DEA Waivers Necessary For Access To Controlled Substances

What is a “Convicted Felon” in the Eyes of the DEA

Most health care providers have implemented some sort of screening process for new employees, contractors and medical staff members.  The screening process usually involves some sort of criminal background check along with review of the OIG and GSA exclusion lists.

One aspect of criminal background checks is rarely discussed and involves individuals who will have “access to controlled substances.”  The Drug Enforcement Agency has rules that prohibit any DEA registrant from employing, as an employee or agent, any party who has ever been “convicted” of a felony involving controlled substances.  No such person may ever be employed in a position where they will have “access to controlled substances” unless a waiver is obtained from the Administrator of the DEA.

I placed a few of the operative terms in quotes above for a reason.  The exact definitions of these the terms “convicted of a felon’” and “access to controlled substances” is what makes application of this rule rather tricky.  The first angle involves whether or not a potential employee, staff physician or other has had a “felony conviction” involving controlled substances.  Oftentimes someone who is accused of a drug related crime under state law will plead “no contest” to a felony but the terms of the sentence will provide that the severity of the sentence will be reduced to a misdomeaner, or sometimes even dismissed, upon completion of terms of probation.  If the terms of probation are successfully completed, a subsequent criminal record search may come up with the action having been dismissed or reduced to a misdemeanor.  No issue, right?  Common sense would dictate that there is no felony conviction and the individual can be employed. 

Wrong.  The DEA rules consider there to have been a felony conviction even though the charges may have eventually been dismissed or reduced.  This is applicable whenever there is a plea of “no contest” or “nolo contendre.”  The DEA considers these please to be an admission of and a conviction of a felony offense.  This can be highly problematic for a health care provider who is doing a record search and comes upon a case that may show up as a misdemeanor or having been dismissed.  The provider must look further to determine whether the event could still be considered to be a felony by the DEA.  If it is considered to be a felony, a Waiver must be sought from the DEA to employ or otherwise permit that individual to use the provider’s facilities.  Waivers can be difficult and costly to obtain.  There are no regulations guiding the process and the final decision is in the sole discretion of the Administrator of the DEA.  There are no meaningful appeal rights.

Another thing that should be pointed out is that once a person is convicted of a felony (as defined by the DEA) that involves controlled substances, the issue carries along with the individual forever.  A waiver only applies to a specific facility.  The employee has no standing to apply for a waiver request.  Every place that the employee wishes to work in the future will need to obtain a waiver.

It should be clarified that a waiver is only required if the individual will have “access to controlled substances.”  This is the second definition that becomes important.  There does not appear to be any regulation or case that defines when an individual is considered to have “access to controlled substances.”  The DEA takes a fairly broad view that would generally prohibit any direct patient care.  Practicing medicine in a hospital and most other settings is likely excluded.  However, this definition probably does not extend to administrative tasks that do not involve seeing patients or being located in areas of the facility that do not hold controlled substances.  Yet, the fact that there is no clear definition of “access to controlled substances” makes this rule very difficult to apply in a specific, practical situation.

The takeaway from all of this is that compliance departments, human resource departments, and credentialing departments may need to take a fresh look at this issue to be certain that they have systems in place to flag cases described in this article.  The DEA may consider even a youthful drug conviction, that shows up as a dismissal or a misdemeanor on a criminal background check to be a felony.  If the event is considered to be a felony, a health care organization cannot employ the individual in a position to have access to controlled substances without first obtaining a waiver from the DEA.

Agressive Anesthesia Billing Advice Can Be Costly

I wanted to alert anesthesia groups to what I consider to be some very bad advice that is being provid ed by some billing consultants.  If taken, the advice could put your group in the midst of a lawsuit with a third-party payor or even a claim of insurance fraud under state insurance laws.

By now, pretty much everyone understands the general rule for billing multiple medically directed CRNAs.  It is industry standard to compensate a provider for up to four medically directed CRNAs; provided that the seven basis elements for medical direction are performed and documents in the patient’s record.  Industry standard and Medicare regulation permit reimbursement for multiple medical directions, but total reimbursement is never allowed in amounts that would exceed 100% of what the anesthesiologist would be paid if he or she had performed the service on their own.

 Medicare imposes the 100% restriction by compensating both the anesthesiologist and the CRNA 50% each when the anesthesiologist is medically directing up to four CRNAs.  The overall limitation is generally followed in the private insurance context by either reimbursing 100% of the anesthesiologist charge or by paying 100% of the first claim to be processed.

Some billing companies have begun giving extremely aggressive, and I believe extremely risky, advice to their anesthesia clients.  In some cases, there may be a history of the anesthesia group “self-discounting” their medically directed cases so they cannot be viewed as double billing for medically directed cases.  Double billing would occur if the group billed and collected for 100% of both the anesthesiologist and the CRNAs charge.  This is fairly clear.  Billing for both providers can be justified in some instances, but the presence of both providers must be medically directed and well documented in the medical record.  Special coding modifiers are used to indicate when a claim is being made for 100% of both the CRNA and anesthesiologist’s time.

Some aggressive billing companies will recommend that the anesthesia group end a previous practice of pre-discounting their bills without notice to the insurance provider.  This is sometimes done by the billing company without first advising the client.  This practice has the effect of greatly increasing revenues because it in effect double bills the insurer for medically directed cases.  The case coding remains the same as the group previously coded; indicating a medically directed case.  The effective per unit cost doubles virtually overnight.  In some cases, it may continue undetected.  Usually the insurance company will eventually notice that anesthesia costs are increasing.  At the point of discovery, the insurance company will seek recoupment of amounts that it has overpaid.  Most contracts will permit the insurance company to withhold future payments to offset previously overpaid amounts.

Even though the group may have relied on the advice of a billing company, the group really has no meaningful defense once the insurance company discovers that a change in billing practice without prior notice resulted in a significant overpayment.  The amount of overpayment can climb into the millions of dollars before it is discovered.

 If this practice took place involving the Medicare program, there is no question that it would create liability under the False Claims Act and could possibly even trigger criminal charges for false billing.  Most states have insurance fraud statutes that create civil and/or criminal liability for submitting false or fraudulent insurance claims that could apply to the type of practice.

The Federal False Claims Act could expose the practice to three times the actual total amount of the improperly billed claims plus between $5,000 and $11,000 per claim.  There can be hundreds of claims involved, so the dollar amount of exposure can be financially devastating.  The application of state insurance law statutes will vary by state.  However, the financial and criminal exposure from this type of practice can be significant under state law as well.

The group will always remain “on the hook” for the consequences of billing for their services; even when they were advised to undertake the practice and often even when the practice was commenced without their knowledge.  You may have a lawsuit against the billing company, but the insurer, the OIG, DOJ or state enforcement agencies will look primarily to the physician or the group when problems arise.

If you have been presented with “unique” billing opportunities that promise to net your increased revenue, take great care.  It is always possible that you can legitimately amend your practices to net more revenue.  You should be cautious before implementing any changes in billing practices.  If you are being promised something that may be too good to be true, it probably is.  If you have any doubts, contact a health care attorney before changing your practices.

Once the issue is raised by a third party, you will necessarily be on the defensive.  The additional revenues that you receive along the way will not come close to justifying the pain and anguish you will go through following detection.

Be careful of who you choose to do your billing.  Make certain that you bind them to a contract that restricts the type of activity described in this article.  Make certain that you have an ongoing dialogue with your billing company about their practices.  Make certain that you periodically audit their activities under your compliance program.

Ambulatory Surgery Center – Anti-kickback Issues and Safe Harbor Regulation Compliance

More and more procedures are being performed in Ambulatory Surgical Centers. The CMS has recently expanded the procedures that it considers to be safely performed in an ASC. Clearly, the trend is to move many procedures to an outpatient facility unless the health care needs of the patient clearly require an inpatient presence. One of the primary sources of capital for these new ASC ventures is the physicians who are involved in performing procedures in the ASC or sending business to the ASC.

From a purely business point of view, it makes sense to have investors who have a direct financial interest in seeing that the business succeeds. However, from the point of view of the party paying for the care, this same financial interest can lead to an increased and arguably unnecessary levels of procedures performed in the facility.  For this reason, the Medicare and Medicaid program, and many states, have enacted the Anti-kickback Statutes and other anti-referral laws that prohibit, or at least limit, the financial interests that a referring provider can have with an organization where there is any control over the referral flow to that entity.

 Anti-Kickback Statute Prohibition

The Federal Anti-Kickback Statute proscribes the offering, payment, solicitation or receipt of any remuneration in exchange for a patient referral or referral of other business for which payment may be made by any Federal health care program. Violations of the Anti-Kickback Statute is a federal felony and can result in substantial prison time and criminal monetary penalties. Violation of the Anti-Kickback Statute can also serve as a basis for imposition of Civil Monetary Penalties. Enforcement of the Federal Anti-kickback Statute has been on the rise since the mid-1980s. Today, the federal government has made health care fraud one of its top priorities. We are hearing about new prosecutions on an almost daily basis as the government ramps up its enforcement through the creation of the HEAT program.

ASC Ownership and the Federal Anti-Kickback Statute

When we look at a typical Ambulatory Surgical Center venture, the primary concern is when the physicians (or hospital) who make referrals to the entity and provide services in the entity receive remuneration from the entity. This normally will involve remuneration in the form of a return on an investment interest. We are not concerned with the reimbursement applicable to the physician’s personally performed service.  What raises the issue is the physician receiving a portion of the technical component related to the use of the Ambulatory Surgery Center where the physician is in the position to make or influence referrals.  The referring physician may purchase an ownership or investment interest in the company that is set up to operate the ASC. The ASC can be set up with capital contributions from a number of physicians or it may involve a hospital sponsored ASC that seeks capital investment from physicians.

 Regardless of the exact structure, the Anti-kickback Statute will come into play to govern the structure and ongoing operation of the ASC. The ASC venture must be structured from the start to comply with the Anti-Kickback Statute. It must also be monitored on an ongoing basis to assure that it does not fall out of compliance with the Anti-Kickback Statute.

 ASC Safe Harbors – The Four ASC Types Qualifying For Safe Harbor Protection

 The ASC Safe Harbor regulations identify four types of Ambulatory surgery center structures that can meet safe harbor protection.  These four types of ASCs include Surgeon-Owned ASCs, Single Specialty ASCs, Multi-Specialty ASCs and Hospital/Physician ASCs.  Each category has different requirements that must be met in addition to the threshold requirements identified above that are applicable to all ASCs to meet the safe harbor.

• Surgeon-Owned ASCs

 Owners in a surgeon owned ASC can only include general surgeons or surgeons in the same surgical specialty.  The surgeons must be in a position to make referrals to the ASC and to perform surgical procedures in the ASC on the patients that they refer.  Each surgeon owner must meet a source of income test for the previous fiscal year or 12 month period.  Each surgeon must derive at least one-third of their total medical practice income from performing surgical procedures that require an ASC or Hospital surgical setting.  This does not require all of these procedures to be performed in the ASC in which they are an investor.  However, when the surgeons annual revenues are calculated at least one-third of the physicians medical practice revenues from all sources must be derived from the surgeon’s performance of procedures that are listed as Medicare covered services in an ASC.  The surgical services can be performed in an ASC or in a hospital outpatient department and are not limited to the procedures actually performed in the surgeon owned ASC.

• Single-Specialty ASC

This safe harbor permits physicians within the same specialty, whether or not they are surgeons, to invest in an ASC to which they refer their patients and perform surgical procedures on their patients in the ASC.  Group practices composed of a single specialty may also own and refer to their own ASC.

 Multi-Specialty ASCs

This safe harbor permits physicians who are in a variety of specialties to form an ASC and make referrals to the ASC.  Physician investors in multi-specialty ASCs must meet the one-third practice revenue test described above in relation to surgeon owned ASCs.  However, unlike surgeon-owned ASCs, physicians in multi-specialty ASCs must actually perform one-third of their ASC procedures in the ASC in which they hold an investment interest.  This has become referred to as the “one-third/one-third” test.  The reasoning behind this requirement is that in these types of ASCs, the physicians are actually using the ASC as an extension of their medical office and this does not create significant incentives to generate referral revenues for other investors.  Group practices composed exclusively of physicians who meet the one-third/one-third test may also invest in multi-specialty ASCs.

• Hospital/Physician ASC

Under this safe harbor, at least one hospital must be an investor in the Ambulatory Surgery Center.  The remainder of the investors must be physicians (or group practices) who meet the requirements for a surgeon-owned ASC. There are a number of additional requirements that must be met by physician/hospital ASCs.

Hospital Physician Owned ASC Safe Harbor Provisions

In a previous post, I discuss the requirements for a Hospital/Physician Owned Ambulatory Surgery Center to meet the ASC safe harbor requirements. Under the Hospital/Physician ASC safe harbor, at least one hospital must be an investor in the Ambulatory Surgery Center.  The remainder of the investors must be physicians (or group practices) who meet the requirements for a surgeon-owned ASC. There are some additional requirements that must be met by physician/hospital ASCs.

The ASC may not use an operating room, recovery room, or other space of the hospital unless it is properly leased from the hospital to the ASC under a lease agreement that meets the requirements of the safe harbor for space rental.  Likewise, any equipment provider by the hospital or services provided by the hospital must be pursuant to an agreement that complies with the equipment rental and/or services safe harbor provisions.

The hospital cannot be in a position to make or influence referrals to the ASC.  This excludes physicians who are employees of the hospital from becoming investors in the Ambulatory Surgery Center.  The hospital is also prohibited from including costs associated with the ASC in its Medicare cost report.

Summary

             The Anti-kickback Statute must be considered in any ambulatory surgical venture where potential referral sources could potentially receive remuneration of any kind.  The Anti-kickback Statute and safe harbors will have a large influence on the structure of most ASC ventures.  At the same time, the Anti-kickback Statute is not the only legal issue that must be considered when structuring ASCs.  In some cases, the Stark Law may be a consideration.  Even though ASC services are not “designated health services” under Stark, the ACS might provide other types of services that are covered by Stark.  Reimbursement issues may also have an impact on structure.  Where a hospital is involved, tax exempt tax issues will also play a role.

             For more information regarding Ambulatory Surgery Center structure and other health care law issues, contact John Fisher in the Ruder Ware Health Care Industry Focus Group.

Mandatory Compliance Programs Under the Affordable care Act

Now Is The Time To Re-Examine Compliance “Best Practices” In Your Organization

Historically, compliance programs have not been per se mandatory.  However, most larger health care organizations have established formal compliance programs to foster an atmosphere of compliance and to take advantage of possible benefits under the Federal Sentencing Guidelines.  The Patient Protection and Affordable Care Act of 2010 has made compliance programs mandatory for many providers.  The exact scope of what type of provider will be required to establish formal compliance programs has not yet been set in stone by the Office of Inspector General.  However, it can probably be expected that most providers will be required to formalize their compliance efforts.

Institutional health care compliance has been growing for well over a decade now.  Compliance is becoming of major importance to health care providers of all nature and size.  The OIG has promoted compliance programs by releasing compliance guidance covering a number of industries, including billing companies, physician practices, hospitals, home health agencies, long term care facilities, ambulatory surgery centers and others.  Smaller providers who have previously not had the establishment of formal compliance programs on their radar will now be required to adopt formal plans.

It is not enough to simply adopt a compliance plan, place it on a shelf, and let it collect dust.  A compliance program requires active monitoring.  There are seven basic elements that are necessary for a compliance program to meet regulatory requirements and the requirements under the Federal Sentencing Guidelines.  The seven primary elements of an effective compliance program include:

1)      The establishment of written compliance policies and procedures;

2)      The designation of a high ranking individual within the organization to serve as compliance officer;

3)      The establishment of an effective training and education program for all levels of personnel;

4)      The establishment of effective lines of communication, such as a compliance hotline,  to enable individuals within the organization to report compliance breaches;

5)      Performing ongoing internal auditing and monitoring

6)      The creation of a system that enforces breaches of the compliance program including appropriate discipline and corrective measures

7)      The establishment of effective measures to respond to compliance problems that are detected.

 An effective compliance program establishes an atmosphere of compliance that permeates the entire organization.  A compliance program should be tailored to the specific circumstances of the provider.  The program should also feed and grow on itself.  As problems are detected appropriate changes should be made to the program and related policies and procedures.

 Mandatory compliance programs also highlight the importance of compliance on larger institutions who may have already adopted formal programs.  These institutions should take the signal that compliance is of growing importance.   Providers who have already adopted compliance plans should take the opportunity to dust them off and re-examine the role of compliance within their organization.  Now is the time to increase the focus on compliance and assure that compliance is an active system rather than a written plan that is sitting on the shelf.

Best Practices In Compliance Program Operation

 Given the increased importance of compliance, it is helpful to for providers to get a feel for what constitutes “best practice” when operating a compliance program.  “Best Practices” is a term that is thrown around all of the time in the business world.  It is used in many contexts and takes on a variety of meanings depending on who is using it and for what purpose.  Wikipedia defines “best practices” as follows:

Best practices are generally-accepted, informally-standardized techniques, methods or processes that have proven themselves over time to accomplish given tasks. Often based upon common sense, these practices are commonly used where no specific formal methodology is in place or the existing methodology does not sufficiently address the issue. The idea is that with proper processes, checks and testing, a desired outcome can be delivered more effectively with fewer problems and unforeseen complications. In addition, a “best” practice can evolve to become better as improvements are discovered.  Best practice is considered by some as a business buzzword, used to describe the process of developing and following a standard way of doing things that multiple organizations can use.  http://en.wikipedia.org/wiki/Best_practice

As I was thinking about the concept of “best practices” in health care compliance, the Wikipedia definition seems to fall al little bit short of what I would have in mind when discussing “best practices” in health care compliance programs.

The Miriam-Webster Dictionary defines “Best” as the superlative form of “good.”  “Best” means “excelling all others” and “offering or producing the greatest advantage, utility, or satisfaction.”  I believe that the definition from Wikipedia is an accurate depiction of what the term “best practices” has become in the business world.  The term has been thrown around loosely to the  point that is no longer carries the meaning of the plain words that make up the two word “buzzword.”

In the health care compliance context, I believe that it is not advisable to direct you efforts toward the standard “buzzword” meaning of “best practices.”  Instead, you should focus toward attempting to achieve the meaning of “best practices” that is tied to the superlative form of the word “good.”  You should not focus on the “we are doing what everyone else is doing” or the “what we are doing will pass by in most cases” version of best practices when looking at your compliance plan.  The consequences of that approach could easily come back to bite you in the superlative.

 In reality, you may never be able to meet the truly “best” standard.  However, the point of the compliance program requirement is that you are trying to make your compliance program and your organization “the best” when it comes to compliance.  Here are a few tips to help you attempt to meet the “best practices” standard:

 1.         Act as if you are under a Corporate Integrity Agreement.  Always assume that the government is looking over your shoulder and that you will be called upon at some point to justify the effectiveness of your compliance program.

2.         Follow the government guidelines to the tee.  Familiarize yourself with the Federal Sentencing Guidelines and OIG Industry Guidance and integrate these requirements into your compliance plan.

3.         Keep up with government releases, speeches, regulations, comments, advisory opinions, and all other communication that help to define your obligations.

4.         Make your compliance plan a “living and breathing” documents that is continually up for revision based on specific things that you learn about your specific organizations.

5.         Make sure your compliance officer focuses on compliance and does not wear other hats that compete for time, attention or perspective.

6.         Make certain that sufficient resources are devoted to compliance.  Adopt the view that it is better to spend money on compliance that to pay for mistakes down the road.

 If there is any area where you are not able to achieve “best practices” for financial or other reasons, be prepared to justify your shortcomings.  Key to all of this is to operate as if you will someday be required to defend the effectiveness of your compliance program.  In all likelihood you will someday be in exactly that position given the current state of the health care industry and mentality of the governmental agencies that are charged with enforcement.

 These are just a few tips to get you thinking about your compliance approach.  Health care reform has made compliance programs mandatory for the first time.  There are also multiple indications that the government wants organizations to devote more to compliance as a way to save health care costs.  It is clearly time for organizations of all types and sizes to re-focus their efforts on compliance within their organizations.

Recent OIG Billing Audits Are Reflective of Risk Areas for Hospital Billing

The Office of Inspector General Audit Division has released the results of a billing audit that it performed relative to Norwood Hospital, a 264-bed acute care facility located in Norwood, Massachusetts. The audit included certain identified claims for inpatient and outpatient services provided to beneficiaries from July 2008 through June 2010.  The OIG  audit covered $1,204,371 in Medicare payments for 198 claims (123 inpatient and 75 outpatient) that were judgmentally selected by the OIG as potentially at risk for billing errors.  A complete report of the Norwood audit can be found at: Norwood OIG Audit Report

The audit found that the Hospital complied with Medicare billing requirements for 99 of the 198 claims. However, 99 claims had errors, resulting in overpayments totaling $206,836. The OIG determined that the overpayments occurred primarily because the Hospital did not have adequate controls to prevent incorrect billing of Medicare claims and did not fully understand the Medicare billing requirements.

The audit of Norwood was part of the OIG’s routine process to identify certain billing areas that are at a high risk of error.  The OIG has announced that it plans to conduct more of this type of review on an ongoing basis.  As such, the nature and outcome of this review process can be instructive to hospitals who may find themselves on the receiving end of one of these audits.
The OIG has outlined the general areas where it will focus its audits and has identified these areas as “risk areas.”  Risk areas identified by the OIG includ claims billed for:

• inpatient short stays,
• inpatient same-day discharges and re-admissions,
• inpatient claims billed with high severity level DRG codes,
• inpatient claims paid in excess of charges,
• outpatient claims billed with modifier -59,
• outpatient claims billed during inpatient stays,
• outpatient evaluation and management services billed with surgical services,
• outpatient claims paid in excess of charges, and
• outpatient dental services.

The report from the OIG identified more specific errors that the Hospital was found to have made and wich led to the overpayment determination.  These specific findings are quite instructive.  Facilities should consider including these areas as potential risk areas for targeted internal review.  In some cases, these areas a facility may wish to provide focused training and instruction to billing staff of other relevant employees in order to reduce the risk of inaccurate claims being made.

Some of the specific areas that were a problem in the Norwood audit included:

• Incorrect billing of Medicare Part A for beneficiary stays that should have been billed as outpatient or outpatient with observation services.
• One claim did not have a valid physician order to admit the beneficiary for inpatient care
• Incorrect billing for inpatient claims with same-day discharges and re-admissions.
• Billing with incorrect DRG codes for several cases with high severity level DRG codes.

Safe Surgery Checklists – New Requirement For Ambulatory Surgery Centers

ASCs should mark their calendars for January 1, 2012 which is the date that CMS requires the use of Safe Surgery Checklists to begin.  Beginning in July of 2013, ambulatory surgery centers will be required to certify that they used a safe surgery checklist throughout calendar year 2012.  The safe surgery checklist covers three key preoperative stages.  The three stages include (1) the period prior to anesthesia and sedation being administered, (2) the period prior to incision, and (3) the period prior to the patient leaving the operating or procedure room.

The certification will need to be made by ASCs within a 45 day window period between July 1, 2013 and August 15, 2013.  CMS will be providing a web-based mechanism that providers can use to certify their compliance with the safe surgery list requirement.

CMS does not provide a required form of safe surgery checklist but has rather left this to the discretion of the ASC.  Comments to the regulations point to external sources that have developed safe surgery checklists including the World Health Organization and the World Federation of Societies of Anesthesiologists.  The WHO safe surgery checklist can be found at the following link.  WHO Safe Surgery Checklist

OIG Fraud and Abuse / HEAT Program Videos

The Office of Inspector General is posting a series of video presentation on the HEAT program.  Topics covered include general information on health care fraud laws, the Anti-kickback Statute, the False Claims Act and dealing with investigations.  The OIG will be posting a total of 11 videos and audio podcasts that are part of the award-winning Health Care Fraud Prevention and Enforcement Action Team (HEAT) Provider Compliance Training initiative. The first educational presentation was posted on the OIG website the week of December 5.  New posting will be made over the next few months.

As of the time of this post, the OIG page includes 4 new videos.  One is an introduction to the new video program.  Other current videos cover the False Claims Act, Anti-kickback Statute and Program Exclusions.

You can access the OIG video web site here:  OIG Fraud and Abuse Videos

Through the OIG video presentation page, you can also access a series of 16 videos covering a variety of compliance related topics including:

Use if Safe Surgery Checklist – Implementing Safe Surgery Checklist

As discussed in previous posts, ASCs and hospital outpatient departments must begin using a Safe Surgery Checklist by January 1, 2012.  Certification will need to be made that the checklist was used throughout 2012.  The regulations contain little detail on what it actually means to “use” a Safe Surgery Checklist.  I have seen a variety of opinions on this issue ranging from simply posting it in the operating room through documenting each checklist item in the medical chart.

A relatively recent article in Outpatient Surgery online magazine may provide some level of guidance for providers who are struggling for an answer on the level of “use” that is required.  Check out the article on Safe Surgery Checklist integration

Attorney John Fisher Receives Certification in Health Care Compliance

Attorney John H. Fisher II, a health care attorney with Ruder Ware in Wausau, Wisconsin, has obtained certification in health care compliance.  Mr. Fisher will now carry the designation of CHC (Certified Healthcare Compliance).  The certification is provided by the Health Care Compliance Association (“HCCA”), a national organization based in Minneapolis.  Mr. Fisher is the fourth attorney resident in the State of Wisconsin to obtain this certification.

The HCCA defined the CHC designation as follows:

 The CHC© is a professional with knowledge of relevant regulations and expertise in compliance processes sufficient to assist the health care industry to understand and address legal obligations, and promote organizational integrity through the operation of effective compliance programs.

The HCCA also states that:

The purpose of certification is to promote health care compliance through the certification of qualified health care compliance professionals by:

1. Recognizing formally those individuals who meet the eligibility requirements of the CCB and pass the Certified in Healthcare Compliance© (CHC©) Examination.
2. Encouraging continued personal and professional growth in the practice of health care compliance.
3. Providing a national standard of requisite knowledge required for certification; thereby assisting employers, the public and members of the health professions in the assessment of a health care compliance professional.

Diagnostic Imaging – Medicare Requirements Radiology Test Coverage

We often get questions regarding the conditions of coverage for non-hospital (radiology group) coverage of diagnostic radiology services. Most questions involve the level of supervision that is required under Medicare rules and the requirements that a treating physician order the applicable test. Oftentimes, these questions are tied to issues relative to the Physician Self-Referral (Stark law) exception for diagnostic radiology services that are performed following a consultation request from another health care provider.

 There are three core requirements for a radiology test to be covered under Medicare. The test must be properly ordered by a treating physician (with limited exceptions), the test must be performed by an authorized supplier, and the test must be performed under the proper level of physician supervision. This article will briefly cover all three of the prerequisites to coverage of diagnostic radiology tests. The requirements described in this article apply to outpatient tests. Tests ordered in the hospital context are subject to slightly different rules and beyond the scope of this article.

 Who may order diagnostic radiology tests?

 he Medicare reimbursement rules have strict standards for determining who is authorized to order a diagnostic radiology test. The rules are different depending upon whether the provider is located in a hospital or in a non-hospital setting such as an independent diagnostic testing facility or physician’s office.

 Generally, in a non-hospital setting, a diagnostic radiology test must be ordered by the treating physician. The treating physician rule is located in the Medicare regulations and requires that the diagnostic test be ordered by the physician (or in certain circumstances a non-physician practitioner) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results of the diagnostic radiology test in the management of the patient’s medical problem.

Generally, the radiologist performing the test is not permitted to order a diagnostic radiology test. There are certain exceptions to the treating physician rule which were described in Medicare Transmittal 80. Transmittal 80 describes limited circumstances where a radiologist is permitted to order a diagnostic test and still receive payment for the technical component under Medicare rules.

A radiologist is authorized to order a diagnostic mammography test based upon the results of an initial screening examination. Where the treating physician cannot be reached and this is documented in the patient’s chart , the testing facility may furnish additional diagnostic tests if the interpreting radiologist at the testing facility documents that there are abnormal results with the test originally ordered by the treating physician and that an additional test is medically necessary. In order to rely on this exception, the fact that the treating physician was not available and that additional tests were medically necessary should be well documented in the chart. This exception requires the results of the test to be communicated to the treating physician and used by the treating physician in treating the patient’s medical condition.

Where medically appropriate, the interpreting radiologist is also permitted to make determinations regarding the parameters of the diagnostic test contained in the initial order from the treating physician. In cases where there is a clear and obvious error in the initial order, the interpreting physician may make appropriate modifications. The intervening physician may also cancel orders based upon the patient’s medical condition at the time of the diagnostic tests.

Except for the limited circumstances described above and included in Transmittal 80, the radiologist must always rely upon the order that is made by the treating physician and may not independently order diagnostic radiology tests.

Who Is Qualified To Perform the Radiology Test?

The second major requirement for the coverage radiology services in a non-hospital setting is that only a qualified provider of the services may be reimbursed. Qualified providers include physicians, group practices of physicians, approved portable x-ray suppliers, independent diagnostic test testing facilities, nurse practitioners or clinical nurse specialists as authorized under state law, FDA certified mammography facilities, clinical psychologists for certain types of tests, qualified audiologists, pathology slide preparation facilities, clinical laboratories for certain tests, and radiation therapy centers.

Level of Physician Supervision For Diagnostic Imaging Tests

The last of the major requirements for coverage of radiology services is the level of physician supervision that is required given the specific test being performed. Radiology services must be provided under at least a general level physician supervision. Additionally, certain tests must be provided under direct or personal supervision, which require higher levels of physician presence and involvement. Failure to provide the appropriate level of physician supervision and to document the supervision in the chart will result in loss of coverage under Medicare and Medicaid. Any claims submitted in spite of not meeting the supervision requirements will be considered to be not reasonable or necessary by Centers for Medicare & Medicaid.

There are a few exceptions from the physician supervision requirements for certain limited types of tests. It must be kept in mind however that these exceptions are Medicare only exceptions and there may be other federal or state laws that apply to require physician supervision. Tests that are excepted from physician supervision requirements include diagnostic mammography procedures, diagnostic tests performed by a qualified audiologist and certain psychological tests.

You must determine whether general, direct or personal supervision is required in order to bill the applicable diagnostic radiology procedure. Failure to meet the appropriate supervision requirement will lead to loss of reimbursement. This can also be an area of potential civil money penalty exposure if billings are made in spite of there not having been appropriate supervision. Thus, the supervision requirement is a significant compliance issue for medical practices who must establish and maintain appropriate policies and procedures regarding supervision of various levels of radiology diagnostic tests.

Each level of supervision has very specific requirements that must be met. For this reason it is important to know which level of supervision is required for the specific test being performed. General supervision requires that the procedure be furnished under the physicians overall direction in control. Physician presence is not necessarily required during the performance of procedures that require general supervision. Under general supervision the physician is responsible for general supervision and training of support personnel who are actually performing the test services. The physician is also responsible for maintaining the necessary equipment and supplies for the safe operation of the diagnostic test.

Direct and personal supervision each require higher levels of physician involvement and generally require some level of physician presence throughout the performance of the test. Direct supervision in the office setting requires that the physician be present in the office suite and immediately available to furnish assistance. Physical presence in the office suite must be maintained throughout the entire performance of the procedure. The physician is not required to be physically present in the room where the procedure is performed unless there is a need for the physician’s presence due to some problem that arises during the course of performing the test.

The highest level of physician supervision is personal supervision. Personal supervision requires a physician to actually be present in the room during the performance of the procedure. Personal supervision generally involves diagnostic tests with invasive or otherwise dangerous aspects. One significant example of a test that requires personal supervision is contrast studies.

It is important to know what level of supervision is required for the test that is being performed. The level of supervision that is required for each test is included in the Physician Relative Value Fee Schedule. The CMS web site includes a spreadsheet that designates the level of supervision that is required for a variety of services including diagnostic imaging services. The spreadsheet includes a column for “physician supervision.” The column indicates a numerical value with “1″ indicating general supervision, “2″ indicating direct supervision and “3″ indicating personal supervision.

Physician practices and compliance officers should be certain that their policies are in line with CMS requirements for coverage of diagnostic radiology tests. Radiology groups must be certain that the tests they are charged with performing meet each of the requirements stated above. Radiology groups need to be certain that the test is ordered by the treating physician unless inapplicable exception is present, and that the appropriate level of physician supervision is met for the type of test that is being performed.

For more information regarding the requirements for radiology services and other legal issues that affect radiology practices and providers, please contact John Fisher, member of Ruder Ware’s Health Care Focus Team.

John Fisher is an experienced health care attorney who has practiced extensively in the health care industry providing counsel to a wide variety of health care providers. John has counseled health care clients, including hospitals, physicians, and health systems on health care regulatory compliance, contracts, mergers and acquisitions, joint ventures, recruitment and compensation issues, integrated network development, and Medicare and Medicaid reimbursement. John is knowledgeable on the laws and regulations that affect financial relationships between health care providers including the Stark Law, Anti-kickback Statute and safe harbor regulations, fraud and abuse, antitrust and exempt organization tax issues.