Patients Deserve Immediate Access to FDA-Approved Innovations — Not Bureaucratic Restrictions

Editor’s note: This op-ed was first published in The Hill on May 21, 2022.

Innovation is the lifeblood that has made America the most economically successful nation in the modern era. Biomedical innovation, however, is a costly and risky business. For example, only 5 percent of new cancer compounds make it to patients. Once breakthrough drugs or devices are approved as safe and effective for use by the Food and Drug Administration (FDA) patients — especially those on public health programs — should have immediate access to them. Unfortunately, this is far from the case. 

For example, Alzheimer’s patients had high hopes for Aduhelm from Biogen, but the Centers for Medicare & Medicaid Services (CMS) apparently did not trust FDA’s judgment in approving the drug. Medicare limited coverage of Aduhelm to only people receiving it as participants in clinical trials.

While highly restricted coverage for an FDA-approved drug is unusual, Medicare regularly exercises coverage discretion with respect to medical devices. Approval from both FDA and CMS takes an average of 4.5 years, and cost as much as $94 million. For comparison, the process in Europe is often completed in about 11 months and in as little as three, and at much lower cost. For example, it took CMS 35 months to make a coverage determination on Independence Ibot Mobility System, a wheelchair that can navigate stairs and restore mobility.

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Such delays disproportionately affect the poor, minorities and seniors. The wealthy among us can afford to pay out of pocket in full for FDA-approved breakthrough therapies and devices if their providers offer them. The more vulnerable members of our society, particularly, minority seniors on fixed incomes, do not have this option, leading to an equity gap because of government red tape.  

Aside from the negative impact on health, such delays increase barriers to innovation, especially for small technology startups. It takes these smaller firms longer to recoup their risky investments, if at all, and increases the costs of taking future risks to develop more lifechanging innovations.  

Health care access for vulnerable people drove the Trump administration to push the Medicare Coverage of Innovative Technologies (MCIT) rule. This policy would have allowed for immediate provisional coverage of breakthrough designated devices approved by FDA, while CMS worked through the process of making a final coverage determination.  

Unfortunately, the Biden administration repealed MCIT shortly after taking office, a move protested by 61 bipartisan members of the House. The fact that CMS and FDA recently felt the need to justify these actions in a joint statement is telling. Promises to replace the program remain unkept.

When the Biden administration ends a program that helps the vulnerable, or severely limits access, the complaints of health disparities and inequity from the left ring hollow, and disingenuous. It is the poor, the underprivileged and the sick who are directly harmed by the repeal of this policy, not the wealthy and the healthy.  

Fortunately, not all policymakers in Washington view things the same way as the Biden administration. The House Republican Healthy Futures Task Force Treatments Subcommittee, spearheaded by Reps. 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 bureaucrats from the equation so patients and their doctors can decide the best treatment options. 

These solutions include speeding up CMS coverage of breakthrough medical devices and treatments. They also include speeding up the FDA approval process for breakthrough technologies and expanding the availability of clinical trials to the willing public. This is a strategy akin to Operation Warp Speed for COVID-19, which would accelerate the discovery to market process while increasing access for more Americans, particularly those in rural areas. Additionally, these lawmakers oppose the use of quality-adjusted life years (QALYs), an arguably flawed measure of the value of a life that other nations use to distribute health care resources. Treatment decisions should remain with patients, families and their doctors. How the Food and Drug Administration saved thousands of livesExecutive privilege for ex-presidents? Not this time

America needs an economically sustainable public financing policy for health that incentivizes innovation and increases access to the latest technologies for the disadvantaged. This is particularly important for FDA approved breakthroughs that can make a difference to the lives of people who can least afford them. Bottom line: We believe that you and your doctor should decide on your care, and have that care available under your health plan — not have it ruled out by some bureaucrat in Washington.

Phillip H. Phan, Ph.D., is Alonzo and Virginia Decker professor at the Johns Hopkins Carey Business School with joint appointment as professor in the Johns Hopkins Department of Medicine.  

Joe Grogan, JD is a visiting senior fellow at the USC Leonard D. Schaeffer Center for Health Policy and Economics, as well as former director of the White House Domestic Policy Council under President Donald Trump.