Alliance of Wound Care Stakeholders Advocacy Update Q2 2018

Alliance of Wound Care Stakeholders 2Q 2018

CMS "Comment Season" Heats Up 

"Comment season" is heating up. As summer temperatures rise, we at the Alliance are busy reviewing and addressing the FY2019 prospective payment system updates from the Centers for Medicare & Medicaid (CMS) that can have impacts large and small across the wound care space.

Earlier this summer, CMS issued the proposed rules for the hospital inpatient prospective payment system (see Alliance comments), skilled nursing facilities PPS and the interim final rule for the durable medical equipment fee schedule adjustments(which also address competitive bidding) - as part of the ESRD DME proposed rule. 

And just this past week, CMS put out the proposed 2019 physician fee schedule, which we will be reviewing and circulating additional information to aid our preparation of comments. 

Still to come is the hospital outpatient PPS, which the Alliance will review with an eye - as always - to impacts in the wound care space. 

Be sure to review the "Recent Publications" section below for links and brief overviews.

We realize that we keep emails flying in the "slow" summer months as proposed rules issue and Alliance draft and final comments are prepared. Below is a summary to keep you up to speed on our comments submitted, comments in process, and comments to be developed and circulated for review over the weeks ahead. Thank you in advance for your input and valuable feedback as comments are developed. And importantly, enjoy these dog days of summer, whether you are at your desk or at the beach or following your bliss to an exotic port of call.

Q2 Submitted Comments: Ensuring Alliance's Clinical Expert Perspective is Heard

CMS Hospital Inpatient PPS 

The Alliance submitted comments to CMS' "Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2019 Rates" supporting efforts to "streamline and de-duplicate measures." We noted some specific concerns and recommendations regarding measures surrounding pressure ulcers.

The Alliance recommends that CMS:

- Remove pressure ulcers (PSI 03) from the NQF #5031 Patient Safety and Adverse Events Composite Measure

- Create a stand-alone quality measure for PSI 03, Pressure Ulcer Rates

- Or, as alternative, increase the weight currently outlined in the proposed rule for pressure ulcers.

- Implement the Equal Measure Weights approach outlined in the proposed rule.

WPS Wound Care LCD

Alliance submitted comments to WPS on its proposed Wound Care LCD that went into effect on April 16, 2018. The Alliance noted specific, significant concerns with some of the language contained in the final LCD - including clinically incorrect statements - and requested clarity on key areas, including: debridement coverage for chronic non pressure ulcers; debridement coverage for diabetic ulcers; utilization parameters for traditional and disposable Negative Pressure Wound Therapy (NPWT); utilization parameters for dressing changes and other issues of concern.

"While we appreciate that WPS did adopt several of our previous recommendations, the Alliance still has significant concerns with some of the language contained in the final LCD - including many clinically incorrect statements...We are reaching out to WPS in order to obtain clarification...so that we can provide clarity to our members."

Key Q2 Meetings & In-Person Advocacy

Alliance Q2 meetings with stakeholders included: 

• Pricing Data Analysis and Coding (PDAC) surgical dressing meeting: On April 12, the Alliance in tandem with the Coalition of Wound Care Manufacturers convened more than 50 PDAC nursing staff and Durable Medical Equipment Medicare Administrative Contractor medical directors at Noridian's offices in Fargo, ND for a full-day educational session that focused on wound care and wound healing topics.  The meeting was unique in that the speakers also addressed each surgical dressing category and then circulated the different dressings so that each attendee could see the different sizes, shapes, etc. to better understand their uses and technology. We were invited to lead this session because of our reputation over the years with the PDAC and DMEMACs of being the "go-to" expert in providing objective comprehensive wound care information. This shows that over the long term persistent advocacy really positions us as credible respected partners and gains us a seat at the table.(see article from our Q1 newsletterfor more information.) 
• HCPCS public meetings:The Alliance participated in the May 16 HCPCS public meetingaddressing Drugs and Biologicals which included cellular and/or tissue based products for skin wounds (CTPs) and the June 6 HCPCS public meetingsaddressing Durable Medical Equipment and Accessories/Orthotics and Prosthetics/Supplies/Other (which included discussion of wound closure devices and dressings).
• ASTM: We mobilized Alliance membership to participate in a May ASTM workgroup conference call in which a new proposal for CTP nomenclature was being discussed for vote. We believe the new proposal contains inaccurate clinical and scientific information.We again ask those Alliance members who either use or manufacture CTPs to become ASTM members so as to have the opportunity to vote on these important issues that impact this wound care segment.
• Palmetto "Ask the Contractor" Teleconference:The Alliance participated by phone in the May teleconference, which focused on HBOT and flagged the opportunity to our members. Palmetto clinical consultants provided information concerning Medical Review Targeted probe, findings for HBOT and how to improve documentation. The Alliance flagged inaccuracies in the discussion and is now awaiting Palmetto's release of the transcript. We may submit additional comments following issuance of the transcript. 
• EWMA presentation: Alliance Executive Director Marcia Nusgart presented the findings of "An Economic Evaluation of the Impact, Cost and Medicare Policy Implications of Chronic Nonhealing Wounds" at the May European Wound Management Association (EWMA) meeting in Krakow, Poland. The findings were very well received and meeting participants were eager to obtain copies of the full study, available here on the Alliance website. 
• Member conferences:Spring conferences of interest to Alliance members included:
  • Health Datapalooza  - April/Washington DC
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)  - May/Baltimore
  • WOCN Society Annual Conference - June/Baltimore (Marcia Nusgart attended and met with WOCN staff and leadership)
  • Society for Vascular Medicine - June/Chicago
  • American Diabetes Association - June/Orlando
  • American Association of Nurse Practitioners National Conference - June/Denver
  • American Physical Therapy Association - June/Orlando
  • Undersea & Hyperbaric Medical Society - June/Orlando (Marcia Nusgart attended and met with UHMS staff and leadership)
• CMS open door forum: The Alliance alerted membership to CMS' June 12 "open door forum" on Templates and Clinical Data Elements (CDEs) for Therapeutic Shoes for Persons with Diabetes.
• Spring SAWC:The Alliance convened an in-person meeting in April at the Spring SAWC in Charlotte, featuring guest speakers Stella R. Mandl, Deputy Director Division of Chronic and Post Acute Care; and Joseph B. Clift, Health Insurance Specialist, who addressed "How the 'Impact Act' Impacts the Alliance of Wound Care Stakeholders." Also at SAWC, the Alliance convened our CTP and NPWT workgroups and had a poster focused on the economic impact of chronic wounds, gleaned from our research published in Value in Health.
• UPCOMING: Fall SAWC - Join the Alliance at our in-person meeting at the Fall SAWC in November in Las Vegas. Specific date and time to be shared shortly.

Recent Publications & Policies Relevant to Alliance

• Physician fee schedule: On July 12, CMS released the proposed 2019 updates to its physician fee schedule. The policy proposes a number of coding and payment changes to reduce administrative burden and improve payment accuracy for E/M visits. The policy includes a proposed new single blended payment rates for new and established patients for office/outpatient E/M level 2 through 5 visits and a series of add-on codes to reflect resources involved in furnishing primary care and non-procedural specialty generally recognized services. Similarly, the proposed rule solicits comment on how documentation guidelines for medical decision-making might be changed in subsequent years. The Alliance will be reaching out to membership as specific impact to wound care providers are assessed and comments are prepared.
• DMEPOS payment policy: CMS released on July 11 proposed changes to DMEPOS payment policy, particularly to address the likelihood that current competitive bidding contracts will expire before CMS can recompete/award new contracts.  CMS is also (finally) looking at ways to revise the gap-filling process. This rule also includes proposals that address Medicare fee schedule payments for DME furnished on or after January 1, 2019 in areas of the country where competitive bidding is not in effect.  The proposed rule also solicits stakeholder feedback on CMS' approach to establishing the fee schedule amounts for new DME technologies. Seethe full text of the rule and the accompanying fact sheet. We will be reaching out as we develop comments.
• Skilled nursing facilities PPS: In May CMS released the update to the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019.
• ESRD DME proposed rule: Within this proposed rule published in May, CMS also addresses DMEPOS and competitive bidding.  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. 
• Home health demonstration project:In May, CMS published for comment "Pre-Claim Review Demonstration for Home Health Services" to "help assist in developing improved procedures for the identification, investigation, and prosecution of potential Medicare fraud." This update includes many elements of concern to wound care and to the Alliance. We will be developing comments (due by July 30). CMS also published an accompanying Frequently Asked Questions document on the demonstration project. 
• GAO Report:The Alliance flagged, shared and discussed with membership the April GAO report "CMS Should Take Actions to Continue Prior Authorization Efforts to Reduce Spending" and accompanying summary sheet.
• Pneumatic compression device policy article: alerted membership to the April policy articleand flagged concerns on certain LCD landing pages that "At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination..."
• MEDPAC report: MEDPAC issued a June report and, as expected, there was a chapter devoted to medical devices in which competitive bidding is addressed. MEDPAC does state that more products could be added to competitive bidding (see chapter 6).  
• Lymphedema Treatment Act:Flagged to membership the Act (H.R. 930), introduced in the House, to provide for Medicare coverage of certain lymphedema compression treatment items as items of durable medical equipment. The Alliance will be submitting a letter of support to submit to House and Senate leadership. 
• Stark Law Reform: In July, CMS published a request for information to seek input from the public on how to address any undue regulatory impact and burden of the physician self-referral law. The RFI outlines 20 specific categories/questions for input.
   

The Alliance of Wound Care Stakeholders is an association of physician and clinical organizations focused on promoting quality care and access to procedures and technologies for patients with wounds through advocacy and educational outreach in the regulatory, legislative and public arenas. The Alliance unites leading wound care experts to advocate on public policy issues that may create barriers to patients' access to treatments or care, with a focus on reimbursement, wound care research and wound care quality measures.