Cellular / Tissue-Based Products (CTPs)
The New LCDs are (Almost Certainly) Coming to Town
I may post more information about the meeting later, but the general tone of the MAC medical directors was confident.
The DOJ Releases its 2023 Report on Healthcare Fraud & Abuse
The lengthy report includes one account related to CTPs/skin subs which I mentioned in a previous blog when it happened.
Skin Substitute (Cellular Tissue Product) Questions From a Patient – Can Anyone Answer These Questions About Signing an ABN?
This email inquiry is from a real patient who is a retired nurse. I can answer some of her questions but not all of them, particularly the ones around when a patient might be required to sign...
Check Out HHS Work Plans on “Skin Substitutes”
Investigations regarding various aspects of “skin substitute” use are on the list along with the expected release dates for the reports.
Cellular Tissue Products / Skin Substitutes, Medicare Coverage & Sales Reps
I wonder what their marketing will look like 12 weeks from now?
Cellular Tissue Products / Skin Substitutes: The Naughty and Nice List for DFUs and VLUs
I will tackle various topics over the next several weeks, but here’s the list of covered and not-covered CTPs/skin subs for diabetic foot ulcers (DFUs) and Venous Leg Ulcers (VLUs).
CGS Announces a Multi-Jurisdictional Town Hall Meeting on the “Skin Substitute” LCD(s) 12/10/2024
The policies will become effective for services on or after 02/12/2025.
Breaking News! LCDs for Cellular Tissue Products / Skin Substitutes Released!
LCD – Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L39756)
CMS Releases the Medicare Physician Fee Schedule Final Rule for 2025
The sad news is that CMS is going ahead with a 2.9% cut to Medicare physician reimbursements for 2025.
The Results Are In! What Are Ideal Attributes for a CTP / Skin Sub?
The Results Are In! What Are Ideal Attributes for a CTP / Skin Sub?
Take the Quiz! What Are Ideal Attributes for a CTP / Skin Sub?
Take the Quiz! What Are Ideal Attributes for a CTP / Skin Sub?
SAHS Billing Activity, the MSSP, and WTF
SAHS billing activity for CTPs threatens the MSSP, and skin subs are part of the reason.
“Research, Not Rebates!” How to Get Cellular Tissue Product Patient Referrals from SNF Directors of Nursing (DONs) & How to Pitch “Research” to Medicare Patients
I started to explain the ethical problems associated with all of this, but I should not have to explain it.
The Accountable Care Organizations are Watching…
If you are a big user of skin subs, particularly among patients who are participating in an ACO, the ACO knows you by name.
Get that Skin Substitute “Clawback Insurance!”
What worries me the most is that that the DOJ may get to decide whether a discount on a skin substitute was actually a kickback.
How Do We Feel About Robin Hood Wound Care?
How do I feel about using the money that falls out of the Brinks van to fund unmet healthcare services? Truthfully, I feel uncomfortable.
What Claims Can an Amniotic “Skin Substitute” Sales Rep Make?
Because amniotic products are the fastest growing sector of the market, I am going to discuss the claims that can be made about them.
Cellular Tissue Products (CTP) / Skin Substitutes with No ASP – How Does That Work?
I assume that the only reason to use an expensive product is to make a profit off the discounted price.
Help! Can Someone Explain if Accepting Discounts Below the Cellular Tissue Product / Skin Substitute Average Sales Price (ASP) is Legal?
Lots of people have told me that this is all legal. I hope someone out there can tell me if it is.
Has Anyone Noticed That the Proposed LCD Limits Cellular Tissue Products / Skin Substitutes to Only Superficial, Clean, Granulated wounds? (Which is Not New…)
We should stop the public outcry about how “vulnerable patients” with “the most serious limb threatening” wounds will lose access to these products.
According to Medicare Data Analyzed by SmartTRAK, Recent DOJ Prosecutions in the Cellular Tissue Product / Skin Substitute Market are the “Tip of the Iceberg”
It seems unlikely that we will see new developments in the field of wound care until there is a very big housecleaning.
The Results Are In! How Much Amniotic Product Did a Sales Rep Sell to a Doctor in One Week?
Thanks to everyone who voted!
What Claims Can Cellular Tissue Product / Skin Substitute Sales Reps Make About Wound Healing? A Closer Look at the Proposed List of 15 in the LCDs
Clinicians should be cautious of the product claims made by exuberant sales representatives of the fifteen skin substitutes in the proposed LCDs.
The Results Are In! How Does One High-Priced Amniotic Distributor Support an NP’s Practice?
Thanks to everyone who voted!
Dermatology Practice Settles a Cellular Tissue Product / Skin Substitute Whistleblower Case for $1.6 Million
The settlement resolves allegations of false claims in connection with Mohs surgeries.
This Invoice Illustrates Why Doctors Who Play by the Rules with Cellular Tissue Products / Skin Substitutes Lose Money
“…CTPs can be offered only to patients with secondary insurance or to those patients who are wealthy enough to afford the copay.”
Two Nurse Practitioners Charged in Connection with APX Scheme with Fraudulent Application of Amniotic Products
District of Arizona | Seven Charged in Arizona as Part of the Department of Justice’s 2024 National Health Care Fraud Enforcement Action | United States Department of Justice The fallout continues...
Is There a Justifiable Price Limit on Cellular Tissue Products (CTPs) / Skin Substitutes? Check Out the Article Now Available
Spoiler alert, a CTP/skin sub that expensive would need to be able to bring sight back to the blind or cure diabetes in order to justify the price.
The Votes Are In! How High Will Amniotic Cellular Tissue Product / Skin Substitute Prices Go?
Thank you for participating in the poll to guess how ridiculously high amniotic prices will go. Check out the final results!
2025 Medicare Physician Fee Schedule is Out (and CMS Did Not “Package Price” Cellular Tissue Products / Skin Substitutes in the Doctor’s Office)
The billing of CTPs in the doctor’s office is unchanged. The 2025 Medicare conversion factor is set to decrease for the fifth straight year.
Breaking News! OPPS Proposed Rule is Out!
At first glance, there are no changes to Cellular Tissue Product /skin substitute payment, which remain under package pricing in this site of care.
The Dual Invoice System for an Amniotic Product
Can anyone explain how this dual invoice system for amniotic products could be used to line the pocket of a practitioner?
How High Will Amniotic Cellular Tissue Product / Skin Substitute Prices Go? Tell Me What You Think!
Sadly, it appears that the CTP/skin sub industry has become a game, the goal of which is to fleece Medicare.
Billion Dollar Medicare Scam? Politico Article Discusses Dramatic Spike in Claims for “Skin Substitutes”
If you are a practitioner involved in this business STOP now, and report yourself. Doing so might keep you out of jail.
What is the Real Problem with Cellular Tissue Product (Skin Substitute) Pricing?
There are amniotic products out there now which are more than $3,000 cm2, and there is ZERO data to suggest that they are any better than amniotic products 100 times cheaper.
Wound Care Company Owners Arrested, Accused of Accepting More Than $330M in Kickbacks Relating to Medicare Charges for Amniotic Products
The report states that more than $900 million in bogus claims were submitted to Medicare for amniotic products applied to fewer than 500 patients. Yes, that is $1.8 million PER PATIENT.
How Much Does Price Impact the CTPs (Skin Substitutes) That Are Selected in the Office Setting?
How much do you think that price impacts the way that CTPs (skin subs) are selected in the office setting?
Counting the Cost of Cellular and/or Tissue Based Products (CTPs) in Diabetic Foot Ulcers: Is There a Justifiable Price Limit Per Square cm?
Check out our just released paper, “Counting the Cost of Cellular and/or Tissue Based Products in Diabetic Foot Ulcers: Is There a Justifiable Price Limit Per Square cm?” for the complete answer.
Don’t Miss Your Chance to Make $594,000 per Cellular Tissue Product (CTP) Application
If you go to dinner with these folks, make them buy you a 300cl Jeroboam of Cristal. They can afford it.
Anger, Endothelial Health, & Blogging
I have been provoked into anger — for good reasons. It’s not my fault! I can’t help how I feel! Right?…
Cellular Tissue Products (CTPs) / Skin Substitutes in the Home Setting – What Do We Think?
I got this letter today about Cellular Tissue Products being administered at patients’ homes. I’d like to know what people think…
Proposed LCDs Would Cover Only 15 Cellular Tissue Products (CTPs), Leaving All Others “Non-Covered”
On April 25, ALL 8 CMS Medicare Administrative Contractors (MACs) released proposed LCD/LCAs for Skin Substitutes/CTPs for DFUs and VLUs.
BREAKING NEWS! 8 MACs Release Draft LCDs for Cellular Tissue Products (CTPs) / Skin Subs (Yes, There is an Annual Limit)
Yesterday morning, 8 MACs issued nearly identical draft coverage policies for the use of CTPs (“skin subs”) in diabetic foot ulcers and venous leg ulcers.
Price & Size Limits to Cellular Tissue Product (CTP) Use in the HOPD vs the Office (This is All So Messed Up)
I am trying to find ways to visually depict our current situation with regard to Cellular and/or Tissue-based products (CTPs).
United Healthcare Updates its Skin and Soft Tissue Substitutes Policy Detailing Coverage for Epifix and Grafix® (and Listing the Products They Won’t Cover)
The policy also includes an extensive list of products that will NOT be covered by United Healthcare.
An Offer You Can’t Refuse? “A 4×4 Would Generate a Little Over $20,000 for Your Practice.”
Where will this end?
Pricing Trends in Cellular Tissue Products (CTPs) / Skin Substitutes / CAMPs – and Why Publishing the ASP is Not Helping
Here’s a visual example of the insanity of Cellular Tissue Product (CTP) pricing and the problem with ASPs.
Algorithm for Selection a “CAMP”: Ideal vs. Real
Last week I attended the inaugural Cellular, Acellular, and Matrix-like Product (CAMP) Summit. It was a very interesting and well-run meeting. I will digress to mention the acronym “CAMP” which is...
It’s Finally Happened – CMS Has Issued Instructions on How to Bill a Claim for $99,999,999,99
I need to know how to justify putting one skin substitute on a patient that is 100 times more expensive than another one.
It’s Happened – a Cellular Tissue Product (CTP) / Skin Substitute That is >$2,800 per cm2
A friend sent me this email from a Cellular Tissue Product (CTP) / skin substitute rep. I ran out of words a long time ago. Message me if you have any words.
The January 1st Physician Pay Cut & Unintended Consequences
Many physicians are either leaving practice or making the difficult decision to stop seeing Medicare patients.
Reaction: Why Hospital Cost Reporting is a Mess
Many thanks to Sharon Hannan, Executive VP of Integumetrix, for her insightful reaction to our “Package Pricing” article.
Salve Lucrum: The Existential Threat of Greed in US Healthcare – and Some Thoughts About Cellular Tissue Products (CTP’s) / Skin Substitutes
I have to agree with the final sentence of this article: Healthcare should not be an engine for excessive private gain.
How Playing by the Rules with Cellular Tissue-Based Products / Skin Substitutes Can LOSE Money in the Doctor’s Office
I thought people should understand what happens to doctors who play by the rules when it comes to the use of CTP/skin subs in their private office.
Thoughts on How to Fix the Cellular Tissue Product (CTP) / Skin Substitute Crisis
We’ve spent a lot of time talking about what is broken, now is the time to collaborate in a positive way about how to make it better.
Big Profits in Medicare Patients Only!
The Medicare trust fund is bankrupt and this “profit” is funded by our tax dollars. How does that make you feel?
Alliance Advisory Panel Recommendations to CMS to Help With the Skin Substitute / Cellular-Based Tissue Products Problems
If you have other ideas that might address the long list of problems identified so far, feel free to send them to me.
Selling the Spread on Cellular Tissue Products (CTP’s) / Skin Substitutes – is That Even Legal?
I am told that this case is cited in training programs for pharmaceutical sales reps to highlight the fact that “Selling the Spread” is a violation of Federal law etc.
Taking a Closer Look at the OIG Report on “Skin substitute” (CTP) ASP Transparency
You should read the whole report (it’s not very long), but I am going to provide some excerpts.
A Different Level of Thinking on Cellular Tissue Product Skin Substitute Policy
I previously posted the list of issues as I see them in this industry. Now I’d like to create a list of the attributes of a good solution.
A Problem Well-Stated is a Problem Half Solved… (Hopefully)
. If CMS or the MACs try to “fix” the situation without input from us, we have seen how unfortunate the results can be.
(Not) Choosing Wisely for Cellular and/or Tissue-Based Products (CTPs)
We could figure this out if we wanted to, but right now there’s so much money to be made that it’s an uphill battle.
Be a Wound Care Millionaire with 25 Patients or Less – and Maybe Lose it All in a RAC Audit?
A physician who is a walking saint with regard to clinical practice, but whose documentation failed in one subjective area, could end up paying back a small fortune.
How to Submit a Medicare Claim for a CTP When the Dollar Amount Exceeds $99,999.99
…with a question about the per cm sq price variations for Cellular / Tissue-Based Products (CTPs).
$180,000 for In-Home Application of Cellular / Tissue-Based Products (CTPs)… I Have Run Out of Words for This
I could provide the names of the companies involved, but I can’t afford the legal bills.
Disparities in Access to Care for CTPs / Skin Subs (and How Package Pricing in the Doctor’s Office Might Actually Improve Access to Them)
Everywhere I turn, there seems to be an issue that is ethically worrisome about Cellular / Tissue Based Products (CTPs).
Wound Care, the “Rodney Dangerfield” of Specialties – At Least Partly Due to the CTP Payment Methodology
Do you think that the [current CTP payment system] supports thoughtful patient care and the medically appropriate use of CTPs in the physician’s office?
More of Your Letters: Skin Substitutes, CMS, Failed Proposals and the Broken System
Here’s another message that I agreed to post anonymously that asks many questions we are asking.
“Research Not Rebates”… and “Our IRB Status with the Department of Health and Human Services…” Hmmmmmm……..
I worry that this is a thinly disguised rebate program, and it would be a shame if that approach backfires on legitimate research initiatives.
How We Got Here – Answers to the Questions I Have Been Asking
With these answers, perhaps we can begin talk about what kind of policies would FIX this mess, pretending we could get anyone to listen.
Can Someone Explain the Math on the Patient Copay for CTPs (Skin Substitutes)?
Where I come from, we’d say that something about this seems as crooked as a dog’s hind leg. However, it’s possible that I just don’t understand it, so I hope you will explain it to me.
The Other Side of the CTP/Skin Substitute Story – How Poorly-Crafted CMS Policies for Package Pricing in HOPDs Created This Mess
HOPDs lose money on CTP/Skin Substitute applications, while doctor’s offices make huge profits from the product. Why is this OK?
“We Will All Lose in the End.” Let’s Discuss the Moral Hazard of the CTP (Skin Substitute) Industry
If you want to send me a message to post anonymously, email me and I will review it and perhaps discuss it with you further.
If You Wonder Why CMS is Looking at Skin Subs, Check Out These Claims…
Can anyone tell me why no invoice is needed to submit these claims and exactly how these profits are being realized?
CTP/Skin Sub Ads to Doctors – Am I the ONLY Person Who Thinks There’s Something Wrong?
Feel free to send me the ads that you have seen. I will redact the name of the company and post them.
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.