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In a trend fueled by consumer backlash against managed care formulary restrictions, a growing number of states are moving to require insurance companies and health plans to cover "off-label" uses of medications approved by the Food and Drug Administration.
According to a recent survey by Pennsylvania-based health care consulting company Scott-Levin, 22 states have already enacted, or are considering, laws or regulations mandating insurance coverage of off-label uses of FDA-approved drugs.
Oregon, for example, mandates that health plan enrollees who have prescription benefits cannot be denied coverage for drug uses not explicitly approved by the FDA; a similar proposal is pending in the Minnesota legislature. The California legislature is considering a measure that would require coverage of off-label uses even if specific efficacy data are lacking. In New York, the legislature is considering several bills that would mandate coverage of experimental therapies for breast cancer and AIDS.
"The trend toward off-label mandates raises serious issues for physicians, insurers, and employers" and poses a serious threat to managed care organizations' cost containment efforts, Scott-Levin CEO Joy Scott commented in a news release.
At least one major insurer, Blue Cross and Blue Shield, has launched
a study of the trend toward coverage of off-label uses and what
impact it might be having on use of hospital
services and overall insurance costs.
Report Blasts Pennsylvania Nursing Facility Oversight
The first performance audit of Pennsylvania's long-term care system has revealed a pattern of slow response to serious quality-of-care complaints, prompting sharp criticism of state nursing facility oversight.
The review, performed by the state's auditor general, found delays of a week to three months in investigating serious complaints, including late medication delivery, failure of staff to carry out physician orders, nurse falsification of resident care checklists, unsanitary conditions, and substandard care.
In one case cited in the audit report, state officials were two weeks late investigating a report of a resident being repeatedly hospitalized for dehydration; an investigation was finally done 10 days after the resident's death. In another case, state officials were a month late investigating an allegation that a resident lay in feces for more than an hour before being cleaned.
The auditor general has recommended a range of corrective measures,
including more aggressive sanctions, establishment of a 24-hour
complaint hotline, and development of a "report card"
system to help consumers choose a nursing facility.
States Receive HCFA Grants for 'Dual-Eligible' Initiatives
Florida, Maryland, and Wisconsin have received federal grants totaling $450,000 for initiatives to coordinate and integrate health care services for "dual eligibles"-Medicare beneficiaries who also qualify for Medicaid benefits. The Health Care Financing Administration (HCFA) will give each state $150,000 in start-up funds, with the potential for additional matching funds of up to $300,000 over a 12- to 18-month period.
The Florida Department of Elder Affairs will apply its grant to integrate acute and long-term care services for dual-eligibles under its Long-Term Care Community Diversion Pilot Project. The pilot will include "pre-dual eligibles," seniors whose assets are depleted by medical costs and who will soon quality for Medicaid.
The Maryland Department of Health and Mental Hygiene has received two grants. One grant will fund development of a "social" health management organization to integrate financing and delivery of Medicare and Medicaid health care and social services. The other grant will be used to establish a managed care plan to assist physically disabled dual-eligibles' transition from nursing facilities to community-based care through coordinated long-term care and personal assistance services.
Wisconsin's Department of Health and Family Services will use its HCFA grant to coordinate services for both elderly and nonelderly persons requiring long-term care. Under this program, payments for Medicaid-covered long-term care services will be capitated; other Medicaid services will be paid on a fee-for-service basis.
According to HCFA estimates, the nation's six million dual-eligibles comprise 17% of the Medicaid population but consume 35% of total Medicaid expenditures.