Legislative Program Review and Investigations Committee
Regulation
and Oversight of Managed Care
Chapter V -
Final Report
Regulation
and Oversight of Managed Care
Chapter
V Benefits,
Utilization Review, and Protocols
While
there is a lot of variation in the types of HMOs, there is some similarity in
the benefits offered in Connecticut and elsewhere. As discussed in the earlier briefing report, to qualify for
federal funds HMOs had to comply with the standards of the Federal Health
Maintenance Organization Act, including offering basic benefits. The same federal act lists services that HMOs are not
required to provide, and those are contained in Table V-1 on the following page.
Although
most health maintenance organizations are currently not federally qualified,
most benefit packages continue to meet those standard benefits requirements. In
fact, Connecticut statutes governing health maintenance organizations require
that, at a minimum, HMOs provide the benefits contained in the federal act, and
they must also provide most of Connecticut’s statutorily mandated benefits.
The committee reviewed all approved health plan policies on file at the
Connecticut Department of Insurance and found that most HMOs also specifically
exclude the benefits that are not required. The committee file review found
other services commonly excluded are: artificial hearts, transexual surgery;
private duty nurse; services required by a third party including insurance,
school, camp, employment, and court-ordered treatment; marriage counseling; and
expenses related to a learning disability.
Often
providers and consumers complain that certain benefits are not included in an
HMO plan. However, the committee
found that, as Table V-1 indicates, many of the benefit exclusions are
sanctioned by the Federal Health Maintenance Organization Act that authorized
HMOs, and which established the framework under which HMOs operate.
In addition to these basic benefits HMOs= health plans in Connecticut must also offer a number of state-mandated benefits. These benefits are required of all licensed health insurers in the state, although there are minor differences between benefits required of HMOs and of other health insurers. As explained above, the Insurance Department reviews all health plans to ensure the policies offered include these benefits. Appendix B contains a list of all state-mandated benefits for HMOs and other health insurers.
|
Table V-1. Standard
Benefits and Exclusions as Contained in the Federal HMO Act |
|
|
Standard
Benefits |
Standard
Exclusions |
|
- physician services;
- inpatient hospital
services; - outpatient services
(including diagnostic, treatment and X-ray); - short-term
rehabilitation and physical therapy (2-month limit, as long as there is
improvement); - substance abuse
treatment; - medically necessary
emergency services in & out of the service area; - 20 outpatient
mental health visits as may be necessary and appropriate for short-term
evaluation and crisis intervention; - laboratory and
radiologic services in support of basic health services; - home health
services; and -
preventive health services including -- family planning, infertility
services, eye and ear care for children, periodic health exams for
adults, immunizations, and well-child care.
|
- corrective appliances and artificial aids; - mental health
services, except as covered under basic benefits; - cosmetic surgery,
unless medically necessary; - prescribed drugs
and medicines, except as inpatient; - military service
disabilities for which care is reasonably available; - ambulance services,
unless medically necessary; - custodial care; -care for conditions
that law requires treatment in a public facility; - regular vision and
hearing exams; - experimental
medical, surgical, or other health care procedures; - personal and
comfort items including private rooms; - whole blood and
blood plasma; - long-term physical
therapy and rehabilitation; - durable medical
equipment such as wheel
chairs, respirators, etc. for home use
|
|
Source
of data: Federal Health Maintenance Organization Act, as Revised October
1993. |
|
Once
a health plan=s
benefits have been approved, the plan may be marketed and sold.
In contrast with health plans offered by regular health insurers, health
plans offered by HMOs must provide each enrollee with evidence of coverage. This proof of coverage must not contain statements that are Aunfair,
inequitable, misleading, deceptive or which encourage misrepresentation.@ (C.G.S.
'
38a-182) The proof of coverage must include several provisions in order to
comply with statutory requirements. Those
provisions must include:
C the name and address of the health care center (health maintenance organization);
C
eligibility requirements;
C
subscriber responsibility for
co-payments, deductibles, and other out-of pocket expenses;
C
list of services or benefits
covered and period covered, and a detailed statement of services or benefits to
be excepted, provided that at a minimum they conform to the federal HMO
requirements;
C
terms and conditions for canceling
or terminating the agreement;
C
claims procedures;
C
procedure for filing a grievance;
C
continuation and extension of
benefits, and conversion of policy;
C
description of service area, and
out-of-area benefits and services;
C
statement of amounts payable in
fees and premiums by the subscriber and others on his/her behalf, and a
statement of the payment grace period;
C statement describing any endorsements or attachments included in the agreement; and
C
a statement that nothing attested
to by the subscriber in the application can void the application or be used in
any legal proceedings, unless there is a declaration of that as part of the
application.
Utilization
Review
Demand
for health care grew out of control in the 1980s and early 1990s, and was
spurred by two factors. First,
patients want health services -- treatment and new technology -- that might help
whatever illness or condition afflicts them. Coupled with consumer demand is
physician motivation to do everything possible for the patient, either to more
accurately diagnose the patient, or to treat a condition after a diagnosis is
made. Physicians repeatedly
confirmed this notion at focus groups and public hearings, stating they view
their role as advocates for their patients.
When consumers of health services and their physician advocates worked in
tandem, they created a demand that was in exhaustive and resulted in annual
double digit per-capita health care cost increases in Connecticut.
Employers,
as the primary health insurance payors, demanded their insurance companies and
health plans do more than just collect premiums and pay claims. Businesses
demanded that health care services be better managed, and utilization of those
services overseen. Managed care organizations and insurers responded by
establishing a utilization review function.
Utilization review staff employed by, or under contract with, insurers,
health plans, or employers determine which services will be covered and in what
setting. As a result, while benefits may be covered in a health plan, the
enrollee is not necessarily entitled to receive them in all circumstances.
Most hospitalizations and outpatient procedures need prior authorization from the HMO or its utilization review company. Utilization review also occurs for prescriptions. Companies known as pharmaceutical benefit managers monitor the kinds and amounts of drugs physicians prescribe. Sometimes mental health benefits are also handled by a separate utilization review company that specializes in behavioral health.
Generally,
the physician or the patient can call the utilization review company via an 800
number to determine if the procedure will be covered
also Once the health plan is operational, health maintenance
organizations, as well as most regular health insurers, oversee how those
benefits are used by subscribers. In other words, while benefits may be offered
in the plan this does not mean that every enrollee is entitled to receive them
in all circumstances. The
procedures in place to determine which services will be covered and in what
setting -- called utilization review -- is a crucial facet of managed care.
Licensure
requirements.
Since October 1, 1992, (via P.A. 91-305) Connecticut has regulated the
companies that conduct utilization review functions.
The statute requires the licensure of organizations Ainvolved
in the prospective or concurrent assessment of the necessity and appropriateness
of the allocation of health care resources and services given or proposed for an
individual.@ (C.G.S. Sec.38-226 to
38a-226(d)). Some of the regulatory
components for utilization review have already been listed in the table
comparing regulatory requirements contained in Chapter III, but a more thorough
explanation of them is contained below.
A
number of health maintenance organizations conduct their utilization review
activities in-house, while others contract out for these services.
In either case, the utilization review company or operation must be
licensed. The Insurance Department
annually licenses utilization review companies.
Prior to initial licensure each utilization review company must submit documentation that demonstrates:
C
it meets certain statutory criteria
concerning notification, appeal, and clinical review procedures;
C
health professionals making the
utilization review decisions have current licenses or certifications from a
state licensing agency in the U.S.;
C
staff
are available via toll-free telephone during normal business hours;
C
no staff person receives
compensation based on the number of denials made;
C
practitioners in related
specialties are reasonably available to review appeal cases not decided in
patient’s favor;
C
it will abide by all applicable
state and federal laws regarding confidentiality of records; and
C
it allows a minimum of 24 hours for
notification by enrollee after emergency care.
The law requires that hospitals
allow utilization review company personnel on hospital premises to conduct their
reviews, unless the hospital and the company have a signed contract to the
contrary. The law also requires
utilization review company personnel in hospitals to carry picture
identification that clearly indicates their employer.
Once the companies have submitted
the documentation prior to being licensed, they need file only any material
changes with the Insurance Department within 30 days of the change.
Annually, the companies are required to submit the name, address, and
phone number of the contact person and the company, as well as its business
hours, and submit a $2,500 annual licensing fee.
Licenses issued and fees collected. Table V-2 shows the number of utilization review licenses issued and the aggregate licensing fees collected each fiscal year, since licensing began in October 1992.
|
Table V-2.
Number of Licenses
Issued and Fees Collected by Year -- FY 93 - FY 96 |
||
|
Year |
Number of
Companies |
Licensing Fees
Collected |
|
FY 93 |
78 |
$195,000 |
|
FY 94 |
101 |
$252,500 |
|
FY 95 |
119 |
$297,500 |
|
FY 96 |
129 |
$322,500 |
|
Total |
129 |
$1,067,500 |
|
Source
of data : Connecticut Insurance Dept. |
||
Filing requirements. The program review committee found several deficiencies with utilization
review regulation and the way in which the laws are implemented. Until
August 1996, the insurance department had been collecting the $2,500 annual fee
but had been doing little oversight of utilization review companies after the
initial licensure. The annual
licensing fees, which were to be used for oversight of these companies only, had
accumulated to slightly more than $1 million in the four years since licensure
began. In August 1996, the
insurance commissioner appointed two people to oversee utilization review
activities and one person to general managed care issues.
Because of the lack of staff
dedicated to this oversight function, the committee found that utilization
review companies have not fully complied with some statutory requirements, and
the insurance department has not fully exercised its statutory authority in
other areas.
First, the insurance department
needs to ensure that all businesses operating like utilization review
organizations are licensed. The
identification responsibility becomes more difficult as more HMOs are Acarving
out@
parts of their health care business. This means the HMO separates specific
health services from the majority of the plan=s business for purpose of compensation and utilization review. The HMO
then subcontracts with other companies to oversee those specific health
components.
Almost all of the nine HMOs that responded to the committee=s request to provide information on Acarve-outs@ indicated that at least one part of the plan was separated, typically behavioral health or pharmacy. As carve-outs become more popular, the insurance department staff must oversee whether these companies are licensed for the functions they are performing. For example, if these carve-out companies are only paying claims then licensure as a utilization review company is not necessary. However, if their responsibility extends to authorizing services, then those companies must be either licensed or accredited.
Second, the Department of Insurance
needs to expand its initial filing requirements to require utilization review
licensees to indicate which health plans they are serving.
Further, utilization review companies need to provide more current
information to the insurance department about organizational changes, staffing
updates, and standards used for medical reviews.
Currently, the statute requires
that any material changes be filed with the department within 30 days of the
change. Only name, address, and phone number along with business hours must be
updated annually. However, a
file review of 12 of the 129 utilization review companies, the program review
committee found none of the files had updated information on company staffing,
changes in protocols used, and the like since initial licensure of the company.
Companies need to comply with the material change notification, and the
department needs to do a better job of verifying that no material changes have
in fact occurred. The Department of Insurance recognizes the need for better
information and has recently surveyed all licensed utilization review companies
to assess their operations.
Utilization review data. In
addition to organizational information, there is also a need for the utilization
review companies to file actual utilization review statistics with the
Department of Insurance. Currently,
the statute gives the insurance department authority to require data relating to
requests for services, denials, and appeals, but until the recent survey, DOI
had not utilized that authority. Thus,
there currently is no one location where these utilization review statistics are
kept in Connecticut.
Therefore, the Legislative Program Review and
Investigations Committee recommends that annually each utilization review
company must file with the insurance department:
C
any organizational or staffing
changes that have occurred within the company since the date of the last filing;
C
the names of all businesses,
HMOs, or other entities that the utilization review company services in
Connecticut;
C any health care services which the utilization review company or HMO has contracted out for servicing, and the name of the company servicing that part of the plan;
C
any changes or revisions in
protocols being used; and
C
utilization review data
including requests, approvals, denials, and appeals and their outcomes.
Utilization
Review Staffing
Physicians
complained in focus groups that they and their office staff must deal with
clerks when they are seeking an approval for a medical procedure or treatment.
However, all of the 12 companies whose files the committee reviewed
indicated they had professionals on staff.
Further,
while the statute does not currently require that health professionals make all
utilization review decisions, it does require that Anurses,
practitioners, and other licensed health professionals making utilization review
decisions shall have current licenses from a state licensing agency or
appropriate certification from a recognized accreditation agency in the United
States.@
Data
obtained from the insurance department=s
recently conducted survey of utilization review companies, and displayed in
Table V-3, indicate that most decision-making responsibility lies with health
professionals and not clerks. While
clerical staff are part of the utilization review operation, just as they are
for almost any business, their decision-making ability is already limited via
their own organizations. As the
table shows, only four of the 23 clerks have approval authority and none can
deny or negotiate the use of a treatment or procedure. In the other 19
companies, while clerks are the first contact they only gather the information;
the decisions are made by health professionals.
The
program review committee believes that requiring all utilization review
decisions to be made by health professionals would be imposing a staffing
standard unnecessary for a great percentage of the decisions that must be made
in a review operation. Further, University of Connecticut consulting staff who
issued the report on which the 1991 utilization review legislation law was based
told the committee that it was not the intent of the legislation to restrict all
review decisions to only health professionals.
|
Table
V-3. Utilization Review (UR) Staff and Decision-Making N=103 |
|
|
Contact with UR
Company |
Decision Making
Responsibility Given to Staff
|
|
Number
of Companies Where Clerk is First Contact
= 23 (N=23 Companies) |
Number
of Companies Where Those Clerks Have Authority To: Approve=4 Deny=0 Negotiate=0 (N=23 Companies) |
|
Number
of Companies Where Nurse is First Contact =56 (N=56 Companies) |
Number
of Companies Where Nurses Have Authority To: Approve=56 Deny=19 Negotiate=46 (N=56 Companies) |
|
Number
of Companies Where Other Staff are First Contact = 24 (e.g. case
manager) (N=24 Companies) |
N/A |
|
Source
of data: Insurance Department Survey of Utilization Review Companies |
|
However, to eliminate statutory
confusion and give greater assurances to the practicing medical community
regarding who performs utilization review functions at what level, the
program review committee recommends that any utilization review decision to
initially deny services be made by a health professional.
This would allow staff who are not health professionals to approve
routine certification requests. These
approvals can be done over the phone with a minimum exchange of information. If
the request cannot be approved based on the information given, or if it appears
the request should be denied, then that request should be handled by a health
professional. Further, according to
the data in the table, authorization for denials (and most approvals) is only
given to medically trained personnel. Therefore,
this recommendation would not require utilization review companies or HMO
internal review operations to incur additional administrative expenses for
hiring additional or replacement staff.
Whatever
the level of staff making the utilization review decisions, it is crucial that
they are all well-trained -- able to gather data on requests, have a basic
understanding of the medical standards being used to make decisions, and relay
the decision to the requesting party. Even
if the staff are health professionals, utilization review is different than
actively delivering health care, and utilization review staff persons need
instruction and preparation. The
program review committee recommends that utilization review companies shall
submit information on their staff training as part of the annual filing report
to the insurance department. The
committee does not recommend any set number of hours of training for utilization
review staff.
Utilization
review decisions. By
statute, utilization review companies must notify the patient or provider within
two days of receiving all information upon which a decision can be made.
However, in the committee=s
review of complaint files, it is apparent that often cases involve complicating
factors, further information is required, and decisions take longer and not as
well-communicated as they might be. In
some cases, health plans were making preauthorization approvals Apending@
a more complete review of all the pertinent medical records, and then denying
just prior to the scheduled treatment or procedure. In other cases, companies
denied the claim after the enrollee had the procedure or treatment.
The patient in these cases believed the procedure had been approved, when
the utilization review company indicated that it had not.
The
committee believes that most of these cases could have been averted with a
clearer exchange of information. Recognizing that communication is crucial to
effectively execute managed care, the Legislative Program Review and
Investigations Committee recommends the following:
(1) Utilization review companies
shall make and communicate a utilization review decision, only if all the
required documentation to make that decision has been received.
Approvals Apending@ receipt of all the information shall be prohibited.
(2) If additional medical
documentation is necessary before a decision can be made, the utilization review
company shall clearly indicate to the physician or patient what information is
still needed. (The statute already requires that the provider of record is
responsible for providing all relevant information necessary to make a decision,
and failure to submit the documentation may be grounds for denial of the
service.)
(3) Utilization review companies
shall communicate the decision to patients within 48 hours of having received
all the medical documentation, as currently required by statute.
Patients must be given written confirmation of an approval and a
confirmation number until a written authorization is received.
If
these procedures are followed, it should significantly lessen any ambiguity
about whether a procedure has been approved or not.
It would give the consumer or the physician a verification confirmation
number or written authorization that would serve as a guarantee that the
treatment was approved. Eliminating
Apending@
decisions should also reduce confusion about whether an approval was actually
granted. Consumers or providers who
believe these processes are not being followed may report potential violators to
the insurance department for further action.
Appeals
Decisions and Medical Necessity
When
consumers are denied a health care service, they often will not agree with the
decision. When the decision deals
with whether a particular benefit is covered or excluded, a review of the
subscriber contract usually provides a clear answer.
That document spells out in great detail which benefits are provided and
which are not. When the decision is
based on whether the service is medically necessary or not, the result is not
always clear cut. Each subscriber
enrollment agreement contains a plan=s
definition of Amedical
necessity@.
A typical definition states:
health
services that are required for illness or injury.
Physician determines the medical care, but coverage is subject to medical
necessity as determined by XHMO. Health
services that are not medically necessary shall not be covered health services
under the agreement.
Of
course, disagreement over medical necessity can arise between the health plan
and the treating physician. The
committee believes the method by which those conflicts are resolved is currently
deficient, because the statutes are unclear, and because they do not provide the
consumer with sufficient procedural redress if disagreement occurs.
State
statutes governing utilization review currently include a requirement that
companies establish a written appeals process, including those appeals involving
medical necessity. The company must inform the patient or provider of their
right to appeal when any medical service is denied.
Appeal decisions must be made as soon as practical, but no later than 30
days after the appeal is received. Statutorily,
on appeal all determinations not to certify an admission, service, procedure or
extension of stay shall be made by a licensed medical practitioner, which is
usually the medical director of the HMO or utilization review company.
The
statutes also state that Ain
cases where an appeal to reverse a determination not to certify is unsuccessful,
each utilization review company should assure that a practitioner in a specialty
related to the condition is reasonably available to review the case@ (C.G.S.
Sec. 38a-226c (7)). The
program review committee finds this statutory section is unclear in terms of
what type of medical review it grants to patients or providers where a denial is
upheld by the utilization review company on appeal.
To
ensure that consumers have a guaranteed opportunity for review outside of the
health plan on issues of medical necessity, the program review
committee recommends that Section 38a-226c of C.G.S. modified to specify that:
In certain appeals that have been denied, the utilization review company shall have the case reviewed by an actively practicing Connecticut specialist in the field related to the medical condition that is the subject of the appeal.
This specialist review shall be granted in cases where an appeal to reverse a determination not to certify has been unsuccessful, and the reason for the denial is based on medical necessity, including whether a treatment is experimental or investigational.
The utilization review company shall be financially responsible for the review, and shall obtain the review within 30 days of the denied appeal. The actively practicing physician=s decision shall be final. Documentation of the review, the name of the physician who performed it, and the decision will be kept at the utilization review company, so that insurance department staff may verify the process was followed.
The
committee believes this recommendation recognizes there is no one definition of
Amedical
necessity@,
nor can one be legislated. The
determination of medical necessity will vary depending on the case and the
patient and will change as medical advances are achieved. Thus, a practicing
physician in Connecticut should make that decision based on the specific
circumstances and his/her medical judgment.
Committee members believe this recommendation is the best option for
reviewing denials involving medical necessity.
The
recommendation ensures a final review of a denial based on medical necessity is
done by a physician who is not the medical director of the HMO or utilization
review company. Medical directors must ensure that medical decisions are
applied uniformly among all enrollees, but some critics charge they deny health
care to increase company profits. The
recommendation also removes the final decision of conflicting medical opinion
from the treating physician, whose objectivity is also in question since he or
she is advocating on behalf of the patient.
This
recommendation places the decision to resolve conflicting medical opinions in
the hands of a qualified third party. Consulting fees for the medical review of
the denied appeal will be paid by the utilization review company or the HMO.
The program review committee concludes that a certain level of trust must
be placed in the physician community in Connecticut to serve as objective
medical consultants, regardless of payment source.
The
recommendation does not call for review responsibility by a governmental agency
or an agency on contract to conduct medical necessity reviews for a number of
reasons. The program review committee considered assigning
responsibility to the Connecticut Peer Review Organization (CPRO), which handles
all utilization review functions for Medicare in Connecticut. However, CPRO told
the committee that it also contracts out to one or more specialists when an
issue of medical necessity arises. Further, the committee considers the
responsibility of handling utilization review for a government-sponsored and
largely tax-supported system with a set benefits package, significantly
different from reviewing decisions on dozens of different employer-paid plans,
and thus does not consider CPRO an appropriate option.
Likewise,
the program review committee believes a state governmental agency would be
ill-suited to staffing such a function with specialty physicians, while
selecting and contracting with such physicians on each case would be too
time-consuming and costly. Further, health care is not a state-mandated program,
like unemployment compensation or workers=
compensation, where the state has an adjudicatory function to ensure eligible
persons are receiving their government-entitled benefits.
Health care is still a benefit purchased largely by employers in the
marketplace. State government should ensure that health plans have consumer
protection features, and that those processes and procedures are followed. It
should not create an alternative medical appeals mechanism.
Finally,
the recommendation clearly limits the outside specialist review to questions of
medical necessity, including whether treatments are investigational or
experimental. It would involve questions of medical interpretation only,
and not legal questions of denials that are limited because of benefits clearly
excluded by contract.
Market
Conduct of Utilization Review Companies
In
addition to reporting requirements to the insurance department, utilization
review companies must be responsible for their conduct in the market place
including being accessible to consumers and providers, as well as meeting the
statutory process for making health services utilization decisions in the
statutorily prescribed time-frame.
Access
to utilization review companies. Control
of utilization of medical services is a key platform upon which managed care is
based. But managing those health
resources must be done through an appropriate process -- by receiving requests,
reviewing the request using written standards, and communicating those decisions
in a timely fashion. To do that,
utilization review companies must be accessible.
One
of the statutory requirements of utilization review companies is to have a toll
free A800"
number available at least 40 hours per week.
Physicians and other providers have complained that utilization review
operations are not accessible, that providers get taped messages, that reviewers
do not return calls or written requests, and that review companies do not make
decisions in a timely fashion.
To
ensure that utilization companies are accessible and responsive to consumers and
providers, the program review committee recommends the Division of Consumer
Affairs within the Department of Insurance be notified if utilization companies
are continually inaccessible, if they lose materials or documents sent to them,
or if they fail to make or communicate decisions in a timely fashion. These
complaints should be coded and tracked, and reviewed by department staff
assigned to utilization review functions. Companies
whose market practices in this area appear to indicate a problem should be
targeted for further attention, either by the Market Conduct Division or
utilization review staff, and if violations of the statute are occurring,
companies could be penalized, after a hearing, as already outlined in C.G.S.
38a-226b (1) through (4).
Section 38a-15 of the statutes allows that the expense of any market conduct examination be paid for by the company being examined. Therefore, the committee does not anticipate that financial or staffing resources at the Department of Insurance should be an obstacle in carrying out these market conduct responsibilities.
Protocols
The
standards used by the utilization review companies or health maintenance
organizations to approve or deny a procedure are known by a number of different
terms – e.g., protocols, clinical criteria, practice standards, or practice
guidelines. These standards have
been and continue to be developed by a wide variety of organizations inside and
outside of government. A recent GAO
study on the development and use of these practice guidelines stated that about
75 organizations have developed 2,000 guidelines over the years.
Federal agencies like the National Institutes of Health and Centers for
Disease Control have a strong involvement in this area as do physician
associations like the American Medical Association and American Academy of
Pediatrics. Other guidelines have
been developed by private for-profit companies such as Milliman and
Robertson(M&R) an insurance actuarial firm based in Seattle, and Interqual,
a medical review specialty company based in Marlborough, Massachusetts.
While
there are no requirements for what protocols should include, how they are used,
or availability to providers, Connecticut statutes do require that each
utilization review company list the protocols used with the insurance department
prior to being licensed. The law also requires that the protocols be written,
periodically evaluated, and updated with appropriate involvement from
practitioners. According to
insurance department records, and the HMO responses to the committee requests
for protocol information, Connecticut HMOs are using a variety of protocols.
Ten different nationally developed criteria are used -- the most common
are Interqual and Milliman and Robertson -- and a number also use internally
developed standards.
Managed
care organizations may adapt prepared standards to meet their needs.
The GAO study10
stated that most of the 19 health plans in their review did not use the
guidelines off the shelf, but modified them for a number of reasons.
For example, physicians are more likely to accept the guidelines if they
have been adapted to local practices. Other
justifications for changing practice guidelines are to: better fit the health
care delivery system of a certain area; promote a more cost-effective approach
to treating an illness: or to simplify complex procedures that might include
complicated formulas or algorithms. Most
HMOs indicated in their response that protocols are used as guidelines only and
that treating physicians set the length of stay, or that a concurrent review of
patients in hospital takes place daily, and that is what determines length of
stay, not the standard.
Protocols
also exist for prescription drugs. Managed
care organizations develop drug formularies -- a list of
prescription drugs approved for use by that health plan -- that are
dispensed to patients by participating pharmacies.
These formularies may be developed either because the listed drugs have
proven benefits over other similar drugs, or because the health plan has a
contract with a pharmaceutical company or companies to purchase the drugs on the
formulary at a discounted price.
Use
of protocols. Physicians
have claimed that they are not informed about what the protocols are, that they
are Acookbook
medicine@
prescribing how they should practice medicine, and that some of the recovery
standards are unrealistic. Many
cite Milliman and Robertson standards as an example.
In
addition to the controversy over the protocols themselves, there is disagreement
about how they are implemented. Physicians
at focus groups indicated that they had to make repeated calls and sometimes Afight@ with
an HMO or utilization review company to obtain approval for a procedure that
might not be indicated in the protocols. However, in phone interviews committee
staff conducted with staff of Milliman and Robertson (M&R) and Interqual,
both insisted that the protocols are guidelines, and not hard and fast rules.
Milliman
and Robertson sent written clarification of their protocols termed Aoptimal
recovery guidelines@,
stating that the Aguidelines
define what clinical progress the patient will have if they do as well as one
expects without complications, and what clinical care should be provided to help
that patient achieve that level of recovery. Therefore each diagnosis has an
assigned goal length-of-stay for each admission.@
&R states that in its experience approximately 80 percent of patients
under the age of 65, and 40 to 50 percent of Medicare (over age 65) patients
should be able to meet the standard. However,
M&R further cautions that in order to achieve optimal recovery and meet
their length-of-stay goals, the necessary healthcare delivery system
infrastructure must be in place.
To
better assess how the protocols are being used, program review staff selected
seven procedures11
and requested Connecticut HMOs provide the standards each used during 1995 for
pre-certifying a length of stay for that procedure. They were also asked to
provide what their actual utilization statistics were on the range of stays and
the average and median length of stay for each of the procedures for the same
year.
There
are several shortcomings with the data that need to be noted. First, not all
HMOs responded even though staff did make repeated attempts.
Second, not all HMOs that responded provided all information. For example
not all supplied median length of stay, thus staff chose to use average length
of stay (LOS) in its analysis to capture as many elements as possible. Third,
because HMOs capture their utilization data using different codes, it is likely
that some utilization statistics of the procedures were missed because of coding
variations. Fourth, because of this coding problem or due to actual low
utilization of some procedures, the average LOS may be based on very low numbers
(5 or 6 cases). However, noting
their limitations, the data do give some indication of what is happening with
medical standards and actual utilization in Connecticut, and are presented in
Table V-4. For three of the seven
selected procedures committee staff developed two timelines.
The top one in each case provides the HMO=s
estimated or standard length of stay, while the second one provides the timeline
showing what the average length of stay was using the HMO=s
actual utilization data.
|
Table V-4.
A Comparison of Standards Used and Actual Utilization Data for
Length of Stay for Three Selected Procedures
Mastectomy Standard Length of
Stay: Days 0_______.5_______1_______1.5_______2_______2.5_______3_______3.5_______
4_______4.5_______5
Cigna
Connecticare
Aetna*
MD*
NYLCare**
Blue Cross*
MD*
Aetna* Actual Average Length
of Stay: Days 0_______.5_______1_______1.5_______2_______2.5_______3_______3.5_______4_______4.5_______5
Kaiser*
PHS* Blue Cross*
PHS*Oxford Aetna*
Blue Cross
Connecticare**
Kaiser
MD*
MD*
Aetna*
Cigna**
Removal of Ruptured Disk Standard Length of
Stay: Days 0_______.5_______1_______1.5_______2_______2.5_______3_______3.5_______4_______4.5_______5
MD
Cigna
Connecticare
Aetna
NYLCare
<Blue Cross
Actual Average Length
of Stay: Days 0_______.5_______1_______1.5_______2_______2.5_______3_______3.5_______4_______4.5_______5
Aetna
Cigna
Blue Cross
Oxford
Connecticare
Kaiser
PHS
MD
Abdominal Hysterectomy Standard Length of
Stay: Days 0______.5______1______1.5______2______2.5______3______3.5______4______4.5______
5_______5.5_______6
NYLCare
MD
Connecticare
Blue Cross
Cigna
Aetna Actual Average Length
of Stay:Days 0______.5______1______1.5______2______2.5______3______3.5______4______4.5______5_______5.5_______6
MD
Cigna Connecticare
Oxford PHS
Aetna
Kaiser Blue
Cross
** NYLCare is listed
only under standard LOS because it was only licensed in 1996 and has no
utilization data * LOS Standard
depends on Code: Mastectomy, Mastectomy with Reconstruction, or Radical
Mastectomy. (** Also, Cigna reported 3 of 31 mastectomies done on
outpatient basis, while Connecticare reported 2 of 35 mastectomies were
done on outpatient basis in 1995 < Blue Cross is
decreasing its standard for this procedure in late 1996 Source: LPR&IC
Staff Analysis of HMO Responses on Protocols and Utilization |
Based
on the data reported in Table V-4 above, the program review committee found
that:
C
use of pre-established standards
not universal among HMOs -- Physicians
Health Services, Kaiser, and Oxford all indicated that they had no
pre-established standards for these procedures;
C
variation between standard and
practice -- almost without exception,
the HMO=s
average length of stay varies from the standard or protocol;
C
actual stays typically longer
than standards -- for all three
procedures, most HMOs had average actual length of stays longer than their
standards;
C
standards can lag behind
practices -- Connecticare had longer
pre-established stays than the actual average length of stay for all three
procedures. Staff inquired about
this and was told that Connecticare had been using Interqual standards in 1995,
which were lagging behind actual medical practices. Connecticare has since switched to Milliman and Robertson
standards;
C
standards used as guidelines --
the differences between the standard and the actual average length of stay
indicate that the protocols are being used as guidelines; and
C
outpatient mastectomies are not
common but were performed prior to adoption of a new, controversial protocol
-- based on the data filed and the
codes used, HMOs indicated that only five mastectomies were performed on an
outpatient basis during 1995. These
outpatient mastectomies would have preceded the adoption of new M&R
protocols in July 1996, indicating these were physician/patient decisions.
One
of the results of managed care and its use of protocols and utilization review
methods has been the continuing drop in hospital stays.
As cited in Chapter I, the average length of hospital stay in Connecticut
has declined from from 6.3 days in 1993 to 5.5 days in 1995 -- a drop of almost
15 percent in two years. Data
analysis performed by the Connecticut Hospital Association, at the committee’s
request, on readmission rates for the same selected procedures confirms that
length of stay for the procedures has indeed decreased from October 1992 through
March 1996, and the data show no clear evidence that readmission rates following
discharge have risen. The CHA
report indicates that the actual numbers of patients readmitted are small, and
that no clear trends on readmission rates can be identified.
12
The
program review committee believes that requiring a minimum length of stay for
any procedure could obstruct progress at further reducing length of stay under
sound medical practices, and is an unnecessary intrusion into the area of
medicine. Establishing standards in
law does not allow for the medical technology that makes a certain surgery
outdated, or a recovery period unneccessary.
Further,
the committee concludes that protocols are being used largely as guidelines, and
therefore makes no recommendation that certain protocols be used nor that others
should be banned. Finally,
Connecticut has recently witnessed what can occur when protocols don=t
match with the public expectations.13
The program review committee believes that when the media, the medical
community, and the public react negatively to an HMO practice (even a
guideline), the HMO will change it. Good
public relations matter to HMOs, as with any enterprise, but the committee
believes it is better that the public and the marketplace demand it and not have
the legislature set it.
While
the program review committee does not recommend legislative adoption of any
standard, nor prohibiting a particular protocol, that does nor mean that the way
protocols are developed and implemented does not need corrective action.
The recommendations adopted by the committee for improving these
processes are contained below.
Local
input to protocols.
The purpose of protocols is to bring more uniformity to the practice of
medicine, as well as to control costs.
However, two important factors concerning protocols were repeatedly noted
during the course of this study. First,
input from local practicing physicians is necessary if protocols are to be
accepted as workable. Second,
there must be a recognition that delivery systems vary in different areas of the
country. Even the protocol
developers recognize that optimal recovery goals assume a certain delivery
structure. Local practicing
physicians have an appreciation for the state or region=s
health care delivery system, and can recognize where aspects may differ from the
delivery system where the protocols are developed.
For example, California may have greater access to sub-acute care than
Connecticut and that must be acknowledged in implementing protocols.
Local
input does not mean that physicians should serve as obstacles to medical
progress or impede legitimate reduction in hospital stays and changes in
treatment settings. It does mean that health plans ought to consider reasonable
local concerns and delivery constraints raised by physicians before implementing
standards developed in other areas of the country.
Currently,
the Connecticut statutes require that plans Autilize
written clinical criteria and review procedures that are established and
periodically evaluated and updated with appropriate involvement from
practitioners@.
However, as currently written, the laws allow those practitioners to be located
in another area of the country. And,
while it may be assumed the statute means actively practicing physicians, it
does not clearly say that. The
program review committee believes this requirement does not ensure adequate
input from actively practicing physicians in the immediate geographic area.
A
recent GAO study on practice guidelines states that when published guidelines
differ from a plan=s
clinical and financial objectives, they are typically customized with the active
with the active participation of network physicians, and local adaptation may be
necessary when the standards are too complex or inconsistent with local
practice. Further, courts have held
medical plans whose standards significantly differ from the community are acting
in bad faith and can increase the likelihood of liability for bad medical
outcomes. Finally, if a protocol was so contrary to local practice that
physicians were continuously being granted exceptions, it would appear to be
more administratively efficient and cost-effective to change the standard.
For
all these reasons, the Legislative Program Review and Investigations Committee
recommends that the statute be modified to require that, prior to implementing
new or revised medical protocols or utilization review procedures, health plans
shall obtain input from physicians actively practicing in Connecticut.
Such input should be obtained from a number of providers in a variety of
medical specialty areas, and should be documented so that it can be verified by
the insurance department. Input
from the medical community objecting to new or revised standards could not
prevent a health plan from implementing such protocols, but the health plan
would have to document why practitioner objections were not warranted, or how
the original standards were changed to accommodate objections.
Health
maintenance organizations assured staff during this review that local physician
input was always sought, a position not substantiated by physician groups.
This recommendation would assure physicians that their input is important
to the protocol implementation process, but would not allow physicians the power
to approve or deny the protocols before their implementation.
Instead,
the recommendation would allow the Insurance Department to use the documented
input as it deemed appropriate. If a health plan implemented protocols despite
continued physician protests, the Department of Insurance may want to report
that as part of a consumer education tool.
On the other hand, if a health plan did not use revised or updated
protocols, the insurance department could note that in the report card.
Access
to protocols. Even
after protocols are developed and being implemented, opinions differ on how
informed physicians and other practitioners are about protocols.
Physicians claim they are kept in the dark about protocols because HMOs
fear doctors will be able to have more treatments approved if they know what the
standards are. HMOs claim they
welcome physician input to the development and revision of standards and that
the plans make very effort to inform and educate physicians about standards and
revisions.
Regardless
of their involvement in the development prior to implementation, physicians must
be informed of the guidelines and criteria under which they are expected to
practice. Committee members
recognize the standards can be voluminous, or computerized, and that health
plans cannot be responsible for making copies of every guideline available to
every practicing network physician. On
the other hand, if a physician wishes to examine the standards or guidelines,
committee staff believes the health plan has a responsibility to accommodate the
provider. Further, the committee
concludes that when a denial of service runs contrary to an established
protocol, the physician must be furnished with a copy of the protocol.
Therefore,
the Legislative Program Review and Investigations Committee recommends that upon
the request of a network provider, each plan make its protocols -- those
standards upon which decisions to approve or deny a service -- available for
that provider=s
examination at a location and time determined by the health plan.
Further, when a health plan denies a treatment because the treatment,
procedure, or service is in conflict with a protocol, the physician shall be
furnished a copy of the protocol, with any supporting criteria, and an
explanation of why the request did not meet the protocol.
Disclosure
of protocols under which physicians are expected to practice is only reasonable.
These standards are developed to help change practice patterns, eliminate
bad practices, and promote uniformity. If
doctors are expected to conform to these guidelines, they at least have to know
what they are. HMOs have to trust physicians in their network to use the
criteria to practice good medicine in an informed way, not to Agame@ the
system to have more treatments approved. Further, the utilization review laws in
Connecticut currently establish prohibitions and penalties against providers or
enrollees who furnish misleading or fraudulent utilization review information.
If a health plan or utilization review company finds that it is not being
given truthful information, it should inform the commissioner of insurance so
that the department can determine whether a violation has occurred and assess a
civil penalty against the violator.
10 Practice Guidelines: Managed Care Plans Customize Guidelines to Meet Local Interests, General Accounting Office, May 1996.
11 The procedures selected were vaginal delivery, caesarean section delivery, singular total hip replacement, lumpectomy, mastectomy, removal of a ruptured disk, double bypass heart surgery, and abdominal hysterectomy.
12 Readmissions Study prepared for the Legislative Program Review and Investigations Committee by the Connecticut Health Information Management Exchange (of the Connecticut Hospital Association) January 1997, and the Mastectomy Procedure Readmission Data Report prepared by the same organization, December 1996.
13 The protocol concerning outpatient mastectomy received much negative publicity in the media, and prompted on HMO to reconsider the use of the protocol
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