05/27/2024
RESPONSES/COMMENTS (DME)
RE: Medicare MACs Release New Cellular Tissue Product LCD for DFU and VLU
From: Eric J. Lullove, DPM
In case you live in a closet or under a rock, the Medicare Administrative Contractors (MACs) have released proposed coverage policy updates to their Application of Skin Substitute and Cellular Tissue Products for Diabetic Foot Ulcers and Venous Leg Ulcers on April 24.
This new policy is a welcome change for most of the providers who have been asking for more evidence-based coverage in relation to the numerous products on the market without clinical evidence. The MACs have answered the question: when is this going to happen and how many applications am I...
Editor's note: Dr. Lullove's extended-length letter can be read here.
12/22/2023
RESPONSES/COMMENTS (DME)
RE: DME 2024 Fee Schedule
From: Paul Kesselman, DPM
The DME 2024 fee schedule has been released. There is an approximate increase of 3% over the 2023 fee schedule for all DMEPOS categories. The DME fee schedule is not based on the same factors as the Medicare Physicians Fee Schedule and instead is based on the CPI and other economic indices that the Medicare Physicians Fee Schedule does not consider. CMS has offered their rationale for a smaller increase than last year because inflation is much less than last year and therefore a substantial increase is not warranted. Supply chain issues and other economic factors including raises to employees, however, mitigate most if not all of this increase. At least suppliers are also not facing the same potential fee schedule decrease as physicians. For more on the 2024 DME Fee Schedule Click Here.
Something new for 2024, with more information to follow is a new policy entitled the Lymphedema Act, which offers new coverage for the treatment of lymphedema. A whole new DMEPOS product category with many new HCPCS codes for lymphedema garments are effective January 1 2024. Look for more information on this during the first quarter of 2024.
Paul Kesselman, DPM, Oceanside, NY
11/30/2023
RESPONSES/COMMENTS (DME)
RE: DMEPOS Initial and Re-Enrollment Fee
From: Paul Kesselman, DPM
CMS announced on its website today that the triennial enrollment fee for suppliers enrolling or revalidating their enrollment in DMEPOS will now increase to $709 per PTAN. Suppliers should be aware that when you are initially enrolling or revalidating, failure to pay the $709 enrollment fee in PECOS, will result in your application not moving forward. The enrollment carriers have been backed up and any hitch in your application will result in suspension of the application process until the errors are resolved. The application can take months to process. Thus, once you are notified that you must revalidate, or have decided to initially enroll as a new supplier or at a new location, one should be sure that you have all the required information needed to process a clean application. Failure to adhere to CMS guidelines can result in revocation of the application.
Unlike your local MAC where you submit medical/surgical claims, one cannot retroactively back date the application for a start date. That is the application and inspection completed prior to the PTAN being activated or revalidated. Additionally, the National Provider Enrollment (NPE) carriers no longer will review applications which are rejected. A new carrier has been established to handle application appeals: Chags Health Information Technology LLC, •Fax: 866-410-7404 •Phone: 800-245-9206 •Email: PEARC@c-hit.com •Mailing Address: P.O. BOX 45266, Jacksonville, FL 32232
To avoid having to suffer with indeterminate lengthy delays and loss of significant income, it is inherent on suppliers to ensure their applications are complete from the beginning. Use of an expert familiar with Medicare applications is strongly encouraged.
Paul Kesselman, DPM, Oceanside, NY
10/02/2023
RESPONSES/COMMENTS (DME)
From: Elliot Udell DPM
Dr. Harvey's comments comparing podiatrists and orthotics to orthodontists and braces made me chuckle, a bit. Some of the dental procedures are definitely being encroached upon. Last night, I saw an ad on television advertising at-home corrections for missing teeth. The company sends you a kit. You take the impression and they make you something you can add to your own mouth without spending thousands of dollars on dental fees. I wonder if dentists seeing those ads feel the same way that we do when we see shoe stores and non-podiatric professionals making orthotics.
Elliot Udell, DPM, Hicksville, NY
09/29/2023
RESPONSES/COMMENTS (DME)
RE: Reimbursement for Custom Orthotics (Alan Mauser, DPM)
From: Pete Harvey, DPM
Here’s just one more thought concerning orthotic fees. The orthodontists don’t charge for those little wires. They charge for knowing and applying HOW the wires work!
Pete Harvey, DPM, Wichita Falls, TX
09/28/2023
RESPONSES/COMMENTS (DME)
From: Steven J. Kaniadakis, DPM, David Bernstein, DPM
I think casting for orthotic devices is a verb, because the fee is for a "service" rather than a "product", justifying the fee and in a response to Dr. Kornfeld's post. Like surgery, the fee is not for the materials or the cost of suture, it is for the service and talent to perform the service.
Steven J. Kaniadakis, DPM, Saint Petersburg, FL.
Many orthotic labs will make a high quality pair for $75.
David Bernstein, DPM, Wayne, PA
09/27/2023
RESPONSES/COMMENTS (DME) - PART 1 A
From: Elliot Udell, DPM
The problem with orthotics is not whether insurance covers them. The problem is if the patient's insurance does cover custom orthoses and pays you 120 dollars for a set, which is some cases, is less than the lab fees. The classic case in my practice was when a patient came in requesting custom sports orthotics. He was an avid tennis player. I called the insurance company and was told that he is covered and they would pay me twenty six dollars and fifty cents per foot. I called the patient and explained that I could not afford it. He begged me and told me that he would pay me out-of-pocket for the orthotics. I accepted his offer and even gave him a discount. He was happy with the orthotics. Six months later, I get a call from his wife and the rep from the insurance company. I was told that I was contractually obligated to reimburse him and take the 26 dollars per orthotic and eat the loss.
I've since learned that if the patient does have insurance that pays below lab costs, I either will dispense Powerstep orthotics or send the patient to a company such as Hangar orthotics and let them handle the finances. If the patient does not want to pay me for non-custom orthotics, I will simply refer them to Amazon and let them buy them but I do let the patient know that should it be necessary, I will not adjust an orthotic bought from Amazon or a sporting goods store.
Elliot Udell, DPM, Hicksville, NY
09/27/2023
RESPONSES/COMMENTS (DME) - PART 1 B
From: Donald R. Blum, DPM, JD
Because you have analyzed the cost of prescribing "custom" orthosis and are finding the cost to your practice as being prohibitive, you might consider an alternative. I think you missed other important costs to your practice - the time it takes to explain the purpose of orthosis, the time it takes to make an impression of the feet, the time it takes to fill in the order form, the time it takes to send the impression to the lab, the cost of postage for the lab to return the product to you when completed, and the cost if you need to return the appliance to the lab for any correction.
I suggest you are not making a $39 profit. Consideration could be made to charge the patient for the service just like you might when using a laser for treatment of nail fungus, or when using extra corporeal shockwave therapy, or selling the patient an OTC product or other services you might offer the patient that are not covered by health insurance. The alternatives are to let the patient go to a retail store for this service or continue taking the ownership for this service and lose money on a service for the benefit of your patient.
Donald R. Blum, DPM, JD, Dallas, TX
09/27/2023
RESPONSES/COMMENTS (DME) - PART 1C
From: Joel Morse, DPM, Robert Kornfeld, DPM
I recommend that you send out another letter and explain what the CPT code is that you use and show us a copy of the notes that you have so that we can see what is going on. I think that as long as you use the L 3000 code and you have all of the specifics of what type of an orthotic you dispense and the correct ICD-10 codes, you should be paid much more than $70 an orthotic.
Joel Morse, DPM, Washington, DC
I think what you charge depends on the value you deliver. I charge more than twice your $400 fee. And it is paid in full in cash. I do not accept insurance of any kind for the past 23 years. Here is why - patients are not just paying you for a product, they are paying you for the value they receive from the orthotic. This is what is missing from insurance-dependency. You are providing services that have lasting benefits for your patients in many ways, and there is way more value in that than just charging them for a piece of plastic. I'm sorry, but providing your patients with orthotics for $30 is downright insulting to you. But as I have stated many times, when you say yes to less, that is what you are going to get. As long as you are beholden to an insurance company to get paid, you will continue to be underpaid and exploited.
Robert Kornfeld, DPM, NY, NY
09/13/2023
RESPONSES/COMMENTS (DME)
RE: AI and Dressings
From: Paul Kesselman, DPM
Yes, AI will affect many things in our lives. One thing we may not have thought of is wounds and dressing changes. However, as I and others have been saying for years, "smart bandages" are coming.
In a recent news story, the use of AI and smart bandages was discussed. A "smart bandage" will have microsized chips to tell you if a new microbe is brewing, antibiotic sensitivity, and other crucial factors such as when the optimal time for a dressing change, what are the wounds current measurements, etc.
Since the cost of chronic wound care eclipses the cost of the five top cancers together, you can be sure everyone invested in delivering and paying for healthcare is going to be watching these developments closely.
Paul Kesselman, DPM, Oceanside, NY
08/08/2023
RESPONSES/COMMENTS (DME)
RE: Medicare EFT Agreement Changes as of August 21, 2023
From: Paul Kesselman, DPM
In the past, whenever initially or re-enrolling as a DMEPOS provider, or when bank changes occurred to your supplier business, one was required to submit electronic funds transfer (EFT) agreements to the DME MAC who paid them. As of August 21, 2023 that is now changing. EFT agreements will now be required to be submitted to the National Provider Enrollment Contractor where your DME application was submitted. Paper checks for those of you still receiving them will also be eliminated as EFT has been mandatory for some time.
Paul Kesselman, DPM, Oceanside, NY
07/13/2023
RESPONSES/COMMENTS (DME)
From: Paul Kesselman, DPM
I have had considerable discussion with AOPA and navigated discussions between AOPA and APMA to ensure that APMA has had the opportunity to discuss this important legislation. This is not the first year AOPA has presented this legislation to Congress, but hopefully with sufficient bipartisan support it will pass. APMA has previously supported this legislation. In May, APMA discussed this legislation during the APMA Health Policy committee meeting after APMA had held discussions with AOPA and other DME stakeholders involved in providing orthotics to patients.
This legislation, as Dr. Richie notes, precludes the drop shipment of orthotics, which often increases the same or similar problem with many criminal enterprises submitting claims for devices either never submitted or using marketing schemes and providing unnecessary devices to unsuspecting patients. But there is more to this legislation. It also supports separating orthotics from DME such as wheelchairs, walkers, etc.
This separation and placement of orthotics into their own category can hopefully remove the stranglehold of the minimal useful lifetime which has created such havoc better known as Same or Similar. By placing orthotics into their own category, as are prosthetics, the hope is that replacement devices can simply be substantiated by medical necessity, without automatic claim denials requiring lengthy appeals. Contact your Congressional delegation and provide them with your rationale for supporting this important piece of legislation
Disclaimer: The opinions provided here are my personal recommendations and should not be seen as the official position of APMA.
Paul Kesselman, DPM, Oceanside, NY
07/12/2023
RESPONSES/COMMENTS (DME)
RE: The Medicare Orthotics and Prosthetics Patient-Centered Care Act
From: Doug Richie, DPM
An important piece of legislation titled the Medicare Orthotics and Prosthetics Patient-Centered Care Act has been recently introduced to the U.S. House of Representatives. The three major provisions of this legislation would: prohibit “drop shipping” of custom orthoses and prostheses to Medicare beneficiaries; ensure Medicare beneficiaries can access the full range of orthotic care from one O&P practitioner rather than requiring patients to visit multiple providers when the treating orthotist or prosthetist does not have a competitive bidding contract and; ensure Medicare beneficiaries can access replacement custom-fitted and custom-fabricated orthoses when a change in their condition or clinical needs occurs.
A press release from the American Orthotic and Prosthetic Association (AOPA) can be accessed by clicking here.
I hope that this pending legislation will also be added to the list of current advocacy campaigns for APMA as the issue of "same or similar" has become a significant challenge for podiatric physicians and their patients.
Doug Richie, DPM, Long Beach, CA
06/03/2023
RESPONSES/COMMENTS (DME)
From: Don R Blum, DPM, JD
I get frustrated every time I see a post regarding diabetic insoles with therapeutic footwear! APMA has been working on pushing a bill through Congress to ease the requirement of an MD/DO signing off for patients. Most patients never see a physician but only see the PA/NP. How many of the readers of PM News have contributed to APMA PAC?; how many have contributed to their state association, and finally how many of the readers are members of APMA/state association?
Please join your state association/APMA. Please keep up with APMA news. Please support your PAC. Many of the diabetic insole questions are answered regularly by APMA.
Don R Blum, DPM, JD, Dallas, TX
06/01/2023
RESPONSES/COMMENTS (DME) - PART 1A
From: Terry Reed, C Ped
Currently, CMS is doing massive audits on diabetic shoes and are very picky about what they allow. An NP may conduct the exam but it has to be signed by the MD or DO overseeing the patient's diabetic plan of service, and not just signed. There must be a statement such as, "I agree with the above findings" or CMS will reject it.
Also, the auditors will claim that the MD or DO is not truly overseeing the patient if they have not personally seen the patient in the past six months. In other words, people in rural areas who go to a clinic manned by an NP who has their practice overseen by an MD or DO are flat out of luck because they never actually see that doctor.
Terry Reed, CPed, Wynne, AR
06/01/2023
RESPONSES/COMMENTS (DME) - PART 1B
From: Paul Kesselman, DPM
It was important to provide an additional response to the letter I provided in a recent issue of PM News. I purposely did not expand on the issue of when the NP/PA does the foot exam and prescribes the shoes (as they have the legal right to) and thus is the prescribing entity. This circumstance was purposefully omitted out of an abundance of creating more confusion. But since Dr. White brought this up, I feel compelled now to clear that issue up as well.
Dr. White is correct in that PAs and NPs under Medicare are eligible prescribers for therapeutic shoes and inserts, as well as ordering many other tests and DMEPOS. That is NPs/PAs can both prescribe shoes and inserts working incident to (under direct supervision with the MD/DO in the office) or under general supervision (when the MD/DO is not in the office but...
Editor's note: Dr. Kesselman's extended-length letter can be read here.
05/31/2023
RESPONSES/COMMENTS (DME) - PART 1A
From: Paul Kesselman, DPM
CMS attempts to facilitate access for therapeutic shoes to patients who only see PAs or an NPs has been a flop. It also has confused the auditors at every level, created a larger paperwork trail. Even my fellow DME council members continue to flood my phone and email box just having reviewed this issue during a council meeting. So to try to give a straight answer covering every scenario in this format would be nearly impossible. This is what a PA can do:
If you are the supplier and prescriber: They (the PA) can perform a systems exam, sign the supervising physician statement, and attest agreement with your notes. However, every single one of those documents must be co-signed and dated by the...
Editor's note: Dr. Kesselman's extended-length letter can be read here.
05/31/2023
RESPONSES/COMMENTS (DME) - PART 1B
From: Josh White DPM, C.Ped
PAs and NPs are permitted to do foot exams, documenting qualifying risk factors for therapeutic shoes and to complete a Statement of Therapeutic Necessity. Medicare still requires an MD/DO to be the Certifying Physician. It is okay if they provide "general supervision (versus direct)" of the NP/PA.
It is still necessary for the certifying physician to co-sign the certifying statement and foot exam. Often, this is a challenge to execute. It is NOT okay to get the NP/PA signatures without a MD/DO co-signing it.
Josh White DPM, C.Ped
08/26/2022
RESPONSES/COMMENTS (DME)
RE: Another OIG Investigation Worthy of Looking at
From: Paul Kesselman, DPM)
Another OIG investigation is worthy of looking at as to how this may affect your practice. Yesterday, the OIG announced the findings of an investigation against an ophthalmic lens manufacturer that seems eerily familiar to a similar issue podiatrists also face when accepting rebates or gifts from manufacturers of cellular tissue products or other products billed to third-party payers.
There are "safe harbors" to the Anti-Kickback and Stark Violations regulations. When offered any rebate or financial incentive from a manufacturer, the wisest choice is to contact a healthcare attorney and provide them with the language of the incentives/discounts being offered to you. If the offer you receive is not within one of the safe harbors, it is wise to decline the offer. For more on this story, click here.
Paul Kesselman, DPM, Oceanside, NY
08/24/2022
RESPONSES/COMMENTS (DME)
From: Paul Kesselman, DPM
Having done further research on the CMS CMN issue, I would like to make one correction and some follow-up comments:
1) Fee-for-service Medicare does not require CMN on NPWT, nor on wheelchairs.
2) Medicare Advantage Plans and other third-party payers have their own myriad of rules on prior authorization and the need for a "CMN-like" form;
3) The Medicare Fee-for-Service announcement may or may not affect your Medicare Advantage Plans and local third-party payers.
It is best to check with them for follow-up on how the recent Fee-for-Service Medicare announcement on CMN discontinuation will affect your patients’ coverage come Jan 1 2023.
4) Look for a full length article discussing this issue as well as other new DME later this fall in Podiatry Management magazine.
Paul Kesselman, DPM, Oceanside, NY
08/22/2022
RESPONSES/COMMENTS (DME)
RE: Discontinuation Certificates of Medical Necessity
From: Paul Kesselman, DPM
Recently there has been a flurry of messages from DME MAC and CMS contractors regarding the discontinuation of Certificates of Medical Necessity (CMN) for dates of service effective January 1, 2023. While I will provide a lengthy description of this issue in an upcoming article in Podiatry Management, I felt it necessary to disseminate this clarification statement.
Certificates of Medical Necessity (CMN) are formal specialized documents which are provided by Medicare for specific categories of DMEPOS. These include devices typically prescribed and ordered but not dispensed by podiatrists, including but not limited to...
Editor's note: Dr. Kesselman's extended-length letter can be read here.
05/05/2022
RESPONSES/COMMENTS (DME)
From: Connie Lee Bills, DPM, Paul Kesselman, DPM
Yes, it happens all the time from DME suppliers as well. I agree with you; it is frustrating.
Connie Lee Bills, DPM, Mount Pleasant, MI
The provider posing this question offers a very valid question. In states where there are no licensure requirements for dispensing orthotics and prosthetics (the vast majority), there are no regulations which restrict who can fit and dispense OTC, custom fit or even custom fabricated orthotics and/or prosthetics. Only approximately 17 states have restrictions requiring licensure regarding the provision of orthotics and prosthetics. Medicare goes further in requiring Facility Accreditation and Surety Bonding for providers who are both not providing devices to their own patients and who do not meet the exemption requirements.
That being said, I advise my clients to do what I did when in private practice, whether it was for a foot orthotic or AFO, to go back to the original dispensing provider in order to obtain a properly fitted device. Should that fail, I would advise the patient to...
Editor's note: Dr. Kesselman's extended-length letter can be read here.
05/04/2022
RESPONSES/COMMENTS (DME)
RE: Urgent Care Center and Walker Boot Braces and DME Items
From: Name Withheld
This past Friday, I saw a new patient for an acute injury. He was referred by his friend, a prior patient of mine, upon whom I had done bunion surgeries. This new patient was seen three days earlier at a local urgent care center, and was correctly diagnosed with acute minimally displaced 4th and 5th metatarsal fractures on one foot, fitted for a walker boot, dispensed crutches, told not to walk on the foot, and told to immediately follow-up with an orthopedic surgeon.
The patient, a 75 year old male, presented with crutches and an improperly fitted ankle height pneumatic walker boot. The crutches were not adjusted to his height and he had great difficulty walking while trying to be NWB on the injured foot. He was given no crutch training at the urgent care center, nor were there any...
Editor's note: This extended-length letter can be read here.
04/30/2022
RESPONSES/COMMENTS (DME)
From: Vince Marino, DPM
In answer to your question, my office manager informed me that you need both the hours of operation AND the business name that you used for your DMERC validation on the front door.
Vince Marino, DPM, Novato, CA
04/28/2022
RESPONSES/COMMENTS (DME)
From: William Tomback, DPM,Jack Ressler, DPM
K.I.S.S.- put “by appointment only” on all days on sign. Otherwise, if a DME Rep comes to office and it is not open as shown on sign, you can lose your right to dispense DME.
William Tomback, DPM, Somers, NY
Although I no longer dispense DME, stating hours of operation was the only requirement for signage when I was dispensing. Be aware that after an office relocation, a representative from Medicare will show up at your office to go over your records. Check with your DME supplier to make sure all pertinent documentation is available and up-to-date.
Jack Ressler, DPM, Delray Beach, FL
