Einiger & Associates

New York Healthcare Law

Are you an Authorized Provider?by Scott Einiger, Esq.

Are you an Authorized Provider of an Office Based Surgery Accredited Facility?

I Background
Private practices that perform office-based surgery (OBS) as defined by PHL § 230-d must be accredited by one of the DOH designated accrediting agencies. (Joint Commission, AAAASF or AAAHC)

Multiple aspects of practices seeking to provide office-based surgery are evaluated and surveyed as part of the accreditation process including, but not limited to: the legal structure of the practice; the education, training and licensure of physicians, podiatrists and other health care practitioners providing care to patients; policies, procedures and protocols used to guide selection and care of patients and operations of the practice; physical plant and equipment used in the care of patients, etc.

All office locations of the OBS practice must be accredited and any/all new locations where OBS will be performed must be accredited before any OBS procedures are performed.

Once a practice is accredited the question arises: what practitioners are permitted to utilize its space? For example may a practitioner who rents space at an accredited facility utilize its space to perform OBS procedures.

II Definition of covered OBS procedures
As set forth on the Department of Health Q and A section of its website:
Examples of procedures that fall under the OBS law include but are not limited to: upper endoscopy, colonoscopy, rhinoplasty, mammoplasty, lithotripsy or vascular access related procedures when accompanied by moderate or deep sedation, major upper or lower extremity nerve blocks, neuraxial or general anesthesia. Most procedures like botulinum toxin injections and minor integumentary procedures are performed with minimal or no sedation therefore can be performed in offices not requiring OBS accreditation. Generally, magnetic resonance imaging (MRI) procedures are not subject to this law. However, MRIs and other imaging studies that involve administration of intravenous contrast must be performed in an accredited OBS office if the patient involved receives moderate or deep sedation, major upper or lower extremity nerve blocks, neuraxial or general anesthesia.

PHL § 230-d indicates that OBS does not include minor procedures and procedures accompanied by minimal sedation. The statute defines minor procedures as: (i) procedures that can be performed with a minimum of discomfort where the likelihood of complications requiring hospitalization is minimal, and (ii) procedures performed with local or topical anesthesia; or (iii) liposuction with removal of less than 500 ml of fat under unsupplemented local anesthesia.

Presently PHL § 230-d onl applies to physicians, physician assistants and specialist assistants. As of February 17, 2014, the OBS law also applies to podiatrists privileged by the State Education Department to perform ankle surgery. This law does not apply to procedures performed by dentists, or podiatrists not performing ankle surgery or other health care professionals.

III. Who may Practice in an OBS setting
Only those practitioners who are “part of the practice”, as defined below, may perform procedures or provide anesthesia services in an accredited OBS office. Renting space in and of itself does not permit a licensed practitioner to otherwise perform OBS in an accredited facility.

Physicians or non-physician licensed health care practitioners may not perform OBS unless they are part of the practice or affiliated with the practice as employees of the OBS practice or working under a contractual arrangement with the OBS practice to perform procedural and/or sedation/anesthesia services, as applicable.
The contractual agreement must at a minimum spell out the terms of the affiliation between the accredited OBS practice and the affiliated physician or non-physician health care provider(s) and at a minimum require the following:

• Credentialing and privileging of all licensed independent practitioners (physicians, podiatrists, nurse practitioners, certified registered nurse anesthetists);
• Adherence to the accreditation related policies, procedures and protocols of the accredited practice including but not limited to patient rights, provision of care, infection control and record keeping;
• Participation in the quality management and performance improvement activities of the OBS practice, and;
• Reporting of adverse events identified in PHL § 230-d (See Q&A 23 above).
Physicians/licensed practitioners who are not part of or affiliated with an accredited OBS practice as set forth above may not perform procedures or provide anesthesia services in an accredited setting on their own behalf simply because they have entered into arrangements such as real estate leases that allow them to use space in an accredited OBS setting. The accrediting agency of the OBS practice must be made aware of all OBS practice affiliations and credentialed/privileged practitioners.

Failure to properly structure your Accredited facility contractual arrangements with other practitioners in accordance with the law may result in licensure investigations or civil actions that could result in catastrophic liability for both parties.

(1)Public Health Law (PHL) §§ 230-d defines Office-based Surgery as “any surgical or other invasive procedure*, requiring general anesthesia, moderate sedation, or deep sedation, and any liposuction procedure, where such surgical or other invasive procedure or liposuction is performed by a licensee** in a location other than a hospital, as such term is defined in article twenty-eight*** of this chapter, excluding minor procedures**** and procedures requiring minimal sedation

(2) Invasive procedures are: procedures performed for diagnostic or treatment purposes which involve puncture, penetration or incision of the skin, insertion of an instrument through the skin or a natural orifice, or insertion of foreign material other than medication into the body.

• Invasive procedures include, but are not limited to, the injection of contrast materials such as used for an MRI or CT scans when these imaging procedures are accompanied by moderate or deep sedation, major upper or lower extremity nerve blocks, neuraxial or general anesthesia

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