Venture Medical Position on CMS and MAC Skin Substitute Proposals
MISSOULA, MT / ACCESS Newswire / August 3, 2025 / The proposed changes to skin substitute reimbursement and coverage in the CY2026 Medicare Physician Fee Schedule (PFS) and Future Effective Local Coverage Determinations (LCDs) are unprecedented and have sparked alarm across the advanced wound care community-particularly among mobile and office-based providers. These proposals, while nominally aimed at consistency and cost control, are based on flawed assumptions and methodologies that will result in reduced access, disrupted clinical practice, and long-term harm to patients and innovation. At Venture Medical we have been working for many months to help chart a course from the current unsustainable system to one which is rational and workable for patients, providers, industry and CMS. As many of you are preparing your comments on these policies, we wanted to share a summary of the direction in which we think the wound care community should be pushing. If you would like to discuss further, please reach out to us.
Rescind the Future Effective LCDs
Originally designed to control cost-now redundant after CMS pricing reform.Restrictive product selection harms access, limits clinician choice, and stifles innovation.Sole reliance on RCTs ignores the value of real-world evidence (RWE) and other valid evidence.Especially harmful for wounds like VLUs, PUs and surgical wounds where RCTs are limited or impractical.Proposed update cycles span years-unworkable for a dynamic clinical field.
Recommendations for the Future:
Support Clinical FlexibilityProducts billed "incident to" clinician services should be selected by the clinician like other incident-to items.Clinicians are best positioned to select appropriate products based on evidence, experience, and patient need.Blocking new products from the market discourages new product innovation and restricts accessIncentivize evidence development with enhanced payments instead.Arbitrary 8-application cap is not evidence-based and should also be removed.Call for a National, Uniform LCD FrameworkEstablish consistent rules and documentation standards across all wound types.Avoid regional disparities and overly prescriptive policies-maximize clinical flexibility for providers.Replace ASP Model with a Higher Fixed-Fee RateASP-based pricing is highly variable ($7-$13,117/cm²), unpredictable, and misaligned with clinical value.Tiered reimbursement creates artificial hierarchies not tied to comparative outcomes.Preferred model for 2026: single flat fee (e.g., $600-$1000/cm²) based on economic modelingFix Reimbursement RatesCMS used only HOPD data-other sites of care must be included in rate calculations.Accurate modeling supports a base rate of $550-$711/cm².Raise non-facility physician application fees to >$500 for equity across care settingsModerate overzealous audit activitySupport Innovation with Evidence-Based EnhancementsEstablish favorable payment enhancements for products which can demonstrate high comparative effectiveness via RCT or RWE - similar to pass-through conceptPush for birth tissue product legislation tied to 2025 Health Services Bill.Reformed biologics pathway for future tissue products.
SOURCE: Venture Medical LLC
press release
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
New York Post
14 hours ago
- New York Post
Dr. Oz touts $200B investment in Medicaid: ‘I'm trying to save this beautiful program'
Centers for Medicare and Medicaid Services (CMS) administrator Dr. Mehmet Oz says the Trump administration plans to invest more than $200 billion 'more dollars' into Medicaid following the passage of the 'One Big Beautiful Bill.' 'I'm trying to save this beautiful program, this noble effort, to help folks, giving them a hand up,' Oz told CBS' 'Face the Nation' on Sunday. 'And as you probably gather, if Medicaid isn't able to take care of the people for whom it was designed, the young children, the dawn of their life, those who are twilight of their lives, the seniors, and those who were disabled living in the shadows, as Hubert Humphrey said, then we're not satisfying the fundamental obligation of a moral government,' he continued. Oz, the 17th administrator for CMS, said the government wants 'an appropriate return' on the Medicaid investment. He addressed the difference in drug costs between the US and Europe, adding that work is being done by the administration in an attempt to bring drug prices down. 3 'I'm trying to save this beautiful program, this noble effort, to help folks, giving them a hand up,' Oz said. Fox News Last week, the Trump administration announced it is launching a new program that will allow Americans to share personal health data and medical records across health systems and apps run by private tech companies, promising that this will make it easier to access health records and monitor wellness. CMS will be in charge of maintaining the system, and officials have said patients will need to opt in for the sharing of their medical records and data, which will be kept secure. 3 The Trump administration announced it is launching a new program that will allow Americans to share personal health data and medical records across health systems. IB Photography – Those officials said patients will benefit from a system that lets them quickly call up their own records without the hallmark difficulties, such as requiring the use of fax machines to share documents, that have prevented them from doing so in the past. 'We're going to have remarkable advances in how consumers can use their own records,' Oz said during the White House event. 3 'We're going to have remarkable advances in how consumers can use their own records,' Oz said. Gina M Randazzo/ZUMA / CMS already has troves of information on more than 140 million Americans who enroll in Medicare and Medicaid. Earlier this month, the federal agency agreed to hand over its massive database, including home addresses, to deportation officials. The Associated Press contributed to this report.
Yahoo
20 hours ago
- Yahoo
Dr. Oz on the future of US healthcare: 'There is a new sheriff in town'
Listen and subscribe to Decoding Retirement on Apple Podcasts, Spotify, or wherever you find your favorite podcasts. In an exclusive interview on Yahoo Finance's Decoding Retirement podcast, Dr. Mehmet Oz, the administrator of the Centers for Medicare & Medicaid Services (CMS), discussed the financial and operational challenges facing the US healthcare system. Ultimately responsible for the healthcare of 66 million Medicare beneficiaries, 78 million people enrolled in Medicaid and the Children's Health Insurance Program (CHIP), and millions more in Affordable Care Act health plans, Oz weighed in on issues ranging from new Medicaid work requirements to Medicare Advantage fraud. This embedded content is not available in your region. Medicaid work requirements The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) could reduce federal Medicaid spending by $793 billion over the next decade and lead to 10.9 million fewer enrollees by 2034. This is partially attributed to the Medicaid work requirements the OBBA will make states enforce for certain adult enrollees by Jan. 1, 2027, which generally involves 80 hours per month of work, community service, education, or work programs. The CBO estimates the requirement will decrease coverage by 5.2 million enrollees by 2034. Concerns about red tape are not hypothetical: In Georgia, where work requirements are already in place, reports show that otherwise eligible workers are losing coverage simply because of paperwork hurdles. However, Oz said that technology and digital solutions could help beneficiaries comply with the rules without losing coverage. 'We've already launched two pilots in Louisiana and Arizona with good results so far,' Oz said. The new digital process, he explained, uses a smartphone app to verify work automatically through payroll providers. "The people running it are the same folks who fixed the passport system in America,' he said. 'Ninety-one percent of people on Medicaid have smartphones. You tap on the smartphone within the app where you're working. Let's say you're an Uber driver, it knows that ADP does your payroll, and so it asks you permission, 'Can I contact ... ADP and ask them about your hours?' You say yes, and boom, ... the entire process is less than seven minutes." Oz, however, stopped short of addressing some key questions, such as how many people might lose coverage under the current system or whether administrative barriers will unfairly affect millions before the new technology is fully in place. Medicare Advantage and 'upcoding' Oz weighed in on the controversy swirling around Medicare Part C, better known as Medicare Advantage. About 33 million people are enrolled in these private plans, offered by companies such as UnitedHealth Group (UNH) and CVS Health (CVS). Medicare Advantage allows enrollees to receive Part A (hospital), Part B (medical), and, when bundled, Part D (prescription drug) coverage in one plan. The program has been under a harsh spotlight. Earlier this month, UnitedHealth confirmed it is under federal investigation. And a Wall Street Journal story detailed how some Medicare Advantage providers allegedly exploited the system through questionable or outright fraudulent billing practices. 'The whole point of launching Medicare Advantage was to give seniors options," Oz said. "But in the middle of all this, if it turns out that Medicare Advantage is costing us a lot more than fee-for-service, you're violating the whole premise.' The big problem is 'upcoding," the practice of inflating the severity of patients' conditions to trigger higher government payments. 'In Medicare Advantage, I do think that there's been an ability for the private companies to game the coding system,' Oz said. 'Instead of just saying, 'I got what I got, I'm going to take care of them and be honest about how sick they are,' they expertly devised tactics to upcode to pretend the patients were sicker than they really were. That got them more money.' Oz said CMS is now taking aggressive steps to recover funds and send a message: 'We have a process called RADV that allows us to go back to the late teens and, for the first time, audit Medicare Advantage companies,' he said. 'Based on what we find, we're going to pull money back from them. We expect it will be billions and billions of dollars. But more importantly, we're sending a message to the industry: Listen, I want you to succeed. I want you to thrive, but not at the expense of the American taxpayer.' Concern about Medicare's financial future According to the 2025 OASDI Trustees Report, Medicare Part B premiums are expected to rise 11.6% in 2026 to $206.50 a month — the steepest single-year increase in nearly a decade. At the same time, the Medicare Hospital Insurance Trust Fund, which finances Part A, is projected to run dry in 2033. If Congress doesn't intervene, that insolvency would trigger an automatic 11% cut in covered hospital services. Oz called the looming Part B increase a 'major concern,' citing the surge in prescription drug prices as the primary culprit. 'But there are other things,' Oz said, 'that are in Part B as well that we believe we have control over and we could get to be more efficient.' Rather than promising immediate regulatory fixes, Oz said his agency should work directly with industry. 'A lot of this is hearing the stakeholders and then pushing back on what you've heard and then letting them actually come up with some ideas themselves,' he said. 'We've gone back to all of them and said, we need better answers. What you're doing now is making you a lot of money, and you can do that for another year or two — and then the bottom's going to fall out.' 'The … Trustees Report predicts that [Part A] is bankrupt in 2033,' Oz added. 'That's three years shorter than we thought a month ago. And in their worst-case scenario, it goes bankrupt in [2029].' For context, Medicare Part A is primarily funded through a dedicated payroll tax under the Federal Insurance Contributions Act, or FICA. The total Medicare tax rate is 2.9% of wages — typically split evenly between employee and employer. That means 1.45% is withheld from your paycheck, and your employer contributes the other 1.45% on your behalf. Navigating Medicare open enrollment As Medicare's annual open enrollment period approaches — beginning Oct. 15 for 2026 coverage — millions of beneficiaries will face one of the biggest financial decisions of the year: whether to stick with their current plan or make a change. Most Medicare beneficiaries never switch plans, even though premiums, provider networks, and drug formularies can change from year to year. So how might retirees navigate this? 'We have to give people information,' Oz said. 'At the same point, I don't want people to panic and jump to changes." His advice is simple: Do your homework, but don't feel pressured to change plans unless you have a clear reason. One big resource is 1-800-MEDICARE. 'It's easy to remember, and it's got a ton of information,' he said. 'Especially during open enrollment, I strongly urge you to do a little work.' Hospice scams Healthcare scams are on the rise — and Medicare beneficiaries are among the top targets. The CMS recently sounded the alarm in a blog post and video featuring Oz, warning older Americans to be on guard for this disturbing trend. 'Beware of scammers, sometimes posing as salespeople, offering 'free' services or gifts,' the CMS blog warned. 'They may be trying to trick you into signing up for hospice care without your knowledge.' 'This is a reprehensible activity,' Oz said. 'It's run by criminal syndicates — not small-time operators. They take advantage of people at their most vulnerable time.' Hospice fraud is insidious because it targets people making some of the most difficult decisions of their lives. Oz said, 'We are hearing horror stories about people who thought they were entering legitimate hospice and there's nothing there for them. And even worse — because you're not really sick — people are on these hospice programs for years. We're going after them in a big way.' 'There is a new sheriff in town' Oz promised a tougher stance against healthcare fraud, both foreign and domestic. 'We already have actions in several states,' he said. 'The Department of Justice is pursuing a lot of these leads. We will leave no stone unturned. There is a new sheriff in town. I promise you, if you're cheating the American people, we will come after you. And if you're doing it to hurt folks who are most vulnerable — we'll be doubly vigilant.' Beyond enforcement, Oz emphasized that better technology and patient identification are key to preventing fraud before it happens. 'You're talking about an agency with a $1.7 trillion budget,' Oz said. 'One policy memo can affect [tens of millions of Americans.] We have to get it right.' One key will be distilling the complexity of the system into actionable information for both the public and his team. 'The goal is the same as it was" on his TV show, Oz said. "Explain it so people understand it and can act on it,' he said. 'If we simplify the rules, give people clear guidance, and enforce the protections already in place, we can change outcomes for millions of Americans." Got questions about retirement? Email Robert Powell at yfpodcast@ and we'll do our best to answer it in a future episode of Decoding Retirement. Each Tuesday, retirement expert and financial educator Robert Powell gives you the tools to plan for your future on Decoding Retirement. You can find more episodes on our video hub or watch on your preferred streaming service. Sign up for the Mind Your Money newsletter 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
Fox News
a day ago
- Fox News
Dr. Oz touts investment in Medicaid: 'I'm trying to save this beautiful program'
Centers for Medicare and Medicaid Services (CMS) administrator Dr. Mehmet Oz says the Trump administration plans to invest more than $200 billion "more dollars" into Medicaid following the passage of the "One Big Beautiful Bill." "I'm trying to save this beautiful program, this noble effort, to help folks, giving them a hand up," Oz told CBS' "Face the Nation" on Sunday. "And as you probably gather, if Medicaid isn't able to take care of the people for whom it was designed, the young children, the dawn of their life, those who are twilight of their lives, the seniors, and those who were disabled living in the shadows, as Hubert Humphrey said, then we're not satisfying the fundamental obligation of a moral government," he continued. Oz, the 17th administrator for CMS, said the government wants "an appropriate return" on the Medicaid investment. He addressed the difference in drug costs between the U.S. and Europe, adding that work is being done by the administration in an attempt to bring drug prices down. Last week, the Trump administration announced it is launching a new program that will allow Americans to share personal health data and medical records across health systems and apps run by private tech companies, promising that this will make it easier to access health records and monitor wellness. CMS will be in charge of maintaining the system, and officials have said patients will need to opt in for the sharing of their medical records and data, which will be kept secure. Those officials said patients will benefit from a system that lets them quickly call up their own records without the hallmark difficulties, such as requiring the use of fax machines to share documents, that have prevented them from doing so in the past. "We're going to have remarkable advances in how consumers can use their own records," Oz said during the White House event. CMS already has troves of information on more than 140 million Americans who enroll in Medicare and Medicaid. Earlier this month, the federal agency agreed to hand over its massive database, including home addresses, to deportation officials.
