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Advocacy in Action
3rd Quarter 2022
Advocacy Updates In This Issue:

  • Submitted comments requesting delay in CTP payment methodology changes in proposed 2023 Physician Fee Schedule until patient access issues are more fully vetted 
  • Urged CMS to correct inadequacies in CTP payments in the 2023 Hospital Outpatient PPS via comments and HOP Panel testimony
  • Questioned the evidence underlying Novitas and FCSO’s re-issued LCDs on Skin Substitutes for DFU/VLU in comments and public meeting testimony
  • Asked Congress to advance policies to mitigate cuts to physician reimbursement
  • Sought clarity on 2023 Home Health PPS provisions on Lymphedema
  • Policy Tracker Updates
  • Welcome to New Members
  • …and more
A Message from Our Co-Chairs:

Oh, the irony!

Just when CMS expressly named amputation avoidance in diabetic patients as a “priority clinical topic” in its draft 2023 Physician Fee Schedule, it also proposed – in the same rule – seismic payment policy changes for cellular and tissue-based products for wounds (CTPs) that will be a significant barrier to patient access, likely leading to more patients receiving amputations.

On the one hand, the Alliance was gratified to see CMS elevating amputation avoidance measures for patients with diabetes. We’ve long been involved with this issue and, in 2014, collaborated with the U.S. Wound Registry to develop measures focused on reducing amputation among diabetics with lower extremity wounds. On the other hand, the Agency’s proposal to reclassify all CTPs products as “supplies incident to a physician service” and package payment into the physicians’ practice expense flies in the face of amputation avoidance. 

To address this irony, we provided detailed recommendations to CMS for quality measures related to wound care and amputation avoidance, and at the same time, requested that CMS remove – or at least delay implementation of – the provisions related to CTPs until the Agency can address the impact that they would have on patient access.

We also weighed in on the proposed 2023 Hospital Outpatient Payment System, where we advocated yet again for common-sense policy adjustments to enable provider-based departments to be reimbursed adequately when CTP products are used on larger wounds and to equalize payment for the application of CTPs on wounds/ulcers of the same size, regardless of where they are on the body. 

If this sounds familiar, it’s because last year we raised these same recommendations to CMS’ Advisory Panel on Hospital Outpatient Payment. While the Panel had endorsed these recommendations, CMS did not adopt them. So we raised them again this year, the Panel supported and elevated them to CMS for consideration, again.

We will keep elevating issues – again and again as needed – to ensure would patients can access the care they need. Find links to our many comments submitted in Q3, below. We send a hearty thanks to all of you who joined our many (many!) conference calls on these issues and submitted edits and feedback to the various comment drafts.

Caroline E. Fife, MD and Matthew G. Garoufalis, DPM
Co-chairs, Alliance of Wound Care Stakeholders
Requested that CMS delay implementation of CTP provisions in the 2023 Physician Fee Schedule until patient access issues - and impacts on amputations/infections - can be further studied.
The Alliance warned CMS that proposed changes to the way CTPs are paid for in the physician office under the 2023 Physician Fee Schedule create barriers to care that could ultimately lead to increased amputations and infections for patients with chronic non-healing wounds. In submitted comments, the Alliance urged CMS to remove or delay implementation of the proposed provisions that would reclassify all CTPs as “supplies incident to a physician service” and packages payment for these “supplies” into the practice expense associated with that service. This change “ignores the therapeutic significance of CTPs,” and “strips the very payment mechanism that currently allows these advanced therapies to be provided” in the physician office. “Physicians will not be able to absorb the cost of purchasing CTPs if they do not receive adequate payment to provide this advanced therapy. This will result in a lack of access for patients who could benefit from receiving a CTP and, as a result, can lead to an increase in infections and amputations,” the Alliance alerted the Agency.
Urged CMS to remove patient access barriers by correcting inadequacies in CTP payments in the 2023 Hospital Outpatient PPS 
The Alliance testified at CMS’ Advisory Panel on Hospital Outpatient Payment Meeting and submitted comments to CMS' proposed CY 2023 Hospital Outpatient Prospective Payment System, urging the Agency to make policy adjustments to enable Provider-Based Departments (PBDs) to be reimbursed adequately when CTP products are used for larger wounds and to equalize payment for the application of CTPs to wounds of the same size, regardless of the anatomic location. The Alliance’s recommendations were again, for the second year in a row, supported by the Panel and elevated to CMS. “With these policy fixes, barriers will be removed and PBDs would be fairly paid for the CTPs purchased to apply to all wound sizes and locations. Medicare patients will have much improved access to CTPs in PBDs regardless of the size or location of their wounds,” the Alliance emphasized to CMS.
Submitted input (again!) to re-issued LCDs/LCAs on Skin Substitutes for Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers
When Medicare Administrative Contractors Novitas and First Coast Service Option re-issued these local coverage determinations and local coverage articles for comment, the Alliance questioned why little previously-provided stakeholder input was reflected in the re-posted policies. “We identified many issues in our public testimony given on April 28 and our extensive comments dated May 27. Therefore, it is baffling that First Coast and Novitas reissued the draft policies without taking into consideration ANY of our or other stakeholders’ comments,” the Alliance voiced in oral testimony at the MACs’ public meetings and wrote in submitted comments. The Alliance again took issue with the shift of 40+ products from the covered to non-covered list and the lack of evidence underlying the non-coverage decisions, recommending that the MACs withdraw these draft LCD/LCAs and work with their Carrier Advisory Committees and stakeholders to craft more accurate policies. The Alliance also submitted a similar letter to Guidewell Source, the parent company of Novitas and FCSO.
Asked Congress to advance policies to mitigate cuts to physician reimbursement
Together with 20+ other members of the Clinical Labor Coalition, the Alliance co-signed a July letter to Members of Congress expressing concerns about the significant cuts in physician reimbursement in the proposed 2023 Physician Fee Schedule. The cuts "undermine the long-term financial viability of physician practices and seniors’ access to critical treatments and procedures, by implementing significant cuts in physician reimbursement. Community-based office setting specialty care is a critical part of the nation’s healthcare infrastructure, and we are certain CMS’ reimbursement policy will have repercussions for the future, impacting access and value." The letter urged Congress to advance policies to mitigate the forthcoming reimbursement cuts. Absent Congressional action, the proposed payment reductions will take effect on Jan. 1, 2023.
Sought clarity to proposed 2023 Home Health PPS provisions on Lymphedema
The Alliance submitted August comments to CMS's proposed 2023 Home Health PPS that included a list of specific questions focused on gaining clarity on provisions related to the reassignment of the ICD–10–CM diagnosis codes related to lymphedema from clinical group E (Musculoskeletal Rehabilitation) and clinical group A (MMTA-Other) to clinical group C (Wounds). The Alliance also urged the Agency not to make many of its proposed cuts in payment to home health agencies.
Dialogued with CMS’ Program Integrity Office to pursue proper implementation of NCCI edits 
Following tenacious Alliance advocacy, in late-2021 CMS’ National Correct Coding Initiative (NCCI) contractor updated its policy manual to allow for debridement and compression to be provided on the same day. However, they failed to make changes to the accompanying edit tables, which are now confusingly inconsistent with the language in the manual. The Alliance has engaged in ongoing discussions with CMS and its contractor, convened meetings, and submitted letters to resolve this inconsistency. The Alliance elevated this issue to CMS’ Director of Hospital & Ambulatory Policy, and, now this quarter, has been in dialogue with CMS’ Division of Program Integrity regarding the lack of CMS action and the barrier to care that remains as a result.

Convened Government Affairs and CTP Workgroups
We convened our CTP Workgroup several times throughout Q3 as we sought input and varied perspectives, then developed consensus comments to CMS policies. The Government Affairs Workgroup also met several times throughout Q3 as we strategized and implemented a Congressional Plan of Action to delay implementation of the Physician Fee Schedule provisions related to CTPs. Members’ government affairs departments have held discussions with Members of Congress and requested that letters be sent from Congressional leaders to CMS.

Upcoming: Alliance in-person meeting at Fall SAWC
The Alliance will be convening an in-person meeting on Oct. 14 at 1:30 pm PT during the Fall SAWC meeting in Las Vegas.
Influential wound care trade publications featured more policy coverage and advocacy updates via a series of by-lined pieces contributed by the Alliance. These recently included:
HCPCS Coding Decisions: Shared CMS’s Second Quarter HCPCS Applications Summaries and Coding Decisions: Drugs and Biologicals

Noridian DMEMAC Probe: Alerted members that Noridian is Conducting Targeted Probe and Education Pre-Payment Reviews on Surgical Dressings and Pneumatic Compression Devices

For more information, visit our
Alliance of Wound Care Stakeholders' Policy Tracker.
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The Alliance of Wound Care Stakeholders