There seems to be a lot of confusion regarding who is responsible for a given task within the US health system. I’ve heard people complain that “the AMA is keeping us from getting a new product” (they don’t have that power), or “the FDA is keeping healthcare prices high” (they don’t regulate pricing or reimbursement). Here’s a quick and simple cheat-sheet that summarizes things.
AMA: The American Medical Association coordinates education and licensing of physicians, though the act of licensure is up to state-appointed boards. The AMA specifically attends to MDs, while nurses, physician’s aids, therapists, chiropractors, etc. have their own similar organizations. There are also numerous specialty-oriented associations for orthopedists, cardiologists, radiologists, urologists, etc. These private associations generate consensus about best clinical practices. They do have significant lobbying power, but cannot directly cause a treatment to be adopted by payers such as CMS or private insurers, or cause a treatment to be ok’ed by the FDA.
CDC: The Centers for Disease Control and Prevention coordinate medical surveillance, epidemiology, federal responses to outbreaks, and related research. The CDC can offer guidelines on best practices, and often works with other agencies such as the CMS or VA to apply pressure on private healthcare facilities to change their behaviors. Thus CDC has been able to encourage adoption of new HAI (Hospital Acquired Infection) control and monitoring measures by getting CMS to offer penalties to non-compliant facilities.
CMS: The Center for Medicare & Medicaid Services (I have no idea why the acronym only uses one ‘M’) administers both Medicare and Medicaid, including determinations as to which medical treatments will be paid for, and how much. While the CMS doesn’t have any power to regulate private insurers, they often follow CMS’s lead. Medical practitioners are free to administer any legally available treatment they deem medically necessary; insurers only determine which treatments they will pay for via the patient’s insurance plan.
FDA: The Food and Drug Administration regulates whether medical drugs, medical devices, medical biologic therapies, vaccines, veterinary products, cosmetics, food components, and nutritional supplements are safe and effective for use. Their mandate comes from both the Food, Drug, and Cosmetics Act (1938) and its amendments, plus the Interstate Commerce clause of the US Constitution*. FDA permission is required to market new products or to market existing products under new labels. The FDA also reviews clinical trial plans and grants exceptions to marketing approval for investigational products. The FDA does not mandate practice of medicine; any legally marketed product can be used in any way deemed necessary by a licensed healthcare professional (called ‘off-label use’). The FDA only controls what the manufacturer, distributor, or importer can claim the product does.
HHS: The US Department of Health and Human Services is an executive-branch entity within the Federal Government. HHS oversees the CDC, CMS, FDA, NIH, PHS, and other offices. The Secretary of Health and Human Services reports directly to the President.
NIH: The National Institutes of Health coordinate and fund health research at the national level. The NIH gathers together 27 Institutes and Centers focused on various aspects of healthcare, including musculoskeletal health (NIAMS), allergy and infectious disease (NIAID), the National Library of Medicine (NLM), and others. As a research-focused organization, NIH can drive resources towards a health issue, but cannot immediately effect treatment during an emergency. Note that there are numerous private foundations that support research in disease-specific areas, but NIH provides the bulk of academic research funding in the US.
PHS: The Public Health Service is the primary field arm of HHS, providing resources and personnel (coordinated with staff from the CDC and FEMA as appropriate) to promote healthy practices and respond to health issues. Interestingly, the PHS includes a uniformed officer corps; the US Surgeon General is the operational head of the PHS, and carries the rank of Vice Admiral.
VA: The Veteran’s Administration oversees healthcare for military veterans. Similar to CMS, they are influential but have no direct power over private insurers. The VA does have some research funding, but it is generally more limited than that of the NIH.
WHO: The World Health Organization is an international entity operating under the United Nations. The WHO provides financial, material, and personnel resources to promote healthy practices and respond to international health emergencies, generally when a nation’s resources are incapable of mounting a coordinated response due to poor infrastructure or an overwhelming emergency. Despite what your buddy on Facebook might claim, the UN has no ability to enact or enforce laws, policy, or practices within a sovereign nation.
So if a new medical product isn’t available in the US, talk to the FDA. If a procedure using existing products isn’t being used, talk to the AMA (or similar advocacy group). If a product or procedure is available but not being paid for by insurance, talk to the CMS, VA, or your insurer. If you’re concerned about the spread of infectious disease, talk to the CDC. If you want research resources to target a particular condition, look to the NIH.
*While a strict reading of the FD&C Act and the Constitution might initially suggest that FDA can only regulate a product if it moves across state lines, the FDA, Congress, and US Courts have broadly interpreted the situation. Thus if a person moves across state lines to obtain a product not available in their state, they have conducted Interstate Commerce and made the product open to Federal regulation.
