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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 other legal news FDA oversight of in vitro diagnostics, blood banks, and radiological devices OSHA, NRC, and state safety standards.
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 | NIR May 12, 2008 (full PDF issue) |
| Snapshot of typical ‘pod lab’ arrangement under scrutiny in pathology anti-markup case
OIG updates provider self-disclosure protocol, drops integrity agreements in most cases
Latest legal, regulatory developments in genetic testing—see the Focus
—Protecting patients from genetic discrimination
—Expanding newborn screening and education
—Expanding regulatory roles for the FDA and CMS
FDA clears new glove as alternative for individuals with high sensitivity to traditional latex
NPI Update: May 23 is Medicare deadline for NPI-only transactions
Maryland is 14th state to enact direct billing for anatomic pathology
G-2 Conference Calendar
Full Article |
| President to Sign Genetic Discrimination Ban |
| While a signing ceremony had yet to be scheduled at press time, the White House said the President will soon sign into law legislation prohibiting employers and health insurers from discriminating against patients based on their genetic information and test results. The measure cleared Congress May 1, capping a 13-year effort to get such a bill to the President’s desk.
Full Article |
| Court Tosses Out Pathology Anti-Markup Lawsuit |
| Pathology and clinical laboratory opponents of "pod lab" business arrangements scored a win May 5 when a federal district court granted the government’s motion to dismiss a lawsuit filed by several urology groups to stop Medicare from applying new anti-markup rules to anatomic pathology services.
Full Article |
| OIG Cuts Providers Some Slack on Integrity Agreements |
| In welcome news to clinical laboratories and other providers who opt to resolve potential federal fraud issues by using the self-disclosure protocol, the HHS Office of Inspector General has announced that it generally will not require them to enter into a corporate integrity agreement.
Full Article |
| Latest Developments in Law and Regulatory Oversight |
| Genetic testing is back in the political spotlight again. On the legislative front, the President, at press time, is poised to sign into law a bill prohibiting genetic discrimination by employers and health insurers. This follows his approval late last month of a new law expanding federal support for newborn screening programs.
Full Article |
| NPI Update: May 23 Is Medicare Deadline for NPI-Only Transactions |
| As of May 23, the Medicare fee-for-service program will accept/send transactions that use only the National Provider Identifier (NPI), and the Centers for Medicare & Medicaid Services is encouraging labs and other providers to make sure that they and their trading partners are ready for the change. CMS recommends the following steps to ensure a smooth transition:
Full Article |
| FDA Clears Glove Made From New Type of Latex |
| Use of gloves has long been part of the universal precautions to protect clinical lab personnel, phlebotomists, and other health care workers from exposure to blood-borne pathogens. But an estimated three percent to 22 percent of all health care workers are sensitized to traditional latex gloves made from the milky sap of a rubber tree containing a protein that may trigger allergic reactions from mild to severe, especially after prolonged and repeated contact.
Full Article |
| Maryland Enacts Pathology Direct Billing Law |
| Under a new law set to take effect Oct. 1, 2008, the state of Maryland will require direct billing for anatomic pathology services, with limited exceptions. Generally, a clinical laboratory or physician practice that performed the service must bill the patient or other responsible party for it directly. The lab or practice may bill for the service only if it performed or directly supervised the service and satisfied other stated requirements.
Full Article |
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