New Jersey - Volume VI, Number 11 - November, 1997
New Jersey - Volume VI, Number 11 - November, 1997
NEW JERSEY MEDICAL BOARD ADOPTS PHYSICIAN PRESCRIBING, DISPENSING AND CDS PAIN MANAGEMENT REGULATION
The New Jersey Board of Medical Examiners (Board) has adopted a regulation, effective November 3, 1997, amending its numerous rules governing the prescribing, administering and dispensing of drugs, including dosage unit limitations on CDS for pain management. The rule defines "drug" to expressly include vitamins and food supplements and defines "dispensing" as the provision of drugs or medications intended for the personal use of the patient outside the physician's office. The rule clarifies the statutory prohibitions against dispensing more than a seven-day supply of a drug and imposing a charge for the drug that exceeds 10% over the practitioner's actual acquisition cost (whether directly or through a global office visit charge that exceeds the usual and customary office visit charge). Some drugs that fall within the exception to the 7-day rule are not excepted from the 10% cost cap. Under the cost rule, a dispensing physician must also provide the patient information regarding the alternative availability of the drug other than through the physician, and disclose to the patient the physician's actual acquisition cost of the drug. The Board initially proposed that the seven-day supply rule also meant that these products could not be dispensed at a frequency greater than once every sixty (60) days. Amid protest from the Medical Society of New Jersey and others, the Board has reserved on that restriction and, notably, has also reserved on its proposed requirement that a physician use a separate prescription blank for each drug prescribed to a patient. While attempting to allow physicians treating patients suffering "pain from cancer, intractable pain or terminal illness" to prescribe the dosage of Schedule II CDS necessary to achieve pain management and to exceed the standard 120 dosage units limitation in certain cases, the provisions of the new rule addressing pain management impose paperwork and other requirements that many believe will deter rather than encourage more liberal pain management treatment plans.
HHS ADVISORY OPINION ADDRESSES PHYSICIAN/HOSPITAL VENTURE
As discussed in our April 1997 Statlaw (Vol. VI, No. 4), the U.S. Department of Health & Human Services (HHS) and the Justice Department are slowly issuing advisory opinions regarding the interpretation and applicability of the Medicare and Medicaid Anti-Kickback Statute. The fifth advisory opinion, recently issued, dealt with an imaging center joint venture among a radiology group and a hospital system. Of concern was whether the hospitals or the radiologists could funnel referrals to the proposed imaging center while receiving distributions of profits from the venture. Although the arrangement did not fit within any safe harbor, the agencies found that, because the participants do not generate referrals to the center, there is no prohibited remuneration for referrals arrangement. The hospital system had also agreed, among other things, to restrict its employed physicians from referring to the center and to not track physician referrals to the imaging center. HHS cautioned, however, that even if each party's return is proportionate with its investment in a joint venture, the mere opportunity to invest and receive profit distributions may in certain instances equal illegal remuneration if offered in exchange for past or future referrals.
POSTSCRIPT: The effective date for compliance with New Jersey's Uniform Prescription Blank Act (see Statlaw, Vol. VI, No. 3, March 1997) has been extended yet again to December 1, 1997, with a 90 day transition period beginning at that time.