Analysis of Statutes, Regulations
and Judicial Opinions:
Legal Methods in Health Services
Research
Mark Hall
Peter Jacobson
Timothy Stoltzfus Jost
Sara Rosenbaum
AcademyHealth
Annual Research Meeting
June, 2009
What this presentation will cover
1. Why focus on legal methods in health services
research?
2. Methods of legal analysis
– Quantitative analytic methods
• Content analysis
– Interpretative analysis
• Judicial opinions
• Statutes and regulations
3. Sources of law and legal analysis
Legal Methods in Health Services
Research
Sara Rosenbaum, JD
Hirsh Professor and Chair
Department of Health Policy
School of Public Health and Health Services
The George Washington University Medical Center
1. Why focus on legal methods in
health services research?
a. Health services research seeks to shed light on
the impact of legal policy, compelling an
understanding of the underlying legal policy,
e.g.:
– Do health insurance vaccine mandates affect immunization
outcomes?
– How do EMTALA stabilization policy reforms affect transfer and
discharge behavior of hospitals and patient health status?
– What are the effects of FTC rulings on clinical integration and
antitrust law on medical group practice patterns?
– Do indoor smoking bans have an impact on restaurant workers’
health?
1. Why focus on legal methods in
health services research? (cont.)
b. The complexity of and subtleties of law, which
must be taken into account when designing
health services research
– The meaning of statutes, regulations, judicial opinions (principles
of legal interpretation)
– Law as a data base that can be quantified in order to discern
patterns of conduct and behavior
• e.g., the effect of health insurance coverage exclusions on
provider practice patterns, e.g. the failure to screen
emergency department patients for substance use (which
could expose EDs to payment denials under insurance
alcohol exclusion clauses)
• e.g., judicial interpretation of medical necessity clauses in
coverage arrangements and their effect on provider
treatment decisions
1. Why focus on legal methods in
health services research? (cont.)
Careful reading matters: TennCare legislation (H.B. 3513) establishing the
program’s medical necessity standard (excerpts)
. . . To be determined to be medically necessary, a medical item or service must be . . .
safe and effective. . . . [T]he reasonably anticipated medical benefits of the item or
service must outweigh the reasonably anticipated medical risks based on the
enrollee’s condition and scientifically supported evidence; . . .
[and must not be] experimental or investigational. A medical item or service is
experimental or investigational if there is inadequate empirically-based objective
clinical scientific evidence of its safety and effectiveness for the particular use in
question. This standard is not satisfied by a provider’s subjective clinical judgment on
the safety and effectiveness of a medical item or service or by a reasonable medical
or clinical hypothesis based on an extrapolation from use in another setting or from
use in diagnosing or treating another condition. . . .
The definition’s legal implications: nearly all standard medical care treatments may be
excluded.
1. Why focus on legal methods in
health services research? (cont.)
c. Errors are possible when health services
research regarding the impact of law (statutes,
regulations, judicial decisions, contracts) does
not consider the law:
Cook et. al. “Differences in Specialist Consultations for
Cardiovascular Disease by Race, Ethnicity, Gender, Insurance
Status, and Site of Primary Care,” Circulation (2009)
• Study finding different patient outcomes in terms of practice style
(referral to cardiovascular specialists) and consequential patient
health status, comparing practice patterns between freestanding
community health centers and hospital-based clinics, both of which
had “affiliation agreements” with a hospital
• Entire study turned on assumption that the “affiliation agreements”
maintained by the two types of entities were identical; no analysis of
the affiliation agreements.
Methods of legal analysis:
Systematic Content Analysis of
Judicial Opinions
Mark A. Hall
Ronald F. Wright
Wake Forest University
Calif. Law Rev. 96:63-122 (2008)
Conventional Legal Analysis
1. Read
2. Think
3. Write
Content Analysis
•
•
•
•
Systematic selection
Standardize coding
Reliability checks
Statistical or rigorous qualitative analysis
Examples
• Hall (1998): Coverage Disputes
• Jacobson (2001): Managed Care Litigation
• Hammer & Sage (2002): Quality of Care
Factors in Antitrust Cases
• Miller (2006): Adequacy of Medicaid
Payment
Well suited when
Documenting what is and is NOT in
case law
Question or debunk conventional legal wisdom
Studying law’s relationship to external factors,
such as social, economic, or other legal
variables
Each decision should receive equal weight
Poorly suited for
When some cases have much greater
influence that others
Predicting outcome of cases based on
factors internal to the case: endogeneity
bias
Sampling Issues
• Sampling “bias”:
disputes > lawsuits > trials > appeals
Universal samples within date frames using
LEXIS or WestLaw
• Subjective winnowing of initial selection
Coding Issues
• Students vs. legal experts
• Accuracy checks
• Level of detail
– e.g., defining basic results
Reliability Issues
• Kappa statistic adjusts for agreement by
chance
• Skewed distribution problem
• “Adequate” reliability
Jurimetrics?
Oliver Wendell Holmes Jr.
“The law is the painting of a picture—not
the doing of a sum.”
Methods of Legal Analysis:
Empirical Research of Judicial
Opinions
Peter D. Jacobson, JD, MPH
Professor of Health Law and Policy
Director, Center for Law, Ethics, and Health
University of Michigan School of Public Health
Role of the Courts in Shaping Health
Policy
• Empirical research
– Define the problem (how courts resolve
conflicting policy issues in managed care
litigation)
– Select methods (function of questions posed
and data availability)
– Analyze the data
Selection of Methods: 1
• Qualitative
– Useful to understand how/why event occurs
– Political and social context
– Generate hypotheses
– Example is role of state/federal law in public
health preparedness
– Small sample size
– Not generalizable
Selection of Methods: 2
• Quantitative
– Test hypotheses
– Data available
– Objective
– Statistical methods
– Large sample size
– Generalizable
– Causality/attribution
Quantitative Analysis
• How judicial decisions shape health policy
• Random sample-559 cases
• Database created (22 key variables)
• Case content analysis (coding form)
• Inter-rater reliability (30 cases, 90%
agreement)
• Used descriptive and bivariate statistics,
plus chi square to test for differences in
proportions
Case Content Analysis: Coding
• Which court
• Ruling
• Case type
– Antitrust
– Benefit denial
– Access to technology
– Quality of care
– ERISA
Policy/Case Type Matrix
Case Content Analysis: Coding
• Policy issues raised (i.e., cost-access tradeoff)
–
–
–
–
Justice/fairness (i.e., access)
Cost/economic efficiency
Quality of care
Autonomy
• Coded from 0-6
– 0=variable not raised
– 6=variable given great weight
– Subjective coding (but high inter-rater reliability)
Findings: Policy Issues
Percentage Distribution of Rulings for Policy Issues Given “Great
Weight”
Policy Issue
Value**
Justice/fairness
0.001**
Cost/economic efficiency
Use of technology
Access to services/quality of care
Physician autonomy
Patient autonomy
Ruling
For the Plaintiff
%(n)
Ruling
For the Defendant
%(n)
75.4 (43)
24.6 (14)
20.5 (9)
75.0 (3)
68.4 (13)
45.5 (5)
55.6 (5)
79.6 (35)
25.0 (1)
31.6 (6)
54.5(6)
44.4 (4)
*P-value for chi-square test of difference of proportions. **Significant at the 0.05 level
P-
0.001
0.317
0.108
0.763
0.739
Findings: Policy Issues
Percentage Distribution of Rulings for Policy Issues Given “Limited
Weight”
Policy Issue
Value**
Justice/fairness
0.033**
Cost/economic efficiency
Use of technology
Access to services/quality of care
Physician autonomy
Patient autonomy
Ruling
For the Plaintiff
%(n)
Ruling
For the Defendant
%(n)
27.3 (6)
72.7 (16)
61.0 (25)
25.0 (1)
62.5 (10)
20.0 (2)
54.5 (6)
39.0 (16)
75.0 (3)
37.5 (6)
80.0 (8)
45.5 (6)
*P-value for chi-square test of difference of proportions. **Significant at the 0.05 level
P-
0.160
0.317
0.317
0.058
0.763
Summary of Findings
• MCOs win most benefit denial cases
• MCOs win when cost/efficiency given great
weight
• In non-ERISA cases, no significant differences in
rulings for plaintiff or defendant
• Within ERISA, defendants win 75%
Summary of Conclusions
• Judicial awareness of conflicting policy
objectives
• Cost containment programs preserved
• Need to study ways of improving framing nature
of policy dispute
• Viability of quantitative analysis despite
limitations
Study Limitations
•
•
•
•
•
•
Based on written opinions
No analysis of legal briefs/trial testimony
Case type categories not mutually exclusive
Some small cell sizes
Subjective coding
Attribution problem re: use of great or limited
weight
References
• PD Jacobson, E Selvin, and SD Pomfret, The Role of the
Courts in Shaping Health Policy: An Empirical Analysis,
Journal of Law, Medicine, and Ethics 2001; 29:278-289.
• PD Jacobson, RA Rettig, and W Aubry, Litigating the
Science of Breast Cancer, Journal of Health Politics,
Policy and Law 2007; 32:785-818.
• D Mendez, PD Jacobson, KM Hassmiller, GL Zellman,
The Effect of Legal and Hospital Policies on Physician
Response to Prenatal Substance Exposure, Maternal
and Child Health Journal 2003; 7:187-196.
• MA Hall, TR Smith, M Naughton, A Ebbers, Judicial
Protection of Managed Care Consumers: An Empirical
Study of Insurance Coverage Disputes, Seton Hall Law
Review 1996;26:1055-1068.
Methods of Legal Analysis:
Interpreting Federal Law - EMTALA
Timothy Stoltzfus Jost, JD
Robert L. Willett Professor
Washington and Lee University School of Law
Epstein on EMTALA
“As part of the price for participating in Medicare,
EMTALA requires hospitals to provide services
free of charge, to all persons, whether or not
enrolled in Medicare, who need emergency
treatment or who are in active labor.”
Richard Epstein, Mortal Peril (Addison-Wesley,
2007), 91.
42 USC 1395dd(a)
In the case of a hospital that has a hospital
emergency department, if any individual (whether or
not eligible for benefits under this subchapter)
comes to the emergency department and a request
is made on the individual's behalf for examination or
treatment for a medical condition, the hospital must
provide for an appropriate medical screening
examination within the capability of the hospital's
emergency department, including ancillary services
routinely available to the emergency department, to
determine whether or not an emergency medical
condition (within the meaning of subsection (e)(1) of
this section) exists.
42 USC 1395dd(b)
(b) Necessary stabilizing treatment for emergency medical conditions
and labor
(1) In general
If any individual (whether or not eligible for benefits under this
subchapter) comes to a hospital and the hospital determines that the
individual has an emergency medical condition, the hospital must
provide either-(A) within the staff and facilities available at the hospital, for such
further medical examination and such treatment as may be required
to stabilize the medical condition, or
(B) for transfer of the individual to another medical facility in
accordance with subsection (c) of this section.
42 USC 1395dd(e)
(1) The term “emergency medical condition” means-(A) a medical condition manifesting itself by acute symptoms of sufficient
severity (including severe pain) such that the absence of immediate medical
attention could reasonably be expected to result in-(i) placing the health of the individual (or, with respect to a pregnant woman,
the health of the woman or her unborn child) in serious jeopardy,
(ii) serious impairment to bodily functions, or
(iii) serious dysfunction of any bodily organ or part; or
(B) with respect to a pregnant woman who is having contractions–
(i) that there is inadequate time to effect a safe transfer to another hospital
before delivery, or
(ii) that transfer may pose a threat to the health or safety of the woman or
the unborn child.
42 USC 1395dd(e)
(3)(A)
The term “to stabilize” means, with respect to an
emergency medical condition described in
paragraph (1)(A), to provide such medical
treatment of the condition as may be necessary
to assure, within reasonable medical probability,
that no material deterioration of the condition is
likely to result from or occur during the transfer
of the individual from a facility, or, with respect to
an emergency medical condition described in
paragraph (1)(B), to deliver (including the
placenta).
42 USC 1395dd(h)
(h) No delay in examination or treatment
A participating hospital may not delay provision of
an appropriate medical screening examination
required under subsection (a) of this section or
further medical examination and treatment
required under subsection (b) of this section in
order to inquire about the individual's method of
payment or insurance status.
Other sources to consult
•
•
•
•
•
•
•
Legislative history
Federal regulations
Subregulatory federal guidance
Court decisions
Academic law review articles
Trade press articles
Other federal and state laws
42 CFR 489.24(d)(4)
(4) Delay in examination or treatment.
***
(ii) A participating hospital may not seek, or direct an individual to
seek, authorization from the individual's insurance company for
screening or stabilization services to be furnished by a hospital,
physician, or nonphysician practitioner to an individual until after the
hospital has provided the appropriate medical screening
examination required under paragraph (a) of this section, and
initiated any further medical examination and treatment that may be
required to stabilize the emergency medical condition under
paragraph (d)(1) of this section.
***
(iv) Hospitals may follow reasonable registration processes for
individuals for whom examination or treatment is required by this
section, including asking whether an individual is insured and, if so,
what that insurance is, as long as that inquiry does not delay
screening or treatment. Reasonable registration processes may not
unduly discourage individuals from remaining for further evaluation.
Preamble to 2003 rules
Comment: Some commenters stated that they understood the need to avoid
delaying EMTALA screening or stabilization to obtain prior authorization, but
suggested that, if such authorization is not obtained, patients might be left
with substantial financial responsibility. The commenters noted that
individuals may request information about the costs of services while
awaiting a screening examination. They stated that, while it is important to
avoid even the appearance of coercion of an individual to leave the
emergency department, it is also important to recognize the patient's right to
be informed of potential financial liability for services (including increased
liability for out-of-network services) before, rather than after, the services
are furnished.
****
Response: As noted in the Special Advisory Bulletin cited earlier (64 FR
61355), current Interpretive Guidelines indicate that hospitals may continue
to follow reasonable registration processes for individuals presenting with
an emergency medical condition. Reasonable registration processes may
include asking whether an individual is insured and, if so, what that
insurance is, as long as that inquiry does not delay screening or treatment.
Reasonable registration processes should not unduly discourage individuals
from remaining for further evaluation.
1999 Special Advisory Bulletin
If a patient inquires about his or her obligation to pay for
emergency services, such an inquiry should be answered by
a staff member who has been well trained to provide
information regarding potential financial liability. This staff
member * * * should clearly inform the patient that,
notwithstanding the patient's ability to pay, the hospital stands
ready and willing to provide a medical screening examination
and stabilizing treatment, if necessary. Hospital staff should
encourage any patient who believes that he or she may have
an emergency medical condition to remain for the medical
screening examination and any necessary stabilizing
treatment. Staff should also encourage the patient to defer
further discussion of financial responsibility issues, if possible,
until after the medical screening has been performed. If the
patient chooses to withdraw his or her request for examination
or treatment, a staff member with appropriate medical training
should discuss the medical issues related to a "voluntary
withdrawal
Grant v. Trinity Health-Michigan, 390
F.Supp.2d 643. 653 (E.D.Mich.,2005).
Although they do not specify which provision of EMTALA
Defendants allegedly violated, Plaintiffs appear to base their
claim on subsection h) of the statute, which provides that
A participating hospital may not delay provision of an
appropriate medical screening examination ... or ... medical
examination and treatment ... in order to inquire about the
individual's method of payment or insurance status.
Plaintiffs' Complaint, however, is devoid of any allegations that
Trinity Health delayed providing them a medical screening or
treatment. Rather, they merely allege that before Trinity
provided them with treatment, it first analyzed their ability to
pay and required them to sign forms agreeing to pay Trinity in
full for their medical care. These allegations are insufficient to
state a claim under EMTALA.
Grant v. Trinity Health-Michigan, 390
F.Supp.2d 643. 653 (E.D.Mich.,2005)
As provided in the EMTALA regulations:
Hospitals may follow reasonable registration processes for
individuals for whom examination or treatment is required by this
section, including asking whether an individual is insured and, if so,
what that insurance is, so long as that inquiry does not delay
screening or treatment.
Here, since the Complaint contains no allegation that the Trinity Health
Defendants delayed screening or treating Plaintiffs, their EMTALA
claim fails. Plaintiffs' claim is further deficient because, by their own
admission, Plaintiffs only incurred “economic injury and other
damages” as a result of the alleged EMTALA violation. Pursuant to
section (2)(A) of the statute, only persons who suffer “personal
harm” as “a direct result of a participating hospital's violation” of the
statute may bring a claim against a hospital.
Conclusions to be drawn from legal
sources
• EMTALA does not require hospitals to provide
emergency care for free, it does not even
significantly limit the aggressiveness of their debt
collection efforts.
• At least through the 1990s, hospitals faced a
significant problem when managed care plans
refused to cover care received in emergency
departments for insured patients under EMTALA.
• A serious problem exists because indigents do not
seek care in real emergencies and even leave the
emergency room before they are seen because of
concerns about the cost of care.