Comment: Two commenters applauded CMS' goals of achieving a more equitable and accurate wage index, but suggested that CMS address the inadequacies in the current reporting requirements for noncore other wage-related costs rather than consider eliminating Line 18 of Worksheet S-3 of the Medicare cost report from the wage index. These commenters asserted that all hospitals have noncore benefits. However, the commenters added, the limited guidance and “significant threshold limitations” in the current instructions prevent hospitals from capturing these noncore benefits. Furthermore, the commenters maintained that benefits are rapidly evolving into more nontraditional structures and, therefore, a mechanism to capture these evolving benefits is necessary for CMS to ensure an equitable survey. The commenters submitted several suggestions to ensure open and transparent reporting of other wage-related costs and to remove the onus from CMS and the MAC to make determinations regarding the acceptability of other wage-related costs. The commenters believed that clear and consistent reporting guidelines create an equitable playing field for all providers and stated that addressing the inadequacies in the current reporting requirements for Line 18 is prudent. However, the commenters suggested an approach different than CMS' clarifications of current policy to more accurately identify and capture other wage-related costs.
The applicant also stated that its studies included surgeons with varied degrees of experience, and that over 62 physicians participated in the US INTUITY trials, which reduces the impact of surgeon bias and allows for greater generalizability of results. The applicant stated that while no study is free of bias, the INTUITY has been shown to have consistent results in both clinical trials and the real-world setting. The applicant further supplemented its application with recently published 5-year follow-up data (Laufer et al., 2017), which found sustained benefits, including effective orifice area (EOA) improvements, low pressure gradients, and reductions in left ventricular mass, as well as excellent survival rates.
Consistent with the requirement of the statute, we proposed to group or stratify hospitals based on the proportion of full-benefit dual-eligible patients determined under the proposals discussed above and proposed to define the proportion of full-benefit dual-eligible beneficiaries as the number of dual-eligible patients discharged during the 3-year applicable period under the Hospital Readmissions Reduction Program. In the FY 2018 IPPS/LTCH PPS proposed rule (), we considered two alternatives for the data period used to define dual eligibility, a 3-year period corresponding to the performance period, and a 1-year period, which would be calculated over the most recent year for which complete data is available.
We intend to explore options including, but not limited to, measure stratification by social risk factors in a consistent manner across programs, informed by considerations of stratification methods described in section IX.A.13. of the preamble of this final rule. We thank the commenters for this important feedback and will continue to consider options to account for social risk factors that would allow us to view disparities and potentially incentivize improvement in care for patients and beneficiaries. We also will consider providing feedback to providers on outcomes for individuals with social risk factors in confidential reports. As we consider the feasibility of collecting patient-level data and the impact of strategies to account for social risk factors through further analysis, we will continue to evaluate the reporting burden on providers. We also will consider the concerns commenters raised about masking disparities associated with adjusting for social risk factors. Future proposals would be made after further research and continued stakeholder engagement.
We also understand the commenters' concerns regarding the effects on hospitals' payments of moving from calculating Factor 3 using a proxy based on low-income days to the use of uncompensated care data from Worksheet S-10. As discussed in prior rulemaking, in using Medicaid and Medicare SSI days as a proxy for uncompensated care, we recognize that it would be possible for hospitals in States that choose to expand Medicaid to receive higher uncompensated care payments because they may have more Medicaid patient days than hospitals in a State that does not choose to expand Medicaid. We believe that the redistribution of payments from hospitals that serve a greater number of Medicaid patients to hospitals that serve more uninsured patients is consistent with the intent of the Affordable Care Act. However, as described below, we have proposed a methodology that would help to stabilize payments and protect hospitals from undue fluctuations by gradually incorporating Worksheet S-10 data into the calculation of Factor 3. In addition, the approximately $800 million increase in the amount available to be distributed as uncompensated care payments will also help to offset some of the redistributive effects of moving to Worksheet S-10 in FY 2018.
A review of the radiographs from the previous thrombectomy procedure revealed the presence of a collateral or accessary vein immediately adjacent to the site of the previous venous anastomotic stenosis (). Lane et al noted that the most common location of any valve is immediately distal to the point of entry of a venous tributary. Taking this information into consideration, a more precise location for the deployment of the original GORE VIABAHN Endoprosthesis would have been to place the stent graft across the accessory vein, thus ensuring stent placement across a potential valve. Ross noted that landing the stent inside or within 1 cm proximal to a valve can lead to rapid endothelial buildup at the edge of the device, which was demonstrated on the follow-up shuntogram ( and ). In our experience, potential recurrent stenosis can be avoided by placing the stent graft across the valve by at least 1 cm.
Cook Medical has a long track record with the Zenith TX2 thoracic endograft platform, having received FDA approval in 2008. This device uses stainless steel Z-stents and active proximal fixation with barbs. The graft has been redesigned with a nitinol Z-stents and proximal bare stent with barb fixation. The bare stents are designed to improve conformability. The device uses a precurved nitinol cannula to improve trackability around the genu of the aortic arch. The delivery process continues to have a manual deployment, but the trigger wire release has been changed to use a rotary dial. The device, called the Zenith Alpha thoracic endovascular graft (Cook Medical), has been commercially available in Europe and Canada and just received FDA approval for commercial use in the United States in September 2015 (). The device has a 2- to 4-F reduction in sheath size, now ranging from 16- to 20-F inner diameter. Grafts are available in diameters ranging from 18 to 46 mm, and indications include aortic aneurysm, penetrating aortic ulcer, and traumatic transection. Cook Medical is continuing the development of a combined proximal stent graft with a distal bare-metal stent for treatment of aortic dissection; this device is currently being studied in the United States.
Dissection into the party wall allowed mobilization of thespecimen and the tracheotomy was completed below, going up the next tracheal ringas well in a steeple or chimneylike fashion.The specimen was removed in one piece and sent for permanent pathologic analysis.
The common challenge in device design for the thoracoabdominal aorta is the variability of the visceral branch anatomy. Fenestrated devices with custom fenestrations have been shown to work well in both commercial and physician-modified designs. However, device planning is time consuming and technically difficult. Commercially manufactured customized devices are more costly than off-the-shelf designs and take weeks or months to produce. As such, manufacturers are currently working to design off-the-shelf stent grafts with a “few-sizes-fit-most” approach.
Angioplasty was performed on the recurrent stenosis, and a new 9 mm x 5 cm GORE VIABAHN Endoprosthesis was deployed within the previously placed GORE VIABAHN Endoprosthesis, and the outflow end was placed in “good vein” ( and ). There was no wall apposition with the newly placed stent in the right axillary vein. Centering the stent in the outflow vein is important so that wall apposition is avoided with an angled stent. Previous studies have shown that if the tip of the stent graft is directed at an angle and opposes the outflow vein and impinges on the native vein, the high-pressure arterial flow causes significant vessel trauma and/or the development of neointimal hyperplasia because of the elevated wall sheer stress.
The patient was seen approximately 1 month later in our outpatient endovascular center because of a rethrombosis right upper arm arteriovenous (AV) graft. The graft was declotted, and the initial shuntogram revealed a patent right arm graft () with an area of recurrent stenosis just distal to the outflow tip of the previously deployed GORE VIABAHN Endoprosthesis ( and ).