Patients should have immediate access to FDA-approved innovations—not bureaucratic restrictions

Innovation is the lifeblood that has made America the most successful nation in the modern economy. However, biomedical innovation is a costly and risky business. E.g, Only 5% of new cancer compounds Give it to the patient. Once a breakthrough drug or device is approved by the Food and Drug Administration (FDA) for safe and effective use, patients—especially those involved in public health programs—should have immediate access to them. Unfortunately, this is far from the case.

For example, Alzheimer’s patients have high hopes for Biogen’s Aduhelm, but the Centers for Medicare and Medicaid Services (CMS) Apparently Does Not Trust FDA’s Judgment in approved drugs. Medicare Limited Aduhelm Coverage Only those who receive it as clinical trial participants.

While coverage for FDA-approved drugs is highly limited abnormal, Medicare regularly exercises coverage discretion for medical devices. FDA and CMS approval required Average 4.5 years, cost up to $94 million. In contrast, European processes are typically 11 months, minimum time Three, and at a much lower cost.For example, CMS took 35 months to make Coverage is determined Wheelchairs about the Independence Ibot Mobility System Can navigate stairs and restore liquidity.

Such delays disproportionately affect the poor, minorities and the elderly. The rich among us can buy FDA-approved breakthrough therapies and devices out of our own pockets, if provided by suppliers. The more vulnerable members of our society, especially fixed-income minority seniors, do not have this option, resulting in equity gaps due to government red tape.

In addition to the negative health effects, this delay also increases barriers to innovation, especially for small tech startups. These small companies take longer to recoup their venture capital, if any, and increase the cost of taking future risks to develop more life-changing innovations.

Vulnerable access to health care prompts Trump administration push Medicare Coverage for Innovative Technologies (MCIT) rule. The policy will allow immediate provisional coverage for FDA-approved breakthrough-designated devices while CMS completes the process of final coverage determination.

Unfortunately, a Biden administration abolition Shortly after MCIT took office, the move was met with 61 bipartisan lawmakers. In fact, CMS and FDA have recently deemed it necessary to Joint Statement is telling. The promise to replace the program remains unfulfilled.

When a Biden administration ends a program that helps the disadvantaged or severely restricts access, complaints from the left about health disparities and inequality are hollow and dishonest. Repeal of this policy directly hurts the poor, the vulnerable and the sick, not the rich and healthy.

Fortunately, not all policymakers in Washington see things in the same way as a Biden administration.The House Republican Health Futures Task Force Therapeutic Subcommittee, led by Rep. Brad Wenstrup, DPM (R-Ohio), John Joyce, MD (R-Pa.), and Bruce Westerman (R-Ark.), released a new set of Policy Solutions Designed to encourage innovation and remove government bureaucracy from the equation so patients and their doctors can decide on the best treatment options.

These solutions include accelerated CMS coverage of breakthrough medical devices and treatments. They also include expediting the FDA approval process for breakthrough technologies and expanding the availability of clinical trials to the willing public. It’s a tactic similar to COVID-19’s Operation Warp Speed ​​that will accelerate the discovery-to-market process while increasing opportunities for more Americans, especially those in rural areas.Furthermore, these lawmakers oppose the use of quality-adjusted life-years (QALYs), an arguably flawed A measure of the value of life That Other countries use Allocate healthcare resources. Treatment decisions should be made by the patient, family, and their physician.

The United States needs an economically sustainable public health financing policy that incentivizes innovation and increases access to the latest technologies for disadvantaged populations. This is especially important for FDA-approved breakthroughs that can change the lives of those who cannot afford it. Bottom line: We think you and your doctor should make decisions about your care and provide that care according to your health plan — don’t be left out by some bureaucrats in Washington.

Dr. Phillip H. Phan is the Alonzo and Virginia Decker Professor at the Johns Hopkins Carey School of Business and co-appointed Professor in the Johns Hopkins Department of Medicine.

Joe Grogan, J.D. is a visiting senior fellow at the USC Leonard D. Schaeffer Center for Health Policy and Economics and White House Domestic Policy under President Donald Trump Former Director of the Committee.

Leave a Reply

Your email address will not be published. Required fields are marked *