BILL TO BRING DOWN INSULIN PRICES INTRODUCED

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===Good until May 10, 2019===

by: Kim Schrier (D-WA, 8th)

Washington, D.C. - April 18, 2019 - (The Ponder News) -- As Congress holds hearings about the high cost of insulin, U.S. Representative Kim Schrier, M.D. (WA-08) has introduced a bipartisan bill that will bring down the cost of insulin. Rep. Schrier, a member of the Executive Committee of the Diabetes Caucus who has Type 1 diabetes and is a pediatrician, knows all too well how the price of insulin is affecting families all across the country.

“My insulin has tripled in price in the last 10 years and now costs $260, which is in between the price of Chanel No. 5 and cobra venom,” said Rep. Schrier. “We should be doing everything we can to make more affordable treatments widely available, because right now for too many of my patients and people across the country, the cost of insulin is a life or death issue. This bill paves the way for less expensive versions of brand name insulins.”

In December 2018, the Federal Drug Administration (FDA) issued guidance giving drug makers a pathway for biosimilar approvals. Like a generic drug, biosimilars can use an expedited approval process that doesn’t need to duplicate expensive clinical trials and are often sold at a fraction of the price of brand name drugs. The Protecting Access to Biosimilars Act, introduced by Rep. Schrier with Rep. Diana Degette (D-CO01) and Rep. Tom Reed (R-NY23) and Rep. Brett Guthrie (R-KY-02) would make this FDA guidance law. This is important to do because guidance can be easily revoked, throwing a future market into chaos and affecting people who were taking biosimilar drugs.

Most biologics are approved by the FDA under Section 351 of the Public Health Service Act. A handful of protein-based biologics, including insulin, however, are approved under Section 505 of the Food, Drug, & Cosmetic Act. Drug makers are not able to make biosimilar (generic) versions of drugs approved under Section 505 due to regulatory issues.

The Biologics Price Competition and Innovation Act, enacted as part of the Affordable Care Act, clarified that all protein-based biologics, including insulin, must be approved under Section 351 of the Public Health Service Act starting on March 23, 2020. Drug makers can make biosimilars of biologics approved under Section 351. Biologics that were approved under Section 505 prior to March 23, 2020 would receive a “grandfathered approval” under Section 351. FDA guidance on how drug makers can file biosimilar applications after the law’s implementation date on March 23, 2020 was issued in December.

Warner, Scott Introduce Bipartisan Legislation to Protect Diabetes Supplies

Washington, D.C. - October 6, 2017 (The Ponder News) -- U.S. Sens. Mark R. Warner (D-VA) and Tim Scott (R-SC) introduced the Protecting Access to Diabetes Supplies Act of 2017 to strengthen patient protections included in the Medicare National Mail Order program for Diabetic Testing Supplies (DTS). The legislation reinforces existing protections that ensure Medicare beneficiaries are able to continue accessing familiar diabetes supplies and test systems through DTS.

The legislation directs the Center for Medicare and Medicaid Services (CMS) to establish new surveillance programs and requirements for mail order suppliers to better guard consumer access.

“We want to ensure seniors can access the life-saving supplies and technologies that work best for them,” said Sen. Warner. “This bill will allow Medicare to continue employing innovative, cost-saving payment models while also guaranteeing patients’ access to necessary medical supplies. This legislation builds on existing consumer protections and aims to strengthen these safeguards in a pointed and data-driven manner.”

“About a quarter of all Medicare beneficiaries suffer from diabetes, and we should be finding ways to ensure they are able to use medical supplies that provide life-saving results,” said Sen. Scott. “I am glad to work with my colleague Senator Warner on this bipartisan, no-cost legislation to help make sure Medicare beneficiaries living with diabetes have the ability to access state-of-the-art diabetes testing supplies.”

Under the Medicare Competitive Bidding Program (CBP) for Durable Medical Equipment and Supplies, suppliers are paid the same amount by Medicare for DTS regardless of what they supply to a beneficiary. To ensure that beneficiaries continue to have access to familiar test systems, Congress enacted the 50 Percent Rule, which required that mail order suppliers make available at least 50 percent of all types of diabetes test supplies on the market before implementation of the CBP. However, feedback data has indicated these protections may not be adequate.

This legislation seeks to strengthen the 50 Percent Rule protection by establishing a surveillance program and additional safeguards to ensure suppliers are compliant. CMS also established the Anti-Switching Rule to protect beneficiary and physician choice of glucose meters. This rule requires suppliers to furnish the test system requested by the beneficiary, and prohibits suppliers from influencing beneficiaries to switch their current glucose monitor and testing supplies brand to another brand. Recent reports show this rule may not be adequately protecting beneficiaries. This legislation would strengthen the Anti-Switching Rule by both codifying the rule and requiring suppliers to provide beneficiaries with an explanation of the beneficiary’s rights.

The Protecting Access to Diabetes Supplies Act of 2017 has been endorsed by The American Association of Clinical Endocrinologists and the American Association of Diabetes Educators.