New York State Public Health Law ("PHL") Section 230-d requires private physician practices in which office-based surgery ("OBS") is performed to maintain accreditation from an accrediting agency designated by the Commissioner of Health ("Commissioner") and to report certain adverse events that occur subsequent to the provision of OBS. The requirements to maintain accreditation and report adverse events became effective July 14, 2009 and January 14, 2008, respectively. To provide guidance to practitioners, the NYS Department of Health ("DOH") issued OBS Frequently Asked Questions (the "FAQs") on its website, which were updated this month. See www.health.ny.gov/professionals/office-based_surgery/obs_faq.htm. We summarized key points.
What is Office-Based Surgery?
PHL Section 230-d defines OBS as any surgical or other invasive procedure, requiring more than minimal sedation, and any liposuction procedure, where such procedure is performed by a licensee in a location other than an Article 28 facility, excluding minor procedures. OBS accreditation (or Article 28 licensure) is not required, and the procedure is considered minor, where (1) the procedure can be performed safely with minimum discomfort, (2) the procedure can be performed using minimal sedation or local or topical anesthesia, (3) the response to procedural/surgical and sedation/anesthesia related complications can be done appropriately and in a timely manner, and (4) the likelihood of complications requiring hospitalization is minimal. If a procedure necessitates the use of moderate sedation, deep sedation, major upper or lower nerve blocks, neuraxial or general anesthesia, then such procedure must be performed in an OBS accredited practice or an Article 28 facility.
PHL Section 230-d applies to all physicians, physician assistants and specialist assistants. However, as of February 17, 2014, it will also apply to podiatrists privileged by the New York State Education Department to perform ankle surgery. These requirements apply to all type of medical practices, including those providing "urgent care" services. PHL Section 230-d also applies to a physician who performs "Office-based Surgery" on behalf of a university faculty practice corporation ("UFPC") because a UFPC is not, and is not part of, a hospital or other Article 28 facility. See questions 3 through 5 of the FAQs.
Private physician practices performing OBS must maintain accreditation from an accrediting agency approved by the Commissioner for each location at which OBS is provided. Accrediting agencies review various aspects of the physician practice including the practice's legal structure; the education, training and licensure of its practitioners; the policies and protocols used to guide selection and care of patients and operations of the OBS practice; and the physical plant and equipment used by the practice. A facility licensed under Article 28 of the PHL may not share space with an OBS practice. The issuance of an operating certificate under Article 28 is site specific, and the recipient of such certificate may not share site control with an entity that is not licensed under Article 28. Further, an accredited OBS practice cannot transfer or sell its accreditation to another party. However, this transfer restriction does not necessarily prohibit an OBS practice from selling its equity or assets. In the event that an accredited OBS practice wishes to sell equity to a new physician, the OBS practice needs to clear the proposed transfer with its accrediting agency. The DOH list of accredited OBS practices can be found at: www.health.ny.gov/professionals/office-based_surgery/practices/. Each accrediting agency maintains a list of the OBS practices they accredit on its website. See questions 10 through 21 and question 34 of the FAQs.
Adverse Event Reporting
Private physician practices performing OBS are required to report to the DOH adverse events within one business day of such occurrence, or of becoming aware of such occurrence. A list of reportable events can be found in the FAQs. Any physician, physician assistant or specialist assistant, or podiatrist after February 17, 2014, directly or indirectly involved in an OBS procedure associated with a reportable adverse event, even if such individual works in a hospital or other setting, must personally file an OBS adverse report. It is the personal responsibility of each mandated licensee to ensure that an adverse event report has been filed. See questions 23 through 31 of the FAQs.
Utilization of OBS Offices by Outside Practitioners
Practitioners who wish to use facilities of an OBS practice to perform procedures or provide anesthesia services must be equity holders, employees or independent contractors of such practice, and independent practitioners must be "working under a contractual arrangement with the OBS practice." Such contractual arrangement should be in writing and require, at a minimum: (1) credentialing and privileging of licensed independent practitioners, (2) adherence to the accreditation-related policies, procedures and protocols of the OBS practice, including making the accrediting agency of the practice aware of such contractual arrangement, (3) participation in the quality management and performance improvement activities of the OBS practice, and (4) reporting of OBS adverse events. See question 33 of the FAQs.
If a practitioner learns that he/she or another person has or may have participated in an OBS procedure in an office that is not accredited to provide OBS, such practitioner must notify the DOH Office of Professional Medical Conduct ("OPMC") if he/she is a physician, physician assistant or specialist assistant, or the New York State Education Department's Office of Professional Discipline ("OPD") if he/she is a podiatrist or other licensed professional. Contact information for OPMC and OPD can be found in question 37 of the FAQs.
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Please contact Gary Fields at 516-944-8200 or email@example.com if you have any questions regarding the provision of OBS or if you would like to discuss any of the areas covered by the OBS FAQs.