Office-Based Surgery (OBS) Frequently Asked Questions (FAQ's) for Practitioners
The FAQ's below have been developed to assist practitioners in understanding PHL 290-d, the Office-based Surgery Law. This law defines office-based surgery, requires physician practices in which OBS is performed to maintain accreditation from an accrediting agency designated by the Commissioner of Health, and mandates reporting of select adverse events that occur subsequent to OBS. Practices seeking to perform OBS must comply with the OBS law as well as all other applicable statutes and regulations; however these FAQ's do not discuss topics not addressed in the OBS law.
Topics not included in the OBS law and therefore not addressed in these FAQ's include:
- Payment for OBS
- Office-based procedures performed by dentists or podiatrists in their private offices
- Authority to practice medicine or scope of practice issues involving physician assistants, specialist assistants, nurse practitioners, etc.
- Physician or physician practice responsibility to comply with relevant laws, i.e. CLIA, blood or tissue banking, radiology services, etc. or
- Regulation of PHL Article 28 hospitals or Ambulatory Surgery Centers
These FAQ's do not address and the Department does not opine on business arrangements between and among private physicians including physicians performing office-based surgery.
Revision date: 12/2011
This revision includes significant changes to the OBS FAQ's posted previously. Questions and answers have been added, deleted, re-numbered and revised.
Office-based Surgery Laws
1. What are the Office-Based Surgery (OBS) laws and where can I find copies?
The OBS laws are:
- Public Health Law (PHL) §§ 230-d and 2998-e
- State Education Law § 6530(48)
To view copies of those laws, return to the Office-Based Surgery home page on this website and go to the section: "Laws of New York". That section contains the laws noted above. Clicking on the appropriate link will bring you to the exact text of the law.
2. When did the laws regarding Office Based Surgery become effective?
- Effective January 14, 2008, OBS adverse event reporting requirements began for any licensed physician, physician assistant or specialist assistant (licensees) under PHL§ 2998-e. See OBS Adverse Events below.
- Effective July 14, 2009, practices performing Office-Based Surgery (OBS) are required to be accredited by an agency determined by the Commissioner of Health.
3. What is Office-Based Surgery?
OBS is any surgical or other invasive procedure performed by a physician, physician assistant or specialist assistant, outside of a hospital, diagnostic and treatment center, ambulatory surgery center or other Public Health Law Article 28 facility (see question 4 below) in which moderate sedation or deep sedation or general anesthesia is utilized.
The only procedure specifically mentioned in the OBS law is liposuction. Liposuction is OBS when 500 ml or more of fat is removed. Liposuction of less than 500 ml of fat under unsupplemented local anesthesia or minimal sedation is not OBS. See also Sedation at question 6 below.
4. What is a Public Health Law Article 28 facility?
A PHL Article 28 facility refers to licensed "hospitals" which are established, operated, and regulated under Public Health Law Article 28 and the Department of Health regulations in Title 10 of the Codes Rules and Regulation of the State of New York. The term "hospital" is defined at Public Health Law section 2801(1) and includes acute care or general hospitals, nursing homes, diagnostic and treatment centers, and free-standing ambulatory surgery centers. Public Health Law Article 28 licensed facilities are not subject to the OBS law.
5. Do the OBS laws apply to only surgery performed in a private physician office?
No. It may also apply to invasive procedures performed in the office. OBS is defined in the law to include invasive procedures as well as any surgical procedures, depending on the level of anesthesia used. For example, a pain management practice may not perform surgery, but may, under moderate sedation, perform epidural or cervical blocks. Those procedures would certainly be considered invasive, therefore office-based surgery. Invasive procedures include but are not limited to the injection of contrast materials such as used for an MRI.
6. What is meant by the term "sedation"?
PHL§ 230-d identifies four (4) levels of sedation consistent with those defined by the American Society of Anesthesiologists (ASA). The use of any of the three levels listed below requires the office to become accredited if the procedure performed is invasive or surgical. Minimal sedation does not require accreditation.
The three (3) levels of sedation used in OBS which require accreditation are:
- Moderate Sedation/Analgesia – a drug-induced depression of consciousness during which patients respond purposefully* to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained without assistance.
- Deep Sedation/Analgesia – is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully** following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained without assistance.
- General Anesthesia – is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.
It is the intended impact/level of sedation of the patient that determines the need for accreditation and provision of care consistent with ASA standards. Please note that neither specific medications nor specific routes of administration are mentioned in the statute.
Health Care Professionals Subject to the OBS Laws
7. What health care professions are subject to the OBS laws?
This law applies to physicians, physician assistants and specialist assistants.
It does not cover procedures performed by dentists and podiatrists or other health care professionals. The State Education Department has issued Regulations for Dental Anesthesia Certification for office-based surgery and conscious sedation that apply to dentists and podiatrists only. These can be found at: http://www.op.nysed.gov/dentanesthes.htm and http://www.op.nysed.gov/podiatryguidesedation.htm.
There are dentists who are dually licensed as physicians. All physicians are affected by this law and therefore a dually licensed MD/DDS, when practicing medicine, may only perform OBS in an OBS accredited practice.
A dually licensed MD/DDS, when practicing dentistry in a dental practice, is not required to provide dentistry in an accredited OBS setting, since dental practices are not required to be accredited. Chiropractors, dentists and podiatrists, are not physicians and thus are unaffected by this law.
8. An anesthesiologist is engaged to administer moderate sedation to patients undergoing invasive or surgical procedure(s). Is the anesthesiologist required to assure that he/she is practicing in an accredited setting or be guilty of professional misconduct?
Anesthesiologists must practice in an accredited setting unless the procedure is not within the definition of OBS (non-invasive; non-surgical), the procedure is to be performed in a setting not required to have OBS accreditation (an ambulatory surgery center) or by a practitioner that is not affected by the law (a dentist, podiatrist ). An anesthesiologist should determine the accreditation status of an OBS practice prior to administering moderate or deeper sedation or anesthesia or providing services for a patient undergoing liposuction in an office-based setting. If practicing in a non-accredited office practice, the anesthesiologist and the physician performing the procedure are both subject to professional misconduct.
What Procedures are covered by the OBS Law?
9. Can you give examples of procedures that are within the definition of OBS?
Examples of procedures that are OBS include but are not limited to, upper endoscopy and colonoscopy, bronchoscopy, rhinoplasty, augmentation or reduction mammoplasty, or herniorrhaphy, when accompanied by moderate or deep sedation or general anesthesia. Most, but not all, botulinum toxin injections and minor integumentary procedures, are generally performed with minimal or no sedation, can be performed in offices without 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 office if the patient involved receives moderate or deeper levels of sedation or anesthesia.
10. What procedures are excluded from OBS?
OBS does not include minor procedures and procedures requiring minimal sedation. Minor procedures are: (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 cc of fat under unsupplemented local anesthesia.
Except for liposuction, the law does not mention any procedure by name. As noted in Question 3, except for liposuction, the determination of whether a particular procedure is OBS is based on whether or not a surgical or invasive procedure is accompanied by a level of moderate or deeper sedation. The sedation level is based on the affect on the patient and is not related to any particular drug, dose, or route of administration. See Question 6 for definitions of sedation.
11. Who are the Accrediting Agencies determined by the Commissioner and how can I contact them?
The determined accrediting agencies are:
- Accreditation Association for Ambulatory Health Care (AAAHC)
5250 Old Orchard Road, Suite 200
Skokie, IL 60077
- American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)
5101 Washington Street, Suite 2F
Gurnee, IL 60031
- The Joint Commission
One Renaissance Boulevard
Oakbrook Terrace, IL 60181
12. How were the nationally recognized accrediting agencies determined?
The accrediting agencies were chosen through a process which involved a written application and interview. They were chosen based on their standards, experience, and accreditation processes. In selecting the accrediting agencies, DOH required that the agencies have standards in various relevant categories. Each of the designated accrediting agencies demonstrated to the satisfaction of DOH that they had appropriate standards and acceptable processes in place for evaluating compliance with those standards. Standards of the agencies that were determined by DOH to accredit OBS practices are not identical. It should be noted however, that NYS has patient safety legislation that requires licensed practitioners to follow specific infection control practices that are somewhat more specific than the infection control standards of the OBS accrediting agencies. For further information see the link below:
13. What Must Be Accredited?
Private medical practices that perform OBS must be OBS accredited. Article 28 facilities (see above for definition) are not required to be OBS accredited. All locations in which a practitioner or group of practitioners will perform OBS must be OBS accredited. If the surgeon or group is adding a practice location where they plan to perform OBS, the new office location must be accredited before any OBS procedures are performed there.
14. Can a physician perform a single surgical procedure involving moderate or deeper sedation without becoming accredited?
No, if the plan is to perform an invasive or surgical procedure while administering moderate or deeper level of sedation or anesthesia, then accreditation is required prior to the performance of the procedure. Practices in the process of attaining OBS accreditation, may not perform invasive procedures involving moderate or deeper sedation or anesthesia prior to receiving official notification of OBS accreditation from a DOH designated accrediting agency.
15. Applicants for OBS accreditation are asked about their organizational structure. Why are those questions asked?
The accrediting agencies ask those questions to verify that practices seeking OBS accreditation are entities legally authorized to provide medicine in the State of New York.
In New York State physicians may conduct the private practice of medicine when they are one of the following: sole practitioner; professional corporation (all of the shareholders, officers and directors must be physicians); professional limited liability company (all of the members and managers must be physicians); or university faculty practice corporation (all of the officers and directors must be physicians); general partnership (all of the partners must be physicians); registered limited liability partnership (all of the partners must be physicians);.
16. Do the OBS laws apply to practices referred to as "urgent care"?
Yes, if it is the private practice of medicine performing OBS. No, if it is a facility licensed pursuant to PHL Article 28, e.g. a diagnostic and treatment center, clinic, ambulatory surgery center or hospital.
If the practice is not a licensed Public Health Law Article 28 facility, and the practice provides "urgent care" that involves surgical or invasive procedures performed under moderate or deeper sedation, it is performing office-based surgery and is subject to the OBS laws. No private practice can perform OBS after July 14, 2009 without having OBS accreditation from one of the DOH designated accrediting agencies.
17. Is a physician who performs office-based surgery and practices in a university faculty practice corporation subject to the OBS laws?
Yes. The definition of "office-based surgery" Public Health Law section 230-d(1)(h) states, in pertinent part, that the law applies when liposuction or any surgical or invasive procedure requiring at least a moderate level of sedation is performed "in a location other than a hospital, as such term is defined in article twenty-eight of this chapter." A university faculty practice corporation is a not-for-profit corporation organized under section 1412 of the Not-for-Profit Corporation Law that is affiliated with, but not part of, a hospital established under Article twenty-eight of the Public Health Law. Because the corporation is not part of the hospital with which it is affiliated, its offices constitute locations other than a hospital. So, OBS performed by faculty practice corporations must be in compliance with the OBS laws, including OBS accreditation.
We are aware that there are instances in which there is a university faculty practice plan without the corporate structure. In those instances in which the practices are structured as separate professional corporations, those professional corporations that perform OBS will need to be accredited. In those circumstances in which the practices are not structured as separate entities, those practices within the school that perform OBS will need to be accredited as the [specialty] practice of "X" school or college.
18. Must tissue banks become accredited under the OBS Law?
Yes in some circumstances. Tissue banks are regulated under Public Health Law (PHL) Article 43-B and must be licensed by the Commissioner of Health through the Wadsworth Center's Blood and Tissue Resources Program. Tissue banks operating out of physician offices that collect tissue, such as oocytes, and/or transplant tissue under moderate or deep sedation or general anesthesia must become accredited pursuant to the new OBS law. Tissue bank licensure does not supplant the accreditation requirement.
19. Will the Department provide a list of OBS accredited practices on the DOH Web site? How do I find out if an OBS practice is accredited?
The DOH Web site has a list of accredited OBS practices and the agency which has accredited the practice. The list is updated monthly and can be found at: http://www.nyhealth.gov/professionals/office-based_surgery/practices/.
In addition, each OBS accrediting agency noted above provides a list of the OBS practices they accredit.
OBS Adverse Events
20. What Must Be Reported?
Office-based surgery adverse events must be reported to the New York State Department of Health, Patient Safety Center within one business day. PHL § 230-d(1)(b) provides reportable OBS adverse events are:
- Patient death within thirty (30) days;
- Unplanned transfer to a hospital;
- Unscheduled hospital admission, of longer than twenty-four (24) hours, within seventy-two (72) hours of the office-based surgery; and
- Any other serious or life-threatening event*.
In addition, PHL § 230-d requires reporting of suspected transmission of blood borne communicable disease from health professional to patient or between patients. Such reporting must occur within one business day of becoming aware of a suspected transmission. See link below for further information:
*Other serious or life-threatening events should include events that occur within 30 days of an office-based surgery procedure resulting in temporary or permanent physical loss of bodily function or mental impairment and /or loss or impairment that substantially limits one or more of the major life activities of the individual; wrong site, person, procedure; or unplanned return to the OR.
21. Is There a Required Form and Where Must OBS Adverse Events Reports Be Sent?
The Office Based Surgery Adverse Events Reporting Form is located on the DOH Web site at http://www.health.ny.gov/professionals/office-based_surgery/ and must be sent by certified mail to the New York State Department of Health, Patient Safety Center, Hedley Building, 433 River Street, Suite 1000, Troy, New York 12180.
22. Who Must Report OBS Adverse Events?
Any physician, physician assistant or specialist assistant directly or indirectly involved in a OBS procedure associated with a reportable adverse event, must file an OBS adverse event form. Mandated reporters, MDs, PAs and SAs, are expected to complete the OBS adverse event form that is posted on the Department of Health website on the date of the occurrence in its entirety and send it by certified mail to the Department of Health Patient Safety Center. The mandated licensees involved in the OBS procedure, usually this includes the proceduralist and the sedation/anesthesia provider, may file a single form that each licensee signs or each licensee may file separate forms individually. It is the personal responsibility of each mandated licensee to ensure that an adverse event form has been filed.
Any physician, physician assistant or specialist assistant in a hospital or other setting who becomes aware of a patient transfer, hospital admission, serious or life-threatening event, potential transmission of a blood borne pathogen or death after performance of an OBS procedure are also responsible to report an OBS adverse event report as soon as they become aware of these events. In such a case, the reporter may not be able to complete the form in its entirety, but should submit as much information as possible to the Patient Safety Center.
23. Are Hospitals Required to Report?
Hospitals are not required to report OBS adverse events, but are encouraged to report events that they identify. In addition, we have encouraged hospitals to assist Emergency Department and other physicians, physician assistants and specialist assistants providing care to OBS patients in hospitals to report the OBS adverse events that come to their attention. Physicians, Physician Assistants and Specialist Assistants that work in hospitals and become aware of OBS adverse events in hospital and emergency department patients are required to report. Hospitals are encouraged to educate their staff about the adverse event reporting requirements. A physician, physician assistant or specialist assistant may fulfill their reporting requirement if the risk manager, or other hospital designee, compiles the information on the report and the mandated reporter(s) signs it. The OBS adverse event report should be sent to the Department of Health Patient Safety Center, see address at question and answer 23 above.
Sending the report to the New York Patient Occurrence Reporting and Tracking System (NYPORTS), the hospital adverse event reporting system, does not fulfill the OBS reporting requirement. Filing the adverse event form remains the personal responsibility of the mandated licensees. Hospitals are required to report suspected professional misconduct within 30 days of obtaining knowledge of any information which reasonably appears to show that a physician is guilty of professional misconduct. PHL 2803-e(2)
24. When Must Adverse Events be Reported?
A physician, physician assistant or specialist assistant involved in the OBS procedure must report mandated adverse events to the Patient Safety Center within one business day of the occurrence, or becoming aware of the occurrence, of such adverse event. The date of reporting will be the date the OBS adverse event form is mailed, not the date that DOH receives the report.
25. If nurses, radiologic technologist or other health care practitioners are involved in an OBS procedure, would they need to complete the adverse event reporting form? Are they required to be listed as "other persons participating in the procedure" or sign the report form?
Nurses, radiologic technologists and other practitioners are not required to submit OBS adverse event reports and are not required to sign the adverse event report form. The form does request reporters to identify the names, licensure/certification status and role of all those participating in a procedure related to an adverse event.
26. When reporting adverse events, is it necessary to call DOH in addition to completing and sending in the form?
No. If a licensee is not certain whether something is a reportable event, the licensee should file an adverse event report form. If a licensee fails to file a report in a timely manner, the licensee must provide an explanation on the adverse event report form.
Confidentiality and Nondisclosure
27. Are Office Based Surgery adverse event reports confidential?
OBS adverse event reports reported to the Department of Health Patient Safety Center are subject to the confidentiality provisions provided by Public Health Law section 2998-e. The reported data is not subject to disclosure under Article 6 of Public Offices Law (Freedom of Information Law) or Article 31 of Civil Practice Law and Rules.
28. Are there any federal or state guidelines addressing the issue of advance directives in OBS practices?
Federal law requires all providers, including physicians in private practice, which would include an OBS practice, to ask their patients whether they have any advance directives – mainly a health care proxy. If the patient requests information on advance directives, the providers should be prepared to either give them such information or refer them to the Department of Health's Web site which has the information (www.health.ny.gov). DOH advises persons who have completed a health care proxy form to bring a copy with them if they are having any type of OBS procedure. The OBS practice should reiterate this as part of their pre-op instructions. If the patient does not have a completed health care proxy form, but would like to complete one before surgery, the OBS practice should either have some routinely available or should download a form from DOH's Web site. The patient can then complete the form and OBS staff can witness the patient's signature. There is no legal prohibition on staff members of a physician practice or an Article 28 facility from witnessing a patient's health care proxy. The only person(s) who are legally prohibited from acting as witness(es) are those named as agent(s) in the proxy form.
29. Does accreditation status qualify a private physicians' office performing OBS (OBS practice) to receive a "facility fee"?
Reimbursement to a private physician office, including those that perform OBS, is a matter between the insurer and the practice/provider. Neither Medicaid nor Medicare pay a facility fee to private physicians' offices for office-based surgery.
30. Are there architectural requirements for office-based practices?
OBS practices must follow the accrediting agency's standards for the physical plant requirements. These requirements include standards for procedure room sizes, the need for soiled and clean utility, standards for pre-op and recovery, sterilization facilities, emergency power, oxygen, suction and gas among others. Additionally, localities have occupancy requirements, based upon the type of occupancies that set standards for building construction, fire and life safety. The local/municipal requirements may be subject to the number of persons rendered incapable of taking action for self-preservation under emergency conditions without assistance from others, or are under the effects of deep sedation or general anesthesia at any one time.
Use of the term Office-Based Surgery
31. When can a practice use "office-based surgery" in their name?
A physician practice may only use that term in their name if they are accredited to perform office based surgery. The term "OB surgery" may not be used to refer to office-based surgery unless the practitioner is performing obstetrics (in that "OB" is generally understood to mean obstetrics). Questions about naming of a private medical practice should be directed to:
- New York State Education Department
Office of the Professions
Division of Professional Licensing Services
Professional Corporations Unit
2nd Floor, West Wing
89 Washington Avenue
Albany, New York 12234-1000
Phone: 518-474-3817, ext. 400
32. What is the responsibility of a physician, physician assistant or specialist assistant, that learns he/she has/may have participated in or becomes aware of an office based surgical (OBS) procedure that was performed in an office that is not accredited?
The responsibility of a physician, PA or SA who learns they or a colleague has or may have participated in an OBS procedure in an office that is not accredited is responsible to notify the New York State Department of Health Office of Professional Medical Conduct that professional misconduct may have knowingly or unknowingly occurred.