[Congressional Record Volume 142, Number 135 (Thursday, September 26, 1996)]
[Extensions of Remarks]
[Pages E1719-E1720]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  MEDICARE AND OUTPATIENT INFECTIOUS DISEASES THERAPY: LEGISLATION TO 
                     PROVIDE A COST-SAVING BENEFIT

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                     Wednesday, September 25, 1996

  Mr. STARK.  Mr. Speaker, Medicare could save money and benefit 
patients by facilitating certain cost-effective outpatient treatments 
in place of inpatient treatment. As the body of medical knowledge grows 
about what diseases can be safely and effectively treated at home, 
Medicare's policies need to be updated to capture the cost savings. A 
crucial area where Medicare policy lags relates to infections and 
treatment. After years of study by health experts, it is well-
established that outpatient intravenous antibiotic therapy for certain 
infectious can be a cost-effective alternative to prolonged 
hospitalization. Although only a subset of patients are medically 
appropriate candidates for outpatient therapy, significant cost savings 
may accrue. The bill I am introducing today provides a benefit for 
outpatient parenteral antimicrobial therapy while ensuring that 
Medicare capture the savings from use of this outpatient rather than 
inpatient rather than inpatient treatment.
  Certain infections require prolonged antimicrobial therapy. These 
include endocarditis, an infection of the heart valves, osteomyelitis, 
an infection of bones, infections involving certain prosthetic devices 
such as prosthetic joints, and certain abscesses such as those of 
liver, lung, or brain. Patients with these diseases often require 
intravenous antibiotic therapy for 4 to 6 weeks and sometimes longer. 
Intravenous therapy can produce much higher and more constant blood 
levels of an antibiotic than oral therapy and is used for serious 
infections. Certain viral and fungal infections also require prolonged 
antimicrobial therapy.
  After initial hospitalization and stabilization of their condition, 
many patients would be well enough to be discharged from the hospital 
except for the need for continued intravenous therapy. For these 
patients, outpatient antibiotic therapy would be beneficial and cost-
effective. Unfortunately, many patients must currently remain in the 
hospital because Medicare does not cover the outpatient treatment. 
Medicare loses because it may have to pay the hospital an outlier 
payment in addition to the usual diagnosis-related group [DRG] payment; 
the outlier payment is an extra amount to help cover the patient's 
longer than average stay. Alternatively, the hospital may try to save 
costs by transferring the patient to an extended care facility to 
complete treatment. Again Medicare loses, because it pays for the 
treatment at the receiving facility in addition to the DRG payment it 
makes to the hospital. If Medicare covered the outpatient treatment, it 
could avoid these extra inpatient payments. In addition, Medicare's DRG 
payments for these diseases could potentially be reduced as the average 
inpatient cost for the conditions decreases.

  Not all patients are medically appropriate candidates for outpatient 
antimicrobial therapy. However, for those that are, outpatient therapy 
avoids the restrictive environment of a hospital and decreases the 
patient's risk for hospital- 

[[Page E1720]]

acquired infections. Studies have documented that the longer a patient 
remains in the hospital the greater the chance of developing a new 
infection due to an organism acquired in the hospital; this results in 
increased morbidity and mortality, longer hospital stays, and 
additional costs. Another benefit of outpatient therapy is that 
patients who are ambulatory and active can often resume work or other 
regular activities during the period of their treatment.
  Several models are used for the administration of outpatient 
parenteral antimicrobial therapy. These include, first, the therapy can 
be administered in a physician's office or hospital treatment room to a 
patient who commutes to the site daily. This type of outpatient 
treatment is already covered by Medicare because the drugs are 
administered incident to a physician's services. Second, the therapy 
can be administered in a patient's home by a health professional who 
visits daily. Third, the therapy can be self-administered by the 
patient after appropriate training and with appropriate backup and 
support services. Fourth, the therapy can be administered via a 
programmable infusion pump in a patient's home or other location since 
some pumps are small and portable. Pumps can be set up to run for a few 
days by a health professional and require little manipulation by 
patients. They can be used with a variety of antimicrobials, including 
ones with frequent dosing schedules which otherwise could not be 
feasibly administered in the outpatient setting.

  Some infectious disease specialists treat a variety of infections 
with outpatient intravenous antimicrobial therapy in addition to the 
ones I mentioned earlier. These include certain skin and soft tissue 
infections, kidney infections, and pneumonia. I invite medical experts 
to help us define the optimal list of diseases for which outpatient 
parenteral therapy is a safe, effective, and cost-effective alternative 
to inpatient treatment. Because Medicare savings may be more readily 
identified with some disease categories than others, I encourage 
development of a list for which the savings are clear.
  The bill I am introducing today establishes a benefit for outpatient 
parenteral antimicrobial drugs, when the outpatient treatment is used 
in place of continued inpatient treatment. Reimbursement for drugs will 
be on the basis of actual costs plus an appropriate administration fee. 
The bill recognizes that certain supplies, equipment, and professional 
services are a necessary part of appropriate outpatient treatment. It 
directs the Secretary of Health and Human Services to determine the 
savings that can be obtained by providing this outpatient benefit which 
facilitates reduced inpatient payments. The diseases for which 
inpatient payments can be reduced if outpatient benefits are provided 
will be determined by reviewing all infectious disease DRG's.
  The bill also calls for repeal of coverage for antimicrobial drugs 
under the durable medical equipment [DME] clause, and provision of the 
coverage under the new outpatient parenteral therapy benefit. The DME 
benefit currently covers three antiviral drugs, one antifungal drug, 
and one anti-bacterial drug called vancomycin. As I have described 
previously in introducing another bill addressing vancomycin policy, 
Medicare's coverage of this single anti-bacterial drug among more than 
50 available antibacterials is causing inappropriate overuse of this 
drug. This is contributing to a public health problem of vancomycin 
resistant bacteria. Incorporating these five antimicrobials into the 
new outpatient parenteral therapy benefit will provide a more rational 
policy that can avoid the pitfalls of the current system. Coverage for 
infusion pumps used to administer these and other antimicrobials 
covered by the outpatient parenteral therapy benefit will be provided 
under the DME benefit.
  This bill focuses on disease categories rather than specific 
antimicrobials. As evident from the vancomycin issue, the naming of 
specific antimicrobials can cause changes in physicians' prescribing 
practices resulting in overuse of the named drugs. The naming of 
antimicrobials poses a different risk than for other classes of drugs 
and should be avoided; if we guess wrong about which antimicrobials 
should be named in a law, the result is not merely lack of coverage for 
the unnamed drugs, but also a potential public health problem of 
increased drug resistance. The legislative process cannot respond fast 
enough to change the list of drugs each time a problem occurs. Focusing 
on disease categories, rather than naming specific drugs, avoids this 
special risk. Also, this strategy helps to ensure Medicare savings by 
clearly identifying the DRG's, outliers, and extended care categories 
for which reduced inpatient payments may be feasible. This bill 
provides the mechanism to update Medicare's policies and capture cost-
savings as healthcare shifts from the inpatient to the outpatient 
arena.

                          ____________________