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This biweekly newsletter provides concise, independent coverage and analysis of fast-breaking lab, pathology, blood banking, imaging and diagnostic radiology news from the Nation's Capital.
You'll find out about:
- Medicare payment and policy directives Billing guidelines and coding changes for diagnostic facilities
- CLIA & MQSA regulatory mandates, changes and interpretations
- Congressional actions & legislative initiatives
- Federal compliance requirements
- OIG anti-fraud initiatives
- Stark self-referral prohibitions
Plus you will get other legal news regarding FDA oversight of in vitro diagnostics, blood banks, and radiological devices OSHA, NRC, and state safety standards.
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 | NIR January 28, 2008 (full issue PDF) |
| Inside ACLA’s model for CMS/FDA oversight of IVDMIAs
Legislative outlook in 2008 for lab/pathology priorities—see the Focus
—Physician reimbursement
—Pathology TC billings by independent labs
—Repeal of lab bidding demo
—CLIA cytology proficiency testing
—Genetic discrimination prohibitions
FDA okays first test to identify 12 respiratory viruses from single sample
Pathology claims advisory
CMS to adjust fee for new metabolic panel code
Correction: Physician quality reporting program to run for all of 2008
Don’t miss LabCompete, Feb. 6-8, Tucson, AZ. Check out details at g2reports.com/LabCompete08
Full Article |
| Physician Fee Fix Issues in Flux |
| Unless Congress steps in, the 10.1% cut in Medicare fees to pathologists and other physicians under the SGR update formula will take effect July 1 of this year. Lawmakers late last year blocked the cut from starting January 1 and approved a 0.5% increase through June 30.
Full Article |
| Labs Ratchet Up Game Plan to Block Lab Bidding Demo |
| At press time, a group of clinical laboratories in San Diego were close to filing a lawsuit to stop Medicare’s competitive bidding demo from going forward, according to a key industry source. The demo is scheduled to get underway July 1 of this year in the San Diego-Carlsbad-San Marcos metro area and to run for three years. The area is the first of two sites to be selected for the lab bidding pilot.
Full Article |
| Regulating IVDMIAs: A Closer Look at ACLA’s Proposed Model |
| The American Clinical Laboratory Association has proposed, in comments to the Food & Drug Administration, a regulatory model addressing the continuing controversy over the FDA’s decision to require premarket review for In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). NIR recently talked with David Mongillo, ACLA’s vice president for policy and medical affairs, about the significance of the proposed model.
Full Article |
| Legislative Outlook for Medicare Changes in 2008: Key Priorities for Clinical Labs, Pathologists |
| Medicare payment rates and other policy reforms are expected to top the healthcare agenda in Congress this year, and for clinical labs and pathologists, there is a lot of unfinished business left over from last year.
Full Article |
| Pathology Claims Advisory |
| On December 29, 2007, President George W. Bush signed into law legislation that blocked a 10.1% cut in Medicare payments to pathologists and other physicians scheduled to start January 1, 2008 in accord with the statutory update formula and replaced it with a 0.5% increase for the first six months of this year, through June 30. The revised conversion factor for this period is $38.0870 vs. $34.0682 under the cut.
Full Article |
| FDA Okays 1st Test to Identify 12 Respiratory Viruses |
| The Food & Drug Administration earlier this month cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses from a single sample. The xTAG Respiratory Viral Panel is the first test to spot and differentiate influenza A subtypes H1 and H3. Influenza A is the most severe form of the flu for humans and has caused major epidemics. The panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.
Full Article |
| CMS to Adjust Payment for New Metabolic Panel Code |
| In response to an inquiry from the American Clinical Laboratory Association, an official of the Centers for Medicare & Medicaid Services has clarified a payment change due for the new CPT code 80047, basic metabolic panel (ionized calcium), added to the 2008 lab fee schedule.
Full Article |
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