Author Archives: Denise Bell
Breakthrough Technology – Add-On Payments for Medical Devices and Antimicrobial Drugs
In its final FY 2020 Medicare Hospital Inpatient Prospective Payment System rule released on August 2, (see fact sheet), the Center for Medicare and Medicaid Services updated payment policies for medical devices that meet the FDA’s Breakthrough Devices designation. Devices that qualify would no longer be required to demonstrate evidence of “substantial clinical improvement” to […]
Advamed Payment Alert: Breakthrough Pathway Payment for Medical Devices
level to 65 percent. These changes represent significant wins for coverage and payment of innovative medical devices and are the latest in a series of payment policy victories that are the result of our multi-year advocacy efforts. Key highlights of the final rule include the following: Alternative NTAP Pathway for Breakthrough Devices and QIDPs Change […]
Medicare to Cover CAR -T-Cell Therapy Nationwide
In an August 7 decision memo, the Centers for Medicare and Medicaid Services announced that Medicare will start covering nationwide CAR T-cell therapy for patients with certain cancers. “President Trump is committed to strengthening the Medicare program by ensuring that beneficiaries have access to new and potentially lifesaving treatments. As the first type of FDA-approved gene therapy, CAR T-cell […]
Industry Talks Life Sciences Careers with Students
On Wednesday, a half dozen Utah life sciences companies loaded up power points, videos and sample products—from syringes and catheters to stroke technology and knee replacements—to talk with parents and students about career opportunities, as part of an evening Medical Innovations Pathways (MIP) orientation at Granite School District. Representatives from BD, Merit Medical, Nelson Labs, […]
Trump Proposes Pathways to Import Canadian Drugs
On Wednesday, The Trump Administration announced a Safe Importation Action Plan – PDF* that outlines two potential pathways that could open the door to import lower cost drugs from Canada. However, no timeline has been specified for the plan, which will be formalized through agency rulemaking. Under Pathway 1, states, wholesalers or pharmacists could submit importation […]
Biomerics Merges with Northeast Laser & Electropolish, Creates New Metals Division
Salt Lake City, UT (August 1, 2019) – Biomerics, a leading contract manufacturer for the interventional medical device market, is pleased to announce a merger with Northeast Laser & Electropolish (NLE), a Monroe, CT-based company. NLE provides contract manufacturing, laser processing, machining, and metal finishing services to a wide range of medical device manufacturers. The merger […]
Senate Finance Committee Approves Drug Pricing Bill
On Thursday, the Senate Finance Committee passed the Prescription Drug Pricing Reduction Act (PDPRA) aimed at cutting drug prices in Medicare Part B and Part D, and Medicaid. The bill, crafted by committee Chairman Chuck Grassley (R-IA) and ranking member, Ron Wyden (D-OR), passed on a bipartisan vote of 19-9, with nine Republicans voting against […]
Recursion Pharmaceuticals Secures $121 Million in Series C Financing
July 15, 2019– SALT LAKE CITY –Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, today announced the closing of a $121 million Series C financing. The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new […]
Recursion Pharmaceuticals Secures $121 Million in Series C Financing
July 15, 2019– SALT LAKE CITY –Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, today announced the closing of a $121 million Series C financing. The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new […]
Trump Administration Withdraws Drug Rebate Plan, TV Ad Rule Blocked, “Favored Nation” Drug Pricing, What Next?
Rebate Rule Withdrawn Yesterday, the Trump Administration withdrew a controversial proposed rule aimed at ending many of the rebates that drug companies pay to pharmacy benefit managers (PBMs) and insurers under Medicare. BioUtah, along with its national partners, the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), had supported the […]
House Increases Funding for National Institutes of Health
On June 19, the House passed a package of health-related FY 2020 Appropriations bills. The legislation, H.R. 2740, contained the Labor, Health and Human Services, and Education Appropriations bill which includes $41.1 billion for the National Institutes of Health (NIH), a $2 billion increase from this year’s funding level. The NIH funding includes $500 million […]
Device Companies Would Have to Report Product Samples Under STAR Act
Drug pricing legislation moving through Congress could force medical device manufacturers to report the value of product samples given to certain healthcare providers. This could include free samples a doctor uses when educating patients on device use. AdvaMed and the Medical Device Manufacturers Association, along with state-based affiliates, including BioUtah, are urging policymakers to exclude […]
