January 01, 2008

Nursing facilities' off-label use of antipsychotic drugs to treat disruptive behavior resulting from dementia continues to draw federal scrutiny. According to a recent news report, the Centers for Medicare and Medicaid Services (CMS) data show nearly 21% of nursing facility residents are on antipsychotic medications despite the lack of a diagnosis of psychosis (The Wall Street Journal, “Prescription Abuse Seen in U.S. Nursing Homes,” Dec. 4, 2007, p. A1). In addition, nearly 30% of all nursing facility residents are taking antipsychotic drugs, and in recent years, Medicaid has spent more money on antipsychotic drugs than any other class of drugs.

U.S. Sen. Chuck Grassley (R- Iowa) has called on the inspector general for the Department of Health and Human Services to review the use of antipsychotics in nursing facilities. He cited his concern that some of the drugs have black box warnings because of their serious side effects, and questioned whether the drugs are necessary. “There have been numerous reports that some physicians are influenced by drug companies to prescribe drugs that may not necessarily be in the best interest of the patient and also to prescribe these drugs off label,” he said.

Sen. Grassley also asked the inspector general to review “payments or other items of value provided to the prescribing physician and/or others in the nursing home facility from sponsoring drug companies.” He also asked the CMS to report on its response to nursing homes that misuse prescription drugs and asked manufacturers of three of the leading antipsychotic drugs for information about their marketing practices and any payments or transfers of value to physicians or nursing facility staff.

Charles A. Crecelius, PhD, CMD, responded to the concerns raised by Sen. Grassley, saying, “the utility and optimal role of off-label antipsychotic medication use in nursing home residents remains unclear. Short-term studies tend to indicate a benefit for severely disturbed residents who pose a serious threat to themselves or others, but long-term benefit for dementia-related behaviors without a true psychiatric diagnosis appears uncertain and probably dangerous.” The correct application of F-Tag 329 on Unnecessary Medications in the survey process “should ameliorate much of the current concern, along with education of physicians and nursing homes alike in the best practices of managing dementia-related behaviors. Pharmaceutical manufacturer influence has no role in this subject and should be discouraged.”

 Impact of F-Tag 329

In fact, F-Tag 329 already may have made a difference as antipsychotic use seems to have peaked in nursing homes, based on a survey of 670 facilities in New York (CARING FOR THE AGES, November 2007, p. 17). “We hope that the small decline between 2005 and 2006 is not a fluke and will continue,” said Christie Teigland, PhD, director of Health Informatics and Research for the New York Association of Homes and Services for the Aging.

In addition to F-Tag 329 in the long-term care surveyor guidelines, federal guidelines for Medicare Part D stipulate that drug plans are responsible for ensuring that covered drugs are prescribed for “medically accepted indications,” as defined by Food and Drug Administration approval and included in either the American Hospital Formulary or DRUGDEX. Drug plans may implement utilization management policies to verify drug use for medically accepted conditions, but pharmacists are not required to contact each prescriber to verify whether a prescription is being used for other than a medically accepted condition.

List of Poor Performers

The CMS has released the first ranking of continually poor-performing nursing facilities, highlighting 54 nursing facilities with a history of providing poor care to residents. These facilities, in 33 states and the District of Columbia, were a subset of 128 “special focus” facilities that require additional oversight and surveys every 6 months. The facilities on the latest list are those that have failed to improve significantly on a subsequent survey.

In addition to more frequent surveys, special focus facilities are subject to progressive enforcement actions until the facility either significantly improves, is granted additional time as a result of promising developments, or is terminated from Medicare and/or Medicaid.

According to the CMS, release of the list “was prompted by a number of facilities that were consistently providing poor quality of care, yet were periodically instituting enough improvement that they would pass one survey only to fail the next (for many of the same problems as before). Such facilities with a 'yo-yo' compliance history rarely addressed underlying systemic problems that were giving rise to repeated cycles of serious deficiencies.” The agency noted that the public spotlight on these facilities would enhance its regulatory efforts to produce consistent compliance.

Sen. Herb Kohl (D-Wis.), praised the CMS as “doing the right thing by letting the public know which homes yo-yo in and out of compliance with the minimum requirements of care.”

The senator also said he plans to introduce legislation that would allow consumers timely access to accurate information on nursing facilities, including the results of government inspections, the number of staff, and information about the facility's ownership. The legislation also should strengthen the enforcement system.

Physician Pay

As 2007 came to a close, Congress passed and the President signed into law a 6-month reprieve from a 10% rate reduction in Medicare payments. The cut to physicians' Medicare reimbursement initially was scheduled to take effect Jan. 1. The American Medical Association “had warned that a cut in reimbursement rates would lead to physicians taking on fewer new Medicare patients,” the Associated Press reported.

Under this new legislation, physicians would “get a 0.5% raise when they treat the elderly and disabled” for the next 6 months. The report said although the “higher reimbursement rates for doctors is expected to cost about $6 billion,” it is much less than the “tens of billions of dollars that Democrats proposed trimming.”

The compromise agreement between Republican and Democratic lawmakers “would trim $1.5 billion from a fund established for certain insurers that entered previously unserved regions.” In addition, the legislation would freeze “payments for inpatient rehabilitation care, and for prescription drugs delivered by physicians through Medicare Part B.”

AMA Concern

The AMA has expressed concern that in taking other Medicare reductions off the table, Congress could reverse the 2008 physician cut, only to shift the cost of relief in 2008 to future years. The AMA is urging Congress to develop a sustainable growth rate provision that properly funds a solution to this problem and does not rely on “balloon” financing.

Meanwhile, the Department of Health and Human Services is urging members of Congress to link adoption of health information technology to any physician fee cuts.

In a letter to the Senate Finance Committee, Secretary Mike Leavitt recommended that “physicians who do not adopt appropriate available technology should receive a lower payment than those who do.”

He is promoting the adoption of electronic prescribing and electronic health records. Secretary Leavitt's recommendation was backed by the American Health Information Community recommendation that the federal agency seek authority from Congress to mandate electronic prescribing in Medicare.

Under the proposal, the secretary would be allowed the discretion to make exceptions. In addition, several senators have proposed legislation to require physicians who participate in Medicare to use e-prescribing by 2011. Physicians who do not would risk financial penalties, but physicians would receive a bonus each time they transmitted a prescription electronically.

The proposed legislation would include funds to help cover costs of adopting information technology and would authorize the HHS secretary to grant 1-year or 2-year hardship waivers to physicians who cannot afford to adopt e-prescribing.

CMSList

The list of chronically deficient nursing facilities is available here.

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