AIDS TREATMENT NEWS Issue #184, October 1, 1993
John S. James

Some of the major benefits (which could, however, be lost in political negotiations):

* Those with no health insurance or Medicaid (about 30 percent of people with AIDS) would get health coverage. However, states will have about two years from passage of the Clinton proposal to implement their health plans and extend coverage to almost everybody.

* Medicaid (MediCal in California) now covers about 40 percent of people with AIDS, and coverage varies tremendously from state to state. The Clinton plan will set standards intended to assure a basic level of coverage wherever one lives. Persons on Medicaid who also qualify for SSI or AFDC will have the same benefits and choice of plans as everyone else. It is still unclear how others on Medicaid will be covered.

* Those who have private health insurance will not risk losing their coverage -- because they change jobs, because their insurance company controls the rules and finds a way to drop them after learning they are sick, or for other reasons. Persons with "pre-existing conditions" who are now stuck in unsuitable jobs will be able to change.

* Prescription drugs will be covered, with patients probably paying $5 or $10 for each prescription.

* Health plans "are required to provide coverage for routine patient care associated with approved clinical trials." This should prevent volunteers in trials from being charged for these costs, as often happens today.

* While individuals will have to pay some fees for health care, anyone's out-of-pocket costs will be limited to $1500 per year.

* People will be able to choose either a managed-care plan, or a fee-for-service plan. Fee for service will be more expensive; but it may be better for persons with special medical needs. In either case, it should be possible to choose a physicians outside the plan and be covered, although one must expect a larger copayment when going outside the plan.

The AIDS Action Council, which lobbies the Federal government on behalf of more than 1000 AIDS organizations, strongly supports the Clinton plan. Jeff Levi, policy director at AIDS Action, recently said, "People with HIV will do well under this plan, if its scope is not reduced. We will be fighting against cutbacks and for strengthening key provisions." AIDS Action Council has identified some potential problem areas:

* It is not clear that "off label" use of FDA-approved drugs will be covered, even though such use is often the standard of care for persons with AIDS, cancer, and other major illnesses.

* Some coverage, such as mental health and substance abuse services, will be phased in slowly, over a number of years.

* Massive computerization of patient records will probably occur, and it is not yet clear how confidentiality will be protected.

* While the Clinton plan is expected to provide long-term care, emphasizing home and community-based care, there could be problems with eligibility criteria for these services.

* Managed-care plans have often been a problem for persons with HIV or other diseases that require expensive and/or specialized care. Patients must have access to HIV experts (not only infectious- disease specialists), without "gatekeeping" by non-experts. They may need to choose physicians outside the plan when necessary. And the plans must have financial incentive to enroll persons with expensive illnesses.

The off-label issue is a difficult one with managed-care systems. These are drugs which are approved by the FDA for some medical conditions ("indications"), but are also used for other conditions -- for example, a cancer drug officially approved for certain tumors, but widely used for other tumors as well. They may be standard, accepted, and necessary treatments when used off label, and not officially approved for those uses only because the pharmaceutical company which sells the drug did not do the research and paperwork to gain official approval. The FDA has long made it clear that off- label use can be legitimate and necessary, and that its labeling is not intended to control reimbursement decisions.

Managed care plans, however, almost by definition are unwilling to pay for everything a physician might want to do. In the absence of generally recognized standards, the plan may make its own decisions on what treatment is legitimate. But these decision are hardly disinterested ones, since clearly there is a financial incentive to refuse to approve requested treatments. And official standards lag well behind the real standard of care, since it takes time to formalize and certify the actual practices which are accepted by competent physicians.

Various ways have been suggested to reduce this problem, including:

- Using formularies, such as the U.S. Pharmacopoeia, or lists prepared by medical centers well regarded for HIV (or other specialty) expertise. If a drug usage appeared in any of the accepted formularies, it would be reimbursed. However, there is often a serious lag between actual practice and publication in the formularies.

- Holding frequent "consensus conferences" of leading experts, to produce up-to-date recommendations for physicians. Any drug usage recommended by these conferences would be automatically reimbursed. - Treating life-threatening conditions differently than other illnesses. Perhaps any treatment recommended by a physician would be reimbursed, without need for prior approval, unless the treatment had been specifically disallowed for extraordinary reasons.

- Having an appeal mechanism, so that an organization with no financial stake could resolve disputes rapidly, without the time and expense required for going to court.

Another issue -- raised by the pharmaceutical industry, not by AIDS Action Council -- concerns price controls on new drugs, which may be included in health care reform. Industry supporters argue that the cost of new drugs for life- threatening conditions is only 0.2 percent of the total health care expenditures in the U.S. -- and that without the incentive of sky's-the-limit prices, industry will not bother to develop drugs to save lives. Our own experience in reporting on AIDS treatment development for the last several years suggests that this self-assessment by industry is unfortunately often true; for example, there was little interest anywhere in developing AIDS treatments until AZT broke new ground on prices and made big money. Instead of waiting for an ethical renewal, we might be better off paying the toll, through an exception from any price controls for drugs which advance the treatment of the most significant illnesses; a partial precedent already exists in the favored handling of "orphan drugs" for serious but rare diseases. High prices are less offensive when we all pay through a small percentage, than when the whole burden hits individuals already in a personal and financial crisis. And nothing in medicine is more important than better treatment for life- threatening and disabling conditions, not only for orphan diseases but also for those which affect large numbers of people.

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