New Jersey - Volume VIII, Number 12 - December, 1999
NEW ANTI-KICKBACK SAFE HARBORS ISSUED: On November 19, 1999, the Office of Inspector General of the U.S. Department of Health & Human Services ("OIG"), issued a final rule establishing eight new safe harbor provisions and clarifying six of the original eleven published in 1991. Safe harbors immunize certain payment and business practices that are implicated by the Medicare and Medicaid Anti-Kickback Statute. Arrangements that do not comply with a safe harbor would be reviewed on a case-by-case basis. Four of the new safe harbors apply only to underserved areas. The other four address: investments in ambulatory surgical centers ("ASCs"); referral arrangements for specialty services; investments in group practices; and cooperative hospital service organizations.
The ASC safe harbor, which initially protected only ASCs wholly owned by surgeons, now includes four categories of free-standing Medicare-certified ASCs, if the safe harbor criteria are met: surgeon-owned; single-specialty (e.g., all gastroenterologists); multi-specialty (e.g., a mix of surgeons and gastroenterologists); and hospital/physician-owned. Certain other investors who are not existing or potential referral sources are permitted. The safe harbor is not available to other types of physician-owned clinical joint ventures, such as cardiac catheterization labs, or ESRD, lithotripsy, or radiation oncology facilities. The speciality referral arrangement safe harbor protects certain arrangements where an individual or entity agrees to refer a patient to another individual or entity for specialty services in return for the party receiving the referral to refer the patient back at a certain time or under certain circumstances. Among other criteria, there can be no remuneration between the parties for the referral, no splitting of a federal program global fee, and the time or circumstance for referring the patient back must be clinically appropriate.
OSHA REVISES COMPLIANCE DIRECTIVE: The Occupational Safety & Health Administration ("OSHA") has advised its inspecting officers to require new and safer needle devices, such as needleless IVs, when inspecting physician offices and other providers for compliance with its 1992 bloodborne pathogens standard.
HEALTHCARE INTEGRITY AND PROTECTION DATA BANK ("HIPDB") OPERATIONAL: Effective November 22, 1999, federal and state governmental agencies and health plans must report to the HIPDB adverse actions taken against physicians since August 21, 1996, the date the authorizing statute was enacted, including licensure actions, criminal convictions, civil judgments, and certain other adjudicated actions or decisions. Queries to the data bank can be made, for a fee, by the reporting entities, or by a practitioner concerning himself or herself, who can dispute the information contained in the data bank.
PATIENT ANTI-DUMPING BULLETIN ISSUED: The OIG and HCFA have issued a Special Advisory Bulletin clarifying requirements of the Emergency Medical Treatment and Labor Act (EMTALA), known as the Patient Anti_Dumping Statute, and hospitals obligations to medically screen all patients seeking emergency services and provide stabilizing medical treatment as necessary to all patients, including managed care enrollees, whose conditions warrant it. Among other things, the Bulletin advises that "dual staffing," where a hospital permits a managed care organization to station its own physicians in the ER, separate from the hospitals own ER staff, cannot delay screening or stabilization. The OIG collected $1.7 mi