Payment for bone marrow transplant (BMT) therapy for breast cancer
from a managed care perspective will be influenced by clinical
arguments put forth by research and clinical communities, outcomes
measures over time, and the subscription agreement itself, C.
Michael Blackwood said at a symposium sponsored by the Western
As complete freedom of choice in health care is giving way to
some mechanisms of control, managed care is taking on a new role,
he said. Now, health-care providers must make recommendations
to the insurance carrier, who applies internal clinical review
processes before making payment recommendations to the health-care
plan. "The dicey area, of course, is dealing with experimental
therapies," said Mr. Blackwood, president and CEO of HealthAmerica
"The subscription agreement is a legal contract between the
employer, the employee, and the plan, and is very important for
the patient and us. Interpreting it is often a real challenge
because there are always shades of gray, no matter how hard you
try to make it straightforward. But that is the driving document,"
Mr. Blackwood said.
Reviewing Experimental Therapies
To standardize the review process for all experimental procedure
payment requests, HealthAmerica developed a detailed experimental
procedures policy, which they submitted to Pennsylvania's Department
of Health. The policy defines the clinical review protocols that
must be followed when making payment recommendations to the plan.
The review is performed by the company's utilization management
committee, composed of voting and nonvoting administrative members
and including two medical directors, senior internists, and family
practitioners, pediatricians, ob/gyns, and cardiologists. A medical
oncologist will soon be added because of the number of oncology
cases being reviewed. Membership is rotated every year, and Mr.
Blackwood's role as a nonvoting member is to ensure compliance
with the review protocol.
To aid the review process, the committee gathers information from
several sources: extensive literature searches of multiple databases;
ECRI, a private Philadelphia company that researches various medical
investigative protocols and approaches; a group of HMOs who routinely
collect, update, and share information; and specialists who are
frequently requested to provide recommendations based on the diagnosis
and clinical status of individual patients.
"We search for the most reliable information and best clinical
minds to give recommendations to that committee," he said.
The group meets once every 2 or 3 weeks and often reviews four
or five transplant recommendations on a given day. "This
places incredible pressure on the group for an accurate and timely
review on behalf of patients and providers."
Committee decisions can be reviewed internally upon request, and
the patient or family has the right to appeal as high as the Pennsylvania
Department of Health. "There's a written protocol for that,
and we follow it religiously," Mr. Blackwood said.
In the last 2 years, HealthAmerica received nine referrals for
BMT for breast cancer and denied two. "So you might ask---where's
the problems in making a decision? Well, if you're sitting on
this committee, here are some of them," he said.
Members are required--and have an obligation to the patient--to
determine the safety and efficacy of every recommendation for
every patient. They must stay abreast of clinical indications,
which are continually changing; define intraoperative and postprocedural
risks of the procedure itself, particularly for young patients;
and evaluate the prognosis for each of the many treatment alternatives.
Mr. Blackwood perceives a trend toward bypassing conventional
therapies and moving directly to newer therapies, like BMT. "So
do we make recommendations with arguably insufficient literature
in support of a given approach for a given outcome, which may
require large expenditures and perhaps put the patient at risk?"
He also noted that there seems to be a treatment migration from
stage IV toward stage III disease. "We must determine whether
that is appropriate. Obviously, we need to track outcomes over
time to see retrospectively if the treatment seems to work,"
Struggle to 'Do the Right Thing'
He stressed that each decision made by the committee, because
of its clinical impact on the patient and financial impact on
everyone involved, must be philosophically and morally sound.
"We struggle to do the right thing," he said, "but
because predicting outcomes is difficult and because we often
receive conflicting recommendations from many well-respected clinicians
and researchers, it's often not clear from our chair what the
right thing is."
The increasing numbers of BMTs being performed and approved every
day, coupled with increasing pressure from outside influences,
will result in a dramatic increase in this mode of treatment.
"For us, however," he said, "the standard remains
the same--we must be convinced the procedure is both safe and
effective within a reasonable degree of predictability for each
individual or we won't make the recommendation. We feel a great
responsibility not to put our patients at unnecessary risk, regardless
of pressure to do so,and we will stand fast on that.