The mega-rule will include:

• Changes to privacy and security rules the HITECH Act mandates
• Requirements for new enforcement and higher penalties
• Final regulations of HITECH  Act’s breach notification rule
• Changes to HIPAA to incorporate Genetic Information Nondiscrimination Act

Just as you will have to adjust to the new provisions in the final rule, you will be under increased scrutiny to comply with them. The government is intensifying its enforcement to protect patients’ confidential health information due in large part to the increased number of security breaches that have resulted from the lack of staff training. Practices will have an arduous task incorporating all of the changes to avoid those HIPAA headaches and potential fines. The most proactive practices have begun to update privacy & security policies as well as re-train employees.

1. Billing Provider Address - Claims are rejecting because the field contains a PO Box or Lock Box address.

2. 9 Digit Zip Code - required for the billing provider. This can be obtained by going to the US postal services website.

3. Provider Accept Assignment Code - claims will be rejected that do not contain a value value for the payers that are live for 5010 transaction (if Live the assignment needs to be “A” for assigned).

4. Priority (Type) of Admission or Visit - payers who are live for 5010 transaction will need a value code for the admission or visit priority. Contact your billing software vendor or your clearing house to insure that you are providing this priority type in the electronic transaction file.

5. Drug Quantity - the CTP segment has been modified to require the drug quantity when a drug is billed. Contact your billing software vendor to insure that the drug quantity is being included in the electronic claims transactions.

Practices must adopt the latest version of the HIPAA electronic transaction standards, Version 5010, by Jan. 1, 2012. These electronic transaction standards include claims, insurance eligibility verification, remittance advice and others.

The agency contracted with Northrop Grumman to develop processes to review claims by beneficiary, provider, service origin or other patterns and identify potential problems. Claims that raise concerns will be flagged and assigned a “risk score,” which will determine the agency’s next steps before it pays the claim. While CMS originally planned to roll out the program gradually, it announced last week that it will go nationwide on July 1. 

How do practices know that this new technology will not interfere with timely payment of legitimate claims, if CMS won’t disclosed any detailed information regarding how the technology will be used. CMS usually rolls new technolgy out to a pilot group first. Not this time, they are rolling this out nationwide. I see cash flow issues for those physician practices who treat large volumes of Medicare & Medicaid patients.

To date, the government has not provided adequate details on this program. Click Here for the official CMS press release.

 Seven Keys to Compliance Success

1. Internal monitoring and auditing needs to be performed on a scheduled basis by well trained and experienced auditors.
2. There should be clearly written and well communicated compliance program and practice standards.
3. Designate a compliance officer.
4. Maintain a high quality training and education program for all staff members.
5. Insure that the lines of communications are open and allow concerned employees to speak freely, without fear of reprisals.
6.  If a problem is identified, have a plan of action to investigate, and take corrective action if required.
7. Enforce the compliance plan without exception.

 Anesthesiologists should be aware of areas that will draw attention from governmental payers and Recovery Audit Contractors (RACs). Facet injections have been the subject of recent OIG reports. Anesthesia start and stop times and protocol for transfer of care have received recent attention from governmental payers also.

If you don’t explicitly document that another physician has relieved you in the OR, an audit could mistakenly show that you were out of the building or performing more than 4 concurrent cases when you were still supposedly medically directing the original cases.

How to do it. You should have a space on the anesthesia record for relief documentation. This could be as simple as two columns of lines, with the headings “Start Time” and “Stop Time.” The first anesthesiologist’s start time should match the anesthesia start time. A medically directing anesthesiologist fills in the time he assumes or passes off medical direction of a case, and signs the same line.

Common relief mistakes. Stay on the lookout for the following anesthesia relief errors:

• A medically directing anesthesiologist gives one of his CRNAs a lunch break. At that point, he’s trying to personally perform at the same time as he medically directs – breaking the rules of medical direction. Technically, it also breaks medical direction if you give your CRNAs bathroom breaks. Many anesthesia groups just decide not to document lunch breaks, which can cause other problems. In such a case, you could bill for the CRNA services until the lunch break, but you’d probably have to absorb the physician’s medical direction fee.
• A CRNA takes over a case from a physician who is personally performing. The case changes to a medical direction situation when the CRNA takes over, but that can be tough to document. When possible, an anesthesia practice should schedule CRNAs to relieve CRNAs and MDs to relieve MDs.
• A physician knows he’s broken medical direction, but chooses not to document, say, a line insertion, or five minutes when a CRNA he’s directing is out of the OR. The omission might not show up in a regular audit, but the government might be able to sniff it out in a more indepth investigation.
• Most anesthesia specific billing software does a good job of concurrency checking to insure that the documentation shows all providers were in the right place at the right times.

Stay compliant and keep deliverying the best anesthesia care available.

Pre-anesthesia Evaluation

The interpretive guidelines for pre-anesthesia evaluation and post-anesthesia assessment have changed somewhat in terms of how hospitals provide surgical services, both on an inpatient and outpatient basis.

For the pre-anesthesia evaluation, some of the expectations continue to apply:

• A pre-anesthesia evaluation must be performed for each patient who receives general, regional or monitored anesthesia.
• While patients receiving moderate sedation be monitored and evaluated before, during, and after the procedure by trained practitioners, a pre-anesthesia evaluation is not required because moderate sedation is not considered to be “anesthesia,” and thus is not subject to this requirement. Hospitals may choose to require the assessment for an increased level of safety.
• The evaluation must be performed by someone qualified to administer anesthesia
• Delegation of the pre-anesthesia evaluation to practitioners who are not qualified to administer anesthesia is not permitted.
• Evaluation must be performed within 48 hours prior to any inpatient or outpatient surgery or procedure requiring anesthesia services.

To provide further clarity, the interpretive guidelines now outline the expected components of a pre-anesthesia evaluation, which includes, at a minimum:

• Medical history, including anesthesia, drug and allergy history
• Interview and examination of the patient
• American Society of Anesthesiologists (ASA) classification
• Any potential anesthesia problems, (e.g., difficult airway, ongoing infection, limited IV access)
• Additional pre-anesthesia evaluation, based on patient condition (e.g., stress tests, labs, additional specialist consultation)
• Plan for anesthesia care, including the type of medications for induction, maintenance and post-operative care and discussion with the patient (or patient’s representative) of the risks and benefits of the delivery of anesthesia

In addition to the documentation requirements for pre- and post-anesthesia assessments, intra-operative documentation requirements are spelled out in the regulations. They note, however, that an intra-operative anesthesia report is not required for patients undergoing sedation, since sedation is not considered anesthesia.

Post-anesthesia Evaluation

Post-anesthesia evaluation requirements have been much discussed in the last several years. While the requirements seem simple and straightforward, they are open to interpretation that may conflict with the spirit of the standard. According to regulation §482.52(b)(3):

• A post-anesthesia evaluation must be completed and documented by an individual qualified to administer anesthesia.
• Evaluation must be completed no later than 48 hours after surgery or a procedure requiring anesthesia services.
• Evaluation must occur any time general, regional, or monitored anesthesia has been administered.
• The evaluation must not begin until the patient is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation, (e.g., answer questions appropriately, perform simple tasks, etc.).
• The evaluation must occur either in the PACU/ICU or in another designated recovery location.

The key topic of discussion has been the setting and timing of the evaluation. While the regulations do not prohibit the evaluation from taking place the minute that the patient is moved to the PACU, the patient’s condition dictates when the evaluation occurs not the work flow or convenience to the anesthesia practitioner. For instance, a patient receiving a regional block may be assessed in short order as the time for extension of the anesthesia has passed by the time the patient enters the PACU. However, it would be inappropriate to evaluate a patient emerging from general anesthesia immediately following entry into the PACU as the patient could slip into unconsciousness again.

Post-anesthesia evaluation must at least include:

• Respiratory function, including respiratory rate, airway patency, and oxygen saturation
• Cardiovascular function, including pulse rate and blood pressure
• Mental status
• Temperature
• Pain
• Nausea and vomiting
• Postoperative hydration

The evaluation needs to take place at a time when the patient has “sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation.” This determination must be made by the anesthesia practitioner.

• Evaluation for readiness for lower level of care—Completed by Nursing,
• Evaluation for readiness for discharge—Completed by Nursing against a protocol developed by Anesthesia; includes additional factors representing ability of patient to care for self (eat, urinate, walk)
• Post-anesthesia care evaluation -Evaluation dictated by the Conditions of Participation; requires professional judgment of an anesthesia provider. Determines patient’s degree of recovery from anesthesia and presence or absence of complications. Cannot be delegated, except to another anesthesia provider.

Tips for Compliance

The key to compliance within the pre- and post-anesthesia evaluation process is under standing the level of compliance in each anesthetizing location and addressing gaps in compliance. While document review is an important first step, it may not provide insight into the timing of the post-anesthesia assessment and the important factor of the evaluation occurring when the patient has “sufficiently recovered.” To avoid common traps that result in citations during CMS survey, assure that the following items are included in the medical record review:

• A completed pre-anesthesia assessment that includes all items noted in the regulations
• A completed post-anesthesia assessment that includes all items noted in the regulations
• A criterion that compares Nursing documentation of the level of patient’s wakefulness at the time of the completion of the post-anesthesia assessment look for conflicting accounts between the anesthesia note of “recovered” with that of Nursing’s documentation.

Based on the review, OIG recommends that CMS conduct provider education, directly and through contractors, about proper documentation and strengthen program safeguards to prevent improper payment for transforaminal epidural injection services.  In addition, OIG recommends that CMS take appropriate action regarding the undocumented, medically unnecessary, and miscoded services identified in the sample.

While many hospitals view Anesthesia Services as primarily a Medical Staff department, like Surgery or Gynecology, the CMS Conditions of Participation view it as similar to departments like Radiology, Food and Nutrition, and Rehabilitation Services. The emphasis lies in the provision of services rather than the positioning or reporting responsibilities set forth on an organizational chart. The Anesthesia Services department provides anesthesia, sedation, and analgesia as defined earlier. Staffing includes anesthesia providers, along with technicians or support staff members who assist in the management of the department. As a department of the hospital, Anesthesia Services has similar responsibilities for meeting the needs of patients, and improving care through the QA/PI process. Additional responsibilities are specified in the regulations.

Responsibilities of Anesthesia Director

The regulations require the Medical Staff to establish criteria for the qualifications of the Director of Anesthesia Services. The Director of Anesthesia department is responsible for:

• Developing policies and procedures governing the provision of all categories of Anesthesia Services, including under what circumstances an MD or DO who is not an anesthesiologist, a dentist, oral surgeon or podiatrist is permitted to administer anesthesia
• Defining the minimum qualifications for each category of practitioner who is permitted to provide anesthesia services
• Integrating Anesthesia Services into the QA/PI program of the hospital

Required Policies and Procedures

The goal for delivery of anesthesia services, centers around consistent use of resources to meet patient needs. Policies outline these expectations, and at minimum, hospitals must address:

• How Anesthesia Services needs will be met at all locations
• Clearly defined pre-anesthesia and post-anesthesia responsibilities
• Delivery of anesthesia services consistent with recognized standards—well designed policies would likely include:
  • Patient consent
  • Infection control measures
  • Safety practices in anesthetizing areas
  • Protocol for supporting life functions (cardiac, respiratory and hyperthermia emergencies)
  • Reporting requirements (errors, incidents)
  • Documentation requirements (both in the medical record and other sources such as narcotic logs)
  • Equipment requirements (monitoring, inspection and maintenance)

Tips for Compliance

To comply with this section of the regulations, changes in policies and practices may be necessary. Begin by assuring that the following items have been established in policy or practice:

• Assure that Medical Staff documents clearly spell out the required items for privileging physicians and others practitioners for the types of anesthesia and complexity of procedures.
• Review policies to assure that each item noted in the Conditions of Participation can be found. 
• Conduct an internal review of all sedation and anesthesia locations to assure consistent standards among all locations. 

According to the regulations, only the following practitioners can administer anesthesia:

• A qualified anesthesiologist
• A doctor of medicine or osteopathy (other than an anesthesiologist)
• A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law
• A certified registered nurse anesthetist (CRNA), under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed, unless in an opt-out state (As of July, 2009, opt-out states include CA, IA, NE, ID, MN, NH, NM, KS, ND, WA, AK, OR, SD, WI, MT.)
• An anesthesiologist’s assistant, who is under the supervision of an anesthesiologist who is immediately available if needed

The Medical Staff bylaws or rules and regulations must include criteria for determining the anesthesia service privileges to be granted to an individual practitioner and a procedure for applying the criteria to individuals requesting privileges for any type of anesthesia services, including those not subject to the anesthesia administration requirements (sedation). The hospital’s Governing Body must approve the specific anesthesia service privileges for each practitioner who furnishes anesthesia services, addressing the type of supervision required, if any. The privileges granted must be in accordance with state law and hospital policy.

The type and complexity of procedures for which the practitioner may administer anesthesia must be specified in the privileges granted to the individual practitioner. When a hospital permits operating practitioners to supervise a CRNA administering anesthesia, the Medical Staff bylaws or rules and regulations must specify for each category of operating practitioner, the type and complexity of procedures that category of practitioner may supervise. However, individual operating practitioners do not need to be granted specific privileges to supervise a CRNA.

Tips for Compliance

To comply with this section of the regulations, changes in policies and practices may be necessary. Assuring that all areas have been addressed is the only reliable way of avoiding violations on future surveys. Begin by assuring that the following items have been established in policy and practice:

• Define what privileges are required for each level of anesthesia services, including sedation and monitored anesthesia care.
• Align policy and practice regarding the appropriate level of supervision for non-physicians permitted to administer anesthesia under supervised situations.
• Define criteria for determining the anesthesia services privileges for individual practitioners, including those that may administer only sedation.

If the hospital will permit anyone other than an anesthesiologists to supervise a CRNA administering anesthesia, specify in the Medical Staff bylaws or rules and regulations, for each category of operating practitioner, the type and complexity of procedures that category of practitioner may supervise.

• On an ongoing basis, assure that the practices occurs as designed:
• The governing body shows approval of the specific anesthesia privileges granted to individual practitioners and any type of supervision required.
• If operating practitioners are allowed to supervise CRNAs, then define the privileges required to permit this supervision and the type and complexity of procedures where allowed.