[Congressional Record Volume 142, Number 135 (Thursday, September 26, 1996)]
[Extensions of Remarks]
[Pages E1702-E1703]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




MEDICARE AND VANCOMYCIN: LEGISLATION TO PRESERVE A BENEFIT AND PROTECT 
                           THE PUBLIC HEALTH

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                     Wednesday, September 25, 1996

  Mr. STARK. Mr. Speaker, current Medicare pharmaceutical payment 
policy is creating distortions in the types of drugs prescribed in our 
society and contributing to a potential public health problem. This 
problem is the threat of increased drug resistance among bacteria that 
cause infections in thousands of people. The policy contributing to 
this public health threat is the unevenness of Medicare coverage for 
outpatient medications, and specifically, Medicare's coverage of a 
single antibacterial drug called vancomycin out of a multitude of 
possible antibacterials. This coverage provides an unintended incentive 
for physicians to preferentially choose vancomycin over other 
antibiotics. Inappropriate use of vancomycin will likely accelerate the 
emergence and spread of bacteria resistant to this drug, causing a 
major public health problem resulting in numerous deaths and increased 
morbidity. The bill I am introducing today counteracts the misdirected 
incentive for inappropriate use of vancomycin by insisting on certain 
criteria for the use of the drug in order for it to be reimbursed.
  Under current law, Medicare reimburses for outpatient medications in 
limited circumstances. Highly specific, unrelated categories of drugs 
are reimbursed. These include drugs administered in a physician's 
office or hospital, oral anticancer drugs, immunosuppressant drugs for 
organ transplant patients, a drug to treat anemia in end stage renal 
disease patients, drugs to treat osteoporosis in certain patients, and 
drugs that require durable medical equipment [DME] for their 
administration. Approximately 20 drugs are covered under the DME 
benefit, of which vancomycin is one. Vancomycin is covered because it 
is administered intravenously through an apparatus called an infusion 
pump. Medicare reimburses for the infusion pump and for the drug for 
which it is used. Thus, although more than 50 drugs are available to 
treat bacterial infections, Medicare singles out one drug for 
reimbursement simply because an infusion pump is used for 
administration. The DME benefit also includes four drugs used to treat 
infections caused by viruses or fungi, again because an infusion pump 
is used for administration, but vancomycin is the only drug used to 
treat infections caused by bacteria.

  Intravenous vancomycin is typically used in home therapy for 
infections requiring prolonged courses of antibiotics, such as 
endocarditis, an infection of the heart valves, or osteomyelitis, an 
infection of bones. Generally patients are hospitalized for an initial 
period, and once stable, can continue treatment at home. Only a subset 
of patients are medically appropriate candidates to receive home 
intravenous therapy. Home therapy is generally cost effective because 
the alternative is for patients to remain in the hospital or other 
inpatient facility to receive the therapy.
  Medicare's reimbursement system is causing overuse of vancomycin. The 
Health Care Financing Administration [HCFA] found a 64-percent increase 
in the home use of vancomycin, as measured by claims submitted for 
infusion pumps for vancomycin, from the fourth quarter of 1994 through 
the third quarter of 1995. Anecdotes from some hospitals and home care 
agencies indicate that vancomycin is preferentially used whenever the 
bacteria causing the infection are susceptible to it. This information 
suggests that the current Medicare policy is having the unintended 
effect of changing physicians prescribing practices.
  Overuse of antibiotics is a principal risk factor for the development 
of drug resistant bacteria. Antibiotics kill or inhibit bacteria that 
are susceptible to them, but the resistant bacteria survive. The 
Centers for Disease Control and Prevention [CDC] has documented a major 
increase in infections among hospitalized patients due to vancomycin 
resistant bacteria called vancomycin-resistant-enterococci [VRE], from 
0.3 percent in 1989 to 7.9 percent in 1993. In addition to this 
increase, a major concern is the possibility that these bacteria will 
transfer their vancomycin resistance to other families of bacteria. 
This transfer has occurred in a laboratory setting but has not yet been 
documented in humans; when it does occur, a major public health problem 
will arise since some of the bacteria to which vancomycin resistance 
may be transferred, such as Staphylococcus aureus, are common causes of 
infection and may already be resistant to many other drugs. In a 1995 
report about the impacts of antibiotic resistant bacteria, the Office 
of Technology Assessment concluded that steps should be taken to 
preserve the effectiveness of currently available antibiotics. It noted 
that Medicare's vancomycin policy runs counter to recommendations 
published by the CDC for judicious use of this drug. It also advised 
that a change in the Medicare policy may secondarily create positive 
influences on other insurers to consider whether their policies might 
also be creating unanticipated effects on antibiotic prescription 
patterns.

  Clearly, some patients need to be treated with vancomycin; it can be 
a lifesaving treatment in patients with serious infections caused by 
bacteria resistant to other drugs, or in patients who are allergic to 
certain other drugs. Unfortunately, HCFA's response to the problem of 
vancomycin overuse is to curtail coverage for vancomycin altogether. 
HCFA has announced that it is planning to curtail coverage of 
vancomycin under the DME benefit starting September 1, 1996. It has 
determined that vancomycin does not require an infusion pump for 
administration and thus will not be reimbursed. Surely, there must be a 
better way to address this problem than penalizing patients who truly 
need vancomycin.
  Instead of curtailing coverage, my bill addresses the public health 
threat by insisting that vancomycin use complies with certain criteria. 
The CDC's published recommendations for preventing the spread of 
vancomycin resistance include guidelines for prudent vancomycin use. 
The bill incorporates the two CDC recommendations that seem most 
applicable in the outpatient setting. Implementation would involve 
having physicians indicate on the request for vancomycin and DME 
reimbursement that the treatment meets at least one of the criteria 
delineated in the bill.
  Vancomycin is used to treat bacteria which are characterized as gram-
positive; this property means that when the bacteria are applied to a 
microscope slide and subjected to a technique called the Gram stain, 
the bacteria pick up the color of the stain, which is a positive 
result. The ability of these bacteria to pick up the stain is related 
to their outer structure; the ability of certain antibiotics to harm 
these bacteria is related to the antibiotic's ability to penetrate or 
disrupt this structure.
  Another large family of antibiotics effective against gram-positive 
organisms is termed the beta-lactam antibiotics because they have in 
common a chemical structure called the beta-lactam  ring. The prototype 
and most well-known of the beta-lactam antibiotics is penicillin. 
Penicillin is the first choice treatment for certain infections. 
However, penicillin has been widely used since the 1940's and many 
bacteria currently are resistant to penicillin; in this case, certain 
other beta-lactam drugs are usually effective. Since the 1980's, 
however, an increase in infections due to Staphylococcus aureus strains 
which are resistant to the whole family of beta-lactam drugs has been 
documented in hospitals; in these infections, vancomycin is often 
effective. Vancomycin is generally the last drug available to 
effectively treat these infections. Thus, today's bill reserves 
vancomycin use for when the bacteria are resistant to beta-lactam 
antibiotics. Although vancomycin could also be used against bacteria 
that are not resistant to the other drugs, it is more prudent to use 
the other drugs whenever possible and to save vancomycin as the last 
resort. Current law does not prevent physicians from prescribing 
vancomycin for infections that could be effectively treated with a 
beta-lactam antibiotic. In contrast, my bill provides for reimbursement 
of vancomycin and the equipment used for its administration if the 
physician indicates that treatment is for a serious infection caused by 
beta-lactam-resistant bacteria.

  Vancomycin is also used for patients who have serious allergies to 
penicillin and other beta-lactam antibiotics. Thus, the bill also 
provides for reimbursement of vancomycin and the equipment used for its 
administration if the patient has a serious allergy to beta-lactam 
antibiotics.
  The bill I am introducing is one attempt to address the public health 
threat of drug resistant bacteria while protecting the needs of

[[Page E1703]]

beneficiaries. However, it may not be the only way to address the 
problem. The policy causing this problem is rooted in the haphazard way 
in which Medicare reimburses for outpatient pharmaceuticals. Perhaps a 
more sweeping change is needed rather than just an adjustment of the 
reimbursement for one drug. The Medicare outpatient drug benefit has 
been adjusted drug by drug over the years. However, this policy is 
causing distortions in the types of drugs prescribed, as evidenced by 
the vancomycin problem. I solicit ideas and suggestions from the 
medical and pharmaceutical community and others to help resolve this 
public health problem and to make Medicare drug payment policies more 
rational, cost effective, and less likely to lead to similar problems 
in the future.

                          ____________________