From holy grail to total fail — misses in our healthcare system

U.S. health reform is supposed to result in achieving the Triple Aim - the equivalent of the Holy Grail — improving care quality, bettering patient outcomes and patient experience whilst lowering healthcare costs by improving value.

Yet, here we are in the fourth quarter of 2016 with a health system in the throes of a crisis that includes opioid overuse that doesn’t discriminate, doctors that don’t have access to effective, safer options to manage chronic diseases, patients pining for medicines that don’t have damaging side effects, and costs that continue to skyrocket.

One could argue that doctors and patients have access to plenty of synthetic drugs (pharmaceuticals) to treat chronic disease, but here are some sobering statistics about prescription drug use in the U.S.:

  • One-third of people aged 45 to 64 and half of people aged 65 and older have taken more than three pharmaceuticals in the last 30 days.

  • Nationally representative surveillance data indicate that adverse drug events (ADEs) account for more than 3.5 million physician office visits, an estimated 1 million emergency department (ED) visits, and approximately 125,000 hospital admissions each year and over 30,000 deaths related to adverse drug reactions in 2009.

  • Long-term use of synthetic NSAIDs and opioids can have dangerous side effects; especially, for those who also suffer from kidney, stomach or heart conditions

  • ADEs cost the U.S. healthcare system $136 billion yearly.

The aging of the population and the vulnerability of older adults to ADEs will have significant implications for Medicare. In 2050, the number of Americans aged 65 and older is projected to be 88.5 million, more than double its population in 2010 of 40.2 million.

Prescription opioid use — and resulting deaths — have quadrupled over the last 20 years. Opioids carry additional risks for older adults such as heart issues, addiction, falls and other accidents due to extreme drowsiness. Unfortunately, the bottom line is that doctors have to make a trade-off between getting patients the symptomatic relief they need and risking serious side effects.

Hitting the bullseye with a better option for chronic disease management

Doctors face limited options due to lack of innovation to manage these conditions. Patients are becoming more concerned about their health and are looking elsewhere for answers. What they don’t know is there is a whole class of natural prescription medicines available already, prescription medical foods.

Medical foods work on the underlying cause of disease, rather than masking symptoms. They are a critical option for people suffering daily from chronic conditions such as osteoarthritis, osteoporosis and chronic venous disease; especially for special patient populations who suffer from other risk factors and aren’t candidates for surgery or other measures.

What is a medical food?

Prescription medical foods contain natural molecules, such as flavonoids found in green tea, red wine and dark chocolate that have been proven to possess potent antioxidant and anti-inflammatory effects that help the body restore its own balance. They are regulated by the U.S. FDA, but are in a separate category than drugs and supplements. A medical food is intended for the dietary (metabolic) management of a disease and must be used under a doctor’s supervision. The ingredients in medical foods are Generally Recognized as Safe (GRAS), the highest standard of safety, by the Food and Drug Administration (FDA).

Prescription medical foods can be effective and safe for managing the underlying cause of variety of conditions in dermatology, obstetrics/gynecology, orthopedics, pain management, podiatry, rheumatology, and vascular health. Like pharmaceuticals, medical foods require physician supervision. However, unlike synthetic prescription drugs, they don’t carry the risk of dangerous side effects.

Due to lack of knowledge and health plan coverage issues, medical foods are not being used to their full extent, including as a first-line option to opioids in the management of osteoarthritis joint discomfort. Most insurance companies, Medicare, Medicaid and Tricare deny coverage to this safer and generally lower cost option to most pharmaceuticals.

There is a clear need for action to stem the growing number of ADEs from synthetic drugs and risks associated with opioid use. Medical foods can provide the option, but we need better access.

It’s time to stop the spin and really reform healthcare.

Despite the clear cut benefits of medical foods with regard to efficacy, safety and cost, more prescription drug plans are dropping them from their formularies, leaving patients to go without or incur the financial strain.

At the federal level, the Senate Special Committee on Aging held a hearing earlier this year about seniors and opioid use that included testimony from clinical experts and the Centers for Medicare & Medicaid Services. All acknowledged that the opioid crisis affects seniors and there is currently nothing in place to stem the alarming increase in usage that threatens their health. That hearing was more than nine months ago, and CMS, health plans and the government still haven’t proposed any solutions beyond legislation for better access to recovery programs. Basically, the government is reacting to a problem versus proactively preventing it.

Our active duty military members and veterans aren’t faring any better with getting Tricare to cover medical foods. In its report on the National Defense Authorization Act (NDAA) for Fiscal Year 2017, the House Committee on Armed Services noted issues with osteoarthritis and prescription opioid use and directed the Secretary of Defense to report on and brief the Committee on the following:

  • Recommendations on prevention and treatment to reduce the suffering of service members from osteoarthritis

  • Research on next-generation analgesics in order to identify new pain relievers with reduced abuse, tolerance, and dependence risk

  • Development of more effective means for preventing overdose deaths

Until the NDAA passes Congress (it is currently in reconciliation between the House and the Senate and not likely to become law until after the 2016 presidential election), it is expected that there will not be any further movement on these studies by either the House of Representatives or the Secretary of Defense. Whether the Tricare coverage of medical foods language in the Senate’s version of the NDAA is accepted into the final language of the bill and the President signs the final bill remains unknown. Last year’s NDAA was vetoed.

Let doctors be doctors.

As medical professionals, our hands are tied. We want to offer patients the best options but have to keep in mind their willingness or ability to pay out of pocket for medicines that federal and commercial plans refuse to include on their formularies.

Patients need to speak with their doctors about whether prescription medical foods are right for them. They should also demand that their insurance carriers provide coverage for this effective and safer option for managing chronic conditions associated with aging. Beyond that, the time is now for Congress to act and help this country achieve the Triple Aim by pushing Medicare, Tricare and commercial health plans to improve access by providing coverage for prescription medical foods to ensure doctors and patients achieve better outcomes.

Dr. George Munoz, M.D., is a Board Certified Internist and Board Certified Rheumatologist. He completed a post-doctoral Fellowship in Integrative Medicine (2006-2008), taught by the world class faculty at the prestigious University of Arizona Center for Integrative Medicine, founded by Andrew Weil, MD. He is a national speaker on topics including nutrition, arthritis and inflammation.


The views expressed by contributors are their own and not the views of The Hill.