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Academic Medicine:
doi: 10.1097/ACM.0b013e318065bb4d
Research Issues

Clinical Trial Billing Compliance at Academic Medical Centers

Boyd, Cynthia E. MD, MBA; Meade, Ryan D. JD

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Author Information

Dr. Boyd is assistant professor of medicine, chief compliance officer, and associate vice president, Rush Medical College, Rush University Medical Center, Chicago, Illinois.

Mr. Meade is assistant professor, Rush University College of Health Sciences, adjunct professor of law, Loyola University Chicago School of Law, and partner, Meade & Roach, LLP, Chicago, Illinois.

Correspondence should be addressed to Dr. Boyd, Rush University Medical Center, 600 S. Paulina Street, Suite 458-D, Acad. Facility, Chicago, IL 60612; telephone: (312) 942-5181; fax: (312) 942-3068; e-mail: (cynthia_e_boyd@rush.edu).

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Abstract

Academic medical centers (AMCs) face a weighty regulatory compliance risk in billing Medicare and other third-party payors for clinical trial services. The culture and structure of many AMCs present significant challenges when attempting to coordinate the necessary information and operations to determine whether clinical trial services can be billed to payors or should be charged to an internal research account that tracks the sponsorship monies or grant award. The federal rules are complex, but at base they revolve around the principle that payors should not be billed for clinical trial services that are either being paid by someone else or not provided for the direct clinical care of the patient. With proper coordination and leadership, an AMC can coordinate its efforts, transform its decentralized culture, and achieve a compliance confidence level. Beginning in 2003, the authors helped guide Rush University Medical Center through its landmark voluntary disclosure and settlement with the United States on cancer clinical trial billing. The corrective actions adopted by Rush have set a model that can be adapted for other AMCs. The attention to Medicare’s clinical trials coverage rules brought about by the Rush settlement has led to the Medicare program revisiting its rules and proposing a number of changes that help clarify Medicare policy.

When an academic medical center (AMC) undertakes clinical research, it stands to gain prestige and profit and ultimately participates in the central mission of advancing medical care. But this undertaking does not come without burdens. Accurately billing for clinical trial services and complying with a tangle of federal rules poses one of the most pressing and complex regulatory and operational challenges for AMCs today. To accomplish clinical trials billing compliance, enormous efforts must be put forth to centralize an environment and culture that is historically decentralized and often has not been developed using efficient business models. However, not pursuing this compliance task places the institution at risk for federal audits, whistleblower suits, and costly fines.

Over the course of three years (2003–2006), Rush University Medical Center (Rush) took on a transformation of its clinical research operations that is still in the process of evolving. The core of this initiative was an evolution of Rush’s research compliance structures to encompass not only protection of human research participants, but also the financial dimension of clinical research—specifically, accurate billing for clinical trial services. As part of a major compliance initiative, Rush voluntarily disclosed the compliance inconsistencies that led to reworking its clinical trials billing structure. This self-disclosure allowed Rush to reform its operations and simultaneously resolve any lingering risk that may have been the result of discordant billing processes of the past.

In the summer of 2003, Rush discovered errors in the billing process for cancer clinical trial services during a routine administrative review of the operations in Rush’s division of hematology and oncology. Within 30 days of identifying the issue, Rush self-disclosed the billing problems to the U.S. Attorney’s Office in Chicago. For the next 30 months, Rush undertook an extensive internal investigation not only to understand and map its internal processes for clinical trials billing but also to identify potential compliance risks of all Rush clinical trials billing, not merely billing of cancer trials.

In December 2005, Rush entered into a settlement agreement with the U.S. Department of Justice to rectify overpayments for the cancer clinical trial services that were originally identified as billed in error. In addition to this settlement agreement, Rush entered into a three-year certification of compliance agreement with the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services that requires Rush to annually certify the effectiveness of its compliance program, report overpayments, and conduct an extensive clinical trials billing auditing and monitoring program.

The settlement with the Department of Justice was just one milestone in Rush’s development of clinical trials billing compliance structures, but it was certainly an important one. The initiative gained more for Rush than merely setting its past practices right; it ultimately generated a complete overhaul of how Rush approached contracting, budgeting, and billing for clinical trials. Essential to Rush’s corrective action was the establishment of a central office to coordinate the necessary information that needs to be harmonized for a provider to know which items and services it can submit to third-party payors for reimbursement.

Rush’s settlement with the federal government was the first to solely focus on Medicare’s national coverage decision on routine costs in clinical trials (the Clinical Trials NCD).1 Now every clinical trial at Rush is subject to a review under the Clinical Trials NCD before any services are billed for enrolled subjects, to determine which services are considered “routine costs.” A reviewer from the central office analyzes each item and service required by the protocol and develops a spreadsheet that identifies whether each service is a routine cost and, therefore, billable to Medicare, or whether it is billable to an internal research fund. Rush refers to this review as a Medicare coverage analysis. The Medicare coverage analysis also assists Rush in negotiating study sponsorship agreements by knowing up front which items and services Medicare will cover once an enrolled study participant receives protocol-required services.

Since the Rush settlement, many AMCs have increased their resources for clinical trials billing compliance to ensure that their processes safeguard the accuracy of claims. The national attention focused on the Rush settlement has also raised concerns about the complexity of the Clinical Trials NCD and whether the Medicare rules accomplish their policy goals. The Centers for Medicare & Medicaid Services (CMS) has proposed a number of changes to the Clinical Trials NCD that do not necessarily change the public policy behind the Clinical Trials NCD but that may alleviate much of the confusion around the rules.

There is no one right way to accomplish clinical trials billing compliance, and Rush needed to change its approach several times to figure out how to keep the correct information flowing and harmonized. This article discusses the regulatory environment and rules associated with clinical trials billing, shares the Rush story, and provides operational suggestions for AMCs to manage their billing compliance risks without jeopardizing their clinical research operations.

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Medicare’s Clinical Trial Policy

On June 7, 2000, President William Clinton issued a presidential directive2 requiring the Medicare program to expand coverage for Medicare beneficiaries to include routine costs of certain qualifying clinical trials. Barely three months later, the Clinical Trials NCD was issued by the Health Care Financing Administration, now known as the CMS. Before President Clinton’s presidential directive, Medicare generally did not pay for any of the costs associated with the care of patients who were enrolled in a clinical trial. This new coverage rule was a significant advance in federal support of medical research. A press release by Medicare at the time stated that the goal of the new rule was “to encourage the greater use of clinical trials by older Americans” and promised that under the new rule, “[p]ayment will include costs associated with providing items and services that would otherwise be covered by Medicare if they were not provided in the context of a clinical trial.”3

The Clinical Trials NCD provides Medicare coverage for what it refers to as “routine costs” of so-called “qualifying clinical trials” when the routine costs are otherwise billable to Medicare outside a clinical trial.1 The Medicare rule sets out criteria that a research study must meet to be considered a qualifying clinical trial, (List 1) and it lists examples of items and services that Medicare considers to be routine costs and not routine costs. Not all of the criteria or definitions in this rule are intuitive, and providers need to set up a standardized process to review clinical trial services for coverage to ensure that only allowable claims are billed to the Medicare program.

List 1
List 1
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CMS did not issue clarifications or guidance on the Clinical Trials NCD until more than five years later, when it released questions and answers on February 22, 2006, in conjunction with an audio conference on the Rush settlement, hosted by the American Health Lawyers Association.4 On July 10, 2006, CMS announced that it would reconsider the Clinical Trials NCD and set out goals and issues that will be addressed in a revised rule, to be renamed the Clinical Research Policy, and CMS subsequently scheduled a public meeting on proposed changes.5 The revised rule will likely smooth out some of the inartful language of the Clinical Trials NCD and better define the type of clinical trials during which Medicare coverage will be allowed, but these are changes on the margin. The essential operational structures demanded by basic Medicare coverage policy will not be changed, and AMCs should expeditiously inculcate the current billing rules.

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Routine costs

Routine costs include items and services that are considered conventional care for the same indications outside a clinical trial.1 Routine costs also include items and services that are for the prevention, diagnosis, or treatment of complications from the clinical trial.1 Once an item or service is identified as a routine cost in the Clinical Trials NCD review, it must also be scrutinized under normal Medicare rules.1 If Medicare were to cover the routine cost item or service outside a clinical trial, then coverage will be afforded during a clinical trial.1

In some ways, clinical trials billing compliance is a simple concept: do not bill for services the sponsor is already paying for, do not bill for services promised free, do not bill for services that are for research purposes only, do not bill for services in a research study that is not designed to have therapeutic benefit, and only bill for services that have no external funding source and are medically necessary. The Clinical Trials NCD specifically excludes certain items and services from the definition of a routine cost. Specifically, anything paid for by the sponsor or offered free to any enrollee in the clinical trial cannot be billed to Medicare.4 Whatever investigational item or service is specifically being studied also cannot be billed to Medicare unless the local Medicare fiscal intermediary or carrier has issued what are known as local coverage determinations (LCDs).1 The Medicare fiscal intermediary and Medicare carrier are the private organizations that have contracts with CMS to administer Medicare claims on behalf of the Medicare program. Fiscal intermediaries and carriers are also called Medicare contractors. The Medicare contractors are allowed considerable discretion to issue LCDs whenever CMS is silent on how the Medicare rules apply to particular items and services. Each of the Medicare contractors has a medical director who provides the clinical input to these coverage determinations and coordinates the LCD process.

However, when a study investigates off-label use of anticancer drugs, there is an exception to this requirement that an LCD be issued before there is coverage of an investigational item or service. In these studies, the provider can rely on either drug compendia acceptance of the off-label use or certain peer-reviewed literature identified by CMS in its Medicare Benefit Policy Manual6 to support Medicare coverage.

Although the Clinical Trials NCD affords considerable latitude for study services and drugs to be considered routine costs, the definition of a routine cost requires a provider to examine a protocol’s schedule of events in the contexts of the sponsorship contract and the research study’s informed consent. A provider must scrutinize the sponsorship contract to identify what items and services the sponsor has agreed to pay for.4 These are not covered by Medicare. If the informed consent’s financial disclosure language promises a study service free to the patient or the patient’s third-party payor, then the provider likewise cannot bill for those services.7

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Qualifying clinical trial

All of these billing rules are premised on the research study being a qualifying clinical trial. The Clinical Trials NCD sets out 10 criteria that must be met to be a qualifying clinical trial.1 Seven of these 10 criteria are known as desirable characteristics, and the remaining three are referred to as requirements. Currently, the only way for a study to meet the seven desirable characteristics is to be classified as a type of study that CMS has already identified as inherently having these seven desirable characteristics. CMS calls these studies deemed trials because CMS has deemed them as meeting the seven characteristics. These deemed trials include studies sponsored by certain government agencies or cooperative groups, conducted under an investigational new drug (IND) application, or pursuant to an IND regulatory exemption. To be a qualifying clinical trial, a deemed study must also fulfill the three other criteria, which include studying something that falls into a Medicare benefit category, enrolling patients with diagnosed diseases, and the evidence of some therapeutic intent (the study cannot be designed solely to test the safety or toxicity of the investigational item or service). There has been considerable confusion in the research community as to whether deemed trials automatically qualify for Medicare coverage. They do not. CMS’s recent clarifications make clear that “all qualifying clinical trials must be deemed and meet all 10 requirements.”4

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The Rush Experience

As the result of an internal investigation of Medicare compliance concerns in July 2003, Rush identified control over billing and financial management of clinical trials—specifically, cancer clinicaltrials—as an area in need of improvement. Like many AMCs, the management of the financial aspects of clinical trials and relationships with the sponsor was decentralized and principally the responsibility of the clinical investigators.

The internal investigation identified a lack of a coordinated process between investigators’ offices and billing personnel. As a result of this lack of a coordinated process, Rush discovered that some items and services (e.g., labs, off-label drugs, radiologic studies, physician office visits) that had already been paid by the study sponsor had also been charged by Rush to third-party payors. The processes that tracked funds being received from research sponsors was not being matched against the services being placed in the billing process for reimbursement from third-party payors. The cancer trials did not have a method to coordinate the grant awards and the compensation arrangement of the sponsorship contracts with the billing process.

In addition to this inadvertent double-billing situation, Rush also identified that there had been a lack of attention to the language in the research informed consent and its impact on Rush’s ability to bill for clinical trial services. Unwittingly, and in much the same disjointed approach to matching up the sponsorship contract with the billing process, there were instances when the informed consent had promised certain items and services free to the patient, but these same items and services were nevertheless charged to the patient’s third-party payor. Although these two errors involved different study documents (the contract or grant and the research informed consent), they represented the same disconnect between the study documents and the billing process.

The world of research and the world of clinical care reimbursement have generally been distinct at AMCs. At Rush, there was not a connection among the various personnel who needed to interact to optimize both research and clinical care.

As a logical conclusion of the internal investigation, Rush looked beyond its division of hematology and oncology to review the billing processes for clinical trial services throughout the institution. The single most striking finding was the heterogeneity of approaches to managing clinical trials among the clinical departments. Every clinical department approached clinical trials billing differently. More often than not, this led to inefficiencies and loss of revenue to the institution, rather than generating monies not owed to Rush.

What began as a corporate compliance initiative has ended with a restructuring of the financial and operational management of clinical trials. Rush has instituted a central office to perform Medicare coverage analyses for each clinical trial before a sponsorship contract is established. This process not only ensures billing compliance but also allows Rush to analyze proposed clinical trials for the financial soundness of the sponsor’s compensation offer. The coverage analysis for each proposed study integrates the billing rules for Rush’s largest single payor, Medicare, and the sponsor’s budget offer. This coverage analysis allows Rush to weigh the level of a trial’s financial risk to the institution against the importance of the proposed medical research and then attempt to negotiate a financially viable research study.

The reality is that few AMCs “make money” on clinical trials. Medical research is part of the mission of Rush, as it is for most AMCs, and this involves a certain level of financial commitment that must be borne by the institution. However, there is no way of knowing each trial’s financial risk to the institution unless reimbursement coverage rules and the proposed sponsor budget are reviewed together.

Along with the financial analysis of a clinical trial before execution of its sponsorship contract, Rush’s clinical trials central office also assumed the responsibility for developing billing guides for each clinical trial on the basis of the study protocol’s required service. Keeping in mind that every clinical trial must pass through a charge capture system in which individual items and services are identified and assigned to reimbursement sources, the central billing office analyzes each clinical trial’s unique billing posture and produces a spreadsheet to ensure that the charge capture system routes each claim to the appropriate reimbursement source. Routing a claim may involve sending a service through the normal payor claim system or charging the service to an internal research fund. Forms, orders, and charge tickets used in the clinical departments are being modified to accommodate the correct reimbursement source for each clinical trial service. This approach addresses the need to have a system that allows for real-time concurrent payor processes, and it also manages the compliance risk for billing errors.

Chart 1 reproduces a hypothetical Medicare coverage analysis spreadsheet. The spreadsheet sets out the items and services required by the protocol and the frequency for providing the items and services. Just like a protocol’s schedule of events, a symbol in each cell denotes whether the item or service is required to be provided to the enrolled subject. Whereas most schedules of events use an X to signal that the service should be provided, the Medicare coverage analysis spreadsheet sets out one of a multitude of symbols that identify whether the sponsor is paying for the service (and, therefore, Medicare and all other third-party payors should not be billed), the service meets Medicare coverage rules and will likely be covered (provided appropriate medical necessity is documented in the medical record), or the service is not billable to Medicare. Every institution must work out the symbols that are appropriate to its system and may have additional symbols it wishes to use.

Chart 1
Chart 1
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The motivation behind Rush’s centralized approach was compliance with the Medicare clinical trials billing rules. Because Medicare is the largest single payor at Rush, it was imperative that the new system keep compliance with federal reimbursement rules foremost in mind, yet be flexible to accommodate other payor rules that may differ from Medicare. To understand Rush’s approach, it is important to be familiar with Rush’s research environment because the solution is very much dependent on Rush’s governance and the nature of the research Rush conducts. Importantly, Rush has a unified governance model. The hospital and the university are operated inside the same corporation, and roughly half the medical staff members are employed by that same corporation. Although Rush has over 8,000 employees, operates a 1,100-bed hospital, enrolls 1,400 university students, has over 900 medical staff members and 640 residents, and maintains approximately 500 clinical trials with active enrollees, the entire operation functions from one legal entity and is under the leadership of one CEO. This centralized governance structure has helped move along the process of reforming the clinical billing process. The structure helped all parties involved reach agreement on how to handle the compliance risk that was uncovered, and it helped move a solution along. Rush’s CEO personally chaired a corrective action committee twice weekly for almost one year. Without the active and visual involvement of senior leadership in the corrective action plan, it will be hard for an AMC to convince its investigators to change their practices.

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Operational Considerations

The legal and compliance issues involved with clinical trials billing for items and services rendered during a research study are likely some of the most complex and challenging issues an institution may face. These issues affect every practice area of a provider who conducts research. Clinical trial services are rarely confined to a particular department. Research study services often involve a sweep of ancillary provider areas, including pharmacy, laboratory, imaging, and other diagnostic services. Ministerial processes from trial registration to charge capture must be looped into the essential information flow needed to achieve compliance. Additionally, all dimensions of an academic medical community must interact with each other. Many academic medical communities are legally splintered into several parts: the university (which usually signs sponsorship contracts or receives federal grants to fund clinical trials), the faculty plan (which employs the clinical investigators who conduct the medical research and have the principal contacts with the funding sources), and the hospital (at which some of the most expensive and sensitive care is undertaken during clinical trials). At Rush, all three components are unified under one governing board.

On the other hand, Rush is not dissimilar from most AMCs in that it has historically been a very decentralized organization. Technological decentralization has hindered the implementation of a centralized clinical trials billing process. While a patient is enrolled in a clinical trial, services provided to that patient need to be considered differently for billing purposes from services provided during regular clinical care, which are usually assumed to be medically necessary. The easiest way to stop regular billing during a clinical trial to check for compliance is to place an institution-wide hold on an enrolled patient’s account. However, because different departments within the organization operate under different information systems, Rush was not able to stop and place an institution-wide hold on an individual patient’s account. For research billing, claims at Rush needed to be stopped and held at multiple places in the organization in multiple information systems that trap groups of claims for many patients. Whether an institution has a fully unified billing system or a multipart billing system, this is known as a bill hold. Personnel must work with the information systems to craft the bill hold carefully, to not hold more claims than are necessary. Once the bill hold is put in place on a study participant’s account and the claims are prevented from automatically being sent to payors as they are in the normal billing process, the claims needed to be individually reviewed by Rush’s billing and finance personnel for accuracy. The billing process Rush implemented needed to direct charges on claims to either the patient’s normal payor or to an internal research account at the point that the services are entered into the billing system, to avoid a bill hold after the charge capture process occurs. This requires identifying whether a service is billable or not billable before patients are enrolled in a study, and then devising a process so that the charge can be directed to the right reimbursement source at the time that the service is performed in the physician’s office, in the lab, in the imaging center, in the pharmacy, or at any ancillary department sites of service. Identifying whether a certain service is billable before a study even begins is intended to reduce the number of unnecessary bill holds in a clinical trials billing system.

The Rush solution is a type of front-end fix, meaning that the charge is directed to either the normal payor or to a research account at the time that the service is initially performed and entered in the billing system. Other organizations may be able to implement a back-end fix that is built on placing holds on all claims associated with an individual patient account at the time the patient is enrolled in a study, and then reviewing the enrollee’s patient account after services are performed but before the claims are sent to payors. If an organization can implement this back-end fix, the process can free the physician from the rigors of scrutinizing where each charge should be sent for each service when performed. Figures 1 and 2 illustrate the front-end fix and the back-end fix, respectively.

Figure 1
Figure 1
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Figure 2
Figure 2
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The solution to clinical trials billing compliance Rush implemented can be broken down into six essential components:

1. The Medicare coverage analysis spreadsheet. Rush established a central office to coordinate the study document information needed to create a Medicare coverage analysis spreadsheet. The spreadsheet serves as a tool to facilitate accurate billing and represents a synchronization of what the sponsor is paying for, what the informed consent promises free, a scrutiny of the protocol’s schedule of events to determine which services are conventional care or for the detection, prevention, and treatment of complications, and—very importantly—whether the study is a qualifying clinical trial under the Clinical Trials NCD.

2. Service codes and classifications. Rush’s Medicare coverage analysis spreadsheet is built around three codes to represent each service (with exceptions made on a case-by-case basis): S, N, and R. Rush decided to use S, N, and R after experimenting with several code systems. Chart 1 uses a more generic coding system, which an organization can use to begin thinking through what system would work best for that organization. In Rush’s process, the codes have the following meanings:

* S means that the sponsor is paying for the service or that the service has been promised free in the informed consent. An S service must never be billed to the normal payor and must be charged to the internal research account or fund.

* N means that the service can be billed through the normal billing process.

* R means that there is no external funding source and the service has not been promised free, but it is being done for research purposes. However, a physician can bill for an R service if, at the time of the service, the patient presents with signs and symptoms and the medical necessity of the service is documented.

3. Clear, user-friendly requisition orders. At a department level, requisition orders have been developed for clinical services with indicators that can be checked to identify whether the service is related to a clinical trial and should be billed to the normal payor or billed to the internal research account or fund.

4. Early identification of a service’s billing eligibility. Billing systems in individual departments have been reworked at point of charge capture to route a nonbillable service to the internal research account and route a billable service through the normal payor process. However, this is dependent on (1) the physician or physician’s staff indicating whether or not to bill for the service by checking the appropriate box on the requisition order form, and (2) the physician or physician’s staff checking the appropriate box on the form to identify the patient as a research patient.

5. Widespread familiarity with new processes and regulations. Investigators and their staff members have undergone training to use the Medicare coverage analysis spreadsheet and how to use the requisition forms. Ancillary department personnel have also received training on using these new tools.

6. Thorough awareness of actual billing practices. The compliance office has instituted an aggressive auditing program that

* Audits the accuracy of a sample of all billing grids that are developed,

* Audits the accuracy of how the billing grids are used for individual services, and

* Implements medical necessity reviews to determine whether, in instances in which an R service is billed, medical necessity has been documented.

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Lessons Learned

There are several lessons we learned from our experience that other AMCs could find useful:

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Understand the governance structure and legal constraints of the organization

Members of an academic medical community should understand the AMC’s governance structure and know the legal operational constraints associated with that structure. Is the AMC a unified model or a separated model? If it is a unified model, then senior leadership should become vested in the reform process. The reality is that the investigators may not “get it” without senior leadership involvement. If it is a separated model, then the peer entities should organize a committee that integrates the hospital, university, and faculty plans. The entity within the academic medical community that organizes the committee should have a realistic outlook. If that entity is the organization that is leading the reform effort, and if the other organizations are slow to cooperate, the reform process cannot be put on hold. Organizations must protect themselves and be willing to institute compliance measures as soon as possible.

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Assess past and current billing processes

Members of an academic medical community should understand current and past procedures and policies for billing for clinical trials. Ignoring the past and focusing just on the future does not erase the past. If a provider is holding money that was received in error, the risk of being penalized for noncompliance is not going to go away by ignoring it—in fact, the risk will only increase. The organization should put together a high-level team that figures out what parts of the current process can be salvaged and which practices are best to adopt for the improved process. Central to a clinical billing compliance structure is the registration process and the information technology infrastructure that supports that registration process. If an organization can place an institution-wide hold on an individual patient account when the patient is enrolled in a study, then the organization may want to consider a back-end fix to the research billing process, as described above. If the organization cannot place an institution-wide hold on an individual patient account, ensuring that no charges for the patient are being billed while that patient is enrolled in a study, then the organization will need to consider a front-end fix and a more complex bill hold process in many departments until the billing process can be straightened out. This is what Rush needed to do.

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Centralize and coordinate the clinical trials billing process

An AMC should organize the research contract/grant, informed consent, and protocol under one department and standardize the approach the institution takes to research billing. This function may reside in a new department, or it could be under patient finance or the compliance office. Wherever this function resides, there should be a central control that develops a consistent and coordinated approach. AMCs should consider developing a billing grid similar to Medicare coverage analysis spreadsheet that replicates the schedule of events in a clinical trial. If the organization uses a billing grid, then it is important to keep the codes in the billing grid simple. This is already a complex process, and there is no need to make it harder.

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Prioritize the corrective action plan

After a review of the situation, members of an AMC should prioritize a “fix” or corrective action plan and should budget for help and resources smartly. The function of clinical trials billing compliance must become a regular in-house function for AMCs. Organizations should consider training in-house personnel on how to develop a billing grid for new studies and hire temporary help to catch up on studies that are already active and enrolling. Developing two tracks (new studies and catch-up studies) clarifies the necessary work ahead and, therefore, minimizes an organization’s dependence on consultants.

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Develop a relationship with the local Medicare medical director

AMC leaders should consider scheduling a meeting with their local Medicare medical director if they do not already have a working relationship with him or her. The local Medicare medical director makes important determinations about the therapeutic intent of studies and about borderline coverage issues that CMS has not ruled on. One of the most beneficial pieces of advice Rush received during its settlement process came from CMS, when CMS advised Rush to meet with Rush’s local medical director. Just as with the meetings with OIG and CMS, Rush brought clinical investigators to the meeting with the medical director. Rush’s medical director provided useful and practical guidance on documenting the medical necessity for a study service that did not have any external funding source. From these discussions with the medical director came the Chicago-area Symposium on Clinical Trial Billing, which Rush hosted as a daylong seminar that provided education to investigators and AMC administration in the Chicago area. The symposium focused on clinical trials billing compliance and process options. The anchor segment of the program was Meet Your Medical Director, highlighting the local Medicare medical director. Few providers establish a dialogue with their medical director, and the Medicare medical director is a much-underutilized resource for providers.

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Involve key stakeholders

An academic medical community must involve its investigators in its compliance solutions. There are some things the investigators, quite frankly, will not be good at—figuring out whether a study is a qualifying clinical trial and applying innumerable counterintuitive Medicare rules to the study will be a waste of the investigator’s time. Investigators may be well suited to lead a coverage analysis on conventional care guidelines. The investigators can usually easily identify good sources for conventional care standards that have integrity.

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Integrate business concepts with clinical operations and processes

An academic medical community must be willing to evolve into a more cohesive business enterprise if it wants to achieve a compliance confidence level. The mission of AMCs is patient focused. That is the reason physicians become physicians and the reason physicians affiliate with AMCs and struggle to advance medical care. But an AMC is not somehow exempt from human organizational theory. The typical academic medical community is a complex organic puzzle that must move beyond its fragmented culture to develop structures that put efficiencies in motion. Academic medical communities must be open to examining their structural deficiencies and moving their institutions to more centralized control over legal and compliance risks.

Above all, an AMC cannot stand by and do nothing in the face of research billing noncompliance. Ignoring clinical trial billing compliance will not make it go away; in fact, it can increase an AMC’s compliance risk. The Rush experience can serve as an example and learning tool for other AMCs seeking to improve clinical trial billing compliance.

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References

1 Centers for Medicare & Medicaid Services. Routine costs in clinical trials, Medicare national coverage determinations manual. Available at: (www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf). Accessed March 27, 2007.

2 The White House, Office of the Press Secretary. President Clinton takes new action to encourage participation in clinical trials [press release, June 7, 2000]. Available at: (clinton4.nara.gov/WH/New/html/20000607.html). Accessed March 27, 2007.

3 Centers for Medicare & Medicaid Services, Office of Public Affairs. Medicare coverage routine costs of beneficiaries in clinical trials. September 19, 2000. Available at: (www.cms.hhs.gov/apps/media/press/factsheet.asp?). Accessed March 27, 2007.

4 Meade R. Legal Issues in Billing Medicare for Medical Research Services, The RAP Sheet. Washington, DC: American Health Lawyers Association; 2006

5 71 Federal Register 63021 (2006).

6 Centers for Medicare & Medicaid Services. Unlabeled use for anti-cancer drugs. In: Medicare Benefit Policy Manual. Available at: (www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf). Accessed March 27, 2007.

7 Meade R. IRB members should know more about the reimbursement rules for clinical trial services, medical research law & policy. BNA 2006;18:65.

© 2007 Association of American Medical Colleges

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