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

What is Health Law and Why Should Doctors Care? • Guides the relationship between 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. )

Early on, the Law Deferred to the Medical Profession A century ago, there was 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

THE 20 TH CENTURY EVOLUTION THE 20 TH CENTURY EVOLUTION

Evolution of Health Care Delivery… Hospitals = almshouses for sickpoor. Often formed by religious Evolution of Health Care Delivery… Hospitals = almshouses for sickpoor. Often formed by religious orgs. 1930 s: Formal Med. Ed. 1900: AMA gains traction 1800 s Rise of “for profit” hosp. MDs as: • Employees (residents, pathologists, radiologists, ER MDs) • Med. Staff (2/3 of MDs) 1900 MDs as solo family practitioners. 1846: Ether 1867: Antisepsis 1895: xray 2000 1965: Medicare & Medicaid 1985: EMTALA 1940 s-50 s: Group health insurance

As the Nature of Medicine Changes, so Does the Role of the Law … 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

… and the Level of Regulation Intensifies • Modification of the “no duty of … 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)

THE MODERN ERA: PATIENT PROTECTION AND AFFORDABLE CARE ACT (ACA) AND BEYOND THE MODERN ERA: PATIENT PROTECTION AND AFFORDABLE CARE ACT (ACA) AND BEYOND

ACA Signed into Law March 23, 2010 After Nearly a Century of Failed Efforts ACA Signed into Law March 23, 2010 After Nearly a Century of Failed Efforts A Big F***ing Deal

What Does the ACA Do? • Title I – “Quality, Affordable Health Care Coverage 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 10

~50 Million Uninsured Were Chief Motivation for Health Reform Total = 303. 3 million ~50 Million Uninsured Were Chief Motivation for Health Reform Total = 303. 3 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. 11

Initially Projected to Insure 32 M in Exchanges &Medicaid by. M 2021 23 (8%) Initially Projected to Insure 32 M in Exchanges &Medicaid by. M 2021 23 (8%) 12 16 M (6%) Other 15 M (5%) Nongroup 24 M (9%) Exchanges 54 M (19%) Uninsured 162 M (57%) ESI Uninsured 16 M (6%) Other 10 M (4%) Nongroup 159 M (56%) ESI 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, 2010 http: //cbo. gov/doc. cfm? index=11379.

Who will Remain Uninsured? Sommers BD. N Engl J Med 2015; 373: 2395 -2397. Who will Remain Uninsured? Sommers BD. N Engl J Med 2015; 373: 2395 -2397.

What’s Ahead? AHCA? Maybe. What’s Ahead? AHCA? Maybe.

ACA, HEALTH LAW, AND THE SUPREME COURT ACA, HEALTH LAW, AND THE SUPREME COURT

ACA and Other Recent Health Law Cases Decided by the U. S. Supreme Court 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?

ACA and Other Recent Health Law Cases Decided by the U. S. Supreme Court 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)?

NFIB v. Sebelius • Holding Individual Mandate: Constitutional under Congress’ “tax and spend” power 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

Current Status of State Medicaid Expansion Decisions: January 2017 VT WA MT* ME ND Current Status of State Medicaid Expansion Decisions: January 2017 VT WA MT* ME ND NH* MN OR WI* SD ID WY UT CO CA AZ* NM PA IL OH IN* WV KS OK MO KY TX DC SC AR* AL VA CT RI NJ DE MD NC TN MS AK MI* IA* NE NV MA NY GA LA FL HI 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. http: //kff. org/health-reform/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/

Contraception Cases: Hobby Lobby v. Burwell & Zubik v. Burwell • ACA requires coverage 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 = $475 M/year (13 K employees); note fine for not providing insurance = $26 M/year • N/p houses of worship are exempt; accommodation made for nonprofit 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.

Religious Freedom Restoration Act of 1993 • Provides that the government “shall not substantially 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

Legal Analysis of the Supreme Court Ruling on Hobby Lobby Burden on Employer Burden Legal Analysis of the Supreme Court Ruling on Hobby Lobby Burden on Employer Burden on Government 2. 1. Is the for-profit employer a “person” capable of religious belief? Does the requirement to provide health insurance for contraceptives substantially burden the employer? YES NO NO Does not violate RFRA SOURCE: Kaiser Family Foundation. 3. 4. 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? NO No Ruling NO YES Violates RFRA

King v. Burwell: Key Background Facts • Subsidies available to people earning 100 -400% King v. Burwell: Key Background Facts • Subsidies available to people earning 100 -400% 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 100 -250% FPL ($11, 800 -$29, 700 in 2016)) • 87% of people who selected a plan in a Federally-run marketplace received subsidies

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

Whole Women’s Health v. Hellerstedt (2016) • 2 dozen clinics closed after House Bill 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

Up Next for Health Law in the Supreme Court? • House v. Price (formerly 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. 3 B owed for the first two years)? – Litigation in Ct. of Fed. Claims (e. g. $240 M by BCBS affiliates in AL and TN) – Mixed success so far (e. g. , Moda Health, Oregon insurer, $214 M judgment)

BACKUP BACKUP

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

In Fact, Misperceptions Run Rampant Do you think each of the following will be 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 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) Worse off Don’t know/Refused