Last year, our group, along with the American Physical Therapy Association (APTA), American Occupational Therapy Association (AOTA), and the Alliance of Wound Care Stakeholders, sent a joint letter to the Centers for Medicare and Medicaid Services (CMS) regarding therapist reimbursement for fitting and measuring services, with an accompanying chart of questions.
CMS’s response to this inquiry is quoted below. Note that the question numbers correspond to the aforementioned chart. While lengthy, we wanted to share their response in its entirety, to ensure that no detail was inadvertently omitted.
As a reminder, the APTA and AOTA are seeking input from lymphedema therapists, and we hope you will participate in their important survey: Lymphedema Treatment Act Year One Implementation and Provider Experience. If you are a patient, please feel free to share this survey with your care providers.
Thank you for your continued engagement!
Heather Ferguson
Founder & Executive Director
Lymphedema Advocacy Group
LymphedemaAdvocacyGroup.org
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CMS Response
“Below are responses to some of the questions you included in your email. If the response is not included below, it is because we plan to include it in an update to the DMEPOS pages on cms.gov in the future.
1) Question: How can therapists privately contract with DME suppliers for garment measuring, fitting, and training services without invoking the Anti-Kickback Statute (AKS)?
3) Question: Does a contract shorter than one year violate the Anti-Kickback Statute or Stark Laws?
5) Question: Is it appropriate for an arrangement to cover services rendered during or prior to the contract negotiations? Do either the Anti-kickback Statute or the Stark Law require that the services not have already been rendered?
7) Question: How can therapists with ownership interest in the DME contract without implicating the Stark Laws?
9) Question: Are there geographic considerations in contracting that therapists should be concerned about? For instance, if an area has only two DME suppliers, would a contract with one, but not the other implicate the Anti-kickback Statute if the therapist only refers to the DME they’re contracted with? Would a permissible contract in one area potentially implicate the Anti-kickback Statute in another?
Answer:
For questions relating to the physician self-referral law, please refer to the response to comments on this issue found on page 77820 from the final rule named Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements (88 FR 77676).
For questions related to the Federal anti-kickback statute, the HHS Office of Inspector General (OIG) offers both an FAQ process and an advisory opinion process to health care industry stakeholders. Further information about OIG’s FAQ process can be found here: https://oig.hhs.gov/faqs/
Further information about OIG’s advisory opinion process can be found here: https://oig.hhs.gov/compliance/advisory-opinions/process/
2) Question: Are therapists expected to contract with DMEPOS suppliers annually, or on a case-by-case basis?
6) Question: Therapists work with a varying number of DMEPOS suppliers—is the expectation that to get paid consistently, they would have to enter into arrangements with each supplier?
11) Question: How should therapists modify their current billing practices in response to the new benefit?
4) Question: If contracts are expected to be annual (or longer), is it appropriate for therapists to enter into the following types of agreements (the amounts and percentages are just hypothetical, assuming they are fair market value):
- For a flat percentage of the garment reimbursement for each garment? (e.g., 15% of the Medicare garment rate)
- (b) For a flat rate of the garment reimbursement for each garment? (e.g., $40 for each garment).
- (c) For a scaling percentage of the garment reimbursement for each garment, based on patient complexity? (e.g., 10% for stage 2, 15% for stage 3, 20% for stage 4)
Answer: This is up to the therapist and supplier as CMS is not involved in private business or contractual arrangements between therapist and suppliers.
15) Question: When can a patient purchase a garment with cash, out-of-pocket? Is it only when the item is non-covered and has a compliant ABN?
Answer: Starting January 1, 2024, Medicare Part B covers lymphedema compression treatment items. When a supplier furnishes an item that is covered by Medicare, the supplier is subject to the mandatory claim submission provisions of section 1848(g)(4) of the Social Security Act (the Act). Therefore, if a supplier charges or attempts to charge a beneficiary any remuneration for an item that is covered by Medicare, then the supplier must submit a claim to Medicare. Suppliers who violate the mandatory claim submission rules may receive a fine of up to $2,000 (see section 1848(g)(4)(B) of the Act). A supplier who wants to treat (and receive payment from) a Medicare beneficiary will stay in compliance with the law by enrolling in Medicare and filing claims on the beneficiary’s behalf.
For information on when it is appropriate to issue an Advanced Beneficiary Notice for a non-covered item, refer to our Advanced Beneficiary Notice of Non-Coverage Tutorial.
16) Question: How is CMS tracking information related to who is providing measuring and fitting services to inform future policymaking under the benefit?
Answer: Medicare claims for DMEPOS do not indicate when a supplier has arranged for fitting services to be performed by another entity. Therefore, CMS has no way to track who is providing measurement and fitting services. Section 1834(j) of the Act, as amended by the Consolidated Appropriations Act, mandates that payment for gradient compression garments and items can only be made to enrolled DMEPOS suppliers. As explained in LCTI payment guidance on CMS.gov, the DMEPOS supplier is responsible for all aspects of providing the item and makes their own arrangement with an external fitter if they do not perform the fitting services themselves. The statute is silent on how the DMEPOS suppliers that are furnishing the garments and items are supposed to interact with external fitters.
17) Question: Where can patients find out about their Medicare options for lymphedema garments?
Answer: Medicare beneficiaries may obtain information about Medicare’s lymphedema compression garment benefit from Medicare educational materials (such as in the Medicare and You Handbook) and their physician. They may also contact their DME Medicare Administrative Contractor (MAC).
18) Question: Does CMS plan on creating new HCPCS codes for surgical dressings?
Answer: Currently, CMS does not have plans to add new HCPCS Level II codes or modify the descriptor of existing gradient compression stocking HCPCS Level II codes to designate use under the surgical dressing benefit. National HCPCS Level II codes are maintained by CMS, and we review requests from manufacturers and other interested parties twice a year as CMS determines whether to make additions or revisions to the code set. HCPCS Level II coding requests can be made using the MEARIS™ system.
8) Question: Are there simple ways of determining fair market value (FMV)? How can therapists be sure their arrangements are designed with FMV for the services?
Answer: For information on fair market value, please refer to pages 77551-77558 from the December 2, 2020, final rule named Medicare Program, Modernizing and Clarifying the Physician Self-Referral Regulations (85 FR 77492).
10) Question: Do therapists and DMEPOS suppliers submitting the claims need to be concerned that MACs would rely on/apply a similar standard to the new LCD for pneumatic compression devices and thereby deny payment if the therapists and DMEPOS suppliers have contractual arrangements for measuring, fitting, and training services related to lymphedema compression garments? Will CMS be providing guidance to DME MACs to ensure this does not happen?
Answer: For information about Local Coverage Determinations, contact the DME Medicare Administrator Contractors (MACs).”
