Submitted Comments

March 2, 2018

 

The Alliance expressed its concern about CMS’ Hospital Harm- Hospital-Acquired Condition -Pressure Injury measure. While the Alliance supports and encourages the continued development of quality measures that assess wound care outcomes, the Alliance flagged that the intended objective will not be achieved the way this measure has been crafted. Overall, the specific language as well as the numerator and denominator, contained within this document are not accurate, wrote the Alliance in its comments. Furthermore, there are scientifically incorrect statements within this proposed measure.  “It is very concerning that CMS has tied a Pressure Injury Measure to Hospital Harm. As stated throughout our comments – it is possible for a patient to develop or have a pressure ulcer without any harm. If this measure continues as a quality indicator to measure harm, there will be unintended consequences - either an increase in the number of lawsuits, or an increased likelihood that hospitals will be unable to defend themselves against frivolous litigation - despite the best care being provided.”

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January 4, 2018
The DMEMACs responded to the Alliance’s December 2017 letter flagging inconsistencies between the guidance the DMEMACs provided to the Alliance in an October 2017 “clarification letter” and the instructions that Noridian gave in a November educational webinar on the surgical dressing LCD.

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December 18, 2017
The Alliance alerted the DMEMACs that the information being given out on the Nov. 30, 2017 Noridian surgical dressing educational webinar about the new surgical dressing LCD differed from the information provided to the Alliance in the Oct. 20, 2017 “clarification letter.” The DMEMAC medical directors had developed the clarification letter for the Alliance in response to its detailed questions. The Alliance suggested that a more formal DMEMAC Advisory would be appropriate so that other stakeholders could benefit from the clarity provided to the Alliance regarding the surgical dressing policy.

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November 21, 2017
The Alliance submitted a letter in support of H.R. 2445, the DMEPOS Access and Transparency Act of 2017, also known as the DATA Act of 2017. The Alliance noted concern about the impact that prior authorization for negative pressure wound therapy (NPWT) will have in a clinician’s ability to continue treatment protocols for patients while awaiting a prior authorization approval. The Alliance recommended that prior authorization should only be used when patients are not already undergoing treatment for a condition. Once treatment begins, any prior authorization requirement will impact their care. The Alliance requested that NPWT technology be carved out from the DATA Act’s prior authorization requirements in order to ensure that patients have uninterrupted access to NPWT for severe and chronic wounds and burns when Medicare local coverage criteria are met.

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November 20, 2017
The Alliance submitted to CMS’ request for information on new directions for the CMMI after convening many conference calls with members to determine issues of importance. Comments focused on opportunities within specialty physician models, program integrity, and benefit design/price transparency. The Alliance focused on the growing importance of real-world evidence and patient registry data. Comments spoke once again to the importance of developing quality measures that are more relevant to wound care and pointed again to the relevance of HCPCS coding reform to the CMMI’s focus on improved payment models – given the correlation of coding and payment in practice. Finally, the Alliance highlighted other models for CMMI consideration, including patient accountability models and Voluntary Quality Improvement Reporting Model for Hyperbaric Oxygen Therapy and population management models.

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October 11, 2017
The DMEMACS sent the Alliance a “clarification letter” in October 2017, responding to our September letter requesting clarity on issues that the Alliance had raised with regard to collagen dressings, staging systems and hydrogels - areas of the LCD that would cause confusion in clinical practice and impact patient care/patient access to products and services.

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September 11, 2017
The Alliance submitted comments to CMS addressing the proposed CY2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and quality reporting programs. Comments focused on issues with the methodology for packaging of skin substitutes (Cellular and/or Tissue Based Product for Skin Wounds, or CTPs). In response to CMS’s request for information on flexibility and efficiency opportunities to increase care, reduce costs and reduce burdens for clinicians and patients, the Alliance asked the agency to consider reform of the process it uses to assign new Healthcare Common Procedure Coding System (HCPCS) Level II billing codes to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).

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September 11, 2017
The Alliance submitted comments to CMS on the proposed CY2017 Physician Fee Schedule. Comment focused on:
  • The under estimation and erroneous valuation of 2 CPT codes: CPT 29580 (Strapping of Unna Boot), and CPT 29581 (Application of multi-layer compression system).
  • Supporting the decision to update the equipment items and the amount of oxygen for hyperbaric oxygen therapy (HBOT) so that the amount of oxygen conforms to the RUC recommended value.
  • Requesting national payment rate for CPT Codes 97607 and 97608 - describing negative pressure wound therapy (NPWT) services using a disposable device - similar to the rate proposed in the CY2018 hospital outpatient proposed rule.
  • In response to CMS’s request for information on flexibility and efficiency opportunities to increase care, reduce costs and reduce burdens for clinicians and patients, the Alliance asked the agency to consider reform of the process it uses to assign new Healthcare Common Procedure Coding System (HCPCS) Level II billing codes to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).

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  • September 11, 2017
    The Alliance submitted a letter to the DMEMAC Medical Directors regarding the application of New Provisions of Surgical Dressing LCD (L33831). The letter reported to the DMEMACs that there was significant disagreement and confusion over how certain LCD provisions should be applied. The Alliance requested clarification on the coverage criteria for collagen dressings and for clarity on confusing wound staging criteria and pressure injury terminology included in the policy.

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    August 21, 2017
    The Alliance submitted comments to CMS addressing the agency’s proposed updates to the Quality Payment Program (CMS-5522-P).  Comments focused on the lack of relevant quality measures addressing the needs of wound care clinicians. The Alliance suggested that the creation of additional wound care quality measures is necessary to ensure continued quality care. Comments supported the use of QCDRs and the ability of all eligible clinicians to use the QCDR option for reporting.

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