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The researchers did not even look at the patients! Studies such as these can serve no real purpose unless useful conclusions are drawn.

THE PHYSICIAN

Rarely have physicians been expected to assume any of the burden of responsibility or blame when over-medication is charged. The public seems to believe that nursing homes can prescribe and administer tranquilizers and any other medications at will, with no one to answer to for their actions.

It is important to remember that all drugs administered to nursing home patients must be ordered by their personal physicians. Each of these orders must be signed every time by that physician. Nursing homes cannot administer drugs to patients in the absence of a physician's signed order, except in a documented emergency.

The reluctance of physicians to visit nursing home patients has been well-documented and it is an area of great concern for the National Council. We are working diligently with physician groups, the American Medical Association, the American College of Physicians, and the American Medical Directors' Association in an attempt to begin resolving this problem. We are seeking cooperative efforts such as educational seminars, revolving internships through nursing homes, and establishing chairs of geriatric medicine in medical schools. We are hopeful that constructive efforts such as these will result in greater physician interest in the elderly and their mental and physical problems.

THE ROLE OF THE CONSULTANT PHARMACISTS

Consultant pharmacists are required to review the drug regimens of skilled nursing patients on a monthly basis. The National Council believes that intermediate patients should be reviewed by consultant pharmacists as well, since they are frequently ambulatory and require more attention. Problems arise, however, in two areas: payment and the definition of drug regimen review.

The issue of payment to consultant pharmacists in nursing homes has become difficult and controversial during the last few years due to federal policy changes which have caught nursing home providers in the middle as so frequently occurs. Previously the services of the pharmacist came in exchange for the opportunity to provide medications to the home. When the federal government decided this practice was unsatisfactory, it promulgated a policy requiring that pharmacists be paid a separate fee for their services. Many states, however, have refused to reimburse for this service, saying that it was already part of the basic nursing home rates (although frequently not an identifiable one). In other states which allow a fee, the reimbursement is below the consultant pharmacist's cost. Thus if HHS were to separate these functions as some have recommended, the program costs would escalate tremendously.

We believe that more effective drug regimen review could be achieved through closer communications between physicians, pharmacists, and nurse supervisors. Further, a clarification is needed of what precisely constitutes a drug regimen review. This has not been clearly defined by HHS and consequently, pharmacists have had to devise their own methodologies. In turn, surveyors have not been given adequate guidance to determine if the drug regimen reviews being conducted are adequate.

Regarding the subject of drug error rates, little current data is available on the magnitude of this problem, nor is there sound data for setting an appropriate drug error rate. Any attempts to do so have been largely arbitrary.

We believe HHS must first clearly define the steps in a drug regimen review in order to determine what is an appropriate drug error rate. We do feel that reductions in drug error rates can be achieved in two ways: first, better training for nurses and medications aides (in states which permit them); and second, a greater acceptance in state Medicaid reimbursement plans of unit dose systems. There is no doubt that homes which utilize unit dose have experienced significantly lower rates of drug error. Additionally, there has been much less wastage since many states require minimum numbers of medications in filling prescriptions. For example, 100 pills might have to be discarded if a patient's prescription were changed. Unit dose packages come in one, two, or three-day increments so that little is ever wasted.

Our experience with our member nursing homes which have used unit dose has been very successful and worthwhile. The greater cost of the system seems to have been made up for in savings of staff time, in reduction of medication errors, and in much less drug wastage.

We suggest that the subject of appropriate levels of medication of the elderly be given careful study. Data which is currently being generated by some National Council members would provide a useful beginning for such a project.5

FREEDOM OF CHOICE

We do have a word of caution which relates to a patients rights area. Some states already have so called “freedom of choice” provisions whereby patients may order their drugs from any pharmacy they wish. While one can appreciate the intent of this proposal, it obviously can cause significant complications for nursing homes in trying to place orders for drugs to many different pharmacies. If the unit dose system is employed, this becomes even more of a complication when patients are free to choose another pharmacy which only dispenses drugs in bottles and containers. While a freedom of choice requirement has been included in the new Conditions of Participation it is doubtful that all the ramifications of this provision have been explored. We feel it is another case where an overzealousness in protecting the rights of patients may interfere with the ability of the facility to perform efficiently.

ACTIVITIES FOR PATIENTS

We believe there has been much improvement in nursing homes over the last six to eight years, but much more needs to be accomplished. First, however, we must recognize that if we are going to expect and demand more in the way of services, it will undoubtedly cost more. Conflict inevitably arises when public demand for services exceeds the ability or willingness to pay for them. For example, many homes have found that in expanding their activities programs, reality orientation and therapy services, they have successfully decreased the use of sedatives and tranquilizers. This implies, however, more staff and more staff training to develop and implement these programs. When there is an overreliance on drugs for patients it is frequently because there is not sufficient staff to care for 100 or so sick and confused patients. Yet state Medicaid systems allow reimbursement for only the minimum of personnel in nursing homes. Homes which staff above these requirements are dependent upon the income from private patients to do so. It should also be pointed out that the federal staffing requirement for ICF patients is less than that for SNFs, yet these patients frequently need more attention because they are more active and demanding of services.

Many National Council members have implemented quality of life programs for their nursing home patients, which focus on giving meaning to patients' lives through community involvement in the homes and where the patients' conditions permit, arranging activities for them to participate in such as picnics and watching softball games. By concentrating our efforts on programs such as these, we believe many beneficial improvements will result.

Mr. Pepper, we have tried to outline some of our perceptions on nursing homes and a few solutions regarding the administering of medications to patients in nursing homes. We would very much like to begin a dialogue with you and members of your Committee in these areas so that we might constructively address some of the issues raised. In addition to resolving many of the problems outlined, we believe that the solutions would also have a very positive impact on the overall quality of life in nursing homes.

NATIONAL COUNCIL OF HEALTH CARE SERVICES,

Washington, D.C., May 6, 1980. PATRICIA ROBERTS HARRIS, Secretary, Department of Health and Human Services, Washington, D.C.

DEAR MRS. HARRIS: This letter is in follow-up to our mailgram of March 28, 1980, regarding our request for a full 120-day comment period for the revised conditions of participation for skilled and intermediate care facilities.

The National Council of Health Centers represents investor-owned multifacility nursing home companies. Our members are also engaged in providing many other health care services such as home health, adult day care, meals on wheels, and hospice.

Mr. Thomas Morford, Director of HCFA's Office of Standards and Certification, responded to our mailgram and outlined the various steps the Department has taken over the last few years in seeking public input in the revision process. The

5 Patient Assessment Computerized, National Health Corporation, Murfreesboro, Tennessee, 1980.

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National Council has participated actively in this process and we are sincerely appreciative of the opportunity to do so.

The National Council, however, strongly feels that the Department's efforts to date do not diminish the need for a full 120-day comment period in order to provide for a comprehensive analysis of the regulations and their impact.

In this regard, the National Council and the American Health Care Association have contracted with Applied Management Sciences Corporation to analyze the revisions after they are issued in proposed form and to determine their impact. AMS will be looking not only at the added cost to facilities, but also to the states and private patients as well as the availability of adequate personnel and other resources. An advisory committee has been named to oversee the project and the methodologies used in the evaluation process. Among the members who have agreed to participate on this advisory committee are three state Medicaid officials, three providers, and two officials of HCFA.

We strongly believe that an indepth analysis is necessary so that all concerned are fully aware of the potential impact of these revisions. Given the importance of this study, I think you will agree that a 120-day comment period is essential to its success.

Another factor which has been given little or no consideration is the impact that the regulations will have on all nursing homes and on all patients, not just Medicare and Medicaid beneficiaries. Since we are talking about a total of more than one and a half million nursing home patients, the impact will be far greater than initially envisioned by HEW. It is simply not realistic to expect that the conditions will be applied to Medicare and Medicaid program patients and not expect the costs to private patients to increase as well. This is especially true where states are presently paying facilities less than their actual costs.

While we would agree that the Department was especially sensitive in seeking the input of providers, consumers, and states during the past three years, that process was cut off for the last seven months. As a result, no one had continuing access to the contents of the working drafts during the final crucial decisionmaking process.

In summary, we respectifully submit that 60 days is simply not enough time to deal with such a comprehensive and important set of issues. It is illogical and unrealistic to give the public only 60 days to respond after it has taken the Department three years to develop its final proposal. In order to seek substantive input from our industry, consumers, and to allow Applied Management Sciences to conduct the most useful study possible, there is a clear need for a 120-day comment period. Knowing it will take months, if not longer, for the Department to issue a final rule, we feel that this is very little to ask on behalf of all concerned parties. Sincerely,

JACK A. MACDONALD,
Executive Vice President.

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[Mailgram]
NATIONAL COUNCIL OF HEALTH CARE SERVICES,

Washington, D.C., Mar. 28, 1980.
Re SNF/ICF conditions of participation.
PATRICIA ROBERTS HARRIS,
Secretary, Department of Health, Education and Welfare,
Washington, D.C.

DEAR SECRETARY HARRIS: On behalf of the members of the National Council of Health Care Services, I would like to express our strong disapproval of the proposed 60-day public comment period for the revised SNF/ICF conditions of participation as reported in the McGraw-Hill newsletter, “Long Term Care Report,” on March 28, 1980.

In view of the fact that it has taken three years for HEW to issue these regulations in proposed form, we take vigorous exception to being given only 60 days to submit our response. There is no doubt that the proposed regulations will seriously impact the Nation's 15,000 nursing homes—both financially and operationally, we urge you to reconsider taking this action and, instead, request that you afford the public the full 120-day comment period as originally planned in order to permit measured consideration by all concerned. Sincerely,

JACK A. MACDONALD,
Executive Vice President.

(From the American Medical News, June 13, 1980)

NURSING HOME OFFICIAL CRITICAL-MD's CHARGED WITH 'ABANDONING' AGED Physicians are walking away from old people, charges a top nursing home official. "The medical society, the physician, has abandoned them."

This indictment is handed down by Marvin Wilensky, president of the National Council of Health Centers, representing investor-owned nursing homes. In an interview with American Medical News, Wilensky took physicians, society, and the government to task for their treatment of the aged.

"People wouldn't be in a nursing home unless they were a medical problem,” he said. “That's one of the reasons I'm pleading for the involvement of the practicing physicians.

"They are giving up their patients when they enter a nursing home. It is a critical problem. Some physicians are not geared to think of their patients getting better and perhaps being discharged back to their homes or to other settings. Physicians have no stimulation to treat a person in a lingering, last home-type of situation,” he said.

“There is a certain percentage of simple abandonment of patients," asserted Wilensky. "There are restrictions on payment at nursing homes. Physicians don't get paid what they would at hospitals for seeing patients; they don't get paid for each patient if they see more than one, and in some states they might get paid for only one visit a month, regardless of the intensity of care required by the patient."

Wilensky said physicians should be exposed to nursing homes during their medical school training. They should learn that nursing homes should not be viewed as places where people go to die, he said. “For physicians who do not take this view, the results often have been excellent. It would be interesting to make a study of the outcome of patients related to the attitude of their respective physicians.”

Much of the problem revolves around payment, Wilensky said. Many physicians are oppressed by the methods they must use in order to get paid a reasonable rate for the time they spend, and many nursing homes aren't located conveniently, he noted.

Physicians blame their problems on the nursing homes when the real culprit is the regulations imposed by the federal and state government, Wilensky said.

Medicare is a vexing problem. Wilensky said that “if Medicare were run the way it was intended to be, it would cost a lot more money than it costs today. The government restricts the use of the program. It is a fraud-we've promised people a program we are not willing to pay for.

“The answer is a hard one to face-either to pay nursing homes at a level that will entice the capital needed to provide the beds or to be honest and say, 'We are going to restrict it to x number of people and you will have to wait your turn to get the service.' The government allows $34 a day under Medicaid for nursing, food, and medicine-chest items, less than the cost of most hotel rooms.

Wilensky has proposed that the per diem travel allowance for state and federal officials be pegged at the highest rate for nursing home care in the city they plan to visit.

The percentage of nursing home patients in Medicare is less than 3 percent. Their average stay is 28 days. “That is the way the government wants it to be,” Wilensky said. “It wants a grandiose-sounding program but doesn't want to pay for it. In 1968, 50 percent of the nursing home patients were in Medicare. Today, 50 percent are Medicaid patients. The government intentionally has restricted the eligibility. You have to be very, very sick to qualify for Medicare,” he said, “People were expecting to be covered by Medicare but they aren't.

“There's a bit of fraud that is being perpetrated by the government against its elderly citizens."

If the Medicaid program were equitable, there would be nothing wrong with a person using his or her savings to qualify for Medicaid, he said. Most Medicaid programs, however, are not equitable, he argued.

“People can't be selective; they can't go where they want to when they want to. Sometimes a lifetime physician will abandon them at that time because he doesn't want to be part of a Medicaid practice,” Wilensky said.

Nursing homes are hamstrung by duplicative surveys, different interpretations by surveyors— “just no end to regulations," Wilensky said. As many as 50 different agencies inspect homes.

Wilensky estimated more than one million people should be in nursing homes, almost twice as many as are now in them.

There has been little construction of nursing homes in the last five years. Certificate of need has restricted it, construction costs have gone up, and payment pro

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grams have become worse, according to the official. “No one in their right mind is going to invest millions of dollars in a home for a zero return,” he said. “What is going to happen, I am afraid, is that states suddenly are going to realize

I they need more nursing homes and they are going to open a floodgate. We will go back to the late '60's and see speculators build and develop, sell, and get out. Much of our bad image dates back to that time. That could happen again and the government is promulgating that approach through its present policies.”.

The existing homes are doing a good job for the elderly, the official said "at least 95 percent of the homes are good institutions.

“We need a 'congregate living' program that is federally-funded in a manner that will attract the private capital to do the job. Congregate living means adequate housing, a mandated dietary program, a central dining area, and an activities program so that the old don't live alone, not eat, and wind up in a hospital due to malnutrition or boredom.”

Such a program could be developed by the American Medical Association and the nursing home industry, and insurance companies, Wilensky said. He said it is imperative to get rid of the “layer upon layer" of federal, state, and local regulations.

AMERICAN ASSOCIATION OF COLLEGES PHARMACY,

Bethesda, Md., July 8, 1980. Mr. VAL HALAMANDARIS, Chief Counsel, House Select Committee on Aging, Washington, D.C.

DEAR MR. HALAMANDARIS: I appreciated the opportunity to talk with you when you called the week of June 15. I also appreciate your kind and generous remarks. I am very pleased that you wanted to have read into the Committee record the paper, “The Cost Containment Value of Drug Utilization Review in Nursing Homes-A Background Paper Prepared for U.S. Representative Don Bonker,” which Dr. Lars Solander and I prepared.

I regret that I was unable to appear before the Committee on June 25. However, I am pleased that Dr. Solander was able, so efficiently, to coordinate the presentation of our testimony, and that Dr. John Schlegel was able to present the Association position. It is my understanding from Dr. Solander that you would welcome a statement from me for the record. This is enclosed.

Thank you for this opportunity to present the position of the American Association of Colleges of Pharmacy in the interest of the activities of your committee. Sincerely,

MELVIN R. GIBSON, Ph. D. Enclosure.

PREPARED STATEMENT OF MELVIN R. GIBSON, Ph. D., PRESIDENT, AMERICAN

ASSOCIATION OF COLLEGES OF PHARMACY Mr. Chairman, I am Melvin R. Gibson, President of the American Association of Colleges of Pharmacy. On behalf of the Association, I would like to thank the Committee for this opportunity to submit a statement for the record.

The American Association of Colleges of Pharmacy represents 5,500 full and parttime faculty, and 30,000 students at 72 colleges-all committed to rational drug therapy. Many of our colleges have programs to train students in the drug therapy of the elderly, and many of our faculty have devoted years of their careers to the improvement of drug therapy for the elderly. Last year I appointed a Task Force on Aging. This Task Force illustrates the Association's on-going commitment to the goals of rational drug therapy for the elderly.

DRUG MISUSE AND THE ELDERLY

America is a drug-taking society. Between five and seven percent of the U.S. health dollar goes to prescription drugs alone. Usage of drugs among the elderly is approximately triple that of the general population. Utilization of an evergrowing variety of highly potent and potentially toxic drugs for a growing number of medical problems and complaints has contributed to an incidence of drug-induced disease and therapeutic misadventure that is unacceptable. Therapeutic misadventures can be caused by many factors. I will focus on three: (1) the aging process, (2) inadequate medical attention, (3) irrational drug therapy.

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