The US government issued two proposals last week that may seem to be a case of the right and left hands not knowing what the other is doing. In the first instance, the Food and Drug Administration (FDA) issued a proposal to allow bio-pharma and medical device companies to more easily distribute published articles that discuss uses not approved by the FDA. In the FDA’s press release discussing the “Good Reprint Practices” draft guidance, Randall Lutter, FDA deputy commissioner for policy, states that “Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” and “This guidance also safeguards against off-label promotion.”
The other government proposal is aimed at controlling Medicare spending. This proposal responds to Medicare consuming an increasing share of general revenues. (See previous post.) The proposal’s major items include:
- Expanding “value-based health care” in the Medicare program by:
- Increasing the use of health information technology, including electronic medical records
- Making more pricing and quality information available to patients
- Authorizing the Department of Health and Human Services to release physician-specific measurements of the quality or efficiency of physician performance, and tying healthcare provider reimbursement amounts to quality measurements, and creating incentives for Medicare patients to see higher quality providers.
- Medical liability reform that limits noneconomic damages to $250,000, and protects deep-pockets entitites from paying more than their “share” of responsibility, by “making each party liable only for the amount of damages directly proportional to such party’s percentage of responsibility.”
- Income-relating the Medicare Part D premium for individuals with incomes greater than $82,000 and married beneficiaries with incomes greater than $164,000. (Note, these amounts would not be automatically increased with inflation.)
So on one hand, it seems that the government is looking to expand the use of innovative medical treatments, and on the other hand it looks like it is seeking to cut back reimbursements and make people with Medicare pay more for their treatments – something that has been shown to reduce use. However, I know that these right and left hands do know what the other is doing, and these two actions are compatible under the principle of individual responsibility and empowerment: Both proposals are advocating that patients, clinicians and companies should have and share more information about treatment options and outcomes, and that they should generally be able to make individual choices about their decisions – as long as they are financial responsible for it.
While this all sounds good in principle, there are real concerns about both sets of proposals. I personally am more comfortable with the FDA proposal since it is really extending practices that have existed since 1997 under a recently expired federal law. And assuming the FDA receives more resources to keep on top of these types of practices, I don’t think physicians will be easily hoodwinked, industry will not wildly abuse this information dissemination option, and patients with uncommon conditions will likely benefit. The Medicare proposal on the other hand is really about saving money. The provisions about increasing “value based health care” all sound good, but are very challenging to actually implement to increase the quality of care. The implementation of such quality improving initiatives is something I’m working on right now in a section of my book project involving cultural problems. Changing the cultural environment in healthcare delivery and financing are important parts of making successful processes changes in healthcare delivery. It is a very complicated area, but crucial to actually increasing the quality and efficiency of our healthcare system.
This post has gone on long enough for now. What are your thoughts?