Innovation is the lifeline that has made America the most economically successful country of our time. But biomedical innovation is a costly and risky business. For example, only 5 percent of new cancer compounds reach patients. Once a breakthrough drug or device is approved for safe and effective use by Food and Drug Administration (FDA) patients, especially those participating in public health programs, they need to be accessible immediately. there is. Unfortunately, this is far from the fact.
For example, patients with Alzheimer’s disease had high expectations for biogen’s aducanumab, but the Medicare & Medicaid Service Center (CMS) did not seem to trust the FDA’s decision to approve the drug. Medicare has limited the scope of aducanumab to those who received it as a participant in a clinical trial.
Although it is unusual for FDA-approved drugs to be severely restricted, Medicare regularly exercises its discretion regarding medical devices. Approval from both the FDA and CMS takes an average of 4.5 years and costs as much as $ 94 million. For comparison, the process in Europe is often completed in about 11 months, only 3 months, at a much lower cost. For example, the CMS took 35 months to determine coverage for the Independence Ibot Mobility System, a wheelchair that can move up stairs to restore mobility.
Such delays affect the poor, the minority, and the elderly disproportionately. Wealthy people among us can afford to pay the full amount for FDA-approved breakthrough therapies and devices if their providers offer them. The more vulnerable members of our society, especially the few older people with fixed incomes, do not have this option, leading to stock inequality due to government bureaucracy.
Aside from the negative health effects, such delays raise barriers to innovation, especially for small technology start-ups. These small businesses take longer to recover their risky investments and increase the cost of taking future risks to develop life-changing innovations.
Access to medical care for vulnerable people has driven the Trump administration to drive innovative technology Medicare Coverage (MCIT) rules. This policy enables immediate, provisional coverage of FDA-approved groundbreaking designated devices, and the CMS has taken the process of making the final coverage decision.
Unfortunately, the Biden administration abolished MCIT shortly after taking office, and 61 bipartisan lawmakers protested. The fact that the CMS and FDA recently felt the need to justify these actions in a joint statement speaks for itself. The promise to replace the program remains unresolved.
If the Biden administration ends a program to help vulnerable people or severely restricts access, health inequalities and inequality complaints from the left wheel will be hollowed out and dishonest. The direct harm of the abolition of this policy is the poor, the underprivileged, and the sick, not the wealthy and healthy.
Fortunately, not all policy makers in Washington see things the same as the Biden administration. The House Republican Health Future Task Force Treatment Subcommittee, led by Congressman Brad Wenstrup, DPM (R-Ohio), John Joyce, MD (R-Pa.), And Bruce Westerman (R-Ark.), Announced a new set of policies. A solution designed to accelerate innovation, remove government bureaucrats from the equation, and allow patients and their physicians to determine the best treatment options.
These solutions include breakthrough medical device and therapeutic CMS coverage acceleration. It also includes speeding up the FDA’s approval process for breakthrough technologies and expanding the availability of clinical trials to the voluntary public. This is a strategy similar to COVID-19’s Operation Warp Speed, accelerating discoveries in market processes while increasing access to more Americans, especially rural people. In addition, these lawmakers oppose the use of quality-adjusted life years (QALYs). This is an arguably flawed measure of the value of life that other countries use to distribute medical resources. Treatment decisions should be left to the patient, family, and their doctor.
The United States needs fiscal policies for economically sustainable health that encourage innovation and increase access to the latest technologies for disadvantaged people. This is especially important for FDA-approved breakthrough products that can make a difference in the lives of those who can’t afford it. Conclusion: We believe that you and your doctor should decide on your care and make it available under your health plan. Must not be excluded by Washington bureaucrats.
Dr. Philip H. Fan is a professor at Alonzo and Virginia Decker at the Johns Hopkins Carry Business School and is co-appointed as a professor at Johns Hopkins School of Medicine.
Joe Grogan, JD, is a visiting senior researcher at the USC Leonard D. Schaefer Health Policy and Economic Center and a former board member of the White House National Policy Council under President Donald Trump.
