Drug-eluting stent manufacturers face an uphill battle in convincing CMS to create inpatient Medicare DRGs for multiple-coronary-stent procedures before 2008.

Physician groups and DES manufacturers Johnson & Johnson and Boston Scientific repeatedly have lobbied CMS to restructure the stent diagnosis related groups (DRGs) to account for procedures in which multiple stents are implanted.

Proponents of a multi-vessel, multi-stent DRG argue that inadequate reimbursement for these procedures will encourage hospitals to recommend bypass surgery to many patients who could be treated with a less invasive stenting procedure.

However, in the ^FDL-1 fiscal year 2006 inpatient prospective payment system final rule, CMS acknowledges that "the use of multiple vessel and stent codes will provide useful information in the future on hospital costs associated with percutaneous procedures."

However, the agency believes "it remains premature to proceed with a restructuring of the current coronary stent DRGs on the basis of the number of vessels treated or the number of stents inserted, or both, in the absence of data reflecting use of this new coding structure."

The proposed rule was released April 28 (¹ Also see "DRG Split For Complex DES May Herald Multi-Vessel Payment Reforms" - Medtech Insight, 2 May, 2005., p. 7).

Multi-Stent Reimbursement Unlikely Before 2008

CMS notes that it recently established a new ICD-9-CM procedure code to capture the number of stents inserted and number of vessels treated, the agency plans to "continue to monitor the MedPAR data and will make future evidence-based changes to the DRG structure and logic as warranted."

However, without "accurate charge data, we cannot predict the correct relative weight for a DRG containing more than one stent," the agency says in the rule.

Because FY 2006 will be the first year in which the agency can track claims under the new codes for multi-stent/multi-vessel procedures, CMS is unlikely to create a new DRG for multiple stent procedures until at least the FY 2008 IPPS.

"We will follow the use of these codes, but may not be prepared to make any DRG changes based on their use with only one year's worth of data," CMS says.

J&J, Boston Scientific and AdvaMed have advocated that CMS incorporate external data in the DRG-creation process in order to establish adequate reimbursement for new procedures faster.

For example, J&J successfully lobbied the agency to create a DRG for drug-eluting stents for FY 2003 even before the technology was FDA-approved.

The agency says it is willing to consider outside data sources, but has so far not accepted any of the outside data presented on multi-stent procedures (² Also see "Medicare DES Rates Sustained; CMS Cites Paltry Data To Back DRG Change" - Medtech Insight, 9 August, 2004., p. 4).

CMS Changes Tack For Four New Stent DRGs

Currently, coronary stent procedures are reimbursed under four DRGs (DRGs 516, 517, 526 and 527) depending on if the stent is bare-metal or drug-eluting and if the patient has an acute myocardial infarction.

The FY 2006 IPPS rule replaces those with four new DRGs, defined by the presence or absence of "major cardiovascular diagnosis," (MCD) and whether or not the stent is drug-eluting.

"This revised structure identifies subgroups of significantly more severe patients who use greater hospital resources more accurately than was possible under the previous DRGs," the agency concludes.

CMS acknowledges that it previously "expressed concerns regarding selectively recognizing secondary diagnoses or complicating conditions, particularly conditions from other [major diagnostic categories], in making DRG assignments."

However, the agency believes those concerns are not relevant under the new cardiovascular DRGs outlined in the FY 2006 IPPS rule.

"While we are adopting an approach for distinguishing patients with complex conditions, with a few exceptions, our approach uses complex cardiovascular conditions (or diagnoses within the MDC) to decide whether a patient should be assigned to the higher weighted DRG," CMS explains.

"In those cases where we have used a diagnosis from another MDC in assigning a patient to the MCV DRG, the condition is generally a closely related vascular condition that is linked to the patient's cardiovascular illness."

This DRG structure is different than the one described in the proposed rule. Instead of "major cardiovascular diagnoses" that plan would have used co-morbidities and complications (CC) to identify stenting cases that might require greater resources.

For complex cases, bare-metal and drug-eluting stent DRGs would have been assigned to 547 and 549, respectively, while the non-complex cases would have been mapped to DRGs 548 and 550.

The agency decided to abandon the co-morbidity-based structure for the diagnosis-based structure as part of its overall restructuring of nine cardiac DRGs based on the presence or absence of a major cardiovascular condition.

"We are making this change in the DRG structure in response to public comments concerning our response to MedPAC's recommendations to better recognize severity in the DRG system," CMS explains (³ Also see "MedPAC DRG Reform Proposals May Impact Specialty-Hospital Cardiac Trends" - Medtech Insight, 14 March, 2005., p. 17).

CMS Keeps Status Quo on Carotid Stents, Kyphoplasty

CMS also cited the inadequacy of existing MedPAR data in its decisions to maintain the DRG structure for carotid stents and kyphoplasty.

In FY 2005, the agency began tracking codes for carotid stenting, which are included in the DRGs for extracranial procedures. MedPAR currently only has about 3,000 carotid stent procedures, suggesting that carotid stenting costs $5,000-$6,000 more than the other extracranial procedures.

"The small number of cases and the magnitude of the difference in average charges are not sufficient to justify a change in the DRGs," CMS concludes.

CMS also began tracking separate codes for vertebroplasty and kyphoplasty. Currently, the procedures are both reimbursed under the same DRGs for musculoskeletal system and connective tissue operating room procedures.

However, CMS does not yet have the MedPAR data to distinguish the two procedures. Therefore, despite receiving comments aruging that kyphoplasty is more complex than vertebroplasty, the agency has elected to maintain the current structure and continue tracking the separate vertebroplasty and kyphoplasty codes.

CMS Creates New Stent DRGs, But Multi-Stent DRG Likely Two Years Away

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