NYUMC Office of Compliance

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NYUHC Regulatory Information Bulletin

Volume 2, Issue 6

Fascinating Additions to Federal Law . . .

· Newly signed law gives the FDA new authority over the safety of marketed prescription drugs.  Read more here.

· The AVMA has issued an update to the 2000 Report of the Panel on Euthanasia with a new title, AVMA Guidelines on Euthanasia. Since the PHS Policy on Humane Care and Use of Laboratory Animals requires IACUCs to use the recommendations of the AVMA Panel on Euthanasia, OLAW has issued a notice in the NIH Guide for Grants and Contracts regarding implementation of the new report.

· The FDA announces efforts to streamline the generic drug approval process.  Read more.

· In a press release, Medicare announces a finalized Clinical Trials Policy.  In an un-precendented response to public comments, CMS has decided not to adopt the changes it proposed on July 19, 2007.  Read the current Clinical Trials Policy.

· Pursuant to the Medicare Modernization Act, CMS designed a demonstration program to determine whether competitive bidding can be used to provide laboratory services under Medicare Part B at fees below current Medicare payment rates. On October 16th, CMS announced that it selected the San Diego-Carlsbad-San Marcos (CA) metropolitan area as the first of two locations under this demonstration program.  For additional details regarding this program, access the CMS press release and the Federal Register publication.

· Review and comment on draft Local Coverage Determinations for Medicare Part A or Part B.

· In a final rule, the FDA reclassifies Remote Medication Management  Systems.

· CMS proposed a rule that would amend the regulatory definition of outpatient hospital services for the Medicaid program. The purpose is to align the Medicaid and Medicare definitions.  Read more.

The RIB is e-mailed monthly to Directors and above.  To remove your name from our mailing list, or for questions or comments, please e-mail the Office of Compliance’s Regulatory Information & Education area or call (212) 404-4070.

· With little pomp and circumstance the Department of Law issued a rule to serve as both the emergency adoption and a notice of proposed rule making in order to establish procedures for investigating persons who defrauded the State or a local government, the handling and processing of civil enforcement actions, and the handling and processing of qui tam actions under the recently passed False Claims Act.  The rule was effective September 10, 2007 (open for comment 45 days from publication) and will expire on December 8, 2007.   Learn more.

· Effective September 28, 2007, the Workers’ Compensation Board has issued an emergency rule extending the time for submitting reports of independent medical examinations from 10 calendar days to 10 business days.

· Read the most recent Medicaid Update.

· Effective October 1, 2007, there are new Medicaid billing procedures for Traumatic Brain Injury program services that do not have established rates.  The change will allow providers to bill their total charges under one rate code for the specific service rendered.  Learn more.

Notable New York Actions . . .

· The 2008 Work Plan, the OIG’s road map for audits, includes some big ticket areas like cost reports, transplant, and “never-events.”

· Still struggling with the changes?  Check out the CMS crosswalk between old and new DRGs.

· A white paper by the Panel on the Nonprofit Sector gives guidelines on legal compliance, effective governance, financial oversight,  and responsible fundraising for nonprofits.

· FDA lab tests waived under CLIA.

· NPI effective, legacy numbers unnecessary as of 01/01/2008.  Enrollment information.

· Latest changes to Medicare EOB summary notices in Spanish.