NYUMC Office of Compliance

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NYUMC Regulatory Information Bulletin

Volume 2, Issue 5

Fascinating Additions to Federal Law . . .

· OFFICE OF HUMAN RESEARCH PROTECTIONS  is requesting information on whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research.  More.

 

· CMS SUBMITs the DFRR for another round of comments.  As previously reported CMS will begin to request, on an annual basis,  the Disclosure of Financial Relationships Report (DFRR).  In a notice published today, CMS states that the report will collect information on a provider’s ownership, investment, and compensation arrangements that  will be used to analyze each hospital's compliance with section 1877 of the Social Security Act (“the physician self-referral law''), and implementing regulations (42 Code of Federal Regulations, Subpart J).  The revised DFRR is available for public comment.

· CMS DISHES UP STARK SURPRISES.  In the Stark III final rule (to complement Phases I and II), CMS makes some bold changes; opening new doors and closing old ones.  Stark Laws I , II and III offer a complex formula for regulating physician self-referral; one that often requires expert consultation.   The top 5 changes are as follows:  (1) Personal service arrangements will now have a six-month "holdover" period, (2) The physician recruitment exception has substantial revisions, the most important of which is that reasonable practice restrictions can be imposed on the recruited physicians, including covenants not to compete, (3) The $329 non-monetary compensation exception now recognizes continued compliance even if gifts and benefits in excess of the limit are exceeded by no more than 50% as long as the physician repays the excess, (4) Hospitals can sponsor one formal event (i.e., Christmas party) for their medical staff members per year without having to track expenses under the $329 non-monetary compensation exception, and (5) The fair-market-value "safe-harbor" definition has been eliminated.  If you think you have a Stark issue, please contact Legal and/or Compliance.

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.

· DHHS OIG has determined that the NYS False Claims Act meets the requirements of section 6031(b) of the Deficit Reduction Act, making NYS eligible for an extra 10 percent of the dollars recouped from Medicaid fraud lawsuits.

· NYS’ Department of Health recently passed an emergency rule authorizing Medicaid payments for private duty nursing services at an enhanced rate when provided to “medically fragile children” in the community.  The enhanced rate is to be given only upon submission of a certification to the DOH that  the provider is trained and experienced in caring for such children. 

· The Dept of Education’s Office of the Professions announces online license renewal effective January 1, 2008.  Read more.

· Gov. Spitzer signed a law requiring all employers with 20 or more employees to permit employees to take up to 3 hours leave of absence a year to donate blood.  Regulations to implement this law are forthcoming from the Commissioner of Labor.  This law becomes effective December 13, 2007.

· Gov. Spitzer signed a law increasing the types of people with the right to control the disposition of a decedent’s body.  The law adds to the bottom of the hierarchy three additional categories including a close friend or relative that knows the decedent’s wishes.  This law was effective on August 1, 2007.

· Gov. Spitzer signed a law permitting Physician Assistants to prescribe, administer, & dispense  Schedule II controlled substances in an outpatient setting for patients under the care of their supervising physician, but only to the extent authorized by their supervising physician.  This law is effective December 13, 2007.

Notable New York Actions . . .

· OSHA is requesting information as it prepares to create a single standard for Emergency Response and Preparedness.  More.

· UNOS releases new live-donor organ-donation guidelines.  More.

· 2nd Edition of the Guide to Medicare Preventive Services for Physicians, Providers, etc.

· MM5694:  IRF Annual Update and Pricer Changes

· Proposed Ambulatory Surgery Centers Conditions for Coverage

· NCD 220.5 Ultrasound Diagnostic Procedures

· NCD 150.10 Lumbar Artificial Disc Replacement (LADR)

September 14, 2007

Preventing Hospital-Acquired Infections– The Leapfrog Hospital Quality and Safety Survey reports that 87 percent of hospitals do not take all recommended steps to prevent different types of hospital-acquired infections.  The survey "asked about three common infections and reported the percentage of hospitals that fully complied with prevention policies: aspiration- and ventilator-associated pneumonia (38.5%); central venous catheter-related bloodstream infection (35.4%); and surgical-site infection (32.3%). In addition, 35.6% of hospitals followed hand-hygiene practices, and 30.7% vaccinated staff against flu." Officials at Leapfrog said low results indicate a need for hospitals "to increase their use of safety protocols."  Click here to read more about the Leapfrog survey.  Of course this directly ties back to the new Medicare IPPPS and beginning October 1st hospitals will be required to record a patient’s diagnosis as it presents on admission (a.k.a. POA reporting) in order for  Medicare to identify hospital-acquired infections.