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Source: United States House of Representatives – Congressman Brad Wenstrup (OH-02)

Washington, D.C.—Congressman Brad Wenstrup (OH-02) introduced H.R. 8624, the Protecting Access to Innovation During COVID-19 Act, to ensure patients can continue accessing innovative new drugs and devices during and beyond the ongoing pandemic.

“Our nation’s medical community made necessary changes, sacrifices, and restrictions over the last year to prioritize combatting COVID-19, but medical innovation and development should not be compromised,” said Congressman Wenstrup. “This May, I joined Rep. Sanford Bishop in sending a letter to Health and Human Services and the Centers for Medicare & Medicaid Services asking them to extend the pass-through period for new drugs and new devices, and I’m proud to join Rep. Bishop again on this bill to ensure that we don’t punish medical innovation because of closures that occurred during the public health emergency.”

“ASCRS strongly supports the Protecting Access to Innovation During COVID-19 Act, which allows the U.S. Department of Health and Human Services (HHS) to extend the pass-through period for devices and drugs, ensuring optimal access to surgical care products once the pandemic recedes. Without it, we are concerned that CMS’ claims data may lead to inaccurate policy conclusions related to products and patient access will be harmed. We applaud this bill to protect the full duration of data collection and reimbursements afforded by pass-through status,” said Terry Kim, MD, President of American Society of Cataract and Refractive Surgery.

“The American Academy of Ophthalmology supports Reps. Wenstrup and Bishop efforts to advance legislation that provides the HHS Secretary authority to give a temporary passthrough extension for products impacted by the COVID-19 public health emergency. The PHE has impacted the accurate data collection on many new treatments, including those related to ophthalmic surgery which was largely shuttered for more than two months this year. This bill will help ensure that providers and patients continue to have access to new treatments. We support similar legislation in the Senate introduced by Sens. Rand Paul and Doug Jones,” said David Glasser, MD, American Academy of Ophthalmology Secretary for Federal Affairs. 

“The American Association of Neurological Surgeons and Congress of Neurological Surgeons thank Representatives Wenstrup and Bishop for their leadership in supporting innovative medical breakthroughs. Giving the Secretary of Health and Human Services the ability to extend Medicare’s pass-through payment status for products effected by the COVID-19 public health emergency will help pave the way to ensure that cutting-edge medical technologies — such as neurostimulators, which relieve suffering from debilitating spinal disorders, including chronic pain — are available for our patients,” said John A. Wilson, MD, President of American Association of Neurological Surgeons.

“During the ongoing public health emergency, physicians are striving to provide the highest quality care and that means being able to use new drugs, devices or biologics,” said American Association of Orthopaedic Surgeons President Joseph A. Bosco III, MD, FAAOS. “This legislation helps ensure the access and flexibilities needed to adopt innovative technologies during these uncertain times.”

Background on Rep. Wenstrup’s H.R. 8624, the Protecting Access to Innovation During COVID-19 Act:

·      To encourage the use of innovative products, the Centers for Medicare & Medicaid Services (CMS) allows for an initial separate payment for new devices and drugs in the hospital-based outpatient department (HOPD) and ambulatory surgery center (ASC) settings using pass-through status.

·      CMS then collects utilization data from the procedures using these new products during a specified time period to determine how to adjust the payment for the service. In statute, this time period lasts 2-3 years.

·      During the COVID-19 public health emergency, the Surgeon General and CMS urged the cancellation of all elective medical procedures.

·      A majority of the products that qualify for pass-through status are furnished during elective procedures.

·      As elective procedures were ceased across the country during the COVID-19 public health emergency, utilization data will be skewed for current pass-through devices.

·      This bill would give the HHS Secretary authority to give a product with pass-through status an extension if the Secretary determines that the cost of the product is unable to be accurately calculated due to the effects of COVID-19.