Submitted Comments

April 16, 2021
The Alliance submited comments to CMS' Interim Final Rule regarding Medicare Coverage of Innovative Technology (MCIT) and the definition of “Reasonable and Necessary.” The Alliance encouraged CMS to move forward with select portions of the rule without additional delay, and provided  feedback to specific questions posed by the Agency. However, the Alliance also reiterated its concern that the MCIT rule and the rule addressing the new definition of “reasonable and necessary” are two very distinct and separate topics of focus that should never have been issued together. 

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March 23, 2021
Over the past four years, CMS has placed the issue of reforming the CTP payment methodology in the Hospital Outpatient Prospective Payment System (OPPS) proposed/final rules, soliciting feedback on Episodic Payment, Single APC, and Comprehensive APC. In March, the Alliance developed and proactively submitted to CMS its recommendations regarding CTP payment methodology for the Agency to  consider as it begins development of proposed rules for CY 2022. In summary, the Alliance encouraged CMS to propose a CTP/skin substitute payment methodology for CY 2022 implementation that collapses the “high cost” and “low cost” products, allows separate payment for the add-on codes, and tracks the base codes and add-on codes to unique APC Groups which are updated annually. See detailed recommendation in CMS letter, below.

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March 15, 2021
When Noridian issued a draft wound care local coverage determination (LCD) in February, the Alliance quickly mobilized to provide feedback and recommendations to shape the final policy. Ensuring that this draft was correct clinically is important to Alliance members since it could be used by other AB MACs in the future. The draft policy as issued was well-rounded and reflected some of the feedback previously provided by the Alliance to Noridian. However, the policy also included a significant number of areas with inaccurate information, outdated terminology, and, in several cases, inconsistent or conflicting language. The Alliance convened a workgroup to bring together the broad expertise of our membership to develop extensive comments to both the draft LCD and its accompanying policy article (LCA).

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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.

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January 19, 2021
The Alliance submitted comments to the National Quality Forum's Measure Applications Partnership (MAP) Coordinating Committee to support inclusion of the Global Malnutrition Composite Score (MUC20-0032) in the Hospital Inpatient Quality Reporting program. This can "improve patient care outcomes through standardized identification and treatment of malnutrition." See the Alliance's full letter to the NQF below.

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January 4, 2021
As part of the Alliance's ongoing advocacy to make the HCPCS coding process more transparent, understandable and predictable, the Alliance submitted comments and recommendations 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. The comments supported the ongoing advocacy work of the Alliance for HCPCS II Coding Reform (of which the Alliance is a member) and focused on code cycles, application re-submissions and other key areas to increase the speed of new products receiving codes so that patients have access to the latest products more quickly.

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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. See full comments, below.

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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 the Alliance's letter and presentation to USP, below.

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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.

See additional recommendations submitted to CMS in the full-text comments, below.

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