Submitted Comments

January 20, 2021

The Alliance submitted comments to CMS in support of the National Coverage Decision (NCD) for Autologous Blood-Derived Products for Chronic Non- Healing Wounds. The Alliance applauded Medicare’s decision to provide coverage for the use of autologous platelet-rich plasma (PRP) for patients with chronic non-healing wounds, but pointed to certain language in the policy that was not clinically accurate and suggested modifications.

January 4, 2021

The Alliance submitted comments to CMS' Medicare CY 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Healthcare Common Procedure Coding System (HCPCS) Level II Proposed Rule as part of our ongoing advocacy to make the HCPCS coding process more transparent, understandable and predictable. 

December 22, 2020
The Alliance submitted comments to CMS urging the Agency to withdraw its proposed rule “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET). The Alliance expressed concern that the SUNSET proposal would place significant new administrative burdens on HHS Agencies at a time when resources and time must be allocated to addressing the Covid-19 Public Health Emergency (PHE) and noted many unintended consequences that could result.

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November 2, 2020

The Alliance submitted comments to CMS' proposed rule regarding Medicare Coverage of Innovative Technology (MCIT) and the new definition of “reasonable and necessary.”  The Alliance applauded CMS for its decision to move forward in providing the pathways to move innovative technologies to market faster but expressed concern that CMS had included both of these very significant but completely different topics together in one proposed rule. As the definition for "reasonable and necessary" is a very complex issue, the Alliance recommended that CMS issue a separate proposed rule regarding the definition of reasonable and necessary in which the Agency could provide significantly more information. The Alliance informed CMS that we "can not take a position on this proposal [for reasonable and necessary] since we believe that there are not enough details provided in this proposed rule," and included in comments a list of specific questions to gain clarity on both the MCIT and "reasonable and necessary" proposed provisions.
Read Alliance Comments

October 13, 2020
The Alliance met (virtually) with USP leadership then submitted a follow-up letter advocating the need for a wound care subcategory in United States Pharmacopeia's (USP) Medicare Model Guidelines. Establishment of this subcategory would help to distinguish the chronic wound products from other subcategories - which in turn would better protect coverage of wound care products under Medicare Part D.
See Alliance Letter
SEE ACCOMPANYING PRESENTATION
October 2, 2020

The Alliance submitted comments to CMS’s proposed CY2021 Hospital Outpatient Prospective Payment System. Our comments:

  • Encouraged use of the “Cellular and/or Tissue Based Products for Wounds “(CTPs)  terminology in policymaking, in place the currently used “skin substitutes.”
  • Supported inclusion of Synthetic CTPs in the definition of “skin substitutes” but expressed significant concerns with the Agency’s proposed establishment of the code C1849 (“Skin substitute, synthetic, resorbable skin substitute per square centimeter) to define an entire class of non- branded products and its placement in the OPPS high cost payment package. The Alliance reviewed the impacts of this code as proposed and submitted a number of alternative recommendations.  
  • Requested that Hyperbaric Oxygen Therapy be added to the list of services that require direct supervision
  • Sought clarification on how provider based departments should make decisions on the level of service assigned to code G0463 (hospital outpatient clinic visit) once the new 2021 E/M guidelines are in place.
READ ALLIANCE COMMENTS
October 2, 2020

The Alliance submitted comments and recommendations to CMS’s proposed CY2021 Physician Fee Schedule. Our comments:

  • Oppose cuts in  payment for surgical procedures and physical therapy services and urged the Agency to prevent drastic cuts from occurring while physicians are still trying to recover and gain their financial footing from the effects of the pandemic.
  • Urge CMS to not only accept the RUC recommendations for the values of E/M codes, as they have proposed, but to also apply these updated values to the global procedure codes. We flagged that implementing new values for E/M codes when billed independently - but not implementing those same values in the global packages - disrupts the relativity in the entire physician fee schedule and creates specialty differentials even when performing the same work.
  • Recommend that the Agency consider creating a MIPS Value Pathway (MVPs) for Chronic Wound Management and utilize the QCDR measures which already exist for wound care. 
  • Encourage CMS to maintain a patient’s home as an originating site even when the Public Health Emergency expires. 

Read Alliance comments

 

August 14, 2020
The Alliance provided written and oral comments to CMS' August 2020 CMS Advisory Panel on Hospital Outpatient Payment. Comments focused on provisions related to "synthetic skin substitutes" and included recommendations to:
  • Eliminate the new code C1849 – synthetic skin substitutes resorbable and require any synthetic skin substitute to apply for an appropriate HCPCS Q code to be considered a “skin substitute.”
  • Remove placement of the C1849 synthetic skin substitute products from the high cost tier.
  • Change the current “skin substitute” terminology to “cellular and or tissue based products for skin wounds."
Read Alliance comments
August 11, 2020
The Alliance co-signed a letter to the Senate Finance Committee expressing concern regarding legislation (S. 4295) that would allow Health and Human Services to extend the period of Medicare pass-through status in the hospital outpatient setting to any product with that status during the COVID public health emergency. As written, the proposed legislation would allow products that have already had well over the statutory period of two-to-three years to have extended pass-through time – in some cases, more than double the statutory limit. The letter focused on the impact such a pass-through extension would have on CTPs and noted the importance of ensuring access to all CTP products in the market to support clinical choice and patient value. “Extending the pass-through term of CTP products well beyond the normal pass-through period drastically detracts from that effort. We believe this skews patient access as it incentivizes use of these CTP pass- through products over others in an otherwise established market,” the letter stated.
Read Co-Signed Letter
July 10, 2020
As a member of the Alliance for HCPCS Coding Reform, we submitted a letter to Representatives DeGette (D-CO) and Upton (R-MI) urging that the upcoming Cures 2.0 legislative package include language to reform and modernize HCPCS Level II coding to ensure that the process is fair, transparent, predictable, accurate, efficient, and independent of a payer’s coverage and payment considerations. The letter is a follow-up to requests made in a December 2019 letter to Congress. 
Read Alliance Letter
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