The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.

Policy Currents

Coalition Supports Use of Video Cameras in Nursing Facilities: Who's Being Abused?


Several of America's leading elder advocacy organizations held a news conference on September 14 to announce their support for use of video cameras in nursing homes to document abuse of seniors. The move followed the release of a report entitled "America's Secret Crisis: The Tragedy of Nursing Home Care."

The group is calling for congressional passage of a law that would allow video cameras to be mounted in resident areas, with the permission of residents or their legal representatives. Nursing home operators would be informed of the presence of cameras, as would anyone who interacts with residents. The cameras, which cost $200 to $500, would be installed at the family's expense.

Nursing home officials say such use of video cameras would invade the privacy of residents at times when they are most vulnerable, during bathing and changes of clothes. In addition, the presence of cameras, and the implications for lawsuits, would heighten employee stress.

According to a September 14 USA Today article, not all lawyers or advocates for the elderly are certain cameras are a good idea. Some lawyers, however, believe cameras will help prevent abuse, and trends in the legal profession should put nursing home administrators on alert. For example:

  • The National Academy of Elder Law Attorneys has increased tenfold in the past decade to 3,500 members.
  • For the nursing home sector, malpractice lawyers expect to win settlements and seven-figure verdicts this year.

What initiatives, besides video camera use, can ensure quality care for the elderly? Nursing homes must be responsive to the demands of both internal customers (residents, nursing staff, pharmacists, and physicians) and external customers (families, regulators, and payers). As shown in the September/October 1999 issue of the Journal of Healthcare Management, nursing home corporate board involvement in quality improvement (QI) initiatives is an important predictor of QI outcomes in resident care and staffing issues.

Nursing home corporate board involvement in QI may be particularly important for the nursing home sector because multiple stakeholders-staff, residents, regulatory agencies, and shareholders-influence decision making and because limited structural mechanisms are in place to ensure accountability.

To ensure quality resident care, nursing home corporate boards could promote greater communications on QI between staff members and board members. In this way, resident care could be enhanced and employees could be empowered instead of monitored.

Limiting Services to the Elderly: The Proof is in the Patient

A recently published study, paid for by the National Association for Home Care and the Home Health Services and Staffing Association, says new Medicare payment caps have prompted home care companies to limit services to elderly and disabled patients who have expensive medical problems such as diabetes or congestive heart failure. Meanwhile the Clinton administration says that before funds can be directed at fixing payment levels, there must be proof that patients are in jeopardy.

Twenty-eight home care companies in nine states participated in the study, which was not designed to be statistically representative of all home care companies. Among those surveyed, two-thirds said they had taken steps to lower the proportion of very sick Medicare patients they serve by:

  • Turning away patients likely to need longer-term or repeat care
  • Firing specialists to avoid attracting patients with complex problems
  • Marketing to attract patients likely to recover quickly
  • Pushing to discharge existing Medicare patients with chronic diseases into nursing homes

Congress provided $1.7 billion last fall to raise payments slightly for the home health industry, and President Clinton has proposed that $7.5 billion be set aside over the next decade to correct the unintended consequences of 1997 Medicare payment changes that also affected hospitals and nursing homes.

'Nutrition Care Alerts' for Use in Nursing Facilities

The Nutrition Screening Initiative, Washington, was launched to fight malnutrition and other health issues in nursing homes and has received support from the Senate Special Committee on Aging and the Health Care Financing Administration (HCFA).

A product of the initiative is a written guide, entitled "Nutrition Care Alerts," that is intended to help caregivers spot signs of unintended weight loss, dehydration, pressure ulcers, and tube-feeding problems with residents. The guide also recommends what caregivers should do when certain warning signs are spotted.

HCFA is testing the alerts at a handful of nursing facilities and is weighing the cost of a collaborative long-term study to determine if the alerts improve nutritional outcomes in nursing facilities.

The "Nutrition Care Alerts" guide is available through the Nutrition Screening Initiative at 202-625-1662.

HCFA Redefines Medication Errors

The Health Care Financing Administration (HCFA) broadened the definition of a medication error in its July 1 changes to nursing facility survey procedures. Medication error is now defined in Federal Survey Tag F332/F333 as follows:

Medication Error

The observed preparation or administration of drugs or biologicals which is not in accordance with:

  • Physician's orders
  • Manufacturer's specifications (not recommendations) regarding the preparation and administration of the drug or biological
  • Accepted professional standards and principles that apply to professionals providing services. Accepted professional standards and principles include the various practice regulations in each state, and current commonly accepted health standards established by national organizations, boards, and councils.

Source: HCFA Guidance to Surveyors - Long Term Care Facilities.

In addition to the traditional errors or omissions, unauthorized drugs, and the typical "wrongs"-wrong dose, route, dosage form, drug, and time-the new regulations list specific examples that might be subject to the new criteria.

Tag F332 requires a facility to be free of medication error rates of 5% or greater; Tag F333 requires residents to be free of any significant medication errors. By performing periodic medication pass observations in facilities, consultant pharmacists can help identify frequency of errors and the number of significant and nonsignificant errors (examples of which are given in the guidelines) to determine if a facility is at risk for citation when a survey occurs.

For more information on Medication Errors and other changes to the HCFA Guidance to Surveyors, refer to the ASCP text Nursing Home Survey Procedures and Interpretive Guidelines, (800-355-2727), or call MED-PASS, Inc., at 800-438-8884.

Off-label Drug Use: Free Speech or Policy Disaster?

Historically, the Food and Drug Administration (FDA) has considered the ability of physicians to use approved drugs for nonapproved indications as part of the practice of medicine. The FDA has kept a watchful eye on manufacturers' efforts to promote off-label uses, and before 1998, FDA policy prevented companies from sharing unsolicited off-label use information with physicians.

On July 28, U.S. District Court Judge Royce C. Lamberth collapsed the FDA's current regulatory plan for off-label drug information. In his decision, Lamberth declared the FDA's off-label drug information regulations to be an infringement on First Amendment protections of commercial speech and, thereby, unconstitutional and unenforceable. The FDA is expected to appeal the decision.

While the FDA makes its decision to appeal, pundits either declare Lamberth's decision to be the beginning of a new world-order or the antithesis-a policy disaster. According to Washington Legal Foundation (WLF) attorney Glenn Lammi, the judge is not allowing "anything goes." The information has to be accompanied by a disclaimer that the use in question would be off-label, and there must be a bona fide scientific review. For example, a drug company may provide a reprint of a medical journal article to a doctor as long as it is not false or misleading and the company discloses its interest in the drug and notes that the application does not have FDA approval.

With drug companies always looking to broaden their markets, only time will tell the decision's impact on the way off-label information is disseminated to doctors and perhaps even direct to consumers.

Off-Label Drug Use; Case At A Glance

Players: Washington Legal Foundation v. FDA; U.S. District Court for the District of Columbia

At issue: Constitutionality of FDA policies regarding promotion of off-label drug uses

Time line:
1994:
WLF filed suit charging that the three FDA guidance documents providing the basis for the agency's off-label drug information dissemination policies infringed on protected speech.

November 21, 1997: The FDA Modernization Act (FDAMA) became law, including a new off-label information regulatory framework.

July 30, 1998: The court found FDA's guidance documents predating FDAMA to be unconstitutional.

November 20, 1998: Implementing regulations for FDAMA's off-label provision took effect.

February 16, 1999: In response to a FDA motion to carve out FDAMA's new off-label policy from the 1998 ruling, the court requested supplemental briefs from both parties.

July 28, 1999: The court concluded that 1998 FDA regulations perpetuated the policies found unconstitutional in the earlier decision.


Source: American Medical News

Who Cares about the Patients' Bill of Rights?

Congress does, but apparently voters don't. According to a recent poll by the Wall Street Journal/NBC News, the public ranked passage of a patients' bill of rights (as managed care regulation is popularly known) as a lower priority than revamping Medicare, cutting taxes, restricting gun sales, and increasing defense spending.

One reason for voters' apathy stems from their overall approval rating of their health coverage (Between 80% and 90% of those polled are satisfied with their health insurance coverage). When asked "Which health care issue do you think is most important for Congress to address?" the majority of those polled (46%) chose "Make Medicare sound."

Which health care issue do you think is most important for Congress to address?

In contrast to voters' apathy over patient rights, lawmakers who are also physicians are very interested in passing a patient protection bill. According to a recent article in American Medical News, part of the doctor-lawmakers' success derives from their passion for the subject. Rep. Charles Norwood, DDS (R-Ga.) and Rep. Greg Ganske, MD (R-Iowa) persevered on the patient protection issue for years.

"This is my fifth bill and the fifth year," said Dr. Norwood. As HMO and business resistance to his bills grew, so did his determination, he said. "If you don't treat patients, your feeling is not the same," he said.

Opponents of the bills use the lawmakers' health care credentials to criticize their motives. Chip Kahn, president of the Health Insurance Association of America, said doctors are unhappy with the transition from fee-for-service medicine to managed care, and they are not able to separate between their experience and what they are legislating.

If the California legislature is an indication of things to come, in spite of polls showing that Californians were generally happy with their health care, California lawmakers passed a series of new HMO regulations, including a liability provision that gives patients a right to sue.

What California and other lawmakers are doing is filtering the good news (80% to 90% patient satisfaction ratings) from the bad news (56% of those surveyed in a Wall Street Journal/NBC News poll rated their feelings about HMOs as negative). This "negative feeling" rating provides a very real measure that voters do indeed care about the legislation, it just depends how you ask them.

Patients' bill of rights: the low-down

  • Voters are happy with their health insurance but have negative feelings about HMOs.
  • Lawmakers sense voters' negative feeling about HMOs.
  • Lawmakers who are doctors are especially interested in patient protection bills.
  • House members are often elected on populist themes that may resonate more in their districts than nationally.
  • California lawmakers passed a series of new HMO regulations, including a liability provision that gives patients a right to sue (after a comprehensive external review process is exhausted).

Tax Deductibility of Long-Term Care Insurance Premiums: Turning Tax Revenue Loss into Medicaid Savings

At least 700,000 new long-term care health insurance policies would be sold by 2005 if a 100% above-the-line tax deduction for long-term care policies is implemented this year, according to a report released by the Health Insurance Association of America (HIAA).

Today, long-term care premiums are deductible only for taxpayers who itemize and who spend more than 7.5% of their annual adjusted gross income on medical expenses. Approximately 4.5 million Americans have long-term care insurance.

The total revenue loss was estimated at $3 billion per year, but the researchers argue that within 12 years, the cost would be canceled out by the associated Medicaid savings. Because middle-income families are most likely to spend down to Medicaid eligibility, selling more policies would mean preserving Medicaid funds, according to researchers Marc Cohen, PhD, Life Plans, Inc., and Maurice Weinrobe, PhD, professor of economics at Clark University. Their calculations assume immediate 100% above-the-line deductibility, although no legislation currently under consideration includes such a provision.

The tax bill passed earlier this year proposes phased-in, above-the-line deductibility, beginning at 25% in 2002, then increasing to 35% in 2005, 65% in 2006, and 100% thereafter. Cohen and Weinrobe project that 100% deductibility would reduce the average policyholder's yearly premium about 20%, from $1,806 to $1,463.

In response to concerns that insurers might raise long-term care premiums if 100% eligibility were enacted, HIAA President Chip Kahn (for whom the report was prepared) predicted that insurers instead would choose to increase revenues by selling more policies, which would increase the size of their risk pools.

North Carolina Recognizes Pharmacists as Clinical Practitioners

The North Carolina Association of Pharmacists (NCAP) is currently working with the state boards of medicine and pharmacy to implement by July 1, 2000, House Bill 1095, which identifies pharmacists as clinical practitioners.

Clinical pharmacists (who have paid an application fee of $100 or less) would be permitted to enter into collaborative practice agreements (that are physician-, pharmacist-, patient-, and disease-specific) under a physician's protocol. They would be authorized to implement predetermined drug therapy, modify prescribed drug dosages, and order medical tests.

The bill has been in development in North Carolina since July 1998. By collaborating with the North Carolina Medical Society, NCAP was able to change language in the state medical practice act to recognize other health care provider groups that can provide drug therapy management service. The bill was modeled in part after language that allows nurse practitioners to provide medical services.

According to NCAP Executive Director Dan Garrett, "Our success was and will be dependent on pharmacists who demonstrate leadership by going the extra mile to get advanced training and earn the respect of the physicians they work with on a daily basis."

Barbara Eilenfield
Senior Editor



The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.