CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
The draft inpatient rule for FY 2022 includes extensions for NTAPs for a number of products because the three-year anniversaries of their FDA marketing authorizations will expire in the second half of FY 2022. Among the items on this list are the Barostim Neo system by Cvrx Inc., of Maple Grove, Minn., and the Optimizer system by Impulse Dynamics Inc., of Marlton, N.J. As is commonly the case in recent years, several biotech and pharmaceutical products appear on the NTAP list as well, such as Janssen Pharmaceutical’s Balversa (erdafitinib) for metastatic urothelial carcinoma.
In one of several nods to the effect of the COVID-19 pandemic on hospital and other clinical operations in 2020, CMS said in an April 27 press release that it will retain NTAPs for 14 products that would otherwise have been discontinued in the upcoming fiscal year. Among these is the Eluvia drug-eluting stent by Boston Scientific Corp., of Marlborough, Mass. The Eluvia is one of several devices swept up in the controversy over whether paclitaxel-coated devices are responsible for late incidents of mortality compared to non-treated devices for the peripheral vasculature, but the FDA’s cautious stance over paclitaxel remains in place despite considerable clinician pushback.
CMS had initially declined to offer an NTAP payment for the Eluvia in the FY 2020 final rule due at least in part to the paclitaxel controversy, but the device broke through in the final rule for FY 2021. Interestingly, the question of whether existing NTAPs might be extended beyond FY 2021 arose during a briefing by the Advanced Medical Technology Association (Advamed), during which Advamed’s former vice president for payment policy, Don May, said the agency may have to resort to extraordinary measures in order to override the usual three-year eligibility question for the NTAP program.
Also enjoying a reprieve from NTAP ineligibility is the Spinejack system by Stryker Corp., of Kalamazoo, Mich., which is indicated for anatomical restoration of osteoporotic vertebral compression fractures. The agency said the Spinejack and Eluvia are among a group of items for which claims data from 2020 are incomplete, due to the lower volume of procedures caused by the COVID-19 pandemic. Because the agency has decided to rely on FY 2019 claims data to set rates, the costs of the affected technologies might not be fully reflected in up-to-date data, hence the decision to propose an additional year of NTAP coverage.
Proposed DRG change for VADs could boost rates
CMS said it has received a request to reassign several procedures that report procedure codes for insertion of an external heart assist device from Medicare severity-adjusted diagnostic related group (MS-DRG) 215 to MS-DRGs 216-218. This request that was premised on the notion that the short-term use of devices such as the Impella series of ventricular support devices (VADs) requires fewer resources during intraoperative-only use rather than for ongoing therapeutic use. The request addresses the proposition that such a shift would relieve DRG-2015 from a number of cases that decrease the relative weight of the procedure because the cases that would remain in DRG-215 would increase both the average costs and lengths of stay of this DRG as a whole.
CMS said its clinical consultants agreed that short-term use of a VAD is both less resource-intensive and clinically distinct from the other cases that currently fall under DRG-215, and that a simulation run on existing claims suggests that switching procedures under three ICD-10 codes would provide a scheme with greater clinical homogeneity. This simulation was run on claims data from fiscal year 2019, and the result of a switch of the three ICD-10 codes to DRGs 216-221 would boost the calculated average cost of the remaining DRG-215 cases by more than $4,500. The agency said the effect on the other DRG assignments would be more significantly diluted, and thus the inpatient final may reflect a shift of the three ICD-10 codes to these alternate MS-DRG assignments.
CMS declined to act on a request that the agency reconsider its assignment of surgically inserted left atrial appendage (LAA) closure devices to MS-DRGs 273 and 274, which separated percutaneously implanted LAA closure devices remaining to DRGs 250-251. The requestor in this instance proposed that DRGs 228 and 229 might be a better fit because these two DRGs describe open thoracic procedures and lengths of stay associated that correspond with lengths of stay associated with implant of LAA closure devices. The agency said its clinical advisors advised against the request because it would disrupt the clinical coherence provided by the reassignment to DRGs 273 and 274.
Ablation for atrial fibrillation may be shuffled
Surgical ablation for atrial fibrillation may be slotted higher in the MDC 05 hierarchy of diseases and disorders of the circulatory system, thanks to a two-part request. This request consists in part of a recommendation that percutaneous ablation be shifted from MS-DRGs 228 and 229 to DRGs 219 and 220 because of a higher cost than the other procedures described in 228 and 229. The other part of the request was that the CMS craft a new classification of DRGs to “better accommodate” the costs of open surgical ablations performed along with other cardiovascular surgeries.
CMS disagreed with the notion that 219 and 220 are more accurately reflective of the cost of endoscopic ablation than 228 and 229, and said it will likely hold to its current assignment of ablation in these scenarios. However, the draft rule proposed that surgical ablation conducted during other procedures, such as bypass surgery or placement of artificial aortic or mitral valves, be allocated to the most resource-intensive procedure performed during the episode, which would account for the higher resource utilization incurred during surgical ablation. The net effect would be to raise the rates paid for these procedures.
The agency’s April 27 statement noted that the draft rule carries provisions directed toward closure of health care equity gaps, and toward providing greater access to diagnostics and therapies during the public health emergency “and beyond.” CMS anticipates that the wave of vaccinations for the COVID-19 pandemic should stanch the number of admissions for those infected by the SARS-CoV-2 virus over the course of FY 2022, and it is considering a revamp of its quality measurement programs for participating hospitals. Several hospital quality measures would fall by the wayside, but among the proposed new quality measures are those for vaccination of hospital staff and a hybrid, hospital-wide all-cause risk standardized mortality measure. This mortality measure would be imposed over two years, the first of which would be a voluntary reporting period running from July 1, 2022, to June 30, 2023.
CMS is taking comment on the proposed rule through June 28 at docket number CMS-1752-P.