1. Healthcare Law and the Role of the Courts
Professor Allison K. Hoffman
May 2, 2017

2. What is Health Law and Why Should Doctors Care?
Guides the relationship between doctors and patients, increasingly so over time (classic law and medicine)
E.g., rules on duties of care (medical malpractice, informed consent, privacy/confidentiality, abandonment)
Antidiscrimination laws
Licensure and scope of practice laws
Regulates the business of health care
Insurance regulation (including Medicare, Medicaid)
Antitrust
Fraud and abuse
Sets ethical rules/guidelines (e.g., end of life, abortion, etc.)

3. Early on, the Law Deferred to the Medical Profession
A century ago, there was limited interaction between medical profession and courts; limited legal obligations and extensive immunities and shields
No duty to care
Professional custom and locality rule as shield against liability = protective of doctors
Learned profession exemption from antitrust law (notion of deference to “noble professions”)
Medicine regarded not as a business subject to industry regulation but as an altruistic calling

4. The 20th Century Evolution

5. Evolution of Health Care Delivery…
Rise of “for profit” hosp. MDs as:
Employees (residents, pathologists, radiologists, ER MDs)
Med. Staff (2/3 of MDs)
Hospitals = almshouses for sick-poor. Often formed by religious orgs.
1930s: Formal Med. Ed.
1900: AMA gains traction
1800s
1965: Medicare & Medicaid
1985: EMTALA
Modern health care is quite recent. The article by Robert Rhodes in your book talks about before /50 chance of harm or help in the hospital.
19th century. Hospitals were for the poor. Often places for people to die. MDs stereotype of family doc with small office or picture of carrying bag form home to home, not working in hospital
Late 1800s – major medical advances.
1900 – AMA starts to professionalize medicine. The American Medical Association has historically had a huge influence on the structure of delivery and financing in the U.S. In the top 10 spenders on lobbying - $22M in 2010.
Major change with growth of health insurance in the mid 20th century, which gave more people access to medical care who couldn’t afford it before.
MDs as solo family practitioners.
1940s-50s: Group health insurance
1846: Ether
1867: Anti-sepsis
1895: x-ray

6. As the Nature of Medicine Changes, so Does the Role of the Law …
Medicine evolves into a regulated industry (e.g., professional and institutional licensure)
Evolution of physician/patient relationship and increase in legal obligations
Rise of medicine as a business, with attendant shifts in law (antitrust, fraud, conduct of tax-exempt organizations, enforcement of corporate law principles)
Courts called on to enforce laws related to all of the above and to take “judicial notice” of social evolution

7. … and the Level of Regulation Intensifies
Modification of the “no duty of care” principle
EMTALA and emergency care
Patient abandonment
Professional and institutional liability
Informed consent,
Privacy and confidentiality (common law duties and HIPAA)
Loss of the “learned profession” exemption under federal antitrust law, expansion of enforcement activities
Creation of federal health insurance programs (Medicare and Medicaid) & conditions of participation in 1965
Scrutiny of tax-exempt organizations
Federal & state laws aimed at curbing health care fraud and authorizing qui tam actions (false claims; Stark, antikickback)

8. The Modern ERA: Patient Protection and Affordable Care Act (ACA) and beyond

9. ACA Signed into Law March 23, 2010 After Nearly a Century of Failed Efforts
A Big F***ing Deal
Efforts at universal coverage attempted since the Turn of the 20th century
Clinton attempted in the mid 1990s, which was a famous disaster. The policies they proposed had much in common with what was enacted in PPACA.
PPACA passed by a hair – tell story of house bill, senate bill, reconciliation
Why did it pass this time? Maybe a little luck and a perfect storm of enabling factors - both structural and strategic moves by key players (60 in senate to pass bill, Nancy Pelosi in house, Recession leaving middle class uninsured in higher numbers, interest group story – AMA declining in power, insurers bought off, MA as example, Obama made some good decisions to avoid following in the path of Clinton and others who failed)

10. What Does the ACA Do?
Title I – “Quality, Affordable Health Care Coverage for All Americans”
Title II – “Role of Public Programs”
Title III – “Improving the Quality and Efficiency of Health Care”
Title IV – “Prevention of Chronic Disease and Improving Public Health”
Title V – “Health Care Workforce …
Title IX – “Revenue Provisions”
Title X – Catch all Revisions
Health Insurance Reform – Creates System of Shared Risk
Health Care Delivery and Public Health Pilots and Investments

11. ~50 Million Uninsured Were Chief Motivation for Health Reform
20% of all non-elderly. And 1/3 of low-income non-elderly
Total = million
NOTE: Includes over age 65. Medicaid/Other Public Incl. Medicaid, CHIP, other state programs, military coverage, and dual eligibles
SOURCE: Kaiser Commission on Medicaid & the Uninsured & Urban Institute estimates based on the Census Bureau's March 2010 CPS.

12. Initially Projected to Insure 32M in Exchanges &Medicaid by 2021
Uninsured
24 M (9%)
Exchanges
54 M
(19%)
Uninsured
16 M (6%)
Other
16 M (6%)
Other
162 M
(57%)
ESI
159 M
(56%)
ESI
10 M (4%)
Nongroup
15 M (5%)
Nongroup
51 M
(18%)
Medicaid
35 M
(12%)
Medicaid
No Reform
PPACA
Among 282 million people under age 65
* Employees whose employers provide coverage through the exchange are shown as covered by their employers (5 million), thus about 29 million people would be enrolled through plans in the exchange. Note: ESI is Employer-Sponsored Insurance.
Source: The Congressional Budget Office analysis for the amendment in the nature of a substitute for H.R. 4872, Reconciliation Act of 2010, March 20,

13. Sommers BD. N Engl J Med 2015;373:2395-2397.
Who will Remain Uninsured?
Changes in the Composition of the Uninsured Population between 2010 and 2015. Estimates adapted from the 2010 Current Population Survey, Sommers et al.,1 Garfield et al., 2 the Office of the Assistant Secretary for Planning and Evaluation, and the Kaiser Family Foundation.
Sommers BD. N Engl J Med 2015;373:

14. What’s Ahead? AHCA? Maybe.

15. ACA, health law, and the Supreme Court

16. ACA and Other Recent Health Law Cases Decided by the U. S
ACA and Other Recent Health Law Cases Decided by the U.S. Supreme Court (1 of 2)
NFIB v Sebelius (2012)
Is the ACA’s so called “individual mandate” constitutional?
Does Congress have the constitutional power to require states to cover all low income nonelderly adults as a basic condition of program funding? I.e. is the Medicaid expansion constitutional?
“Hobby Lobby”: Contraceptive Coverage Round 1 (2014)
Does the Religious Freedom Restoration Act (RFRA) protect corporations, and, if so, can the government compel corporations to cover all FDA-approved contraceptives as part of their employer-sponsored health plans?
Zubik v. Burwell: Contraceptive Coverage Round 2 (2016)
Does the Hobby Lobby work around, requiring insurers to provide contraception coverage when employers object, violate the employers’ religious liberty b/c employers must report their intention not to cover?

17. ACA and Other Recent Health Law Cases Decided by the U. S
ACA and Other Recent Health Law Cases Decided by the U.S. Supreme Court (2 of 2)
King v Burwell (2015)
Is it plausible that the ACA intended for premium tax credits to be available in states that did not establish and operate their own Exchanges under the ACA, but instead relied on the Federal Exchange?
Whole Women’s Health v. Hellerstedt (2016)
Does a Texas law that requires MDs at clinics to have hospital admitting privileges within 30 miles of the clinic and for clinics to have facilities comparable to an ambulatory surgical center impose an undue burden on women who seek abortions?
Gobeille v. Liberty Mutual (2016)
Are state requirements to report claims data “preempted” by federal law (ERISA)?

18. NFIB v. Sebelius
Holding Individual Mandate: Constitutional under Congress’ “tax and spend” power
Holding Medicaid: Requiring expansion to 133% of federal poverty unconstitutionally coercive (Chief Justice Roberts: loss of all existing funding for failure to expand is “like gun to the head”)
But penalty severable, which means states can keep pre-ACA Medicaid programs or expand

19. Current Status of State Medicaid Expansion Decisions: January 2017WY
WI* WV WA VA VT UT TX TN SD SC RI PA OR OK OH ND NC NY NM NJ
NH* NV NE
MT* MO MS MN
MI* MA MD ME LA KY KS
IA*
IN* IL ID HI GA FL DC DE CT CO CA
AR*
AZ* AK AL
Adopted (32 States including DC)
Not Adopting At This Time (19 States)
NOTES: Current status for each state is based on KCMU tracking and analysis of state executive activity. *AR, AZ, IA, IN, MI, MT, and NH have approved Section 1115 waivers. WI covers adults up to 100% FPL in Medicaid, but did not adopt the ACA expansion.
SOURCE: “Status of State Action on the Medicaid Expansion Decision,” KFF State Health Facts, updated January 1, 2017.

20. Contraception Cases: Hobby Lobby v. Burwell & Zubik v. Burwell
ACA requires coverage of FDA-approved contraceptive methods “as prescribed” for women with no cost sharing
Includes counseling, insertion, and removal
Services related to follow-up & mgt. of side effects, counseling for continued adherence, & device removal
Applies to all new private plans (individual and employer) but exempts “grandfathered” plans
Fine on emp. for non-compliance = $100/enrollee /day
Est fine for Hobby Lobby = $475M/year (13K employees); note fine for not providing insurance = $26M/year
N/p houses of worship are exempt; accommodation made for non-profit religiously-affiliated orgs (insurer or TPA must pay for coverage if org indicates it won’t provide it). Mandatory for all secular N/p and f/p orgs.

21. Religious Freedom Restoration Act of 1993
Provides that the government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest

22. Legal Analysis of the Supreme Court Ruling on Hobby Lobby
Is the for-profit employer a “person” capable of religious belief?
Does the requirement to provide health insurance for contraceptives substantially burden the employer?
Does the government have a compelling interest to provide health insurance coverage for preventive care including contraceptives?
Is the government meeting the compelling interest in the least restrictive way?
Burden on Employer
Burden on Government 2. 3. 4. 1.
YES
YES NO
No Ruling NO NO NO
YES
Does not violate RFRA
Violates RFRA
SOURCE: Kaiser Family Foundation.

23. King v. Burwell: Key Background Facts
Subsidies available to people earning % of the Federal Poverty Level (FPL) without adequate/affordable employer coverage (FPL = $11,880-$47,520 for an individual in 2016)
Cost sharing reductions available to those earning % FPL ($11,800-$29,700 in 2016))
87% of people who selected a plan in a Federally-run marketplace received subsidies

24. What Was at Stake?: King v. Burwell

25. Whole Women’s Health v. Hellerstedt (2016)
2 dozen clinics closed after House Bill 2 passed
5-3 ruling held that the law posed an “undue burden” (Casey v. Planned Parenthood, 1991) on women’s constitutional right to an abortion (Thomas, Alito, and Roberts dissented)
Whole Women’s Health Clinic in Austin, TX just reopened, 3 years after closing
Most clinics that shut down have not reopened.
Precedent informs challenges of TRAP (Targeted Regulation of Abortion Providers) laws

26. Up Next for Health Law in the Supreme Court?
House v. Price (formerly House v. Burwell)
Is the President acting outside of his constitutional powers by spending money on cost-sharing subsidies that Congress had not explicitly appropriated?
Contraceptive Coverage Round 3?
January 2017 – Department of HHS said no new accommodation because it’s unworkable to have an accommodation without written notification
Is the accommodation a violation of a religious liberty when notice is necessary to provide completely separate coverage?
Litigation on risk corridor payments
Is the Obama Administration violating its statutory obligations by not paying out risk corridor payments to insurers whose losses exceeded financial limits (Congress blocked appropriations for the $8.3B owed for the first two years)?
Litigation in Ct. of Fed. Claims (e.g. $240M by BCBS affiliates in AL and TN)
Mixed success so far (e.g., Moda Health, Oregon insurer, $214M judgment)

27. Backup

28. PPACA Has Failed to Wow the Public
Source: Kaiser Family Foundation Health Tracking Polls

29. In Fact, Misperceptions Run Rampant
Do you think each of the following will be better off or worse off under the health reform law, or don’t you think it will make much difference?
Better off
No difference
Worse off
Don’t know/Refused
The uninsured
Lower income Americans
The country as a whole
Seniors, that is those ages 65 and older
Your state
People currently covered by Medicaid
Middle class Americans
You and your family
Source: Kaiser Family Foundation Health Tracking Poll (conducted May 12-17, 2011)