcement rights, 784–785
Enrollment mandates, 770, 770n29, 772
Enterprise liability, 559
Enthoven, Alain, 53, 853
Entitlement spending, 876n12
Environment as social determinant, 1100
Epidemics, 942, 946–950. See also Communicable disease control law; specific diseases
Episode-based payments, 837–839, 842
Equal opportunity, 168, 190, 904, 1111
Equal protection, 495, 1035, 1043, 1114
Equitable distribution, 905, 905n43
Errors. See Medical errors
Establishment Clause, 949
Establishment license application (ELA), 645
Ethics, 289–417
antitrust laws and, 625–626, 631
assisted reproductive technologies and abortion, 330–353. See also Abortion; Assisted reproductive technologies (ART)
behavioral health services, 311–329
coercive measures, 963 (p. 1154)
of communicable disease reporting, 966
conscientious refusals of care, 354–374. See also Conscientious refusals of care
of contact tracing, 967
of cross-border insurance, 1085
disability and, 375–398. See also Disability
of disease surveillance, 981
emergency ethical preparedness, 1008–1030
of emergency preparedness, 1017–1020. See also Emergency preparedness
of genomic research, 1115–1116, 1119–1120
of healthcare rationing, 892–913. See also Rationing healthcare
of human research subjects, 586
impaired decisional capacity and. See Impaired decisional capacity
of medical tourism, 1093
mental health services, 311–329
new, experimental, and life-saving therapies, 291–310
of partner notification, 967–968
of quality of care, 621
of scarce resource allocation, 1025–1028
Ethics in Patient Referrals Act of 1989 (Stark Law), 667, 668, 828, 858–860, 862, 867, 871
Ethnicity as social determinant of health, 1101. See also Discrimination in healthcare
EUAs (emergency use authorizations), 1011
Eugenics movement, 1114
European Medicines Agency (EMA), 595–596
European Union
cross-border insurance in, 1084–1085
on globalization regulation, 1095
on medical tourism, 1094
telemedicine regulation by, 1091–1092
Euthanasia, 413–416
Evidence-based medicine
age-related problems and, 1072–1073
clinical autonomy and, 678
communicable diseases, 974
comparative-effectiveness research as, 663–664
as delivery system problem, 662
quality measurement tools and, 682
Excise taxes, 994–995
Exclusions from health insurance
Medicaid and, 766
regulations to compel coverage, 739
in unregulated market, 738
Exclusivity periods for pioneer drugs, 643, 643n27
Exculpatory language, 588, 588n13
Ex parte. See name of party
Expert testimony for medical liability and malpractice, 423–425
Explicit rationing, 894–895, 895f, 897, 898, 899, 900–901
Express right of action, 785
External shock events, 675
Extralabel uses of drugs and devices. See Off-label pharmaceutical use
Fabrication, defined, 598
Facially egalitarian theory, 909–910
Facially neutral rules, 904, 1020
Facilities. See Healthcare facilities
Faculty practice plans (FPPs), 530–531
Fair chances/best outcomes problems, 930, 1027
Fairchild, Amy L., 966–967
Fair Housing Act (FHA), 386–387, 392
Fair innings principle, 905–906, 928
Fair process in rationing healthcare, 904, 904n41, 907, 910
Fall rates, 498–499
False Claims Act of 1863 (FCA), 227, 571, 604, 691–692, 856, 862–863
False imprisonment claims, 1047–1049
Falsification, defined, 598
Family dynamics and care of aging population, 1057–1058, 1061, 1063–1065
Family Educational Rights and Privacy Act (FERPA), 273
Family Medical Leave Act (FMLA), 276
Family Smoking Prevention and Tobacco Control Act of 2009, 988
Fast-twitch muscles, 1128
Faya, Sonja, 235
Faya v. Almaraz (1993), 235
FCC (Federal Communications Commission), 993
FDAAA (Food and Drug Administration Amendments Act of 2007), 595–596
FDAMA (Food and Drug Administration Modernization Act of 1997), 595
Fear of liability. See Defensive medicine
Federal budget, 873–891
baselines, 878–879
basics of, 875–876
discretionary spending, 876
history of, 874–875
limits, 879–881
mandatory spending, 877
Medicaid and, 777
Medicare and, 752, 757, 761
overview, 873–874
scorekeeping, 881–882, 883–885, 886, 888–889
sustainable growth rate, 886–887
tax spending, 877–878
tobacco control, 882–886
universal coverage, 888–890
Federal Communications Commission (FCC), 993
Federal Crop Insurance Act of 1938, 734n33
Federal duties, 784–785
Federal funding. See also Federal budget
of CHCs, 1107–1108
Common Rule compliance, 591
emergency preparedness and, 1017
grant principles, 603–604
for health promotion, 1004–1005
for Medicaid, 768–770, 777–778, 781, 800–801
research misconduct and, 599
for stem cell research, 601–602
technology transfers and, 604–605
Federal insurance programs. See Affordable Care Act; Medicaid; Medicare
Federalism, 93–113
ACA and, 106–111
after Lochner, 96–98
employer-sponsored insurance and, 103–104
ERISA and, 106
future of, 111–113
history of, 94–101
Medicare and Medicaid, 104–105, 494–497, 780
New Deal programs and, 98–99, 102–103
Progressive-era regulation, 101–102
Federally Qualified Health Centers (FQHCs), 322–323, 775
Federal Medical Assistance Percentages (FMAP), 769, 888–890, 888n42
Federal Policy for the Protection of Human Subjects, 215
Federal Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 1011
Federal quarantine power, 961
Federal Trade Commission (FTC)
on ACOs, 669
on advertising restrictions, 991–992
antitrust enforcement by, 612
on clinical integration, 868
on competition, 608, 632
economic terminology defined by, 633
on hospital mergers, 544–546, 615–616
on licensing boards’ self-regulation, 627–628
online reputation management, 693–694
on reverse payments, 628
on scope-of-practice competition, 505–506
on teeth-whitening services, 503
Federalwide Assurance (FWA), 586, 600
Federation of State Medical Boards, 496
Fee contracting, 623
Fee-for-service (FFS) model
capitation comparison, 826
competition and, 635–636
delivery system innovation and, 661
fraud and, 853, 857, 870
for hospitals, 513
rationing healthcare and, 932
FERPA (Family Educational Rights and Privacy Act), 273
Fertility treatments, 347, 354, 367, 373, 625–626. See also Assisted reproductive technologies (ART)
FHA (Fair Housing Act), 386–387, 392
Fiduciary duty, 232, 247–249, 252–253, 261
(p. 1156) Fifth Amendment, 125
Financial Accounting Standards Board, 698–699
Financial disclosure requirements for biomedical research enterprise, 597–598
Financial integration, 865–866
Financial risk, 667, 827, 827n35
Financial scarcity, 916–917
Firearms in elderly homes, 1068
Fire insurance, 728
First Amendment
advertising restrictions, 943, 991
antitrust immunity and, 611
claims against licensing boards using, 627
commercial speech, 986–987, 989
government-sponsored speech, 987
health plan ratings and, 694–695
off-label promotion and, 641, 650, 652–654
quality ratings programs, 698
on vaccination laws, 949
First-come, first-serve principle, 907
First-dollar coverage, 709
First fundamental welfare theorem of economics, 914
Fishbein, Morris, 825
Flexner Report (1910), on modern hospitals, 513
Flood, Colleen, 70
Flood insurance, 734n33, 741
Florida
antitrust enforcement in, 612
preemption bills in, 1001
on scope of duty for genomic results, 1125
Flynn v. Holder (2011), 30, 46
FMLA (Family Medical Leave Act), 276
Food and Drug Administration (FDA), 637–658
on antimicrobial resistance, 949–950, 973, 976–977
antitrust enforcement, 612
bioethics and, 38–39, 46
conflict of interest disclosure regulations, 259–260
conflicts of interest disclosure and, 258–260
data privacy and, 270, 284
disclosure mandates of, 988–990, 988n33, 993
discretionary spending funding, 876
drug approval and oversight, 496, 638–644, 879
drug product liability, 444–456, 459, 461–463
enforcement powers, 296
experimental therapies and, 291, 296, 298–299, 304–305
federalism and, 101
financial disclosure requirements for biomedical research, 597–598
on food safety and regulation, 954, 956, 962, 999
funding of, 876
as gatekeeper of medical products, 656–658
globalization and, 1076, 1086–1089, 1095
health information law and, 206
health policy and, 14–15
on human subjects protections, 585, 588, 588n13, 590–591
intellectual property and patent law, 642–644, 646–647, 649–655, 961
on joint development of drugs and devices, 651–652
on medical devices, 647–650
medical privacy and, 270, 284
on off-label promotion, 641, 652–654, 653n67
overview, 637–638
practice of medicine and, 654–655
quality of healthcare oversight role, 496, 502
research regulations, 590–591, 600
on tobacco control, 873, 953
trans-fats ban, 999
Food and Drug Administration Amendments Act of 2007 (FDAAA), 595–596
Food and Drug Administration Modernization Act of 1997 (FDAMA), 595
Food, Drug, and Cosmetic Act (FD&C Act)
on biologics, 645, 645n34
on comparative efficacy and cost-effectiveness of products, 658 (p. 1157)
drugs and, 445, 462, 638–641, 644
emergency preparedness, 1011
experimental therapies and, 296
medical devices and, 647–648, 647n44, 649, 652n60
risk evaluation and mitigation strategy, 655, 656
Food industry regulation. See also Food and Drug Administration
advertising restrictions for, 991–993
antibiotic use, 975–977
disclosure mandates, 988–989
by interstate commerce laws, 961–962
public health law and, 949–950, 953–954
Food labeling, 954, 992–993
Food Safety Modernization Act of 2011 (FSMA), 962
Food Stamp Program, 995–996
Fordice, United States v. (1992), 184
Forensics, 1128–1130
Formularies
pharmaceuticals exclusions and inclusions, 656–657, 656n82, 657n86
rationing and, 898, 898n17
For-profit vs. nonprofit health organizations, 537–538
Fortuity principle, 726–727, 726n15, 732–733
Foucault, Michel, 300
Fourteenth Amendment, 125, 175, 314, 1035, 1060
FPPs (faculty practice plans), 530–531
Fragile X syndrome, 1124
Fragmentation of healthcare
coordinated care models addressing, 667–668
disease treatment as, 651
fraud and, 853–854
gainsharing and, 666
as healthcare delivery problem, 661, 673
healthcare payments and, 834–843
Frakes, Michael, 573, 914
Framework Convention, on Antibiotic Resistance, 978
France
healthcare payments in, 845, 846
private health insurance in, 156
Francis, Leslie, 375
Frank, Matthew B., 914
Franklin, David, 863
Fraud and abuse laws, 852–872
ACOs and, 669
anti-kickback statute, 858–859
civil monetary penalties, 860–862
for co-management agreements, 528
defensive medicine and, 571
False Claims Act, 862–863
financial integration, 865–866
fragmentation of healthcare market, 853–854
fraud reduction through integration, 870–871
healthcare fraud overview, 855–858, 856t
integration, 853–854, 863–869
niche hospitals and, 661
operational integration, 868–869
overview, 852–853
research misconduct, 598–601
Special Fraud Alerts, 859
Stark Law, 667, 668, 828, 858–860, 862, 867, 871
structural integration, 867–868
Fraud Prevention System (CMS), 855–856
Free-care programs, 549
Freedom of movement, 962–963, 970–972
Free Exercise Clause, 949
Free rider problem, 280–281
French, James, 215–216
Frieden, Thomas, 950
Friedman, Milton, 627
FSMA (Food Safety Modernization Act of 2011), 962
FTC v. See name of opposing party
Fulghum, Robert, 559, 582
Fully integrated healthcare system, defined, 811
Furman, Jason, 636
Furrow, Barry R., 31, 33–35, 421
FWA (Federalwide Assurance), 586
G8 countries, telemedicine regulation by, 1092
Gainsharing
ACOs and, 667, 669, 671
as clinical autonomy incentive, 678 (p. 1158)
as fraud, 846n48, 861, 864
fraud law and, 864
health policy and, 26
Garfield, Sidney, 816, 826, 869
GATS (General Agreement on Trade in Services), 1091
Gatter, Robert, 240
Gawande, Atul, 575, 675
Geisinger Clinic, 270, 825
Geisinger Health System, 814