Goldner. Heath Care Quality. Spring 2014
Overview: Introductory health law course looks at health law through an institutional perspective. Comparatively, Health Care Quality is more litigation oriented. Through the lens of the doctor/patient relationship, we will discuss: (1) doctor/patient contracts; (2) confidentiality; (3) disclosure issues; (4) informed consent; and (5) tort reform.
Readings: Chap. 1 (p. 1-71); Chap 4, 5, 6, 10 (ERISA) – maybe a small part of chap. 2 (about 20 pages per hr of class)
I. Introduction to Health Law and Policy
a. Cost
i. Usually defined as cost of care, but includes private, public, social costs.
1. Lost wages, opportunity costs.
ii. Cost containment: Often just shifts costs elsewhere.
1. Avoid nursing homes: Huge costs elsewhere for families.
2. Discharge to nursing homes to avoid hospital costs: Brings other issues.
b. Purpose of Medical care
i. In the past, we have only covered illness.
ii. Insurance: Covers what is medically necessary.
iii. We’ve reached a place where to continue to cut costs, we must start trying to prevent it.
1. Transition from FFS to preventive care/incentives for better outcomes.
2. However, with different policies and with people jumping between plans, no incentive to cover prevention.
iv. Need the beneficiary of the incentive to be the payer/implementer of the improvement.
c. Defining Sickness
i. Lecture: What’s the difference between sickness and disease?
1. Sickness: sickness is impairment of function (i.e., sciatica).
2. Disease: Deviation from the normal, healthy state of the body, which may or may not have a detrimental effect.
a. Disease does not always impair daily function, although may have that impact later (i.e., diabetes).
b. Diagnostic and Statistic Manual of Mental Disorders/International Classification of Diseases (DSM/ICD) – Vote to determine what will be considered a disease.
3. So, is aging a disease?
a. No, because it is something that’s inherent in the human condition, but think about the cost implications of treating aging as if it is a disease.
4. Syndrome: Group of symptoms that consistently occur together (not necessarily a disease).
ii. Katskee v. Blue Cross/Blue Shield of Nebraska (contracts)
1. Facts: Woman had breast/ovarian carcinoma syndrome, which greatly increased her chances of developing cancer. Under the terms of the policy, her condition was not an illness and thus the treatment (radical hysterectomy) not medically necessary.
2. Holding: Illness, and surgery was medically necessary.
3. “‘[B]odily disorder’ and ‘disease,’ as they are used in the policy to define illness, encompasses:
a. any abnormal condition of the body or its components of such a degree that in its natural progression would be expected to be problematic;
b. a deviation from the healthy or normal state affecting the functions or tissues of the body;
c. an inherent defect of the body; or
d. a morbid physical or mental state which deviates from or interrupts the normal structure or function of any part, organ, or system of the body and which is manifested by a characteristic set of symptoms and signs.”
iii. Problem with infertile couple: Ct determined that infertility, while not necessary an illness, is the result of a deviation from the natural function of the reproductive organs.
d. Alain Enthoven: Medicine is an art, not a science.
i. Great deal of uncertainty.
ii. There is no “best” treatment, but many, each of which is associated with many benefits, treatments, and costs.
iii. Can’t be subjected to regulations like other fields.
e. Quality in Health Care
i. How do you define the nature of quality in healthcare? Quality is defined as how care will give a favorable risk/benefit ratio?
ii. Clinical effectiveness: Ratio of level of intervention/success.
1. The less intervention, the better.
a. Less invasive/less taxing/lower cost.
2. Want better results for less work/intervention/cost/resources.
iii. Quality Assurance Strategies
1. Patient Satisfaction
2. Outcomes (cost is relevant)
3. Inpatient days
4. Clinical practice guidelines: Supported by data, a supposedly ‘best method’ for care of an identified problem.
a. Reduces costs and errors.
b. PPACA: Beginning to develop national standards of care.
5. Readmissions (ACA readmission reduction program)
6. Randomized clinical trial: Gold standard
a. Yet, not always done: Expensive, difficult, can’t test on some groups.
7. Comparative Effectiveness Research: Studies that will lead to something similar to a ‘practice guideline.’
iv. Complementary and Alternative Medicine (CAM) Intervention: begin to test alternative interventions to see if the same or better result can be reached with a less invasive/costly procedure.
1. Ex: Move from coronary artery bypass graft (CABG) to balloon angioplasty, to stent.
2. CAM intervention becoming standard of care: Usually requires a number of published, successful studies.
v. Defining the Nature of Quality in Health Care
1. Quality = (1) technical aspects + (2) interpersonal aspects + (3) “amenities.” These could also be classified as the “science,” “art,” and “facilities” of healthcare.
a. Want the best risk/benefit ratio
2. Role of costs
a. Cost effectiveness: Does unnecessary care = bad care?
b. See Medicare: DRGs
f. Quality and Cost
i. Cost decisions: Patients, Doctors, Insurers, Employers
ii. Care decisions not always being made for the best reasons: Medical necessity
II. ADD DRG & RBRVS
i. Who decides the distribution of benefits – the justice principle?
1. Physicians
2. Hospitals
3. Insurers
4. Government
5. Case Managers
6. Employers
ii. Possible Quality Legal Issues (Outside of Med Mal)
1. Nursing Home Care
a. How do you define “quality care”?
i. Square feet per patient?
ii. LOS?
iii. Outcomes?
iv. Number of therapists per patient?
2. Mental Health Care
3. Consumer Fraud
4. FDA concerns (fraud, access, etc.)
iii. Assessing Quality
1. Nature of Quality and Medicine
a. IOM def. of quality: “degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”
b. Unnecessary care that causes harm: Poor quality (no expectation of benefit)
c. Necessary care that causes harm: Not necessary poor quality (unless poorly performed)
2. Institutional v. Individual Practiioner Quality
a. Individual doctors:
i. Policed by complaints to medical boards
ii. Only have to report lawsuits – not mistakes (NPDB).
iii. Only really lose licenses to drug/alcohol abuse – infrequently.
b. Hospitals:
i. Lots of checks and balances.
ii. Must report adverse events.
iii. Quality compare website: Medicare.gov/hospitalcompare
3. Medical
malnutrition injures more people than iatrogenic disease in its various manifestations.”
2. New York Study: The NY study looked at NY hospitals in 1984. Government hospitals had higher rates of AE, followed by non-profit, and for-profit institutions. Higher AE rates occurred in elderly patients and minorities, and much lower rates in newborns.
a. Teaching hospitals have half the negligent AE rates of non-teaching hospitals.
i. Better strategies for preventing filings?
iii. The Extent of Medical Misadventures
iv. Strategies for Reducing Medical Errors
1. “Error in Medicine” Lucian L. Leape; (1) culture of medicine, (2) task redundancy/repetition
a. Argues handling of medical errors is rooted in the nature of medical practice. Reaction to a mistake occurs in a vacuum where few others benefit from its knowledge. Litigation risk suppresses willingness to share of mistakes. Many physicians desire emotional support/knowledge gained from revealing and studying errors.
i. Train, punish, disapprove rather than “root cause” analysis.
b. Studies show that disclosure of AE can avoid lawsuits, although the culture of medicine fosters an environment for individuals to internalize their mistakes and not to share them.
c. Aviation Model
i. Assume that errors will occur
ii. Standardize procedures using checklists.
iii. Mandate use of trainings, exams, certifications, and re-certs.
iv. Institutionalize safety concerns: Don’t penalize for reports of near misses. Use the knowledge to prevent similar errors.
2. “To Err is Human: Building a Safer Health System” Committee on Quality of Health Care in American Institute of Medicine
v. Regulatory Responses to Medical Risks
1. Joint Commission for Accreditation of Health Organizations (JCAHO)
a. Must report serious events and conduct “root cause analysis”
2. State Reporting Systems (Hospital Licenses): States license the hospitals
3. IOM proposed mandatory sentinel event reporting and public disclosure.
a. Rejected.
4. National Quality Forums: “Never” Events or “serious reportable events”
a. Business owners started looking into quality to keep their insurance costs down.
5. Leapfrog Group: Business coalitions
a. Focused on safety issues, affordability, apologies to pts and family, tying pmts to quality and efficiency, mandating reporting to JCAHO, waiving costs related to the issue.
b. Wouldn’t allow their insureds to use non-Leapfrog hospitals.
6. Disclosure of Errors to Patients: VA System (5 different types of AEs)
a. “Disclosure of Adverse Events to Patients” VHA Directive
b. Problem: Disclosing Errors
7. CMS (and some states): Tie pmts to quality and efficiency.
a. Lower pmts for readmissions; both positive and negative pmt effects.
b. Reduction of pmt for HACs and exclusion of pmts for ‘never events.’
8. “Sorry works” apology campaign.
