Primary replacement after fracture of the radial head.

In the FY 2014 IPPS/LTCH PPS final rule (), we removed the chart-abstracted versions of AMI-2 and AMI-10 due to “topped-out” status. However, as noted in FY 2015 IPPS/LTCH PPS final rule (), we readopted these measures, though only in the electronic form, because we believed that we should continue aligning the Hospital IQR Program and the Medicare EHR Incentive Program in order to minimize reporting burden and to facilitate the transition to reporting of eCQMs. We believed that voluntary reporting of these measures would further that aim. In addition, we believed that allowing hospitals the option to electronically report “topped-out” measures would provide them with an opportunity to test the accuracy of their EHR reporting systems.

Intended Use: The Acumed Anatomic Radial Head System is indicated for use in:I.

For use of the radial head prosthesis including radial head fractures not amenable to fixation, radiocapitellar arthropathy due to degeneration or malunion of a radial head fracture, complex fracture dislocation of the elbow with loss of radial head support and Essex-Lopresti fracture-dislocation with loss of the radial head, rupture of the interosseous membrane and disruption of the distal radioulnar joint. In these cases, Landsman and Seitz have shown silastic to be inadequate, metallic replacement to be stable and biologic reconstruction to be promising but unproven and with the potential for high degree of complications. The “off-the-shelf” prosthesis which are available are relatively few and are extremely expensive. What the surgeon finds is that the limited available sizes fit no particular anatomy perfectly. In general one size fits a limited few patients correctly, but will not fit all patients. The question which must be asked is why not provide a custom prosthesis which is easy to insert and provides a degree of stability necessary for these complex injuries.

Primary replacement afterfracture of the radial head.

The DePuy Synthes Radial Head Prosthesis System is intended for primary and revision joint replacement of the radial head.

The EVOLVE PROLINE Radial Head System was designed in collaboration with The Hand and Upper Limb Centre at the University of Western Ontario in London, Ontario.

Indications for Radial Head Replacement Following …

To further target potential cases that may be eligible for Idarucizumab, the applicant also excluded specific cases based on Dabigatran contraindications, including all cases representing patients who have been diagnosed with chronic kidney disease (CKD) stage V (diagnosis code 585.5), end-stage renal disease (diagnosis code 585.6), prosthetic heart valves (diagnosis code V43.3), and cases representing patients who have been diagnosed with both CKD stage IV (diagnosis code 585.4) and either DVT or PE (using the same ICD-9-CM diagnosis codes listed above). As a result, the applicant identified 84,224 cases that mapped to 684 MS-DRGs. The applicant standardized the charges and computed an average standardized case-weighted charge per case of $60,089.


In consideration of the applicant's statements that the mechanism of action of the MAGEC® Spine, which uses growing rods in the treatment of patients diagnosed with EOS, is unique because the technique of using magnetic distraction (lengthening) does not require patients to endure the potential and adverse effects of additional surgeries, in the proposed rule, we stated that there are other technologies and products currently available that achieve spinal growth without the need to subject patients to potential and adverse effects of additional surgeries. For example, the Shilla growth guidance system, which received FDA clearance in 2014, uses a non-locking set screw at the proximal and distal portions of the construct's rods. This specific feature is designed to allow the rod to slide through the screw heads as a child's spine grows, while still providing correction of the spinal deformity. The Shilla technique also eliminates the need for scheduled distraction surgeries, as the applicant pointed out are needed with the use of TGRs. Therefore, in the proposed rule, we stated that we believe that the MAGEC® Spine's mechanism of action may be similar to the mechanism of action employed by the Shilla growth guidance system because both technologies achieve the same therapeutic outcome and do not require the patient to endure the potential and adverse effects of additional surgeries.


We note that commenters have suggested that there are a number of procedure codes that may not appear to be clinically feasible due to a specific approach or device value in relation to a unique body part in a given body system. These commenters have not identified a comprehensive list of codes to be deleted. However, they have suggested that CMS examine these codes further. Due to the multiaxial structure of ICD-10-PCS, the current system allows for multiple possibilities for a given procedure, some of which may not currently be used. As our focus to refine the ICD-10 MS-DRGs continues, for FY 2018, we will begin to conduct an analysis of where such ICD-10-PCS codes may exist. In the FY 2017 IPPS/LTCH PPS proposed rule (), we welcomed suggestions from the public of code refinements that could address the issue of current ICD-10-PCS codes that capture procedures that would not reasonably be performed. We indicated that commenters should submit their recommendations for these code refinements to the following email address: by December 7, 2016.