Comments

Items Related to CMS

September 11, 2023

Comments to Proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS)

The Coalition submitted comments to CMS's proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS) focused on the CTPs (skin substitutes) section of the proposed rule, flagging patient access issues as well as inconsistency in the way products are being treated in both payment and coverage depending on the HCPCS code being issued despite the products all being categorized as skin substitutes. The Coalition recommended that CMS withdraw its policy to package payment and instead utilize ASP +6 for all skin substitutes and publish all data in the pricing data file. "Given the mandatory submission of ASP for all skin substitutes, CMS should use the data that is already being provided to it to form the payment for any given skin substitute," the Coalition wrote. To address inequities in the current payment system that continue to create barriers to access, the Coalition elevated the following recommendations - each of which was endorsed by the Agency's Advisory Panel on Hospital Outpatient Payment:
  1. assign the existing CPT® add-on codes (15272, 15276, 15274, and 15278) and HCPCS codes (C5272, C5276, C5274, and C5278) to appropriate APC groups allowing for separate payment; and issue an exception to separately pay for these add-on codes.
  2. assign the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
  3. assign all new CTPs with both Q and A HCPCS codes to the low-cost APC groups until a manufacturer provides cost information to CMS.
  4. realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs.
  5. not assign CTPs that are not in sheet form (e.g., gel, powder, ointment, foam, liquid, or injected) to any APC group.

Read Coalition Comments
September 11, 2023

Comments to draft 2024 Medicare Physician Fee Schedule

The Coalition submitted comments to CMS' proposed 2024 Medicare Physician Fee Schedule voicing opposition to the Agency's proposal to treat CTPs (skin substitutes) as “incident to supplies” when furnished in non-facility settings and to include the costs of these products as resource inputs in establishing practice expense RVUs for associated physician’s services, rather than reimburse them separately. The Coalition outlined specific concerns, requested that CMS withdraw the proposal, and recommended instead that CMS maintain and enforce ASP pricing – "the most consistent pricing for CTPs that should and can be utilized across payment settings."
Read Coalition Comments
September 24, 2022

Comments to Novitas and FCSO Draft LCD on Skin Substitutes for DFU/VLU

The Coalition submitted comments to Novitas and First Coast Service Option expressing its major concerns with the proposed LCD (DL35041/DL36377) and LCA (DA54117/DA57680) on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The comments follow initial submission of detailed feedback in May 2022and oral testimony at MACs' August public meeting. The Coalition again raised the following objections in its submitted comments:
  • The policies are not in the best interest of patients.
  • The policies are not supported by clinical evidence or guidelines. Evidence has been omitted from the policy review. What has been utilized is either not the most currently available, or is used in such a way that is contradictory to the points Novitas/FCSO is trying to make.
  • There is NO new evidence to support the movement of more than 40 products from the covered to the non-covered list.
See Coalition Comments
June 16, 2022

Comments to draft 2023 Hospital Inpatient Prospective Payment System (IPPS)

The Coalition submitted comments to CMS' draft 2023 Hospital Inpatient Prospective Payment System (IPPS) recommending that the Agency:
  • Include the Hospital Harm - Pressure Injury eCQM in the CY 2023 Inpatient PPS final rule, or alternatively, propose this eCQM in next year’s CY 2024 IPPS rule.
  • Reinstate the PSI-90 composite measure or create a stand-alone quality measure for PSI-03, Pressure Ulcer Rates to maintain focus on pressure ulcers/injuries.
  • Adopt as proposed and include in its final rule NQF #3992 the Global Malnutrition Composite Score.

Read Coalition Comments
June 22, 2021

Comments to CY2022 Hospital Inpatient Prospective Payment System (IPPS)

The Coalition submitted comments to CMS' CY 2022 Hospital Inpatient Prospective Payment System (IPPS) focused on provisions including Hospital Harm – Pressure Injury electronic clinical quality measure (eCQM) and adoption of Global Malnutrition Composite Score NQF #3592.

Read Coalition Comments
November 2, 2020

Comments to CMS proposed rule regarding Medicare Coverage of Innovative Technology (MCIT) and the new definition of “reasonable and necessary"

The Coalition submitted comments to CMS' proposed rule regarding Medicare Coverage of Innovative Technology (MCIT) and the new definition of “reasonable and necessary." The Coalition encouraged CMS to establish a payment system for MCIT devices allowing for appropriate reimbursement - as without appropriate payment, the expanded MCIT coverage will be meaningless. We also recommended inclusion of provisions preventing the MACs from denying coverage of any technology eligible for new technology add-on payments or transitional passthrough payments. With regard to "reasonable and necessary," the Coalition expressed concerned about language which permits CMS to use commercial insurance medical policies for Medicare purposes.  "The Coalition is extremely concerned that CMS will cherry pick commercial payers that restrict coverage and therefore," we wrote in comments. "At this time, we do not support any definition of 'reasonable and necessary' that goes outside of what has already been published and adhered to in the Program Integrity Manual."
Read Coalition Comments  
October 4, 2020

Comments to CMS CY2021 Proposed Physician Fee Schedule

The Coalition submitted comments to the CY 2021 proposed physician fee schedule. We:

  • Recommended that CMS add codes for disposable negative pressure wound therapy (dNPWT) to the eligible telehealth list, 
  • Opposed CMS failure to adopt ALL of the RUC recommended work and time values for the revised office visit E/M codes for CY 2021, including and especially the RUC’s recommendation of commensurately including the updated E/M values in procedure codes with 10 and 90 day global periods.
Read Coalition Comments
September 27, 2019

Comments to CY2020 ESRD / DMEPOS Competitive Bidding

The Coalition submitted comments to the DMEPOS Competitive Bidding Proposed Amendments included in CMS's CY 2020 End-Stage Renal Disease Prospective Payment System. In comments specifically focused on the provisions related to "Establishing Payment Amounts for New Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Items and Services (Gap-filling)," the Coalition counseled CMS on a number of issues, flagging concerns and suggesting solutions:
  • CMS should not move forward with a final rule on payment methodologies for DMEPOS until further work is completed.
  • CMS should work with stakeholder groups and experts outside of CMS to ensure that the agency has a sufficient understanding of all costs associated with the provision of wound care products and other various types of technology classified under the DMEPOS benefit.
  • The Medicare “gap filling” payment determination methodology must be replaced as it is archaic, and does not result in reimbursement rates that allow access to medically necessary technology.
  • Fee schedules developed through comparable technology or technology assessments should be transparent and should include manufacturer’s input to ensure a thorough understanding of all associated costs.
  • CMS should institute an efficient and expeditious appeals process for manufacturers to challenge reimbursement levels established by this new pricing methodology and gap filling.
  • HCPCS public meetings should be limited to input on HCPCS codes, which are universal and as such should be focused on needs of all payers.
See Coalition comments
September 27, 2019

Comments to CY2020 Hospital Outpatient Prospective Payment System

The Coalition submitted comments to CMS regarding its proposed CY2020 Hospital Outpatient Prospective Payment System Updates. Comments focused primarily on the provisions related to payment methodologies for cellular and tissue-based products for skin wounds (CTPs) and offered the following recommendations for CMS to take into consideration in the development process:
  1. CMS should move quickly in establishing the CTP payment reforms
  2. CMS must work with wound care stakeholders in creating whatever methodology is ultimately chosen
  3. CMS must be transparent in providing the data utilized.  
  4. CMS’s revised payment methodology should support reduced copays for Medicare beneficiaries.
  5. CMS needs to utilize the correct CTP cost information
  6. CMS must ensure that facilities are billing correctly for CTPs
  7. CMS must ensure that patients come first and they continue to have access to this valuable adjunctive therapy.
  8. When CMS proposed packaging, the Agency did not perform an impact analysis on payment rates or patient access. Therefore, CMS must conduct an impact analysis and provide its results in a transparent manner.
  9. CMS should take into consideration that there are a wide variety of patients with chronic wounds, that wounds heal differently and that treatment is individualized.
READ COALITION COMMENTS
September 9, 2018

Comments to CMS DME/ESRD Prospective Payment System (PPS)

The Coalition submitted comments to CMS's End-Stage Renal Disease Prospective Payment System, which also covers the DMEPOS competitive bidding program. Comments focused on concerns surrounding the proposed calculation of single payment amounts (SPAs) and the gap-filling pricing methodology that applies when new technologies receive a new HCPCS code and CMS must establish a fee schedule amount for these new items.

Read Coalition comment
July 22, 2018

Comments on CMS Pre-Claim Review Demonstration Project for Home Health Services

The Coalition submitted comments to CMS in response to the agency's request for comments on its “Pre-Claim Review Demonstration for Home Health Services.”  The Coalition urged CMS to withdraw the policy. Coalition comments expressed concern with about access issues and disruptions in patient care and noted the overall lack of implantation detail provided. “While it appears that CMS is trying to curb what it perceives is fraud and abuse in the home health sector, CMS should simply utilize data and resources it already has on hand to target specific types home health agencies whose behavior indicates that there may be fraudulent activity rather than implement a widespread demonstration project which will overburden and penalize home health agencies that have no record or patterns of fraud and abuse,” wrote the Coalition.

Read Coalition comment.
July 9, 2018

Comments to Interim Final Rule on Durable Medical Equipment Fee Schedule Adjustments

The Coalition submitted comments to CMS on the agency's DME Interim Final Rule- which addresses competitive bidding issues. Within the interim final rule, published in May, CMS temporarily increases the fee schedule rates from June 1, 2018, through December 31, 2018, for certain durable medical equipment (DME) items and services and enteral nutrition furnished in rural and non-contiguous areas (Alaska, Hawaii, and U.S. territories) of the country not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program. 

Read Coalition Comment
September 11, 2017

Comments to CMS on the proposed CY 2018 Hospital Outpatient Prospective Payment System

The Coalition submitted comments to CMS on “CMS 1678-P, the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.” Coalition comments addressed:
  • Issues with the methodology for packaging of skin substitutes (Cellular and/or Tissue Based Product for Skin Wounds, or CTPs)
  • Support for grandfathering in eight CTP products to the high-cost bucket of the newly established threshold between low and high costs
  • Request for CMS to work with stakeholders to obtain the proper data for creating appropriate APCs for the application of CTP products.
  • 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 Coalition 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).
View Coalition Comment
September 11, 2017

Comments to CMS on the proposed CY 2018 Physician Fee Schedule

The Coalition submitted comments to CMS on “CMS 1676-P: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018.” The Coalition comments requested that CMS consider establishing office-based PE RUV’s for disposable Negative Pressure Wound Therapy (dNPWT). Comments also noted issues with codes and payment rates for NPWT services. The Coalition recommended that CMS assign direct cost inputs to disposable negative pressure wound therapy, which would allow the establishment of national payment rates for CPT codes 97607 and 97608 in the final Physician Fee Schedule (PFS) rule for CY 2018. 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 Coalition 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).
View Coalition Comment
December 25, 2016

Comments to CMS on Interim Final Rule with Comment Period on Hospital Outpatient Prospective Payment Systems (OPPS)

The Coalition submitted comments to CMS on the Interim Final Rule for the Hospital Outpatient Prospective Payment Systems, CMS-1656-IFC. The Coalition states that under this payment model, hospitals would lose the ability to provide cellular/ tissue based products (CTPs) and Negative Pressure Wound Therapy (NPWT) products to patients. The Coalition recommends that CMS reconsider their choice to adopt the Medicare Physicians Fee Schedule (MPFS) so that hospitals may have the ability to provide NPWT and CTP products. 
view coalition comment
September 6, 2016

Comments to CMS on Hospital Outpatient Prospective Payment System (PPS)

The Coalition submitted comments to CMS on the CMS on Hospital Outpatient Prospective Payment System (OPPS) proposed rule, CMS-1656-P, on issues regarding the packing of CTPs. The Coalition states that CMS has been using flawed data to calculate the setting rate for CTPs, something the Coalition has informed CMS about for years. The Coalition states that CMS needs to require correct coding for CTPs, ensuring that claims forms reflect the correct number of units being billed for. Furthermore, the Coalition recommends that whether or not a product falls into the low cost bucket or high cost bucket should be a function solely of the size of the CTP, regardless of its anatomic location.
view coalition comment
August 26, 2016

Comments to CMS on CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements

The Coalition submitted comments to CMS on the CY 2017 Home Health Prospective Payment System (PPS) Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. The Coalition noted that its members had been involved and closely monitoring the creation of the Patient Access to Disposable Medical Technology Act of 2016. That Act became section 504 of the Consolidated Appropriations Act of 2016. Because Coalition members were so closely monitoring that process, the Coalition was very aware of the original congressional intent of these statutes as they relate to add-on payments to home health agencies (HHAs) and Negative Pressure Wound Therapy (NPWT). The Coalition clarified in comments that the intent of these statues was not for home health agencies to absorb to entire cost of care for a patient requiring NPWT in the home. The Coalition recommended that CMS revise their proposal to match the Congressional intent and language revolving around disposable NPWT devices in home health settings. 
view coalition comment
August 22, 2016

Comments to CMS regarding Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures; Proposed Rule

The Coalition submitted comments to CMS regarding Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures; Proposed Rule, recommending that CMS address their backlogged appeals process and minimize improper denials of Medicare contractor appeals. The Coalition suggested accomplishing this by means of proposals to improve broad audits and contractor reviews. Further, the Coalition advocated for a prohibition on contractors collecting provider overpayments until the appeals process has been exhausted on all levels. The Coalition also supported:
  • Mandatory education and training for all providers and Medicare contractors
  • The creation of a process for interested stakeholders to challenge published case precedent
  • The assurance that attorney adjudicators will have experience in Medicare coverage, coding, and payment and that those attorneys, too, receive continuous education and training on these issues. 
view coalition comment

August 22, 2016

Comments to CMS on Medicare Program Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosth

The Coalition submitted comments to CMS on CMS-1651-P: Medicare Program Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment, stating that while the Coalition agrees with some provisions that CMS has adopted regarding the competitive bidding program, significant problems remain. Specifically, the Coalition is concerned that CMS does not do a sufficient job vetting vendors for the competitive bidding program or ensuring the implementation of quality standards and products. The Coalition also takes issue with CMS’s decrease in reimbursement for NPWT, as the ramifications of that decrease can have devastating impacts on rural communities.  
view coalition comment
May 9, 2016

Comments to CMS on Medicare Program; Part B Drug Payment Model

The Coalition submitted comments to CMS on to CMS on CMS -1670-P -Medicare Program; Part B Drug Payment Models, requesting that CMS withdraw the proposal entirely. The Coalition believes that the payment model lacks any evidence supporting its methodology. Furthermore, the regulation was proposed without taking stakeholder input into account. The Coalition believes that CMS has not sufficiently proved that their methodology will save costs or improve the quality of care, citing many gaps in the proposal. 
view coalition comment
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