Regulatory Issues

SVS Signs Onto ICD-10 Comments Asking for a Delay
SVS recently signed onto comments sent to the Department of Health and Human Services, asking for a delay in replacing ICD-9 code sets with ICD-10 code sets in HIPAA transactions. This will be a significant change - the current ICD-9 is limited to 17,000 codes, whereas ICD-10 could have up to 155,000 codes. This transition is scheduled to become effective on October 1, 2011. Because of many complexities, the comments request this be postponed.

SVS Comments on Three CMS Proposed Rules for 2009
SVS has submitted comments to the Centers for Medicare and Medicaid Services (CMS) on three proposed rules regarding the following: Hospital Inpatient Prospective Payment System, Physician Fee Schedule and Hospital Outpatient Prospective Payment System. Comments were made on many important Medicare issues that have an impact upon vascular surgeons. Drafts of these were presented to the SVS Health Policy Committee and members concerns were included in the final versions. Copies of the final letters can be viewed here.

FDA Mandates TEVAR Tracking
FDA requires manufacturers to track certain devices in order to facilitate notification and recall in the event that a device presents a serious risk to health that requires prompt attention. The Guidelines from August 15, 2008 have added thoracic aortic aneurysm stent grafts to the list of devices subject to medical device tracking requirements. The entire guidelines can be accessed here.

CMS Reverses Decision on Peripheral Vascular Interventions
CMS has rescinded a decision on peripheral vascular interventions and has replaced it with the following, which was originally published in the Medicare Manual in 1996: "When percutaneous angioplasty of a vascular lesion is followed at the same session by a percutaneous or open atherectomy, generally due to insufficient improvement in vascular flow with angioplasty alone, only the most comprehensive atherectomy that was performed is reported. This change will be retroactive to October 1, 2007. Please check with your carrier regarding this. The entire letter can be accessed here.

Medicare Announces Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) announced October 17, 2007 that it has decided to make no change to the clinical trial policy (CTP) national coverage determination (NCD) issued on July 9, 2007, at this time, and is not imposing additional conditions for coverage.

Final Decision On CMS Coverage For Carotid Stenting
On April 30, 2007 the CMS Coverage and Analysis Group posted their Final Decision for the year regarding Medicare coverage for Carotid stenting with embolic protection.

National Provider Identifier (NPI) Rule Effective May 23, 2007
As part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, an NPI is required for all “covered entities”, which include health care providers who conduct transactions in electronic form, health care clearinghouses and health plans. NPIs will need to be used by covered entities on all HIPAA covered transactions that call for health care provider identifiers to be in compliance with this rule, which is effective on May 23, 2007.

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