The public comment period for the Centers for Medicare & Medicaid Services (CMS) proposed home health rule is winding down: Comments must be submitted by the end of the day, Eastern time, on Friday, Aug. 29.
As of Monday, Aug. 25, more than 8,000 comments had been submitted by stakeholders concerned about how the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) portion of the proposed rule will affect them. Here are eight of those comments, as submitted to the Federal Register, which published the proposed rule on July 2.
‘They are prosthetic devices, not medical equipment’
I am an ostomy nurse practitioner, and I work closely with ostomy patients of all ages, shapes and sizes.
Unfortunately, ostomy supplies are not a one size fits all. An incorrectly fit ostomy appliance will severely impact the quality of life for a patient and will limit their ability to work and take care of themselves independently.
They are prosthetic devices, not medical equipment. CMS cannot arbitrarily change the definition (as this is related to their function). Ostomy appliances are clinically prescribed, based on unique patient characteristics. This prevents leaks, odor and severe skin complications.
If the wrong equipment is provided, this leads to increased emergency room visits. I see this frequently with Medicaid patients who are limited in supply choices and not supplied the appropriate quantity. If more patients do not have access to appropriate supplies, they will come to the emergency room, leading to longer emergency room wait times and greater expense overall.
A caregiver’s perspective
Based upon personal experience as a caretaker for a quadriplegic spouse, I adamantly oppose any restrictions or limitations that would include trach, ostomy, urological and/or incontinence supplies in the upcoming round of competitive bidding.
This would only serve to limit the options and availability for patients requiring these supplies as well as limit the number of suppliers.
Annual accreditation would strain small businesses
I am a small business owner and have been for over 22 years. I have a women’s mastectomy boutique.
The women of New Jersey and New York depend on my service. I have been accredited since I opened my business, first with Joint Commission and over the last 12 years, the American Board of Orthotics and Prosthetics. We have always complied with every Medicare requirement, down to the needed documentation, the survey requirements, the postings, the documents for the patient, and of course, the billing. We have a true storefront full of inventory, with all the invoices from the vendors.
As a small business, it is absolutely absurd to have us go through the accreditation process every year. We do not have the manpower or the time or money to undergo this on a yearly basis.
We have always passed with a perfect score, and I do not see any need for a yearly survey. I consider it just plain harassment! … Whoever came up with this idea clearly has no idea of what the real world of orthotics and prosthetics is all about. It is about servicing people who are at their most vulnerable time in their lives, and trying to help them pick up the pieces to go on. It is a valuable service we provide, and we simply cannot do our jobs if we are bogged down with this ridiculous idea of undergoing a survey every year.
Our patients will suffer. Our finances will suffer, as meager as they are, and our ability to work effectively and compassionately with each individual will be compromised. I implore you to drop this idea.
‘I spent the time helping them to find the right product’
I have worked closely with ostomy and urological patients since 2008. I have worked for two DME [durable medical equipment] providers in Arkansas that stock ostomy and urological supplies. I have seen SO many desperate ostomy and urological patients over the years. I have had countless patients come in to get supplies from the DME provider I worked for because I spent the time helping them to find the right product.
So many of these patients received the cheapest product possible from mail order companies, and they were given no other option when they expressed that the products did not work for them or made their issues worse. A lot of the patients came to us because they were tired of their products shipping late or not at all.
Making these categories competitive bid will have devastating effects on many ostomy and urological patients. I foresee intermittent catheter patients reusing catheters because their shipment hasn’t come in (leading to urinary tract infections and hospitalizations). Ostomy patients will suffer because competitive bidding will eliminate many of their product options.
The fee schedule is already impossibly low for some of the ostomy HCPCS [codes]. These patients will suffer because less than optimal products are coming into contact with skin that is already compromised. This will lead to infections and hospitalizations, as well.
‘My health depends on consistent access to high-quality, individualized supplies’
I rely on urinary catheter supplies. These supplies are critical to my health and have been prescribed by my physician based on my specific medical needs. I use products that are specially tailored for me three times each day. I am a 67-year-old male that is in otherwise good health. However, without reliable access to these catheters, my health will suffer. Without them I will likely develop kidney problems that will be far more expensive to Medicare than the cost of the catheters.
I am very concerned that CMS is proposing to include urological and ostomy supplies in future rounds of the Medicare competitive bidding program. Including these supplies in the competitive bidding program could force suppliers out of the Medicare program and severely limit my access to medically necessary, customized products. My health depends on consistent access to high-quality, individualized supplies, and I’m worried that this proposal will put that at risk.
The impact of limiting the number of participating suppliers
As a local DMEPOS supplier, we are deeply concerned about the implications of the 2025 CMS proposed rule for the DMEPOS competitive bidding program.
We strongly urge CMS to reconsider aspects of this proposal, particularly those that limit the number of DMEPOS suppliers and impose downward pressure on reimbursement rates. These changes threaten the viability of local suppliers and, more critically, the health and well-being of Medicare beneficiaries who rely on timely access to essential medical equipment and services.
‘Will not have the end result’
I am the business owner of a DMEPOS supplier. We have been in business since 2006 and currently gross about $1 million. The following changes make it very hard for smaller businesses to compete; however, larger DMEPOS suppliers are often the culprits in fraud and abuse. The local, family-owned companies that are truly serving their communities are negatively impacted by rules such as these, and we are the “good guys” with store fronts run by locals. With faces patients can see, complain to, thank, etc.
In regards to the proposed rule I have multiple concerns:
1) The elimination of 90-day accreditation for secondary locations will delay patient access if new locations are unable to bill Medicare until an on-site survey is complete.
2) The annual survey requirement will be extremely costly. In the DMEPOS industry, profit margins are already extremely low in comparison to other health-care organizations. Our site visit is thousands of dollars every three years. If this became a yearly expense, many DMEPOS suppliers will not be able to continue to bill Medicare, thus diverting resources away from patient care.
3) Pertaining to the unannounced survey requirement, the rule does not fit all business models, and CMS should consider being more flexible.
I agree that it is time to stop fraud and cut back on wasted expenses; however, this action harms the “good guys” the most and will not have the end result lawmakers think it will have.
‘This pulls staff from being able to do direct patient care’
We are a small DMEPOS supplier in a rural area. The proposed changes to the accreditation requirements will put an undue, added burden [onto] an already understaffed industry.
As a small DMEPOS, we have staff that do multiple job functions because we cannot hire enough staff or pay overtime to existing staff to cover all functions with cost of goods constantly going up and reimbursements barely covering the cost.
As such, the change in accreditation from every three years to every year would put a large strain on an already overworked staff. There is a lot of preparation and time that goes into getting ready for the accreditation, not to mention the actual cost of the accreditation. This pulls staff from being able to do direct patient care.
It is bad enough when we have to pull staff to do this every three years, but changing it to yearly would greatly impact patient care, as this is currently done by our only respiratory therapist, who also serves as our compliance officer, in conjunction with the office manager, who also does all of the billing, insurance credentialing, audits, accounts payable, etc.
Small DMEPOS locations do not have the ability to have a person dedicated to accreditation. Each employee wears many “hats,” and this change would cause undue stress and lead to falling behind in order processing and deliveries, which could lead to patients not getting the equipment they need in a timely manner, which could be detrimental to their well being.
Editor’s note: Some comments were lightly edited for clarity and/or to redact identifying information.
