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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 September 25, 2006 (full PDF issue) |
| Proposed Medicare crosswalks, fees for new 2007 lab tests
Big challenges ahead in ICD-10 switch, labs advised to name transition team to prepare
FDA clamps new controls on certain new types of DNA ‘home-brew’ tests, warns about ASR marketing practices––see Focus
Red Cross slapped with $4.2M fine for blood safety problems
Medicare Coverage Advisory:
—New waived tests
—ICD-9 changes to National Lab Policies
—Reminder: 9-day payment hold
Medicare to start increasing Part B premiums based on income January 1
Washington Watch: Problem seen in how Medicare would pay pathologists, other ‘indirect’ providers based on quality measures
Full Article |
| FDA Expands Oversight of ‘Home-Brew’ Lab Tests |
| Clinical laboratories and diagnostics manufacturers have been put on notice that the Food & Drug Administration is tightening the rules for in-house developed lab tests and will require premarket review for new types of DNA tests that combine assays and algorithms to produce results tailored to a specific patient.
Full Article |
| CMS Proposes Crosswalks to Set New Lab Fees |
| The Medicare program is proposing to use the crosswalk method to set payment levels for all eleven new CPT lab test codes to be added to the Part B lab fee schedule, starting January 1, 2007. The new tests are for conditions such as liver cancer, heart disease, West Nile virus, and staphylococcus (see table).
Full Article |
| Labs Urged to Get Ready for ICD-10 Transition |
| The proposed nationwide switch to ICD-10 diagnosis and procedure coding for billing and payment purposes poses major operational issues for the clinical laboratory industry. Medicare requires labs to provide a diagnosis code on all claims for reimbursement under the Part B lab fee schedule.
Full Article |
| FDA to Regulate New Types of ‘Home Brew’ DNA Tests |
| The Food & Drug Administration requires approval of diagnostic test kits sold to clinical laboratories, hospitals, and doctors, regarding these kits as medical devices subject to the agency’s regulation. But the FDA has generally exercised discretion in its oversight of in-house developed (home-brew) lab tests.
Full Article |
| FDA Fines American Red Cross $4.2M for Blood Safety Lapses |
| The Food & Drug Administration has fined the American Red Cross $4.2 million for failure to meet established blood safety requirements for collection of blood products. The ARC acknowledged that it had received an adverse determination letter from the FDA and said in a September 8 statement it will respond to agency concerns within 20 days.
Full Article |
| Medicare Coverage & Claims Advisory |
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New Waived Tests
In the latest update of the list of clinical laboratory tests that the Food & Drug Administration has approved as waived under CLIA, local Medicare contractors have been notified by the Centers for Medicare & Medicaid Services to recognize the following waived test billing codes, effective October 1, 2006: …
Full Article |
| Medicare to Increase Part B Premium, Begin ‘Means-Testing’ |
| The Medicare Part B premium will increase to $93.50 in 2007 and, for the first time, will be scaled to income—or "means-tested"—as beneficiaries with higher incomes pay more, the Centers for Medicare & Medicaid Services announced.
Full Article |
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