Latest news with #NationalCoverageDetermination
Business Upturn
11-07-2025
- Health
- Business Upturn
Recor Medical Supports Proposed CMS National Coverage Determination of Renal Denervation for the Treatment of Hypertension
Palo Alto, CA, July 10, 2025 (GLOBE NEWSWIRE) — Recor Medical, Inc. ('Recor') and its parent company, Otsuka Medical Devices Co., Ltd. ('Otsuka Medical Devices'), today announced their support for the Centers for Medicare and Medicaid Services' (CMS) proposed National Coverage Determination (NCD) for Renal Denervation (RDN), a device-based therapy for patients with uncontrolled hypertension—individuals whose blood pressure cannot be properly managed with lifestyle changes and medication. The proposed NCD, released on July 10, 2025, recommends coverage for ultrasound renal denervation (uRDN) and radiofrequency renal denervation (rfRDN) for uncontrolled hypertension. A 30-day public comment period is now open for healthcare professionals, professional societies, and industry to provide input before CMS issues its final determination in October. 'We are encouraged by CMS's proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need,' said Lara Barghout, CEO of Recor Medical. 'This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.' Recor has been focused on developing and testing the Paradise uRDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an 'off-meds' setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study, which intends to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension. The Paradise uRDN system is currently commercially available for patients in the US having received FDA approval in November 2023. It is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. About the Paradise uRDN System The Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall. About Recor Medical, Inc. Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved for sale in the United States, and is CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ('GPS') Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States. Recor Medical About Otsuka Medical Devices Co., Ltd. Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. ( a global healthcare company listed on the Tokyo Stock Exchange (JP 4578). Media ContactLisa OwensThe Mullings Group [email protected] +1-210-601-6647
Yahoo
25-06-2025
- Business
- Yahoo
Medtronic Stock Rated Outperform as Renal Denervation and Spin-Off Drive Growth Potential
Medtronic, Inc. (NYSE:MDT) ranks among the top stocks for an early retirement portfolio. On June 18, RBC Capital reiterated a $101 price target and an Outperform rating on Medtronic, Inc. (NYSE:MDT), emphasizing the company's renal denervation system as an undervalued market opportunity. Pixabay/Public Domain The firm assessed the potential of Medtronic's Symplicity Spyral renal denervation system, which treats hypertension, using a private survey with forty-four respondents. The survey results will be made public in advance of the crucial Centers for Medicare & Medicaid Services (CMS) National Coverage Determination, which is scheduled for July 11, 2025, at the latest. Furthermore, Medtronic plc (NYSE:MDT) declared that it would spin off its diabetes division into a separate company named MiniMed. About 8% of Medtronic's overall revenue comes from the diabetes segment, and the spin-off is anticipated to streamline operations. A prominent name in medical technology, Medtronic plc (NYSE:MDT) focuses on the creation, production, and marketing of device-based therapeutics. With notable breakthroughs in spine and minimally invasive treatments, the company ranks as a leader in robotic-assisted surgery technology. While we acknowledge the potential of MDT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
03-06-2025
- Business
- Yahoo
Opinion - The Medicare device coverage gap delays life-saving treatment for seniors
Imagine dying of thirst with a glass of water just out of reach. The analogy is extreme, but that is how helpless some patients feel when they can't access therapies approved to treat their deadly disease. That vulnerability is particularly acute for people aged 65 and older whose lives depend on access to advanced medical devices. This is due to the Centers for Medicare and Medicaid Services' current reimbursement policies that delay Medicare coverage of these groundbreaking therapies because they are administered by a device, not a pill or a syringe. Over the last decade, there has been a welcomed emergence of cutting-edge medical devices that treat a wide range of chronic diseases — including glioblastoma, a deadly brain cancer with a significantly poor prognosis. These groundbreaking technologies put patients in control of their care by providing them with the freedom to receive the treatments they need from the comfort and convenience of their many cases, the Food and Drug Administration has recognized the importance of these therapies by approving them for patient use. However, CMS' reimbursement policies for medical devices continue to prevent many of these same patients from gaining timely access to those treatments. As it stands, there is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare. This is time that many patients diagnosed with hard-to-treat cancers do not have. Modernizing the reimbursement framework for new FDA-approved medical devices would provide patients access to game-changing treatments that can improve their overall quality of life and give them more time with their friends and family. Nothing can prepare you for the heartbreaking news that you or a loved one has been diagnosed with a primary or metastatic brain tumor. Yet, this is the reality for the 1.3 million Americans living with this devastating disease. Throughout my own battle with cancer, I was blessed to have friends and family by my side as I underwent treatment. Their support was critical to my survival, and that experience continues to inspire my commitment to patients who deserve unrestricted access to innovative therapies that can extend and improve their lives. Washington leaders are broadly in agreement over the need to close this gap in coverage. The previous administration tried to fix it by releasing the long-awaited Transitional Coverage for Emerging Technologies pathway last year. Unfortunately, it fell well short of patients' expectations. Among other things, it forced most devices through the National Coverage Determination pathway, which does not guarantee a faster review. It also capped the number of devices eligible for expedited Medicare coverage to five annually. A bipartisan group of lawmakers likewise attempted to solve the problem. They introduced common-sense legislation that would have eliminated the five-product maximum under Transitional Coverage for Emerging Technologies and ensured that all new FDA-approved medical devices are instantly covered by Medicare. It garnered robust support in both chambers, passing out of the House Ways and Means Committee before running out of time to advance in the Senate. Thankfully, Sens. Todd Young (R-Ind.) and Alex Padilla (D-Calif.) have recently teamed up in the 119th Congress to introduce the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2025, which seeks to streamline Medicare's regulatory process, cutting red tape and strengthening access to proven therapies for seniors. Far too many seniors are being told to wait, not because the necessary treatments don't exist but because Medicare's reimbursement policies have overlooked the critical treatment timeline and failed to keep pace with innovation. Looking ahead, Congress must prioritize the passage of this pivotal legislation so that patients have unobstructed access to innovative treatment options that the FDA has deemed safe and effective. In the fight against cancer, patients should have access to every approved therapy. Refusing to cover groundbreaking treatments is like putting hope just out of reach. Kelly Sitkin is the president and chief executive officer of the American Brain Tumor Association, the first national advocacy organization dedicated solely to brain tumors. ABTA is an advocacy partner of Novocure, the maker of the Tumor Treating Fields therapy. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
03-06-2025
- Business
- The Hill
The Medicare device coverage gap delays life-saving treatment for seniors
Imagine dying of thirst with a glass of water just out of reach. The analogy is extreme, but that is how helpless some patients feel when they can't access therapies approved to treat their deadly disease. That vulnerability is particularly acute for people aged 65 and older whose lives depend on access to advanced medical devices. This is due to the Centers for Medicare and Medicaid Services' current reimbursement policies that delay Medicare coverage of these groundbreaking therapies because they are administered by a device, not a pill or a syringe. Over the last decade, there has been a welcomed emergence of cutting-edge medical devices that treat a wide range of chronic diseases — including glioblastoma, a deadly brain cancer with a significantly poor prognosis. These groundbreaking technologies put patients in control of their care by providing them with the freedom to receive the treatments they need from the comfort and convenience of their many cases, the Food and Drug Administration has recognized the importance of these therapies by approving them for patient use. However, CMS' reimbursement policies for medical devices continue to prevent many of these same patients from gaining timely access to those treatments. As it stands, there is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare. This is time that many patients diagnosed with hard-to-treat cancers do not have. Modernizing the reimbursement framework for new FDA-approved medical devices would provide patients access to game-changing treatments that can improve their overall quality of life and give them more time with their friends and family. Nothing can prepare you for the heartbreaking news that you or a loved one has been diagnosed with a primary or metastatic brain tumor. Yet, this is the reality for the 1.3 million Americans living with this devastating disease. Throughout my own battle with cancer, I was blessed to have friends and family by my side as I underwent treatment. Their support was critical to my survival, and that experience continues to inspire my commitment to patients who deserve unrestricted access to innovative therapies that can extend and improve their lives. Washington leaders are broadly in agreement over the need to close this gap in coverage. The previous administration tried to fix it by releasing the long-awaited Transitional Coverage for Emerging Technologies pathway last year. Unfortunately, it fell well short of patients' expectations. Among other things, it forced most devices through the National Coverage Determination pathway, which does not guarantee a faster review. It also capped the number of devices eligible for expedited Medicare coverage to five annually. A bipartisan group of lawmakers likewise attempted to solve the problem. They introduced common-sense legislation that would have eliminated the five-product maximum under Transitional Coverage for Emerging Technologies and ensured that all new FDA-approved medical devices are instantly covered by Medicare. It garnered robust support in both chambers, passing out of the House Ways and Means Committee before running out of time to advance in the Senate. Thankfully, Sens. Todd Young (R-Ind.) and Alex Padilla (D-Calif.) have recently teamed up in the 119th Congress to introduce the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2025, which seeks to streamline Medicare's regulatory process, cutting red tape and strengthening access to proven therapies for seniors. Far too many seniors are being told to wait, not because the necessary treatments don't exist but because Medicare's reimbursement policies have overlooked the critical treatment timeline and failed to keep pace with innovation. Looking ahead, Congress must prioritize the passage of this pivotal legislation so that patients have unobstructed access to innovative treatment options that the FDA has deemed safe and effective. In the fight against cancer, patients should have access to every approved therapy. Refusing to cover groundbreaking treatments is like putting hope just out of reach. Kelly Sitkin is the president and chief executive officer of the American Brain Tumor Association, the first national advocacy organization dedicated solely to brain tumors. ABTA is an advocacy partner of Novocure, the maker of the Tumor Treating Fields therapy.
Yahoo
20-03-2025
- Health
- Yahoo
Hawley skeptical of Trump pick Oz: 'I hope he's changed his views'
Sen. Josh Hawley, R-Mo., said he was "skeptical" of Dr. Mehmet Oz's views, particularly on transgender procedures for minors and abortion, and released a series of questions Wednesday that he plans to ask President Donald Trump's nominee to lead the Centers for Medicare and Medicaid Services (CMS) during his road to confirmation. "I've been reading up on Dr. Oz - I see he's praised trans surgeries for minors and supported hormone treatments & puberty blockers for kids in the past," Hawley wrote on X on Wednesday. "And has also criticized state laws protecting life. I hope he's changed his views to match President Trump! We need the Trump agenda at CMS." In a series of written questions for Oz, Hawley asked the former heart surgeon and TV personality if his views have changed since hosting a television show. Dr. Oz Bats Back Democratic Attempts To Paint Him As A 'Snake Oil' Salesman In Senate Hearing Hawley noted that Oz had on his show "various transgender advocates as well as a surgeon who performed transgender surgery" and "also invited children to discuss switching genders and praised parents for helping their children 'transition'." "Do you support President Trump's position that gender transition procedures for minors should be banned?" one question directed at Oz and shared by Hawley's press office asked. Read On The Fox News App The senator also asked if Trump's nominee supported the president's executive order barring biological men from competing in women's sports. "Do you believe that CMS has a role in promoting or supporting gender transition surgery in any way?" Hawley asked. The senator asked Oz if he would commit to never issuing a National Coverage Determination at CMS for "gender reassignment surgery" or equivalent procedures, including the use of hormone and puberty blockers, in line with Trump's policies. He also asked if Oz would support Trump's efforts to halt federal funding to hospitals that provide so-called "gender-affirming care" to minors. Hawley noted Oz had stated in the past that he did not want to "interfere" with doctors prescribing puberty blockers for minor children and asked if that was still his position. "Do you believe the Dobbs decision overturning Roe v. Wade, which every Justice appointed by President Trump supported, was correctly decided?" Hawley asked. The senator questioned whether Oz's position has changed since he in 2019 opposed state limitations on abortion related to fetal heartbeat by describing it as "little electrical exchanges in the cell that no one would hear or think about as a heart." In 2019, Oz predicted a state would face a "big sucking sound of business leaving" over its pro-life law, the senator noted, asking Trump's nominee to answer if he would allow his decisions as head of CMS to be "influenced by corporate preferences." Oz testified last week that CMS would abide by the Hyde Amendment, which bars federal taxpayer dollars from funding abortions. 3 Things Dr. Oz Can Do As Cms Administrator To Help Fix American Health Care "As a physician, I've been in the room when there's some difficult conversations happening. I don't want the federal government involved with that at all," Oz stated in 2022, according to Hawley's office. The senator cited how Oz also said he did not want the federal government "impinging" on actions the states may make regarding abortion. "But many federal laws and regulations implicate life issues," Hawley said. "President Trump's administration has opposed federal funding for abortion, for example, at home and abroad. Will you support the President's position and commit to upholding existing laws that prevent federal funds from being used for abortions?" Hawley asked Oz if he would uphold protections for conscience rights related to abortion, including under the Weldon, Church and Coats-Snowe Amendments. The senator noted that CMS under Trump approved waivers allowing states to exclude abortion-performing clinics from the Medicaid program and asked Oz if he would support the president's policy and back similar waivers if he is confirmed by the Senate. Hawley questioned whether Oz would "support action at the federal level to directly exclude abortion providers from the Medicaid program." "The Biden administration issued guidance via CMS suggesting that the Emergency Medical Treatment and Active Labor Act (EMTALA) required hospitals to perform abortions, overriding state laws," Hawley noted. The senator asked Oz if he would return to the Trump policy and "clarify that EMTALA does not mandate abortions." Finally, Hawley noted that CMS under Trump required separate billing plans that covered abortion in Affordable Care Act (ACA) marketing plans and the Biden administration eliminated that requirement. He asked if Oz would support returning Trump's policy of "transparent billing practices and ensure that consumers pay properly separate charges for abortion." The 64-year-old was a respected heart surgeon who turned into a popular TV pitchman. He sold everything from supplements to private health insurance plans on "The Dr. Oz Show," which ran for 13 seasons and helped him amass a fortune. If confirmed, Oz will oversee health insurance for about 150 million Americans enrolled in Medicare, Medicaid or ACA coverage. As CMS administrator, he could wield significant power over most health companies operating in the U.S., because he can make decisions about who and what is covered by Medicare and Medicaid. Oz faced over two and a half hours of questioning Friday before the Republican-controlled Senate Finance Committee, which has yet to vote on whether to forward his nomination to the full Senate for consideration. Hawley is not a Finance Committee member and did not question Oz during the hearing last week. The Associated Press contributed to this report. Original article source: Hawley skeptical of Trump pick Oz: 'I hope he's changed his views'
