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Articles Posted in Anesthesia

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Earlier this month, Transmittals to the State Operations Manual for ASCs (Appendix L) implemented certain clarifications/changes to the anesthetic risk assessment, H&P and pre-surgical evaluation Conditions of Participation at ASCs, effective 5.13.11. The new standards from the Transmittal are set forth below, followed by the provisions in which these new standards of Appendix L have been incorporated.

1. Anesthetic Risk Assessment: When the comprehensive H&P assessment is performed in the ASC on the same day as the surgical procedure, the Transmittal indicates that the assessment of the patient’s procedure/anesthesia risk must be conducted separately from the history and physical, including any update assessment incorporated into that history and physical.

2. H&Ps:

a. The H&P (conducted within 30 days of the scheduled surgery) must be comprehensive in order to allow assessment of the patient’s readiness for surgery and, as clarified by the Transmittal, is required regardless of the type of surgical procedure.

b. While the comprehensive H&P may be performed in the ASC on the same day as the surgical procedure (provided that it is conducted by qualified personnel, is comprehensive, and the results of the H&P are placed in the patient’s medical record prior to the surgical procedure), according to the Transmittal, it is not acceptable to conduct the H&P after the patient has been prepped and brought into the operating or procedure room. The rationale for this requirement is that the purpose of the H&P is to determine, prior to surgery, whether there is anything in the patient’s overall condition that would affect the conduct of, or possibly require cancellation of, the planned procedure.

3. Pre-Surgical Assessment:

a. Independent of the H&P requirement discussed above, upon admission to the ASC each ASC patient must have a pre-surgical assessment by a physician to evaluate the risk of the anesthesia and of the procedure for that patient. The Transmittal notes that this component must be conducted by a physician, immediately prior to surgery, and must be performed in a manner consistent with the anesthetic risk assessment requirements discussed in paragraph 1 above.

b. In accordance with the Transmittal, if the H&P is performed on the day of the surgical procedure in the ASC, some, but not all, elements of the pre-surgical assessment may be incorporated into the H&P. However, the assessment of the patient’s risk for the procedure and anesthesia (as discussed in paragraph 1 above) must still be conducted separately, by a physician and immediately prior to surgery.

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Below are the sections from the Transmittal in which each of the foregoing is discussed. The new clarification language is highlighted in red.

(Rev.71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)

§416.42(A) STANDARD: ANESTHETIC RISK AND EVALUATION
(1) A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed.
Interpretive Guidelines: §416.42(a)(1)

The purpose of the exam immediately before surgery is to evaluate, based on the patient’s current condition, whether the risks associated with the anesthesia that will be administered and with the surgical procedure that will be performed fall within an acceptable range for a patient having that procedure in an ASC, given that the ASC does not provide services to patients requiring hospitalization. The assessment must be specific to each patient; it is not acceptable for an ASC to assume, for example, that coverage of a specific procedure by Medicare or an insurance company in an ASC setting is a sufficient basis to conclude that the risks of the anesthesia and surgery are acceptable generically for every ASC patient. The requirement for a physician to examine the patient immediately before surgery is not to be confused with the separate requirement at 42 CFR 416.52(a)(1) for a history and physical assessment performed by a physician, although it is expected that the physician will review the materials from such pre-admission examination as part of the evaluation. Nevertheless, this requirement does constitute one component of the requirement at 42 CFR 416.52(a)(2) for a pre-surgical assessment upon admission. In those cases, however, where the comprehensive history and physical assessment is performed in the ASC on the same day as the surgical procedure, the assessment of the patient’s procedure/anesthesia risk must be conducted separately from the history and physical, including any update assessment incorporated into that history and physical. See the interpretive guidelines for§§416.52(a)(1) & (2).

The ASC must have approved policies and procedures to assure that the assessment of anesthesia-related and procedural risks is completed just prior to every surgical procedure. (Ideally, the ASC would conduct such an assessment prior to the patient’s admission as well as immediately prior to surgery, but this is not specifically required by the regulations.)

The ASC‟s policies must address the basis or criteria used within the ASC in conducting these risk assessments, and must assure consistency among assessments.
The regulations do not specify the content or methodology to be employed in such assessments. As an illustrative example, an ASC might choose to incorporate consideration of a patient’s ASA Physical Classification into its criteria. Although the American Society of Anesthesiologists did not create its ASA Physical Status Classification System for the purpose of predicting operative risk, this system has nevertheless been found to be useful in predicting morbidity and mortality in surgical patients1 and has been used by surgical facilities as a standard tool. This system classifies patients‟ physical status in 6 levels:

ASA PS I – Normal healthy patient;
ASA PS II – Patient with mild systemic disease;
ASA PS III – Patient with severe systemic disease;
ASA PS IV – Patient with severe systemic disease that is a constant threat to life;
ASA PS V – Moribund patient who is not expected to survive without the operation; and
ASA PS VI – Declared brain-dead patient whose organs are being removed for donor purposes.

As the ASA PS level of a patient increases, the range of acceptable risk associated with a specific procedure or type of anesthesia in an ambulatory setting may narrow. An ASC that employed this classification system in its assessment of its patients might then consider, taking into account the nature of the procedures it performs and the anesthesia used, whether it will accept for admission patients who would have a classification of ASA PS IV or higher. For many patients classified as ASA PS level III, an ASC may also not be an appropriate setting, depending upon the procedure and anesthesia.

If a State establishes licensure limitations on the types of procedures an ASC may perform that are based on patient classifications and would permit ASCs to perform fewer procedures than they would under the CfCs, then the ASC must conform to those State requirements. However, State requirements that would expand the types of procedures an ASC may offer beyond what is permitted under the CfCs are superseded by the Federal CfC requirements.
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(Rev. 71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)

§416.52(A) STANDARD: ADMISSION AND PRE-SURGICAL ASSESSMENT
(1) Not more than 30 days before the date of the scheduled surgery, each patient must have a comprehensive medical history and physical assessment completed by a physician (as defined in section 1861(r) of the Act) or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.
Interpretive Guidelines §416.52(a)(1)

The purpose of a comprehensive medical history and physical assessment (H&P) is to determine whether there is anything in the patient’s overall condition that would affect the planned surgery, such as a medication allergy, or a new or existing co-morbid condition that requires additional interventions to reduce risk to the patient, or which may even indicate that an ASC setting might not be the appropriate setting for the patient’s surgery. The H&P must be comprehensive in order to allow assessment of the patient’s readiness for surgery and is required regardless of the type of surgical procedure. The H&P
should specifically indicate that the patient is cleared for surgery in an ambulatory setting.

The H&P must be completed and documented for each ASC patient no more than 30 calendar days prior to date the patient is scheduled for surgery in the ASC.
In cases where the patient is scheduled for two surgeries in the ASC within a short period of time, the same H&P may be used so long it is completed no more than 30 calendar days before each surgery. For example, if a patient has two surgeries for cataracts scheduled, one eye on May 3rd, and the other eye on May 18th, and H&P performed on April 20th could be used for both surgeries.

The H&P is still required in those cases where the patient is referred to the ASC for surgery on the same day as the referral and the referring physician has indicated it is medically necessary for the patient to have the surgery on the same date. The H&P may be performed by the referring physician, if the ASC‟s policies permit this, or qualified personnel in the ASC. If there are elements of the H&P that are essential to the performance of the physician assessment required under §416.42(a) or under this requirement at §416.52(a)(1), based on the type of procedure to be performed as well as applicable State health and safety laws, standards of practice, or ASC policy, and those elements cannot be completed prior to the scheduled time of the surgical procedure, then it is questionable whether the case is suitable for that ASC.

The H&P may be performed on the same day as the surgical procedure, and may be performed in the ASC, as long as it is conducted by qualified personnel, is comprehensive, and the results of the H&P are placed in the patient’s medical record prior to the surgical procedure (see §416.52(a)(3). It is not acceptable to conduct the H&P after the patient has been prepped and brought into the operating or procedure room, since the purpose of the H&P is to determine before the surgery whether there is anything in the patient’s overall condition that would affect the conduct of the planned procedure, or which may even require cancellation of the procedure.

The medical history and physical examination must be completed and documented by a physician (as defined in Section 1861(r) of the Act) or other qualified licensed individual practitioner in accordance with State law, generally accepted standards of practice, and ASC policy.

Section 1861(r) defines a physician as a:

doctor of medicine or osteopathy;
doctor of dental surgery or of dental medicine;
doctor of podiatric medicine;
doctor of optometry; or a
chiropractor.

In all cases the practitioners included in the definition of a physician must be legally authorized to practice within the State where the ASC is located and providing services within their authorized scope of practice.

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the ASC to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician assistants.
More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When performance, documentation, and authentication are split among qualified practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.
In the case of an ASC the H&P is typically completed by the patient’s primary care practitioner rather than a member of the ASC‟s medical staff. The ASC‟s policy on H&Ps should address submission of an H&P prior to the patient’s scheduled surgery date by a physician who is not a member of the ASC‟s medical staff and should indicate whether it will accept H&Ps performed by a qualified licensed individual who does not practice at the ASC but is acting within his/her scope of practice under State law or regulations.

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(Rev. 71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)

§416.52(A) STANDARD: ADMISSION AND PRE-SURGICAL ASSESSMENT
(2) Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy that includes, at a minimum, an updated medical record entry documenting an examination for any changes in the patient’s condition since completion of the most recently documented medical history and physical assessment, including documentation of any allergies to drugs and biologicals.

Interpretive Guidelines: §416.52(a)(2)

Each ASC patient upon admission to the ASC must have a pre-surgical assessment. The requirement at §416.42(a)(1) for a physician to examine the patient immediately before surgery to evaluate the risk of the anesthesia and of the procedure for that patient is one component of the requirement at 42 CFR 416.52(a)(2). This component must be conducted by a physician, immediately prior to surgery, and must be performed in a manner consistent with the requirements at §416.42(a)(1). (See the interpretive guidelines for §416.42(a)(1). Other elements of the assessment may be conducted by a licensed practitioner who is credentialed and privileged by the ASC to perform an H&P. In all cases, the update must take place prior to the surgery.

If the H&P required under §416.52(a)(1)is performed on the day of the surgical procedure in the ASC, some, but not all, elements of the pre-surgical assessment may be incorporated into the H&P. However, the assessment of the patient’s risk for the procedure and anesthesia required under §416.42(a)(1) must still be conducted separately, by a physician and immediately prior to surgery.

The patient must be assessed for any changes in his/her condition since the patient’s H&P was performed that might be significant for the planned surgery. Patients may have had a change in health status after the H&P, but may not recognize the significance for their planned surgery. Any changes in health and medication can have an impact on the patient’s ability to tolerate the surgery or anesthesia, and the post-admission pre-surgical assessment is designed to identify these changes and take appropriate action, up to and including postponing or cancellation of the surgery. In addition, the pre-surgical assessment must identify and document any allergies the patient may have to drugs and biologicals, or indicate that the patient has no known allergies to drugs and biologicals.

Further, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P prior to the surgery.
The patient’s medical record must include documentation that the patient was examined prior to the commencement of surgery for changes since the H&P. The physician or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient’s condition and co-morbidities, if any, in relation to the patient’s planned surgery to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient’s medical record.

If, upon examination, the licensed practitioner finds no change in the patient’s condition since the H&P was completed, he/she may indicate in the patient’s medical record that the H&P was reviewed, the patient was examined, and that “no change” has occurred in the patient’s condition since the H&P was completed. Likewise, any changes in the patient’s condition must be documented by the practitioner in the update note prior to the start of surgery.
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May 10, 2011, the Miami Lakes, Florida council passed a zoning ordinance requiring pain clinics in its town to obtain a special permit. A pain clinic’s grand opening advertisement featuring the words “pain” and “opiates” put a Miami Lakes councilman in fear of potential pill-mill activity coming to town and prompted the council’s efforts to pass the ordinance.

The fear is not completely ungrounded. South Florida has been called the “national epicenter” of the funneling of illegal prescription drugs, and law enforcement officials’ recent raids have targeted the area. Broward County, located only a few miles from Miami Lakes, in particular has significantly contributed to the nation’s pill-mill problem.

The Miami Lakes zoning ordinance would allow the town two to three months to review a pain clinic’s application. The ordinance also prohibits anyone operating or owning a pharmacy in town from running a pain clinic, requires special zoning approval to establish a new pain clinic within 500 feet of another clinic, and requires all current town medical offices, labs, and clinics to register with the town and provide detailed information within six months.

The existence of some pain mills places all pain physicians under greater scrutiny. As such, it is vital for well-intentioned pain management physicians to proactively protect themselves.
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In an effort to better educate the anesthesia community with regard to the impact of Accountable Care Organizations (“ACOs”) on the specialty, the ASA Ad Hoc Task Force on ACOs has been carefully analyzing the March 31, 2011 ACO proposed regulations. As a preliminary step, at the end of April 2011, the ASA released 21 FAQs relative to ACOs. The ASA also plans to continually update the FAQs as new information emerges. The ASA FAQs can be accessed here.
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South Florida has been called the “national epicenter” for the illegal dispensing of prescription drugs. Law enforcement officials have targeted South Florida for quite some time, with February 23 being no exception. On February 23, law enforcement officials and Drug Enforcement Agency (DEA) agents raided six pain clinics accused of illegally dispensing prescription drugs, arresting 22 people–five of who were doctors.

While most pain physicians do not conduct pill mills, because of the few that do, all pain physicians are subject to increased scrutiny. As such, it is important for well-intentioned pain management physicians to proactively protect themselves. For example, it is important to carefully review internal documentation practices; review any applicable state law or guidance; and establish patient narcotics agreements and consistently monitor and enforce them.
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The recovery audit contractor (“RAC”) for Region B covering the Midwestern states, CGI Federal, Inc., is requesting additional documentation from providers regarding facet joint injections without reported imaging guidance (CPT codes 64470-64476). The requests for additional documentation acknowledge that CMS has not yet approved this issue for complex review and further acknowledge that the RAC Statement of Work mandates that no improper payments may be recovered until CMS approves the area for complex review. However, the RAC is requesting documentation to determine whether overpayments exist. If overpayments are identified, the claims will not be sent to the Medicare claims processor for adjustment unless and until CMS approves the topic of facet joint injections for complex review.

According to the RAC, the issue of facet joint injections was identified for review based upon the OIG report related to facet joint injections, the National Government Services, Inc. (“NGS”) local coverage determination (“LCD”) covering pain management, Coding and Compliance Focus News and an American Society of Anesthesiologists (“ASA”) Committee on Economics Memorandum.
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CMS has issued revised Interpretive Guidelines for the Hospital Conditions of Participation. The revised Interpretive Guidelines, which are effective immediately, contain significant changes affecting anesthesia providers, including the following:

Labor Epidurals. CMS removed language exempting labor epidurals from the physician supervision requirements. The revised Interpretive Guidelines note that, “there is often no bright line, i.e., no clear boundary, between anesthesia and analgesia. This is particularly the case… with respect to labor epidurals.” The revised Interpretive Guidelines require hospitals to “establish policies and procedures, based on nationally recognized guidelines, that address whether specific clinical situations involve anesthesia versus analgesia… [H]ospital anesthesia services policies and procedures are expected to also address the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services.”

Pre-Anesthesia Evaluation. CMS relaxed timeframes associated with the completion of certain elements of the pre-anesthesia evaluation. Within 48 hours immediately prior to surgery or other procedure requiring anesthesia services, the following must be documented:

o Review of the patient’s medical history, including anesthesia, drug and allergy history; and
o Interview, if possible given the patient’s condition, and examination of the patient.

The remaining elements, listed below, must be reviewed and updated as necessary within 48 hours, but “may also have been performed during or within 30 days prior to the 48-hour time period, in preparation for the procedure”:

o Notation of anesthesia risk
o Identification of potential anesthesia problems
o Additional pre-anesthesia data or information (e.g., diagnostic tests, consultations)

o Development of the plan for the patient’s anesthesia care
Post-Anesthesia Evaluation. Federal regulations require that a post-anesthesia evaluation be completed and documented no later than 48 hours after surgery or other procedure requiring anesthesia services. The revised Interpretive Guidelines clarify that, “While the evaluation should begin in the PACU/ICU or other designated recovery location, it may be completed after the patient is moved to another inpatient location or, for same day surgeries, if State law and hospital policy permits, after the patient is discharged, so long as it is completed within 48 hours.” If a patient is unable to participate in the post-anesthesia evaluation, the post-anesthesia evaluation still should occur within 48 hours, and the reason for the patient’s inability to participate should be documented (e.g., post-operative sedation, mechanical ventilation, etc.).
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From the medicine cabinet to the street. 33 people have been charged so far as Buffalo, NY investigators devote increasingly greater resources toward an emerging class of suppliers in the illicit drug trade: medical patients, including many who rely on Medicaid to fund their prescriptions. Often at no charge, patients visit multiple doctors and are coached by dealers on how to receive the most lucrative prescriptions. For example, Oxycontin, a time-released form of Oxydone, a narcotic pain killer, is a highly sought after drug. If a patient is on Medicaid, the program is billed about $1,060 for a typical 60-pill, 80-mg prescription, along with doctors’ fees.

The patient can turn around and sell the bottle for around $1,000 to a dealer, who might fetch as much as $7,200 on the street for it. Clearly this is a profitable business for those who are willing to break the law and defraud the government. The growing underground market for the types of pills often found inside the medicine cabinets of average people has surprised even seasoned DEA officials, who are equating this problem with that of street drugs like heroin or crack. They are now using sophisticated methods to capture the criminals involved, such as wiretaps, surveillance and cross-agency cooperation to follow the narcotic trail from pharmacy to street.

A GAO report last year that examined Medicaid abuse in New York, California, Illinois, North Carolina and Texas concluded that in these states, the cost to Medicaid for the fraudulent acquisition of prescription drugs was $63 million. Across the country, efforts are underway to curtail Medicaid prescription abuse and fraud. For example, in several states, state approval is required before OxyContin prescriptions are filled. In New York, the Office of Medicaid Inspector General restricts recipients to coverage for a single doctor and single pharmacy if suspicious activity is indicated. Nearly 10,000 New York Medicaid recipients are currently on restricted status, though they are not allowed to be dropped from the Medicaid program unless a crime has been proven.

With the onslaught of these recent investigative actions, it is becoming increasingly more important to have proper compliance programs in place protecting practices from patient drug seekers, as well as having narcotics agreements and random drug screening policies and practices in any pain practice.
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As HLP reported, in April, CMS requested that the RAC for Region D remove an anesthesia care package it had posted to its website. Now, the issue has been re-posted, with some changes:

Under NCCI Edit rules, the anesthesia care package consists of preoperative evaluation, standard preparation and monitoring services, administration of anesthesia, and post-anesthesia recovery care. Anesthesia CPT codes 00100 to 01999 include Evaluation & Management (E&M) services rendered on the day of the anesthesia procedure. If the only service provided is management of epidural/subarachnoid drug administration, then an E&M service should not be reported in addition to CPT code 01996.

The above lacks clarity around two issues: (1) whether this refers to E&M services provided only on the day of the procedure and E&M services billed with 01996; and (2) whether this is being treated as automated or a complex review. As you may recall, CMS directed the removal of the issue when it was written more broadly to include all E&M services billed before and after anesthesia.

You can view the posting by clicking “next” to page 2 of this RAC Info page.
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Last year, Governor Arnold Schwarzenegger requested exemption from the federal supervision requirement of nurse anesthetists. After unsuccessfully seeking a rescission of the opt-out, on June 3, 2010, the California Society of Anesthesiologists (CSA) and California Medical Association (CMA) filed a lawsuit against the governor.

Medicare required a physician to supervise a nurse anesthetist until 2001, when CMS amended the supervision requirement to authorize a governor to “opt-out” of such requirement if the following conditions are met: (1) a governor must consult with the medical and nursing boards regarding issues related to access and quality of anesthesia services in the state; (2) the opt-out must be consistent with state law; and (3) the governor must conclude that an opt-out is in the best interest of the state citizens.

CSA and CMA contend that the governor failed to meet these requirements prior to opting out, by failing to consult the Medical Board of California regarding the administration of anesthesia by nurse anesthetists and by violating California law.
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By letter dated June 16, 2010, the American Society of Anesthesiologists (“ASA”) continued its efforts to request that the OIG intervene to issue a Special Advisory Bulletin prohibiting what is called the anesthesia “company model.” The ASA originally made the request to the OIG in March of 2009; however, to date, the OIG has not responded. Given that the company model has been gaining traction among ambulatory surgery center (“ASC”) owners, the ASA renewed its request and also attached an article published in March of 2010 specifically discussing the risks and concerns presented by the company model. The anesthesia company model involves the creation of a separate anesthesia company by the same or similar owners of the ASC. The establishment of this company essentially allows the owners of the ASC to share in the profits earned through the provision of anesthesia services at the ASC. The anesthesia company employs the anesthesia providers and bills for the professional anesthesia services. The same anesthesiologists who once held a professional service contract to provide anesthesia at the ASC and bill for those services are now required to be employed by the anesthesia company in order to continue to provide anesthesia services for facility patients. The ASA asserts that the company model is designed to incentivize over-utilization for anesthesia services since the owners of the ASC also own the anesthesia company and have a stake in the profits generated from anesthesia billing. The ASA notes that this problem leads to increases in the cost of care and may subject patients to unnecessary services. Moreover, the ASA takes the position that the company model results in anesthesia providers essentially being required to pay remuneration to the facility for the ability to provide anesthesia at the facility. Conversely, ASC owners respond that they have structured these arrangements to comply with the Anti-Kickback Statute.

As ASC owners continue to evaluate ways in which to increase revenues, it is unlikely that the company model and similar arrangements will go away anytime soon. ASC owners and anesthesiologists will clearly be monitoring the OIG actions as this issue heats up around the country. For more information on this topic, feel free to contact Abby Pendleton, Esq. or Carey F. Kalmowitz, Esq. of The Health Law Partners at (248) 996-8510 or (212) 734-0128.

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