Clinical Practice Guidelines and the Utilization Quality Nexus
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AHLA Seminar Materials
Clinical Practice Guidelines and the Utilization Quality
Nexus
I. Clinical Practice Guidelines: Historical Development
A. Length of Stay Norms
1. Mandated with PSRO program
2. Commercial vendors
B. PSROs: Norms, criteria and standards
1. Norms
a. “principal points of evaluation and review”
b. “professionally developed”
c. “based on typical patterns of practice”
2. National Professional Standards Review Council to provide for preparation
and distribution to each PSRO appropriate materials indicated “regional
norms to be utilized”
3. Definitions:
a. norms: numerical or statistical measures of usual observed performance
b. criteria : predetermined elements against which aspects of the quality of
medical services may be compared
c. standards: professionally developed expressions of the range of acceptable
variation from a norm or criterion
4. National Council to provide sample sets
5. PSROs permitted to adopt or adapt or develop their own subject to
National Council approval -- resulting in local norms, criteria and
standards
6. To be used in four types of review and profiling
a. preadmission review
b. continued stay review
c. concurrent admission certification
d. retrospective review
7. Incentives to mandate conformity
a. Denied payment
b. Sanctions
c. Malpractice exemption no physician and no provider “shall be civilly liable
to any person ... on account of any action taken by him in compliance with
or reliance upon professionally developed norms of care and treatment
applied by a PSRO (§ 1167(c) of the Social Security Act, 1972)
8. Applied to HMOsAHLA Seminar Materials
“potentially the most effective anticompetitive device yet put in the hands
of the medical profession” Testimony of Clark C. Havighurst, before
Subcommittee on Antitrust and Monopoly, U.S., Sen., May 17, 1974
See, Gosfield, PSROs: The Law and the Health Consumer , Ballinger
Publishing Co., Cambridge, 1975, 265pp
C. PROs
1. Basic determinations
a. Medical necessity and reasonableness
b. In most economic setting
c. In accordance with professional recognized standards of care
2. Applying “professionally developed norms of care, diagnosis and treatment
based upon typical patterns of practice within the geographic area, ...taking
into consideration national norms.” (§ 1154(a)(6)(A))
3. ...[A] PRO must use national, or where appropriate, regional norms in
conducting review (42 CFR §466.100(a))
4. A PRO must establish written criteria based upon typical patterns of
practice in the PRO area, or use national criteria where appropriate; and
establish written criteria and standards to be used in conducting quality
review ( 42 CFR §466.100(b))
5. A PRO may establish specific criteria and standards to be applied to certain
locations and facilities in the PRO area if the PRO determines that the
patterns of practice in those locations and facilities are substantially
different from patterns in the remainder of the PRO area; and there is a
reasonable basis for the difference which makes the variation appropriate. (
42 CFR §466.100(c))
6. HMO Review: a PRO must determine whether the quality of services
(including both inpatient and outpatient services) provided by an HMO or
CMP meets professionally recognized standards of health care including
whether appropriate health care services have not been provided or have
been provided in inappropriate settings. ( 42 CFR §466.72(a)(1))
See also, Gosfield “Utilization Management, Quality Assurance, and
Practice Guidelines,” (Vol III, Payment Issues, Chapter I), NHLA Health
Law Practice Guide , Clark Boardman Callaghan, 1993
II. Agency for Health Care Policy and Research §6103 OF OBRA ‘89
creating a new Title IX of the Public Health Service Act
A. Relationship to Part B Reimbursement
B. Major Functions
1. Conduct and support research, demonstration projects, evaluations, training,
guideline development, and the dissemination of information, on health care
services and on systems for the delivery of such services, including activities
with respect to
a. the effectiveness, efficiency and quality of health care services and
procedures
b. the outcomes of health care services and procedures
c. clinical practice, including primary care and practice-oriented researchAHLA Seminar Materials
d. health care technologies, facilities and equipment,
e. health care costs, productivity and market forces
f. health promotion and disease prevention
g. health statistics and epidemiology
h. medical liability
2. Health technology assessment
3. Establishment of Advisory Council for Health Care Policy, Research and
Evaluation
C. Office of the Forum for Quality and Effectiveness
1. Arrange for the development, periodic review and updating of
a. clinically relevant guidelines that may be used by physicians, educators
and health care practitioners to assist in determining how diseases,
disorders and other health conditions can be most effectively and
appropriately be prevented, diagnosed, treatment and managed clinically;
and,
b. standards of quality, performance measures, and medical review criteria
through which health care providers and other appropriate entities may
assess or review the provision of health care and assure the quality of such
care ( 42 USC §299b-1(a))
2. Guidelines, standards, performance measure and review criteria shall
a. be based on the “best available research and professional judgment...”
b. be presented in formats appropriate for use by physicians, health care
practitioners, providers, medical educators, and medical review
organizations and in formats appropriate for use by consumers of health
care; and
c. include treatment-specific or condition-specific practice guidelines for
clinical treatments and conditions in forms appropriate for use in clinical
practice, for use in educational programs, and for use in reviewing quality
and appropriateness of medical care (§299b-1(b))
3. Priorities based on needs of Medicare
a. high cost items
b. items with substantial variation nationally or controversial
4. Initial topics selected
a. Post operative pain management
b. Urinary incontinence in adults
c. Prediction and prevention of bedsores
d. Benign prostatic hyperplasia
e. Sickle cell anemia: screening, diagnosis, management and counseling new
newborns and infants
f. Low back pain problems
g. Treatment of depression by primary care physicians in the outpatient
setting
h. Evaluation and management of early HIV infectionAHLA Seminar Materials
i.Management of cancer related pain
j.Treatment of pressure ulcers in adults
k.Quality determinants of mammography
l.Otitis media with effusion in children
m.Heart failure: evaluation and care of patients with left ventricular systolic
dysfunction
n. Post stroke rehabilitation
o. Screening for Alzheimer's and related dementias
p. Cardiac rehabilitation
q. Diagnosis and management of unstable angina
r. Smoking prevention and cessation
s. Diagnosis and treatment of anxiety and panic disorder in the primary care
setting
D. Guidance to the Agency: See, Institute of Medicine, “Clinical Practice
Guidelines: Directions for a New Program,” National Academy Press,
1990
1. Definitions
a. practice guidelines : systematically developed statements to assist
practitioner and patient decisions about appropriate health care for specific
clinical circumstances
b. medical review criteria: systematically developed statements that can be
used to assess the appropriateness of specific health care decisions,
services and outcomes
c. standards of quality are authoritative statements of (1) minimum levels of
acceptable performance or results, (2) excellent levels of performance or
results or (3) the range of acceptable performance or results
d. performance measures (Provisional): are methods or instruments to
estimate or monitor the extent to which the actions of a health are
practitioner or provider conform to practice guidelines, medical review
criteria or standards of quality
2. Attributes of good guidelines
a. Validity: when followed, they produce expected outcomes
b. Reliability/reproducibility: another group of experts would produce the
same set, guidelines are interpreted and applied consistently in given
circumstances
c. Clinical applicability: appropriate definition of patient populations to
which they pertain
d. Clinical flexibility: identify known or generally expected exceptions
e. Clarity: unambiguous language, logical to follow
f. Multidisciplinary process: developed by diverse group
g. Scheduled review
h. Documentation available and meticulously described as to participants,
evidence assumptions and rationalesAHLA Seminar Materials
III. Guideline Differences
A. Sponsorship
1. Specialty societies
2. Different practitioner groups: e.g., nurses, PTs, etc
3. Payors: coverage and technology exclusions
B. Local Variation
1. How much should be permitted?
2. Why is it done?
a. ownership
b. understanding
C. Types
1. Randomized clinical trials based
2. Literature search
3. Consensus based
4. Consumer participatory
D. Controversies
1. Cost driven
P.L. 102–410 AHCPR reauthorization requires “information on costs...where
cost information is available and reliable” (§5(a)(5))
2. How to include patient choice
3. Minimal or optimal
4. What about socio-economic factors
E. Evidentiary value of each
See, Institute of Medicine, Guidelines for Clinical Practice: From
Development to Use , National Academy Press, 1992
IV. Applications
A. Coverage
1. Benefits Design
2. Case Management
3. Coverage and Technology Exclusions
B. Selective Contracting
1. Selection
2. Profiling practitioners
3. Corrective action
C. Risk management and lower premiums
COPIC mandated performance
D. Fraud and Abuse
Failing to provide medically necessary items and services to Medicare
beneficiaries:§1128(b)(6) of the Social Security Act
E. PRO ReviewAHLA Seminar Materials
F. Malpractice
1. Whose guidelines are evidence?
2. What value are they given?
See, Brennan, “Report to Physician Payment Review Commission: Practice
Guidelines and Malpractice Litigation,” January 25, 1994
3. State experiments: Maine, Minnesota, Florida, Maryland
4. PRO statute
G. Will they apply in actions based on consent?
H. Guidelines and Tort Reform
I. Translating Guidelines into Medical Review Criteria, Standards of Quality and
Performance Measures
1. What methodology?
2. New forms of producer liability
3. Bona fides of selecting guidelines
V. The Law of Utilization Management
A. Federal Fraud and Abuse Laws as surrogates: The need for UM
1. Anti-referral legislation
2. HMO Liabilities
a. Civil money penalties of up to $2,000 per claim to be imposed upon any
HMO which makes a payment directly or indirectly to a physician as an
incentive for the reduction or limiting of services provided to a Medicare or
Medicaid beneficiary -- effective April 1, 1991, extended from April 1,
1990, but not eliminated in face of proposals that more study was
necessary (§4204 OBRA '90: Establishes criteria for incentive plans
effective January 1, 1992 (§1876(i)(8)(A).
b. HMOs which fail substantially to provide medically necessary services
required under law or contract, where the failure to provide them either
adversely affects or has a substantial likelihood of adversely affecting a
Medicare or Medicaid patient are subject to a civil money penalty of up to
$25,000 (§1876(i)(6)(A))
B. RBRVS and VPS
1. Utilization assumptions
2. Based on what?
C. “Anti-managed care” laws which run contrary to these premises
1. Mandated benefits
2. Unlimited provider selection
3. Mandated coverage and approaches to provider networks and benefits
4. Restricted financial incentives
5. Utilization review Issues, (Examples)
a. Immunity for individual physicians conducting review
b. Requirement for adequate numbers of physicians
c. Requirement for a physicianAHLA Seminar Materials
d. Review by physician on appeal
D. ERISA
1. Preemption
2. Who has discretion in the plan: Firestone Tire and Rubber Co. v. Bruch , 489
US —, 109 S. Ct. 948, 103 L. Ed. 2d 80 (1989)
3. Difference in review by court
a. Arbitrary and capricious
b. De novo
c. but see, Brown v. Blue Cross and Blue Shield of Alabama , 898 F.2d 1556
(11th Cir., 1990)where conflict of interest in plan exercise of fiduciary
responsibility can overcome standard of review
4. Cases in which utilization management was at issue under ERISA
a. Elsesser v. Hospital of PCOM , (D. Ct., E.D. Pa., Civ. Action 92-3045,
September 300, 1992)
Patient has holter monitor removed after one day because HMO wouldn't
pay; ERISA does not preempt malpractice claim but does preempt on
instructions to physician that it would not pay, misrepresentation claim and
breach of contract.
b. Corcoran v. United Healthcare Inc. , 965 F. 2d 1321 (5th Cir, 1992)
Baby dies after mother discharged on recommendation of UR company and
insurer; ERISA preempts as a medical decision incident to a benefit
decision. No remedy.
c. Kuhl v. Lincoln National Health Plan , Nos. 92-2604/92-2607 (D.C. W.D.
Mo., July 7, 1993)
ERISA preempts where requirement for precertification denies access to
highly specialized cardiac surgery since precert had not been obtained;
patient died awaiting heart transplant after delay.
d. Damare v. Occidental Petroleum Corporation Medical Care Plan , (D.C.
E.D. La., Civ Action 92-1779, March 24, 1993)
ERISA preempts on denial of payment for non-emergency hysterectomy
for failure to obtain precertification and failure to perform appropriate
diagnostic tests where Aetna handles determinations on ASO contract.
e. Dearmas v. Av-Med, Inc. , 1993 WL 51541 (S.D. Fla.)
Patient transferred among four hospitals in three days following auto
accident within ERISA definitions of benefit determination, but violation
of anti-dumping statute does not state and ERISA claim and cannot be used
against an HMO; see also Bangert v. Christian Health Services , (No. 92-
613 WLB, D.C. So.D. Ill., December 17, 1992)
f. Nazay v. Miller and Bethlehem Steel , 949 F. 2d 1323 (3d Cir., 1991)
Retired employee, hospital admission agreed necessary, but failure to
obtain prior approval by the plan, 30% financial penalty imposed. Retiree
had an outdated card which did not state pre-cert requirement, so hospital
did not check with Blue Cross either. Amount at issue $2,231.51.
1. Trial court: imposition of 30% penalty for failure to obtain prior
authorization was arbitrary and capriciousAHLA Seminar Materials
2. Ct. of Appeals:
“Bethlehem as an employer is free to develop an employee benefit plan
as it wishes because the creation of a benefit plan is a corporate
management decision unrestricted by ERISA's fiduciary duties.”
VI. Non-ERISA based Liability of the reviewing entity
A. Wickline. v. California , 228 Cal Rptr 661, 231 Cal Rptr 560, 727 P 2d 753 (1986)
Everybody into the pool: Liability to all who deny care with resulting patient harm
where standard is not proper, appeals are ignored, arbitrary decision-making
B. Sarchett v. Blue Shield of Ca , 729 P 2d 276 (1984), Sup Ct of Ca., LA 31988 (Jan
2, 1987)
Must allow appeals, but notice must be sufficient to permit the appeal right to be
exercised; not enough to put it in the contract
C. Hughes v. Blue Cross of Northern California burden on the insurer to investigate;
must use community standard of care; must provide enough information for
subscriber to pursue appeal rights (245 Cal. Rptr 273, 199 Cal. App. 3d 958 (1988);
215 Cal App 3d 832 (1989)
D. Wilson v. Blue Cross of Southern Ca , 1990 Cal Lexis 4574
Denial of motion for summary judgment where reviewing entity sought to avoid
liability on the grounds that Wicklin imposes it only on physicians. Suit
proceeded to trial with verdict for defendants -- no bad faith; but a reported
settlement with the utilization review company after insurer and utilization review
company, counterclaimed against the attending physicians and hospital after their
motion for summary judgment was denied
E. Stout v. Board of Pensions , Super Ct. No. 601876, 4 App. Dist Cao., January 29,
1993)
Long term psychiatric patient care reviewed by Preferred Health Inc., decision to
discharge made by all treating physicians and utilization review physicians, at a
point when patient had exhausted all of $2000 cap on outpatient mental health
benefits. Patient told he cannot continue in outpatient therapy if he does not pay.
He runs away and lives in his car. Eventually he is readmitted to the hospital.
Plaintiff appeals granting of summary judgment for plan. Court of appeals affirms
distinguishing Wilson because all physicians agreed he needed outpatient care, and
alternative arrangements had been made. Court finds for plan.
VII. Practical Guidance on Avoiding Review Liability
A. What does the contract say about medical necessity?
1. Definition of medical necessity in the contract terms will be important, even
where courts have held that the right to deny payment based on utilization
review exists, it is not inherent: Schroeder v. Blue Cross and Blue Shield of
Wisconsin, Ct. of Appeals , Wisconsin, Nov. 1, 1989, No. 89-00150
2. Se also, Patterson v. HMO Nebraska Inc. , Lancaster County, Nebraska, 422,
Jan. 25, 1988where primary physician certification dispositive of issue of
coverage of twenty-four hour nursing in the home, since if no nursing
rehospitalization would be required and if rehospitalized, 24 hour nursing
would be providedAHLA Seminar Materials
B. What type of process did you use?
1. Staff Builders v. Armstrong , 37 Ohio St 3d 298 (1988), $25,095.01 at issue for
in-home nursing. Issues involved the level of investigation by the insurer and
the nature of the notices sent to the patient and assigned-to nurse agency,
indicating nothing more needed to be done; claims subsequently denied.
Damages: $35,000 compensatory damages; $50,000 for bad faith, $125,000
punitives
2. ERISA does establish what kind of review must take place: see, Reed v.
Lincoln National Corporation , U.S. D.Ct., Civil No. F 88-20, Nov. 22, 1989,
where plan tried to use out of contract case management to lower benefit pay-
out; court found that plaintiff did not receive a “full and fair review” of his
claims -- denied access to report, report not specific, no evidence Committee
reviewing made its own determination
3. Bellanger v. Health Plan of Nevada , CV-92-020-PMP D.C. Nev., Dec. 22,
1992)
Prior authorization for surgery required, PCP did not approve, patient went out
of network, patient sued for cost of surgery alleging that ERISA requires that
notice of denial state requirements for perfecting appeal along with specific
reason for denial which had stated denied as “out of area services” but real
reason was second opinion required. Court found in favor of plaintiff.
C. Prior authorization
1. Psychiatric pilot program
Two psychiatrist sue Blue Cross and Blue Shield of Michigan challenging prior
authorization and concurrent review; challenge based on requirement to deal
with unlicensed personnel and intrusion on physician-patient relationship.
Varol v. Blue Cross Blue Shield of Michigan , No. 88-40095, E.D. Michigan,
March 2, 1989
a. ERISA preempts
b. Unlicensed personnel could approve only; but a psychiatrist had to deny
c. Like Wickline , physician retains the right and ethical and legal obligation
to decide whether and how to treat
2. But beware of Bush v. Dake , Boyd v Einstein type cases where patient
does not receive necessary care
3. Newell v. Prudential Insurance . (904 F 2d 644 (11th Cir., 1990)where
conflict of interest in plan administrator functioning as insurer as well,
burden is on fiduciary under ERISA to prove its interpretation of plan is
appropriate -- upheld preadmission and continued stay review, upheld
determination of need for further hospitalization for substance abuse, but
abused its discretion in failure to follow notification procedures for
concurrent review and failure to notify that claim would be subjected to
retrospective review
D. Guidelines as a bolster in UM
VI. Scorecards
A. Intarplan
1. US Healthcare
2. United Healthcare CorporationAHLA Seminar Materials
3. Kaiser
4. Ethix
B. NCQA Based upon HEDIS measures
C. AHCPR report card (project announced September 19, 1994)
D. See GAO Report, “Report Cards” Are Useful but Significant Issues Need to Be
Addressed,” September 1994
E. Guidelines as a basis
1. Some performance measures are not clinical
2. Good guidelines project outcomes from their application
3. Deciding what to measure
4. Severity adjustments
F. Controversies
1. Common data collection
2. Implications from formatting
3. Advertising issues related to guarantees
4. Consumer fraud and RICO?
Attachments:
Physicians Reference Guide to AHCPR Guidelines on Post Operative Pain
Management
Gosfield “Clinical Practice Guidelines and The Law: Applications and
Implications”
Attention ____
This Quick Reference Guide contains excerpts from the Clinical Practice
Guideline for Acute Pain Management: Operative or Medical Procedures and
Trauma , which was developed by an interdisciplinary non-Federal panel made
up of health care practitioners, an ethicist, and a consumer. Panel members
were: Daniel B. Carr, MD, (co-chair); Ada K. Jacox, RN, PhD, FAAN (co-
chair); C. Richard Chapman, PhD; Betty Ferrell, RN, PhD, FAAN; Howard L.
Fields, MD, PhD; George Heidrich III, RN, MA; Nancy O. Hester, RN, PhD;
C. Stratton Hill, MD; Arthur G. Lipman, PharmD; Charles L. McGarvey, MS;
Christine Miaskowski, RN, PhD; David Stevenson Mulder, MD; Richard
Payne, MD; Neil Schechter, MD; Barbara S. Shapiro, MD; Robert Smith, PhL;
Carole V. Tsou, MD; and Loretta Vecchiarelli.
For a description of the guideline development process and information about
the sponsoring agency (Agency for Health Care Policy and Research), see:
Acute Pain Management Guideline Panel. Acute Pain Management: Operative
or Medical Procedures and Trauma, Clinical Practice Guideline. AHCPR
Pub. No. 92-0032. Rockville, MD: Agency for Health Care Policy and
Research, Public Health Service, U.S. Department of Health and Human
Services. Feb. 1992.
A second guide presents excerpts from the Clinical Practice Guideline on acute
pain management in pediatric patients; see: Acute Pain Management Guideline
Panel. Acute Pain Management in Infants, Children, and Adolescents:
Operative and Medical Procedures: Quick Reference Guide for Clinicians .
AHCPR Pub. No. 92-0020. Rockville, MD: Agency for Health Care Policy andAHLA Seminar Materials
Research Public Health Service, U.S. Department of Health and Human
Services.
Users should not rely on these excerpts alone but should refer to the complete
Clinical Practice Guideline for more detailed analysis and discussion of
available research, critical evaluation of the assumptions and knowledge of the
field, considerations for patients with special needs (e.g., intercurrent illness or
substance abuse), and references. As stated in the Clinical Practice Guideline,
decisions to adopt any particular recommendation must be made by the
practitioner in light of available resources and circumstances presented by
individual patients.
For further information or to receive additional copies of guideline documents,
call: 1-800-358-9295 or 301-495-3453; or you may write to the:
Center for Research Dissemination and Liaison AHCPR Publications
Clearinghouse P.O. Box 8547 Silver Spring, MD 20907
This document is in the public domain and may be used and reprinted without
special permission, except for those copyrighted materials noted for which
further reproduction is prohibited without the specific permission of copyright
holders. AHCPR will appreciate citation as to source, and the suggested format
is provided below:
Acute Pain Management Guideline Panel. Acute Pain Management in Adults:
Operative Procedures. Quick Reference Guide for Clinicians. AHCPR Pub.
No. 92-0019. Rockville, MD: Agency for Health Care Policy and Research,
Public Health Service, U.S. Department of Health and Human Services.
Acute Pain Management in Adults: Operative Procedures
Introduction
The obligation to manage pain and relieve a patient's suffering is an important
part of a health professional's commitment. The importance of pain
management is further increased when benefits for the patient are realized-
earlier mobilization, shortened hospital stay and reduced costs. Yet clinical
surveys continue to show that routine orders for intramuscular injections of
opioid “as needed” result in unrelieved pain due to ineffective treatment in
roughly half of postoperative patients. Recognition of the inadequacy of
traditional pain management has prompted recent corrective efforts from a
variety of health care disciplines including surgery, anesthesiology, nursing,
and pain management groups. The challenge for clinicians is to balance pain
control with concern for patient safety and side effects of pain treatments. This
Quick Reference Guide is intended to assist clinicians with these deviations.
Patients vary greatly in their medical conditions and responses to surgery,
responses to pain and interventions, and personal preferences. Therefore, rigid
prescriptions for the management of postoperative pain are inappropriate.
Several alternative approaches, appropriately and attentively implemented,
prevent or relieve pain. This Quick Reference Guide contains excerpts from the
Clinical Practice Guideline for Acute Pain Management: Operative or Medical
Procedures and Trauma and addresses the assessment and management of
postoperative pain in adults. The excerpts contained in this Quick Reference
Guide provide clinicians with a practical and flexible approach to acute pain
assessment and management. However, users should not rely on these excerptsAHLA Seminar Materials
alone but should refer to the complete Clinical Practice Guideline for a more
detailed analysis and discussion of the available research, critical evaluation of
the assumptions and knowledge of the field, considerations for patients with
special needs (e.g. intercurrent medical illness or substance abuse), and
reference.
The flow chart, which follows, shows the sequence of activities related to pain
assessment and management. This Quick Reference Guide provides
information about the events listed in the flow chart.
Postoperative Pain Management: A Brief Flow Chart
Effective Management of Postoperative Pain
Requirements
• Pain intensity and relief must be assessed and reassessed at regular
intervals.
• Patient preference must be respected when determining methods to be
used for pain management.
• Each institution must develop an organized program to evaluate the
effectiveness of pain assessment and management. Without such a program,
staff efforts to treat pain may become sporadic and ineffectual.
Principles
• Successful assessment and control of pain depends in part on
establishing a positive relationship between health care professionals and
patients. Patients should be informed that pain relief is an important part of
their health care, that information about options to control pain is available to
them, and that they are welcome to discuss their concerns and preferences with
the health care team.
• Unrelieved pain has negative physical and psychological
consequences. Aggressive pain prevention and control that occurs before,
during, and after surgery can yield both short- and long-term benefits.
• It is not practical or desirable to eliminate all postoperative pain, but
techniques now available make pain reduction to acceptable levels a realistic
goal.
• Prevention is better than treatment. Pain that is established and severe
is difficult to control.
Pain Assessment and Reassessment
Principles
• Patients who may have difficulty communicating their pain require
particular attention. This includes patients who are cognitively impaired,
psychotic or severely emotionally disturbed, children and the elderly, patients
who do not speak English, and patients whose level of education or cultural
background differs significantly from that of their health care team.
• Unexpected intense pain, particularly if sudden or associated with
altered vital signs such as hypertension, tachycardia, or fever, should beAHLA Seminar Materials
immediately evaluated, and new diagnoses such as wound dehiscence,
infection, or deep venous thrombosis considered.
• Family members should be involved when appropriate.
Pain Assessment Tools
• The single most reliable indicator of the existence and intensity of
pain—and any resultant distress—is the patient's self-report.
• Self-report measurements scales include numerical or adjective ratings
and visual analog scales (see Table 1 for examples).
• Tools should be reliable, valid, and easy for the patient and the nurse or
doctor to use. These tools may be used by showing a diagram to the patient and
asking the patient to indicate the appropriate rating. The tools may also be used
by simply asking the patient for a verbal response (e.g. “On a scale of 0 to 10
with 0 as no pain and 10 as the worst pain possible, how would you rate your
pain?”).
• Tools must be appropriate for the patient's developmental, physical,
emotional, and cognitive status.
Preoperative Preparation
• Discuss the patient's previous experiences with pain and beliefs about
and preferences for pain assessment and management.
• Give the patient information about pain management therapies that are
available and the rationale underlying their use.
• Develop with the patient a plan for pain assessment and management.
• Select a pain assessment tool, and teach the patient to use it. Determine
the level of pain above which adjustment of analgesia or other interventions
will be considered.
• Provide the patient with education and information about pain control,
including training in nonpharmacologic options such as relaxation (see Table 2
for a sample relaxation exercise.)
• Inform patients that it is easier to prevent pain than to chase and reduce
it once it has become established and that communication of unrelieved pain is
essential to its relief. Emphasize the importance of a factual report of pain,
avoiding stoicism or exaggeration.
Postoperative Assessment
• Assess the patient's perceptions, along with behavioral and physiologic
responses. Remember that observations of behavior and vital signs should not
be used instead of a self-report unless the patient is unable to communicate.
• Assess and reassess pain frequently during the immediate
postoperative period. Determine the frequency of assessment based on the
operation performed and the severity of the pain. For example, pain should be
assessed every 2 hours during the first postoperative day after major surgery.
• Increase the frequency of assessment and reassessment if the pain is
poorly controlled or if interventions are changing.
• Record the pain intensity and response to intervention in an easily
visible and accessible place, such as a bedside flow sheet.AHLA Seminar Materials
• Revise the management plan if the plain is poorly controlled.
• Review with the patient before discharge the interventions used and
their efficacy and provide specific discharge instructions regarding pain and its
management.
Management Options
One or more of these approaches may be used:
• Cognitive-behavioral interventions such as relaxation, distraction, and
imagery. These methods may reduce pain and anxiety and control mild pain,
but they do not substitute for pharmacologic management of moderate to
severe pain.
• Systematic administration of opioids and/or nonsteroidal anti-
inflammatory drugs (NSAIDs), including acetaminophen.
• Patient-controlled analgesia (PCA) usually denotes self-medication
with intravenous opioids, but may include oral or other routes of
administration. PCA offers patients a sense of control over their pain and is
preferred by most patients to intermittent injections.
• Spinal analgesia, usually with an epidural opioid and/or local
anesthetic injected intermittently or infused continuously.
• Intermittent or continuous local neural blockade, such as intercostal
nerve blockade or infusion of local anesthetic through an interpleural catheter.
• Physical agents such as massage or application of heat or cold.
• Transcutaneous electrical nerve stimulation (TENS).
• Note: The use of spinal analgesia or neural blockade or the infusion
of local anesthetic through interpleural catheters require special expertise
and well-defined institutional protocols and procedures for accountability.
The administration of regional analgesia is best limited to specially trained
and knowledgeable staff, typically under the direction of an acute or
postoperative pain treatment service.
Pharmacologic Management
• Pharmacologic management of mild to moderate postoperative pain
should begin, unless there is a contraindication, with an NSAID. However,
moderately severe to severe pain should normally be treated initially with an
opioid analgesic, with or without an NSAID.
NSAIDs
• Even when insufficient alone to control pain, NSAIDs, including
acetaminophen, have significant opioid dose-sparing effects on postoperative
pain and hence can be useful in reducing opioid side effects (see Table 4 for
information on prescribing NSAIDs).
• If the patient cannot tolerate oral medication, alternative routes such as
rectal administration can be used. At present, one NSAID (ketorolac) is
approved by the Food and Drug Administration for parenteral use.
• NSAIDs must be used with care in patients with thrombocytopenia or
coagulopathies and in patients who are at risk for bleeding or gastric ulceration.
However, acetaminophen does not affect platelet function, and some evidenceAHLA Seminar Materials
exists that two salicylates (salsalate and choline magnesium trisalicylate) do
not profoundly affect platelet aggregation.
Opioid Analgesics
• Opioid analgesics are the cornerstone for management of moderate to
severe acute pain. Effective use of these agents facilitates postoperative
activities such as coughing, deep breathing exercises, ambulation, and physical
therapy.
• When pain cannot be adequately controlled despite increasing the
opioid dose, a prompt search for residual operative pathology is indicated, and
other diagnoses such as neuropathic pain should be considered.
• Opioid tolerance and physiologic dependence are unusual in short-term
postoperative use in opioid-naive patients. Likewise, psychologic dependence
and addition are extremely unlikely to develop after the use of opioids for acute
pain.
Choice of Opioid Agent
• Morphine is the standard agent for opioid therapy. If morphine cannot
be used because of an unusual reaction or allergy, another opioid such as
hydromorphone can be substituted.
• Meperidine should be reserved for very brief courses in patients who
have demonstrated allergy or intolerance to other opioids such as morphine and
hydromorphone. Meperidine is contraindicated in patients with impaired renal
function or those receiving antidepressants that are monoamine oxidase (MAO)
inhibitors, Normeperidine is a toxic metabolite of meperidine, and is excreted
through the kidney. Normeperidine is a cerebral irritant, and accumulation can
cause effects ranging from dysphoria and irritable mood to seizures.
Dosage of Opioid Analgesics
• Patients vary greatly in their analgesic dose requirements and
responses to opioid analgesics. The recommended starting doses presented in
Table 5 may be inadequate. Subsequent opioid doses must be titrated to
increase the amount of analgesia and reduce side effects.
• Relative potency estimates provide a rational basis for selecting the
appropriate starting dose, for changing the route of administration (e.g., from
parenteral to oral), or for changing from one opioid to another. Equianalgesic
doses for opioids are listed in Table 5.
• Patients who have been receiving opioid analgesics before surgery may
require higher starting and maintenance doses postoperatively.
Dosage Schedule
• Opioid administration relying on patients' or families' demands for
analgesic prn, or “as needed,” produces delays in administration and intervals
of inadequate pain control.
• Analgesics should be administered initially on a regular time schedule.
For example, if the patient is likely to have pain requiring opioid analgesics for
48 hours after surgery, morphine might be ordered every 4 hours around-the-
clock (not prn) for 36 hours. Opioid administration is contraindicated when
respiratory depression is present (less than 10 breaths per minute).AHLA Seminar Materials
• Once the duration of analgesic action is determined, the dosage
frequency should be adjusted to prevent pain from recurring.
• Orders may be written so that a patient may refuse an analgesic if not
in pain or forego it if asleep. However, since a steady-state blood level is
required for the drug to be continuously effective, interruption of an around-
the-clock dosage schedule (e.g., during sleep) may cause a resurgence of pain
as blood levels of the analgesic decline.
• Late in the postoperative course, it may be acceptable to give opioid
analgesics prn. Switching to prn dosing later in the postoperative course
provides pain relief while reducing the risk of adverse effects as the patient's
analgesic dose requirement diminishes.
• Clinicians should assess patients at regular intervals to determine the
efficacy of the intervention, the presence of side effects, the need for
adjustments of dosage and/or interval, or the need for supplemental doses for
breakthrough pain.
Route
• Intravenous administration is the parenteral route of choice after major
surgery. This route is suitable for bolus administration and continuous infusion
(including PCA).
• Repeated intramuscular injections can themselves cause pain and
trauma and may deter patients from requesting pain medication. Rectal and
sublingual administration are alternatives to intramuscular or subcutaneous
routes when intravenous access is problematic. All routes other than
intravenous require a lag time for absorption into the circulation.
• Oral administration is convenient and inexpensive. It is appropriate as
soon as the patient can tolerate oral intake and is the mainstay of pain
management in the ambulatory surgical population.
Nonpharmacologic Management
• Patient teaching should include procedural and sensory information,
instruction to decrease treatment and activity-related pain (e.g., pain caused by
deep breathing, coughing) and information about the use of relaxation.
• Cognitive-behavioral (e.g., relaxation, distraction, imagery) and
physical interventions (e.g., heat, cold, massage) are intended to supplement,
not replace, pharmacologic interventions.
• Cognitive/behavioral interventions include a variety of methods that
help patients understand more about their pain and take an active role in pain
assessment and management.
• Simple relaxation strategies can be effective in helping to manage pain.
Basic approaches (see Table 2 for an example) require only a few minutes to
teach and can reduce pain and anxiety. Patients benefit from periodic
reinforcement and coaching in the use of relaxation techniques.
• Commonly used physical agents include applications of heat and cold,
massage, movement, and rest or immobilization. Applications of heat and cold
alter the pain threshold, reduce muscle spasm, and decrease local swelling.
• Transcutaneous electrical nerve stimulation (TENS) may be effective
in reducing pain and improving physical function.AHLA Seminar Materials
Special Considerations for Elderly Persons
The Clinical Practice Guideline contains a more complete discussion of the
special considerations for pain management in the elderly. A summary is
provided here.
• Elderly people often suffer multiple chronic, painful illnesses and take
multiple medications. They are at greater risk for drug-drug and drug-disease
interactions.
• Pain assessment presents unique problems in the elderly, as these
patients may exhibit physiologic, psychologic, and cultural changes associated
with aging.
• Misunderstanding of the relationship between aging and pain is
common in the management of elderly patients. Many health care providers
and patients alike mistakenly consider pain to be a normal part of aging.
Elderly patients sometimes believe that pain cannot be relieved and are stoic in
reporting their pain. The frail and oldest-old (>85 years) are at particular risk
for undertreatment of pain.
• Aging need not alter pain thresholds or tolerance. The similarities of
pain experience between elderly and younger patients are far more common
than are the differences.
• Cognitive impairment, delirium, and dementia are serious barriers to
assessing pain in the elderly. Sensory problems such as visual and hearing
changes may also interfere with the use of some pain assessment scales.
However, as with other patients, the clinician should be able to obtain an
accurate self-report of pain from most patients.
• When verbal report is not possible, clinicians should observe for
behavioral cues to pain such as restlessness or agitation. The absence of pain
behaviors does not negate the presence of pain.
• NSAIDs can be used safely in elderly persons, but their use requires
vigilance for side effects, especially gastric and renal toxicity.
• Opioids are safe and effective when used appropriately in elderly
patients. Elderly people are more sensitive to analgesic effects of opiate drugs.
They experience higher peak effect and longer duration of pain relief.
Institutional Responsibility for Pain Management
The institutional process of acute pain management begins with the affirmation
that patients should have access to the best level of pain relief that may safely
be provided. (See Table 3 for a summary of the scientific evidence for
interventions to manage pain in adults.) Each institution should develop the
resources necessary to provide the best and most modern pain relief appropriate
to its patients and should designate who and/or which departments are
responsible for the required activities.
Optimal application of pain control methods depends on cooperation among
different members of the health care team throughout the patient's course of
treatment. To ensure that this process occurs effectively, formal means must be
developed and used within each institution to assess pain management
practices and to obtain patient feedback to gauge the adequacy of pain control.
The institution's quality assurance procedures should be used periodically toAHLA Seminar Materials
assure that the following pain management practices are being carried out:
• Patients are informed that effective pain relief is an important part of
their treatment, that communication of unrelieved pain is essential, and that
health professionals will respond quickly to their reports of pain. They are also
told that a total absence of pain is often not a realistic or even a desirable goal.
• Clear documentation of pain assessment and management is provided.
• There are institution-defined levels for pain intensity and relief that
elicit review of current pain therapy, documentation of the proposed
modifications in treatment, and subsequent review of their efficacy.
• Each clinical unit periodically assesses a randomly selected sample of
patients who have had surgery within 72 hours to determine their current pain
intensity, the worst pain intensity in the first 24 hours, the degree of relief
obtained from pain management interventions, satisfaction with relief, and
satisfaction with the staff's responsiveness.
Table 2. Sample Relaxation Exercise
Slow Rhythmic Breathing for Relaxation
1. Breathe in slowly and deeply.
2. As you breathe out slowly, feel yourself beginning to relax; feel the tension
leaving your body.
3. Now breathe in and out slowly and regularly, at whatever rate is comfortable
for you. You may wish to try abdominal breathing. If you do not know how to
do abdominal breathing, ask your nurse for help.
4. To help you focus on your breathing and breathe slowly and rhythmically:
Breathe out as you say silently to yourself, “out, two, three.”
Breathe out as you day silently to yourself, “out, two, three.” Each time
you breathe out, say silently to yourself a word such as peace or relax.
5. You may imagine that you are doing this in a place you have found very
calming and relaxing, such as lying in the sun at the beach.
6. Do steps I through 4 only once or repeated steps 3 and 4 for up to 20 minutes.
7. End with a slow deep breath. As you breathe out say to yourself “I feel alert
and relaxed.”
Additional points:
If you intend to do this for more than a few seconds, try to get in a comfortable
position in a quiet environment. You may close your eyes or focus on an object.
This technique has the advantage of being very adaptable in that it may be
used for only a few seconds or for up to 20 minutes.
Adapted with permission from : McCaffery M. and Beebe A. Pain: Clinical
manual for nursing practice .
St. Louis: C.V. Mosby.
Table 3. Scientific Evidence forInterventions to Manage Pain in Adults
Pharmacologic InterventionsAHLA Seminar Materials
Intervention [1] Type of Evidence Comments
NSAIDs Oral (alone) Ib, IV Effective for mild to mode
Begin preoperatively. Rela
contraindicated in patients
disease and risk of or actu
coagulopathy. May mask
Oral (adjunct to opioid) la, IV Potentiating effect resultin
sparing. Begin preop. Cau
above.
Parenteral (ketorolac) Ib, IV Effective for moderate to s
Expensive. Useful where
contraindicated, especiall
respiratory depression an
Advance to opioid.
Opioids Oral IV As effective as parenteral
doses. Use as soon as or
tolerated. Route of choice
Intramuscular Ib, IV Has been the standard pa
but injections painful and
unreliable. Hence, avoid t
possible.
Subcutaneous Ib, IV Preferable to intramuscula
volume continuous infusio
painful and absorption un
this route for long-term re
Intravenous Ib, IV Parenteral route of choice
surgery. Suitable for titrate
continuous administration
PCA), but requires monito
Significant risk of respirato
with inappropriate dosing.
PCA (systemic) Ia, IV Intravenous or subeutane
recommended. Good, ste
analgesia. Popular with pa
requires special infusion p
staff education. See cauti
opioids above.
Epidural and intrathecal Ia, IV When suitable, provides g
analgesia. Significant risk
depression, sometimes de
onset. Requires careful m
of infusion pumps require
equipment and staff educ
Local Anesthetics Epidural and intrathecal Ia, IV Limited indications. Expen
pumps employed. Effectiv
analgesia. Opioid sparing
opioid to local anesthetic
analgesia. Risks of hypote
weakness, numbness. Us
pump requires additional
staff.
Peripheral nerve block Ia, IV Limited indications and du
action. Effective regional a
Opioid sparing.
Nonpharmacologi Interventions
Intervention [1] Type of Evidence Comments
Simple Relaxation (begin Jaw relaxation Progressive muscle Ia, IIa, IIb, IV Effective in reducing mild
preoperatively) relaxation Simple imagery pain and as an adjunct to
drugs for severe pain. Use
patients express an intere
relaxation. Requires 3–5 m
time for instructions.
Music Ib, IIa, IV Both patient-preferred and
listening” music are effect
mild to moderate pain.
Complex Relaxation (begin Brofeedback Ib, IIa, IV Effective in reducing mildAHLA Seminar Materials
preoperatively) pain and operative site mu
Requires skilled personne
equipment.
Imagery Ib, IIa, IIb, IV Effective for reduction of m
moderate pain. Requires
personnel.
Education/Instruction (begin Ia, IIa, IIb, IV Effective for reduction of p
preoperatively) include sensory and proce
information and instruction
reducing activity related p
5–15 minutes of staff time
TENS Ia, IIa, III, IV Effective in reducing pain
physical function. Require
personnel and special equ
be useful as an adjunct to
Type of Evidence - Key
Ia Evidence obtained from meta-analysis of randomized controlled trials.
Ib Evidence obtained from at least one randomized controlled trial.
IIa Evidence obtained from at least well-designed controlled study without
randomization.
IIb Evidenced obtained from at least one other type of well-designed quasi-
experimental study.
III Evidence obtained from well-designed nonexperimental descriptive studies,
such as comparative studies, correlational studies, and case studies.
IV Evidence obtained from expert committee reports or opinions and/or
clinical experiences of respected authorities.
Note: References are available in the Guideline Report. Acute Pain
Management: Operative or Medical Procedures and Trauma . AHCPR Pub.
No. 92-0001. Rockville, MD: Agency for Health Care Policy and Research,
Public Health Service, U.S. Department of Health and Human Services. In
press.
Table 4. Dosing Data for NSAIDs
Drug Oral NSAIDs Usual adult dose Usual pediatric dose [1] Comments
Oral NSAIDs
Acetaminophen 650–975 mg q r hr 10–15 mg/kg q 4 hr Acetaminophen lacks the
anti-inflammatory activity
NSAIDs
Aspirin 650–975 mg q 4 hr 10–15 mg/kg q 4 hr[2] The standard against whic
NSAIDs are compared. In
aggregation; may cause p
bleeding
Choline magnesium trisalicylate 1000–1500 mg bid 25 mg/kg bid May have minimal antipla
(Trilisate) also available as oral liqui
Diflunisal (Dolobid) 1000 mg initial dose followed by 500 gm
q 12 hr
Etodolac (Lodine) 200–400 mg q 6–8 hr
Fenoprofen calcium (Nalfon) 200 mg q 4–6 hr
Ibuprofen (Motrin, others) 400 mg q 4–6 hr 10 mg/kg q 6-2-8 hr Available as several brand
as generic; also available
suspension
Ketoprofen (Orudis) 25–75 mg q 6–8 hr
Magnesium salicylate 650 mg q 4 hr Many brands and generic
available
Meclofenamate sodium (Meclomen) 50 mg q 4–6 hr
Mefenamic acid (Ponstel) 250 mg q 6 hr
Naproxen (Naprosyn) 500 mg initial dose followed by 250 mg 5 mg/kg q 12 hr Also available as oral liqu
q 6–8 hrAHLA Seminar Materials
Naproxen sodium (Anaprox) 550 mg initial dose followed by 275 mg
q 6–8 hr
Salsalate (Disalcid, others) 500 mg q 4 hr May have minimal antipla
Sodium salicylate 325–650 mg q 3–4 hr Available in generic form f
distributors
Parenteral NSAID
Ketorolac tromethamine (Toradol) 30 or 60 mg IM initial dose followed by Intramuscular dose not to
15 or 30 mg q 6 hr Oral dose following days
IM dosage: 10 mg q 6–8 hr
Note: Only the above NSAIDs have FDA approval for use as simple analgesic, but clinical experience has
been gained with other drugs as well.
Table 5. Dosing Data for Opioid Analgesics
Drug Approximate equianalgesic oral Approximate equianalgesic Recommended starting
dose parenteral dose more than 50 kg body w
Apioid Agonist
Morphine[2] 30 mg q 3–4 hr (around-the-clock 10 mg q 3–4 hr 30 mg q 3–4 hr
dosing)
60 mg q 3–4 hr (single dose or
intermittent dosing)
Codeine[3] 130 mg q 3–4 hr 75 mg q 3–4 hr 60 mg q 3–4 hr
Hydromophone[2] 7.5 mg q 3–4 hr 1.5 mg q 3–4 hr 6 mg q 3–4 hr
Hydrocodone (in Lorcet, Lortab, Vicodin, 30 mg q 3–4 hr Not available 10 mg 1 3–4 hr
others)
Levorphanol (Levo-Dromoran) 4 mg q 6–8 hr 2 mg q 6–8 hr 4 mg q 6–8 hr
Meperidine (Demerol) 300 mg q 2–3 hr 100 mg q 3 hr Not recommended
Methadone (Dolophine, others) 20 mg q 6–8 hr 10 mg q 6–8 hr 20 mg q 6–8 hr
Oxycodone (Roxicodone, also in 30 mg q 3–4 hr Not available 10 mg q 3–4 hr
Percocet, Percodan, Tylox, others)
Oxymorphone[2] (Numorphan) Not available 1 mg q 3–4 hr Not available
Opioid Agonist-Antagonist and
Partial Agonist
Buprenorphine (Buprenex) Not available 0.3–0.4 mg q 6–8 hr Not available
Butorphanol (Stadol) Not available 2 mg q 3–4 hr Not available
Nalbuphine (Nubain) Not available 10 mg q 3–4 hr Not available
Pentazocine (Talwin, others) 150 mg q 3–4 hr 60 mg q 3–4 hr 50 mg q 4–6 hr
Note: Published tables vary in the suggested doses that are equianalgesic to morphine. Clinical response is
the criterionthat must be applied for each patient; tiltration to clinical response is necessary. Because there is
not complete cross tolerance among these drugs, it is usually necessary to use a lower than equianalgesic
dose when changing drugs and to retitrate to response.
Caution: recommended doses do not apply to patients with renal or hepatic insufficiency or other conditions
affecting drug metabolism and kinetics.
Acute Pain Management in Adults: Operative Procedures-Selected
Bibliography
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Armstrong, P.J. & Bersten, A. (1986). Normeperidine toxicity. Anesthesia and
Analgesia , 65, 536–538.
Flaherty, G.G. & Fitzpatrick, J.J. (1978). Relaxation technique to increaseAHLA Seminar Materials
comfort level of postoperative patients: A preliminary study Nursing Research
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H. (1987). The morphine sparing effects of diclofenac sodium following
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International Association for the Study of Pain. (In press). Report of the task
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(1982). Narcotics in the elderly. Medical Clinics of North American , 66,
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Care. American College of Surgeons, Care of the surgical patient (vol. 1. pp.
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[letter]. New England Journal of Medicine , 302, 123.
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& Wild, L.M. (1988). Development of an anesthesiology-based postoperative
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Wood. M.M. & Cousins, M.J. (1989). Iatrogenic neurotoxicity in cancer
patients. Pain , 39, 1–3.
Clinical Practice Guidelines and the Law: Applications and Implications
Alice G. Gosfield
In the overall health care reform debate, the clinical content of health care
services is under scrutiny with unprecedented intensity. Some of the impetus
for major reform in both financing and delivery has emanated from widespread
uncertainty regarding what society's health care dollars currently buy--the
“value” of health care. To make any type of judgment regarding the “value” of
services purchased, some notion of what is necessary and appropriate to treat
medical conditions (or to prevent them) is required. Increasingly, the goal is to
define clinical content in terms founded upon a scientific basis rather than more
arbitrary administrative judgments which have historically been used for these
critical decisions. At the same time, the issue of costs are inextricably entwined
in the debate over “value.”
In a changing system which relies upon professional expertise to deliver care,
but which continuously makes judgments external to the practitioner-patient
relationship regarding what to buy (benefit packages), what to deliver
(utilization management), and what to reimburse (medical necessity
determinations), the tensions are not inconsiderable. A growing body of policy
and law is grappling with the countervailing pressures in a new way. More and
more, the law is incorporating into its controls, whether regulatory orAHLA Seminar Materials contractual, methodologies intended to rest upon scientific evidence as the foundation for all of the myriad decisions which drive the ultimate determination of value. Variously referred to as “clinical practice guidelines,” “protocols,” “practice parameters,” “care maps,” “practice policies” and “critical pathways,”[1] they are all efforts to provide some objective statement of a common, more scientific view of the essential clinical choices which must be made in providing and buying health care services. More and more often, these guidelines are premised upon a nationally applicable approach to care. As is discussed here, guidelines have enormous legal implications--and not just for malpractice liability. Concurrent with this increased emphasis on the scientific validity and appropriateness of care choices and their impact on costs, additional factors have taken on new importance in the social dialogue. With the introduction of manufacturing principles of total quality management and continuous quality improvement into health care delivery,[2] not only has the view of the customer changed, but so has the view of the product. Waste and overutilization have long been discussed in any consideration of health policy and financing. Today, with the expansion of managed care initiatives of various types in both the public and private sectors, concern for underutilization (failing to deliver appropriate or enough services) is receiving attention in addition to overutilization (which is discussed today primarily in the context of fee-for-service medicine).[3] In the techniques of evaluation of both administrative and overall program costs as a component of service value, there has also been a shift away from the traditional emphasis on case-by-case, individualized judgments of appropriateness to consideration of effectiveness of services measured across populations--outcomes.[4] No longer is the debate simply over controlled costs. Today the definition of “value” that is emerging is controlled costs, using high quality processes, with good patient outcomes, as demonstrated in data. The measure of “value” in health care is dynamic, and is being defined by many players and forces--private group purchasers of health care services and benefits, financing systems seeking to succeed strategically, the government, and even individual consumers. Although the focus of value for individuals has often been on fees and charges,[5] there is a growing concern for patient satisfaction and patient preference for individuals as well as across groups.[6] All of these factors are at issue in the controversies, hopes and expectations for the applications of guidelines as a tool to mediate a wide variety of tensions in the health care system. No longer futuristic, clinical practice guidelines are well insinuated in the here and now of policy debate. Some estimate that thirty different commissions are now involved in developing guidelines, and that at least eighty different professional societies are working on more than 1,400 sets of guidelines.[7] But to the dismay of those who are wary of their effects, policy debate is not the end of the guideline story. Newsletters proliferate solely to report on real world applications of these tools, by hospitals, payors, managed care organizations and others.[8] Many of the health reform proposals currently under consideration include some aspects of this expanding movement, and, as discussed here, the federal government is firmly in the business of stimulating this new mini-industry aimed at creating,
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