[Congressional Record Volume 143, Number 38 (Friday, March 21, 1997)]
[Extensions of Remarks]
[Pages E547-E548]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     THE MEDICARE MEDICATION EVALUATION AND DISPENSING ACT OF 1997

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                        Thursday, March 20, 1997

  Mr. STARK. Mr. Speaker, today, I am reintroducing a bill that could 
dramatically improve the quality of medical care received by our 
Nation's elderly. This legislation calls for implementation of an 
online prescription drug information management program for Medicare 
beneficiaries. This system, referred to as the Medicare Medication 
Evaluation and Dispensing System [MMEDS], would provide beneficiaries 
and their health care providers with tools and information that are 
necessary to reduce instances of adverse drug interactions, over-
medication, prescription drug fraud, and other problems that plague the 
elderly related to prescription drug use.

                               Background

       The inappropriate use of prescription drugs is a health 
     problem that is particularly acute for the elderly. The 
     elderly not only use more prescription drugs than any other 
     age group, but are more likely to be taking several drugs at 
     once--thereby increasing the probability of adverse drug 
     reactions.
       In July 1995, the General Accounting Office reported that 
     17.5 percent of almost 30 million noninstitutionalized 
     Medicare recipients 65 or older used at least one drug 
     identified as generally unsuitable for elderly patients. In a 
     study published by the Journal of the American Medical 
     Association [JAMA], researchers concluded that nearly one in 
     four noninstitutionalized elderly patients take prescription 
     drugs that experts regard as generally unsuitable for their 
     age group. Accounting for other scenarios, such as incorrect 
     dosage levels, the number of Medicare patients affected by 
     the inappropriate use of prescription drugs would far exceed 
     25 percent.
       Several studies featured in the January 1997, issue of JAMA 
     demonstrate the consequences of adverse drug reactions and 
     errors in medication prescribing. One study found that 
     adverse drug events [ADE's] lead to longer lengths of 
     hospital stay, increased costs of hospitalization, and an 
     almost twofold increase in the risk of death.
       Inappropriate use of prescription drugs has been proven 
     expensive as well as dangerous to the health of the elderly. 
     The Food and Drug Administration estimates that 6.4 percent 
     of all hospital admissions are caused by inappropriate drug 
     therapy--imposing costs of $20 billion; others estimate costs 
     to be as high as $77 billion. JAMA also recently reported 
     that drug-related morbidity and mortality have been estimated 
     to cost more than $136 billion per year in the United States. 
     Researchers found that a major component of these costs was 
     ADE's which may account for up to 140,000 deaths annually. 
     The study analyzed one hospital in Salt Lake City and found 
     that a total of 567 ADE's caused direct hospital costs of 
     over $1 million in 1992 alone.
       Moreover, another JAMA study concluded that the costs of 
     ADE's are underestimated since they exclude malpractice as 
     well as injuries to patients. The researchers concluded that 
     the high cost of ADE's economically justify investment in 
     preventive efforts. Therefore, the researchers recommended a 
     solution similar to MMEDS--reduction of system complexity, 
     improved education, expanded use of the expertise of 
     pharmacists, and computerization and standardization of the 
     drug prescribing process.


                 MEDICAID MEDICATION EVALUATION SYSTEM

       The concept of using computer-based systems to improve 
     patient care and identify potential problems is not new. 
     Advanced online computer technology that permits 
     prescriptions to be screened before they are filled is 
     available. Thirty States currently operate automated drug 
     utilization review information systems for their Medicaid 
     populations.
       In response to widespread knowledge of the high costs of 
     adverse medical reactions, Congress required States to 
     establish prospective prescription review for the Medicaid 
     program. This MMEDS-like system reviews prescriptions before 
     they are dispensed. In June 1996, the General Accounting 
     Office studied five States using an automated prospective 
     drug utilization review [PRODUR] system. Medicaid's online 
     system screens the prescription against the patient's known 
     medical and prescription history and sends the pharmacy a 
     message stating whether any potential drug-therapy problems 
     exist. Over a 12-month period, the automated systems for five 
     States alerted pharmacists to over 6.3 million prescriptions 
     that had a potential to cause ADE's--including drug-drug 
     interaction, preventing overutilization, and pregnancy 
     conflict; over 650,000 (10 percent) of these prescriptions 
     were subsequently canceled.


                           COST EFFECTIVENESS

       The 1996 GAO study found that automated prospective drug 
     utilization review, like that called for in MMEDS, is cost-
     effective to implement and to operate. The GAO concluded that 
     in addition to increasing patient safety, PRODUR's reduced 
     Medicaid program costs by over $30 million over the course of 
     1 year. Savings were from rejecting early refills (preventing 
     overutilization), cancellation of potentially wasteful 
     prescriptions, and denials due to ineligibility; yet, a 
     majority of savings were a result of using low-cost 
     technology to avoid hospitalization due to drug reactions. 
     Overall, the GAO found that program savings can more than 
     offset the costs of relatively inexpensive online systems.
       Moreover, in 1995, in the State of Tennessee, the GAO 
     observed a reduction of over $4 million in Medicaid drug 
     costs in just a 6-month period, representing 3.9 percent of 
     the total cost of claims processed. In Maryland, over 7,000 
     prescription doses considered excessive for elderly Medicaid 
     patients were modified, resulting in $385,252 in savings in 
     just 10 months, and a total of $6.7 million in claims were 
     reversed as a result of their online system, accounting for 
     7.1 percent of the cost of Medicaid claims processed overall.
       The GAO recommends implementation of an automated drug 
     utilization review system on a nationwide basis. There is no 
     doubt that if Congress acts to approve this bill, the 
     taxpayer's investment will be saved and Medicare 
     beneficiaries will be healthier as a result.


                        PRESCRIPTION DRUG FRAUD

       The August 18, 1996, edition of the Los Angeles Times 
     featured an article on the massive amount of prescription 
     drug fraud in the United States and the deaths and illnesses 
     that are the result. The abuse of prescription drugs is 
     believed to rival the estimated use of cocaine and crack. 
     Hundreds of millions of prescription pills reportedly enter 
     our Nation's illicit drug market each year. The abuse 
     involves physicians who illegally prescribe drugs, patients 
     who illegally obtain prescriptions, and a double standard of 
     leniency toward doctors and the wealthy who may overuse 
     prescription drugs.
       Medicaid's PRODUR system can alert for early refills and 
     therapeutic duplication--

[[Page E548]]

     providing tools needed to detect potential fraud and to 
     prevent abuse before it occurs. When the GAO analyzed data 
     from five States over the course of a 15-month period, over 
     2,200 Medicaid recipients were each found to have obtained a 
     20-months' supply or greater of controlled substances in the 
     same therapeutic drug class. By employing a drug management 
     monitoring program, the MMEDS program would help end 
     prescription drug market abuse, save lives, and avoid 
     billions of dollars in medical injuries and expense.


                                 GOALS

       The goal of this legislation is to provide a comprehensive 
     outpatient prescription drug information system available to 
     all Medicare beneficiaries which educates physicians, 
     patients, and pharmacists concerning: instances or patterns 
     of unnecessary or inappropriate prescribing and dispensing 
     practices; instances or patterns of substandard care with 
     respect to such drugs; potential adverse reactions and 
     interactions; and appropriate use of generic products.


                             MMEDS PROGRAM

       The Medicare Medication Evaluation and Dispensing System 
     will build on the existing Medicaid infrastructure. MMEDS 
     will give all Medicare beneficiaries and their health care 
     providers the medication management tools needed to identify 
     the direct threats posed by inappropriate medication. In the 
     process, hospital and other medical costs otherwise absorbed 
     by Medicare as a result of these adverse reactions will be 
     reduced.
       The program would provide online, real-time prospective 
     review of drug therapy before each prescription is filled or 
     delivered to an individual receiving benefits under Medicare, 
     as well as retrospective review. The review by a pharmacist 
     would include screening for potential drug therapy problems 
     due to therapeutic duplication, drug-drug interactions, and 
     incorrect drug dosage or duration of drug treatment.


       ASSURING APPROPRIATE PRESCRIBING AND DISPENSING PRACTICES

       While the MMEDS system will be operated under contract with 
     private entities, the Secretary of DHHS would be responsible 
     for overseeing the development of the program to assure 
     appropriate prescribing and dispensing practices for Medicare 
     beneficiaries. The program would provide for prospective 
     review of prescriptions, retrospective review of filled 
     prescriptions, and standards for counseling individuals 
     receiving prescription drugs. The program would include any 
     elements of the State drug use review programs required under 
     section 1927 of the Social Security Act that the Secretary 
     determines to be appropriate.
       As part of the prospective drug use review, any 
     participating pharmacy that dispenses a prescription drug to 
     a Medicare beneficiary would be required to offer to discuss 
     with each individual receiving benefits, or the caregiver of 
     such individual--in person, whenever practical, or through 
     access to a toll-free telephone service--information 
     regarding the appropriate use of a drug, potential 
     interactions between the drug and other drugs dispensed to 
     the individual, and other matters established by the 
     Secretary.
       The Secretary would be required to study the feasibility 
     and desirability of requiring patient diagnosis codes on 
     prescriptions, and the feasibility of expanding prospective 
     drug utilization review to include the identification of 
     drug-disease contraindications, interactions with over-the-
     counter drugs, identification of drugs subject to misuse or 
     inappropriate use, and drug-allergy interactions.
       The Secretary, directly or through subcontract, would 
     provide for an educational outreach program to educate 
     physicians and pharmacists on common drug therapy problems. 
     The Secretary would provide written, oral or face-to-face 
     communication which furnishes information and suggested 
     changes in prescribing and dispensing practices.
       In addition, the Secretary is instructed to, directly or 
     through contract, disseminate a consumer guide to assist 
     beneficiaries in reducing their expenditures for outpatient 
     drugs and to assist providers in determining the cost-
     effectiveness of such drugs.


                         PHARMACY PARTICIPATION

       Participation by pharmacies would be on a voluntary basis. 
     Participants would be required to meet standards including, 
     but no limited to, maintenance of patient records, 
     information submission at point-of-sale, patient counseling, 
     and performance of required drug utilization review 
     activities. Participating pharmacies would be required to 
     obtain supplier numbers from the Secretary. Supplier numbers 
     would only be provided to pharmacies that meet requirements 
     specified by the Secretary. Beneficiaries would be notified 
     of which pharmacies are designated Medicare participating 
     pharmacies.


                          payment of services

       Within a 2-year period after the initial operations of the 
     MMEDS system, the Secretary would be required to submit to 
     Congress an analysis of the effect of MMEDS on expenditures 
     under the Medicare Program and recommend, in consultation 
     with actively practicing pharmacists, a payment methodology 
     for professional services provided to Medicare beneficiaries. 
     The payment methodology would be designed in a manner that 
     generates no net additional costs to the Medicare Program, 
     after accounting for the savings to Medicare as a result of 
     demonstrable reductions in the appropriate use of outpatient 
     prescription services. The Secretary would submit a report to 
     Congress regarding such recommendations as the Secretary 
     determines appropriate.


                  privacy of prescription information

       Standards would be established to maintain the privacy of 
     protected health information. Protected health information 
     means any information collected in any form under this 
     provision that identifies an individual and is related to the 
     physical or mental health of the individual, or is related to 
     payment for the provision of health care to the individual.


                               conclusion

       As the number of elderly in our society increases, the 
     number and proportion of drugs used by these older Americans 
     will also grow. It is true that drugs, when used 
     appropriately, can reduce or eliminate the need for surgical 
     and hospital care, prevent premature deaths, and improve 
     quality of life. Unfortunately, a good deal of drug use among 
     older persons is inappropriate, and often results in 
     hospitalization. While some drug-related hospital admissions 
     are unavoidable, many can be attributed to errors in 
     prescribing. Utilizing an online prescription drug management 
     program to reduce the cases of adverse drug reactions is 
     clearly cost effective. Although the primary goal of MMEDS is 
     safety, dollar savings are also a result. Most importantly, 
     by implementing the Medicare Medication Evaluation and 
     Dispensing System Act, we stand to greatly improve the 
     quality of medical care received by our Nation's elderly.

                          ____________________