Submitted Comments

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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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.
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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

• USP

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

• CMS
• CTPs/(skin substitutes)
• Hyperbaric Oxygen Therapy (HBOT)

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. 

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• CMS
• Physician Fee Schedules

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."

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• CMS
• CTPs/(skin substitutes)
• HCPCS

• CTPs/(skin substitutes)
• legislation

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

The Alliance submitted comments to CMS's COVID-19 Public Health Emergency Second Interim Final Rule that provided additional policy and regulatory revisions to provide flexibility during the pandemic. The Alliance  providing specific comments and recommendations addressing:

• The codes that should be utilized by Provider Based Departments (PBD) when billing for wound care services via telehealth that has been temporarily relocated to a patient’s home
• Competitive bidding program concerns
• Temporary relocation sites
• The Appropriate Use Criteria (AUC) program
• Merit-based Incentive Payment System (MIPS) Program Relief
• LCD/DME issues

Read Alliance press release
See Alliance Comment

• Competitive Bidding
• LCDs
• Quality Payment Program

The Alliance submitted a letter to three Medicare Administrative Contractors (MACs) addressing payment policies for services provided in the home (POS 12), assisted living facilities (POS 13), and nursing facilities (POS 32). In comment to Palmetto, National Government Services (NGS) and Wisconsin Physician Services (WPS), the Alliance suggested that for practitioners providing wound care  in these sites, application of cellular and/or tissue products for skin wounds (CTPs) and disposable negative pressure wound therapy services be paid at the applicable Medicare physician non-facility rate. "We submit that Policy Manual provisions along with the waivers that have been issued support our request…We are concerned that [MACs] have not been covering these services in these settings, even though there is a dire need to provide care to these patients.  Enabling payment of these proven wound care therapies (already covered by Medicare) would allow access to care while reducing the risk of COVID transmission for vulnerable wound care beneficiaries," the Alliance wrote. 
Letter to Palmetto
Letter to NGS
Letter to WPS

• CMS
• CTPs/(skin substitutes)
• Medicare
• Medicare Administrative Contractors (MACs)
• Negative Pressure Wound Therapy (NPWT)
• COVID-19