INVESTIGATIONAL TREATMENTS NOT COVERED AUTOMATICALLY UNDER CLINTON HEALTH SECURITY BILL, COVERAGE WOULD BE AT DISCRETION OF INDIVIDUAL HEALTH PLANS

Investigational therapies are not covered under all circumstances under the comprehensive benefit package as defined in President Clinton's Health Security Act. Instead, the decision to cover an investigational treatment would be left to the discretion of individual health plans, the administration proposal states. "A health plan may cover an investigational treatment [as herein described] at its discretion," the Clinton plan explains. The comprehensive benefit package would, however, include coverage of routine care that is given in the course of a qualifying investigational treatment if the care would have been provided anyway. The comprehensive benefit package would include "an item or service [which in other instances would be covered], subject to the limitations and cost sharing requirements applicable to the item or service, when the item or service is provided to an individual in the course of an investigational treatment," the Clinton plan states. There are two prerequisites, however. First, the treatment must be a "qualifying investigational treatment," and, second, the item or service must be one which "would have been provided to the individual even if the individual were not receiving the investigational treatment." The Clinton plan defines a qualifying investigational treatment as a treatment that is "administered for a life- threatening disease, disorder or other health condition (as defined by the National Health Board)...the effectiveness of which has not been determined, and that is under clinical investigation as part of an approved research trial." An "approved research trial" is one which has been approved by the HHS secretary, the director of the National Institutes of Health, the FDA commissioner, the secretary of the Department of Veterans Affairs, the secretary of the Defense Department, "or a qualified nongovernmental research entity as defined in guidelines of" NIH. An approved trial could also be "a peer-reviewed and approved research program, as defined by the secretary of [HHS], conducted for the primary purpose of determining whether or not a treatment is safe, efficacious, or having any other characteristic of a treatment which must be demonstrated in order for the treatment to be medically necessary or appropriate." With regard to immunizations, the proposed National Health Board would be responsible for updating the periodicity schedules for the age-appropriate immunizations covered among the clinical preventive services of the comprehensive benefit package. The board would also establish rules with respect to coverage of an immunization "that is not provided to an individual during the age range for such immunization...that is specified" in the Health Security Act. The plan specifies that an age-appropriate immunization as defined in the Act that is provided consistent with the schedule established in the Act or by the Board would be covered under the basic benefit package. An immunization given during an age range other than the age range specified in the Act is covered only when "provided consistent with any requirement for such immunizations... established by the National Health Board," the plan states. The vaccines that the plan specifies for children under six are hepatitis B, haemophilus influenzae b, diphtheria, tetanus, pertussis, polio, measles, mumps and rubella. Tetanus and diphtheria boosters are covered every 10 years throughout life, and age-appropriate immunizations for influenza and pneumococcal invasive disease are covered for individuals age 65 or older. The plan also notes that the administrative fee for a vaccine provided consistent with an established periodicity schedule is covered "even if the immunization...is not administered during a clinician visit."