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
Health Line
3 days ago
- Health Line
What to Know About 5-Star Medicare Advantage Plans
Star ratings can offer useful insight into how Medicare Advantage plans perform across various metrics. Earning an overall rating of 5 stars is rare and indicates superior quality, according to the Medicare rating system. Medicare Advantage (Part C) plans are coverage options offered by Medicare-approved private insurance companies. These plans are alternatives to Original Medicare that include additional benefits, such as vision, dental, and hearing care, and prescription drug coverage. Since there are many different plan options from a range of insurance carriers, the Centers for Medicare & Medicaid Services (CMS) developed a rating system that aims to help buyers understand the quality of a potential plan before they enroll. Five stars is the highest score a plan can earn. In this article, we list the 5-star plans for 2025 and discuss how the rating system works. 5-star Medicare Advantage plans in 2025 If a plan earns 5 stars, the CMS considers it to be 'excellent.' The list below includes the health plans (and their parent organizations) that earned overall ratings of 5 stars in 2025: Highmark Choice Company (Highmark Health) Leon Health, Inc. (LMC Family Holdings, LLC) Network Health Insurance Corporation (Network Health, Inc.) Alignment Health Plan of North Carolina, Inc. (Alignment Healthcare USA, LLC) HealthSun Health Plans, Inc. (Elevance Health, Inc.) MCS Advantage, Inc. (MHH Healthcare, L.P.) Optimum Healthcare, Inc. (Elevance Health, Inc.) These seven health plans represent roughly 1% of all Medicare Advantage plans offered across the United States. Medicare Advantage plans are offered regionally and typically have area-based networks of healthcare professionals, hospitals, and care facilities. Thus, not everyone will have access to a 5-star Medicare Advantage plan. The plans previously mentioned are only available in the following states: Florida North Carolina Nevada Pennsylvania Wisconsin How the ratings work Every October, prior to the start of the Medicare open enrollment period, the CMS releases its star ratings for Medicare Advantage and Part D drug plans for the coming year. Medicare open enrollment runs from October 15 through December 7. The CMS assesses plans on 30 or 42 independent quality and performance measures, depending on whether the plan includes drug coverage. It bases its ratings on data it collects from the health plans themselves, CMS contractors, CMS administrators, and member surveys. Measures include elements such as: health screening and vaccination rates management of conditions such as diabetes and heart disease member satisfaction efficiency of appeals processing These measures are grouped into five categories, with each plan receiving its own star rating in each category: Staying Healthy: Screening, Tests, and Vaccines Managing Chronic (Long-Term) Conditions Member Experience with Health Plan Member Complaints and Changes in the Health Plan's Performance Health Plan Customer Service The CMS has a coverage finder tool that you can use to compare Medicare Advantage plans in your area. The initial search results page will show the overall rating of every plan listed. When you click through to see further details on an individual plan, you can view a breakdown of the plan's star ratings across the various metrics that contribute to the overall rating. How to use star ratings If a Medicare Advantage plan has a 5-star rating, you can expect it to deliver superior quality service. However, the most important thing to consider when shopping for a Medicare Advantage plan is defining your personal needs. While a plan's star rating can be a useful point of data to consider during your search, it shouldn't be the sole factor you use when making your final decision. Also, do not judge a plan solely on its overall rating. The overall rating reflects an average of the plan's performance on various unique measures. The result is a comprehensive picture of where a plan excels and where it might fall short. This granular look at plan performance can be useful for narrowing your search. For example, if a plan has low marks in an area of care or performance that you find valuable, it may suggest looking for alternatives. Summary In 2025, seven Medicare Advantage health plans received an overall rating of 5 stars. This indicates that they deliver excellent quality care and perform well in key measures assessed by the CMS. Five-star plans are rare and limited to certain geographic areas. Thus, they won't be available to all individuals. Medicare's star ratings can be a useful consideration when shopping for health insurance. However, a person should prioritize finding a plan that meets their personal needs. The information on this website may assist you in making personal decisions about insurance, but it is not intended to provide advice regarding the purchase or use of any insurance or insurance products. Healthline Media does not transact the business of insurance in any manner and is not licensed as an insurance company or producer in any U.S. jurisdiction. Healthline Media does not recommend or endorse any third parties that may transact the business of insurance.
The Hill
3 days ago
- The Hill
HHS pilot program raises Democratic concerns over Medicare red tape
House Democrats are sounding the alarm and demanding more information about a new Department of Health & Human Services (HHS) demonstration they say will increase red tape by adding prior authorization requirements in Medicare. Led by Reps. Suzan DelBene (D-Wash.) and Ami Bera (D-Calif.), a group of 17 Democrats questioned why HHS would want to test adding prior authorization requirements in traditional Medicare when the Trump administration is touting efforts to reduce the practice in Medicare Advantage (MA). Traditional Medicare has rarely required prior authorization, but private MA plans have come under fire for relying on the controversial practice as a tool to increase profits. 'The Trump Administration publicly recognized the harm of prior authorization…And yet, not a week after these statements, CMS put forward a new proposal to increase the utilization of prior authorization in a type of health coverage that had seldom used the tactic before, replacing doctor's medical knowledge with an algorithm designed to maximize care denial in order to increase profits,' the lawmakers wrote in a letter to Centers for Medicare and Medicaid Services Administrator Mehmet Oz. The lawmakers are concerned about a new CMS pilot program to test a model targeting 'wasteful, inappropriate services in Original Medicare.' Under the model, CMS will partner with private companies, including some of the Medicare Advantage plans that are under fire for using prior authorization to deny a clinician's request to provide care. The model will require prior authorization for a list of outpatient procedures that the agency has flagged as vulnerable to fraud, waste and abuse, or inappropriate use. Participants will be rewarded based on the 'effectiveness of their technology solutions' for reducing spending on medically unnecessary or non-covered services. The lawmakers said they were concerned about creating perverse incentives that reward the companies that deny the most care. 'Prior authorization has long been abused, and it is bad for patients and providers,' the lawmakers wrote. An analysis of 2023 HHS data from KFF found about 81 percent of denials were partially or fully overturned after being appealed. 'The use of prior authorization in Medicare Advantage shows us that, in practice, [the demonstration] will likely limit beneficiaries' access to care, increase burden on our already overburdened health care work force, and create perverse incentives to put profit over patients,' the letter stated. The letter asked CMS for details on the pilot's scope, implementation plan and safeguards for beneficiaries. Meanwhile, the Trump administration is touting voluntary pledges they have received from the health insurance industry to streamline and reform the prior authorization process for MA plans. Lawmakers said the move shows the administration recognizes the harms of prior authorization. 'There's violence in the streets over these issues,' Oz said during an event announcing the industry pledges.
Newsweek
3 days ago
- Newsweek
Medicare Update: Lawmakers Sound Alarm About Major Change to Program
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. More than a dozen House Democrats pressed Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz in a letter last week over CMS's announced plans to expand prior authorization requirements to traditional Medicare through a pilot program. The new model incorporates artificial intelligence to help make decisions and is being tested in six states beginning in January. "Let's call it what it is: profit-driven healthcare," a financial expert told Newsweek, "And profit motive and patient care mix about as well as oil and water. Lawmakers are sounding the alarm, because this directly affects many of their constituents." Why It Matters The pushback highlights a growing partisan debate over how to reduce Medicare spending without restricting beneficiaries' access to care. It also underscores tensions between the Biden-era expansion of oversight and the Trump administration's stated aim to cut waste while modernizing CMS operations. House Democrats argued the new prior authorization pilot would create administrative burdens for providers and patients, while some Senate Republicans believe the Medicare reforms are necessary for rooting out fraud and overpayments. Democratic Congressional Campaign Committee Chair Rep. Suzan DelBene (D-WA) speaks at a news conference after a meeting with the House Democratic Caucus at the U.S. Capitol Building on September 19, 2023 in Washington, DC. Democratic Congressional Campaign Committee Chair Rep. Suzan DelBene (D-WA) speaks at a news conference after a meeting with the House Democratic Caucus at the U.S. Capitol Building on September 19, 2023 in Washington, To Know More than a dozen House Democrats, led by Democratic Representatives Suzan DelBene of Washington and Ami Bera of California, sent a letter to CMS Administrator Mehmet Oz on Thursday, requesting information and urging cancellation of a planned prior authorization pilot for traditional Medicare. The lawmakers wrote that "traditional Medicare has rarely required prior authorization," and said that, while prior authorization is "often described as a cost-containment strategy, in practice it increases provider burden, takes time away from patients, limits patients' access to life-saving care, and creates unnecessary administrative burden." The letter asked CMS for details on the pilot's scope, implementation plan and safeguards for beneficiaries. "Prior authorization is often seen as a roadblock to timely, even life-saving care—replacing the doctor's judgment with an algorithm," Kevin Thompson, the CEO of 9i Capital Group and the host of the 9innings podcast, told Newsweek. "Let's call it what it is: profit-driven healthcare. And profit motive and patient care mix about as well as oil and water. Lawmakers are sounding the alarm, because this directly affects many of their constituents." CMS has planned to roll out the prior authorization program in six states starting in January. The Trump administration previously announced a voluntary pledge from major insurers to simplify prior authorization in Medicare Advantage. Lawmakers said that prior voluntary pledges showed public recognition of the harms of prior authorization, and they urged CMS to reconsider extending similar rules to traditional Medicare. Separately, Senate Republicans discussed broader Medicare changes as part of proposals to reduce waste, fraud and abuse and to modernize CMS operations. Republican Senator Thom Tillis of North Carolina said lawmakers were examining CMS contracting practices, duplicate payments and upcoding as potential savings sources, according to The Hill. The Hill also reported that legislation from Louisiana Republican Senator Bill Cassidy and Democratic Senator of Oregon Jeff Merkley to reduce Medicare Advantage overpayments had bipartisan interest and might be folded into larger budget measures considered by Senate Republicans. Idaho Republican Senator Mike Crapo said his committee was "evaluating" Cassidy's proposal. Newsweek reached out to CMS for comment via email. What People Are Saying Lawmakers wrote in their letter to CMS administrator, Dr. Mehmet Oz: "Prior authorization has long been abused, and it is bad for patients and providers. The American Medical Association notes, 'Among America's physicians, more than nine in 10 surveyed say that prior authorization has a negative impact on patient clinical outcomes." We urge you to put patients and providers first by cancelling the WISeR model and exploring other ways to limit fraud, waste, and abuse in the Medicare program." Kevin Thompson, the CEO of 9i Capital Group and the host of the 9innings podcast, told Newsweek: "Will the letter change things? I doubt it. They'll probably get an answer, but expect the same vague, carefully worded response. The current administration is clear on its intent: privatize more of Medicare and crack down on what they label "waste, fraud, and abuse." Alex Beene, a financial literacy instructor for the University of Tennessee at Martin, told Newsweek: "Few Americans would be in disagreement that services like Medicare and Medicaid should have strong oversight to ensure funding is being properly used, but the concern with the WISeR model being employed is the use of prior authorization for some Medicare services. Medicare Advantage has a history of requiring prior authorization, and while not all uses have been a source of criticism, it is viewed by some beneficiaries as one of several reasons why Advantage has garnered more negative reactions in recent years." What Happens Next CMS faced requests from House Democrats to provide documentation and to cancel the planned prior authorization pilot. Lawmakers in the Senate continue to debate broader Medicare reforms, and committee deliberations could determine whether proposals addressing Medicare Advantage payments or CMS operational changes move into larger legislative packages. "For the time being, the model isn't nationwide and will be piloted in select states," Beene said. "It's difficult to say if this will eventually be implemented nationwide and will largely depend on how this pilot program goes."
