NYUMC Office of Compliance

If it concerns you, it concerns us.

NYUHC Regulatory Information Bulletin

Volume 2, Issue 3

Fascinating Additions to Federal Law . . .

· CMS releases the final version of its new clinical trial policy.  In this revised policy, CMS may determine that an item or service is only reasonable and necessary in a clinical trial.  In addition, CMS plans to reopen this NCD for further development.

· CMS has issued a final rule that refigures the Medicaid drug-pricing formula, makes the pricing more transparent and requires states to collect specific data from physicians about the drugs they administer in their offices.

· CMS is preparing to send the Disclosure of Financial Relationships Report to 500 hospitals.    The information collected will be reviewed  for compliance issues and to determine whether it should be mandated for annual reporting for all Medicare-participating hospitals.  More. . .

· The FDA announced, under the authority of the MQSA of 1992, that it is increasing fees for inspecting mammography facilities effective October 1, 2007.  This fee will be assessed for all inspections conducted under §354(g) of the Public Health Service Act.  Written comments can be submitted before 10/1/2007.

· FDA has reclassified filtering face piece respirators used in public health medical emergencies to a class II in order to provide a reasonable assurance of the safety and effectiveness of these devices.

· CMS announces the creation of a new database that will combine data from the Social Security Administration and unrestricted state death data.  The purpose is to ensure that no future payments are made to any individually enrolled provider for whom CMS has a record of death, and to  investigate whenever a deceased provider’s billing number has been used as the basis for a request for payment for services rendered after the physician's date of death.

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 NYSDOH has posted their regulatory agenda for the remainder of this year.  It contains a list of all regulations that DOH is considering and includes several changes to labs, food protection, early intervention programs, hospital reimbursement, and more.

 

· The OMIG has finally published the NYS guidance on mandatory compliance plans under the Deficit Reduction Act of 2005.

Notable New York Laws & Regulations . . .

· CMS discusses the proper use of Modifier 59

· MM5643:  IC9-CM updates effective for dates of service 10/1/2007 and later.

· Proposed Physician Fee Schedule.  Comment by 8/31.

· Additional Education for NPI

· P4P Study shows no significant quality changes

· OIG Review of Graduate Student Compensation Costs Charged to NIH Grants

· NCD Revised—20.7 Percutaneous Transluminal Angioplasty (PTA)

· MM5613: Charges for Missed Appointments.

July 13, 2007

Just when you thought it was safe to delve back into the HIPAA waters. . .It has been two years since the April 2005 compliance deadline for the HIPAA Security Rule.  Industry experts suggest that it’s time to dust off those old security risk analyses, risk management policies and procedures, and  take a fresh look.  This is especially true with respect to policies on the remote use of electronic protected health information.  This advice is based largely on the recent enforcement activity of DHHS and it’s OIG.