NYUMC Office of Compliance

If it concerns you, it concerns us.

NYUHC Regulatory Information Bulletin

Volume 2, Issue 1

Fascinating Additions to Federal Law . . .

· Through NCD 20.7, CMS has determined that PTA and stenting of intracranial arteries is reasonable and necessary for treatment of cerebral artery stenosis greater than or equal to 50% in patients with intracranial atherosclerotic disease when furnished in accordance with FDA-approved protocols governing Category B IDE clinical trials. All other indications for PTA with or without stenting to treat obstructive lesions of vertebral and cerebral arteries remain non-covered.  You may also want to review MM5432.  Change is effective 2/5/2007.

· In Transmittal # 1133, CMS clarifies the taxonomy codes used to identify provider subparts on institutional claims.

· The FDA has withdrawn its direct final rule, published in 71 FR 55,729, that would have amended certain classification regulations of reprocessed single use devices (SUDs). The classification requirements of SUDs govern when a hospital must submit a pre-market notification (510k) or pre-market approval (PMA) to the FDA prior to use of the reprocessed SUD. As the classification regulations will no longer be revised, hospitals should continue to adhere to the processes currently followed with respect to reprocessed SUDs and submit a 510k application for non-exempt Class I and II devices, or submit a PMA for Class III devices. Hospitals are not required to submit a 510k for exempt Class I and II SUDs.  For more information access the Federal Register.

· Embedded in the PTA information mentioned above, CMS issued some guidance to address billing no cost items in regular and clinical trials billing.

· A small correction was made to the hospital discharge appeal right notification.

The RIB is e-mailed monthly to managers 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.

· The Department of Health adopted new regulations updating existing requirements for the treatment of sexual assault survivors (405.9(c)), including emergency services, and adding a section to establish standards and processes for the DOH hospital-based Sexual Assault Forensic Examiner (SAFE) Program designation.  The regulations were effective 1/17/2007.

· The Department of Insurance adopted new regulations to establish guidelines and requirements for medical malpractice merit rating plans and risk management plans.  The regulations were effective 1/24/2007.

· Last week, Gov. Spitzer gave a major address outlining his vision for the future of New York's health care system.  The Governor’s speech indicates that in his budget proposal he will request a freeze on Medicaid rates for hospitals and a cut in Medicaid GME payments all in an effort to create patient-focused healthcare.

· Check out the latest copy of the Dept. of Health’s Medicaid Update.

· The Office of Professions is requesting comments on the professional rules surrounding pharmacy assistants, midwives, & physical therapists.  The rules are being reviewed for possible modification. Click here to learn about the rules and submit comments.

Notable New York Laws & Regulations . . .

· Office of Research Integrity December 2006 Newsletter

· CMS’ Pay for Performance Pilot netted $8.7M in bonuses to 115 top-performing hospitals.

· FDA announces initiatives to improve drug safety post-market

· IFPMA revealed a new code of ethics that limits gifts from pharmaceutical reps to physicians.

· MM5428: Billing for Pre-Administration Services for IVIG

· MM5468:  Independent Lab Billing for the Technical Component of Physician Pathology Services

· Newly approved LCD 23391:  Morphometric Analysis.  Effective 2/21/2007.

 January 31, 2007

· Former AOL chief launches health site.  A new online healthcare portal and personal health record service was launched this month. RevolutionHealth.com is being touted as the brainstorm of Steve Case, a former chairman and CEO of America Online. The site will include medical content, "social networking" features & will allow users to rate their doctors, locate a new doctor & schedule an appointment.

· President Bush’s 2008 budget proposal will request new funds to support a “rapid-learning” healthcare system that uses data from electronic health records to accelerate clinical research.  This is according to Carolyn Clancy, Director of the Agency for Healthcare Research and Quality, said at a news conference sponsored by Health Affairs. Such a system would include private- & public-sector initiatives drawing on data from the electronic health records of millions of people to rapidly advance the evidence base for clinical care, according to researchers.  Read the Health Affairs articles.

This year, especially in New York, proves to be very active from a regulatory perspective.  Stay tuned as we lead you through the regulatory maelstrom. . .

Editor’s Corner!