CLINICAL RESEARCH ADMINISTRATION: NEW REGULATORY PROCESSES FURTHER COMPLICATE COMPLIANCE ENVIRONMENT
By Megan Trost, Vice President, PFS Clinical
- New centralized device (IDE) submission process through CMS as of January 1, 2015.
- NCT number required on Medicare claims that include research items and/or services as of January 1, 2015.
- Condition code 53 option available from CMS to indicate initial placement of a device as of July 1, 2015.
- The importance of the coverage analysis process and how to accurately execute the document.
- Differences between drug and device determinations surrounding clinical trial billing.
Compliance is daunting, especially for roles immersed in state and federal regulations that govern nearly every aspect of healthcare. It is exponentially more complex for institutions conducting clinical research, which must comply with Medicare and third party guidelines, Clinical Trial Policies and other internal and external regulations. Responsibility for these tasks typically falls to internal clinical staff with neither the time nor the expertise to stay current in a fluid regulatory environment.
The regulation and process modifications released in 2015 provide a clear illustration of why compliance is critical to an institution’s financial and ethical well-being. These modifications include a revised submission process for investigational device exemption (IDE), the conclusion of the grace period for documenting the National Clinical Trial (NCT) number on Medicare claims, and the introduction of Condition Code 53 (CC-53). Failure to understand and adhere to several new rules could potentially put clinical trials on risky financial ground.
New IDE Study Approval Process
As of January 1, 2015, the Centers for Medicare and Medicaid Services (CMS) expanded criteria for coverage of IDE studies and centralized the review and approval process. Previously, institutions conducting clinical research device trials were obligated to submit the required documents to their respective local Medicare Administrative Contractors (MAC). (1) Under the new rule, CMS put the onus to secure approval of coverage of an IDE study on the sponsoring organization, rather than on each individual study site.
For example, if the study is sponsored by a pharmaceutical company, it would be responsible for seeking coverage approval. However, if the study is sponsored by a principal investigator (PI) for an investigator-initiated trial, the PI would be responsible for central submission.
It is a significant change that, if overlooked, could have a devastating financial impact on a clinical study and could delay treatment for patients in critical need. Failure to seek coverage approval through appropriate channels will delay or negate reimbursement for expenses related to the use of an FDA-approved device, even the device itself depending upon whether it is a Category A (Experimental) or Category B (Non-experimental) IDE study. Category A devices are statutorily excluded from coverage while Category B devices may be covered, as determined by CMS. (2)
The change impacts device studies that obtained an FDA approval letter dated on or after January 1, 2015. Trials approved by the FDA or MACs prior to January 1, 2015 will continue to be administered by the MAC. Further, Medicare claims for routine care items and services related to Category A or B IDE studies continue to be submitted to MACs for payment.
Revised Chapter 14 of the “Medicare Benefit Policy Manual” contains detailed instructions on seeking CMS approval of Category A and B IDE studies for purposes of Medicare coverage. (3) Additional information along with the list of CMS-approved studies is available on the CMS Coverage Website (http://www.cms.gov/Medicare/Coverage/IDE/).
Conclusion of the NCT Number Grace Period
On January 1, 2014, CMS added an 8-digit National Clinical Trial (NCT) Number (a.k.a. clinical trials identifier) to its list of data required to be included on all study-related claims submitted to Medicare. This requirement had many downstream effects on institutional processes, including registering all trials that performed items and services routinely billed to Medicare on ClinicalTrials.gov to obtain an NCT Number. If the NCT number is not listed, the institution would risk claim denials and lack of payment.
During the transition period, CMS recognized that certain physicians, hospitals and providers did not have the resources to secure and submit for an NCT Number, as it is a time-consuming and potentially expensive process. It could potentially constrict an already resource-strapped small, physician-initiated trial facing near-certain financial hardship. To help alleviate the administrative and financial burden, CMS gave providers a one-year grace period during which they could file claims using a generic 8-digit (999999999) clinical trial number. That grace period came to an end on January 1, 2015. (4)
Today, any applicable clinical trial must be registered with ClinicalTrials.gov by the responsible party. For industry sponsored clinical trials, the responsible party is the commercial sponsor, while investigator-initiated and federally funded trials must be registered by the PI or designee. Once the information has been properly submitted, the NCT Number is assigned, the enroller is notified via email, and it will also be available on ClinicalTrials.gov within 2–5 business days.
Condition Code Confusion
By July 6, 2015, local MACs should have implemented the new Condition Code 53 (CC-53). According to CMS’ Pub 100-04 Medicare Claims Processing, Transmittal 3181, CC-53 should be listed when “Initial placement of a medical device provided as part of a clinical trial or a free sample” on claims received on or after July 1, 2015. The new code is designed to identify and track medical devices that are provided to a hospital by the manufacturer at no cost or with full credit due to a clinical trial or a free sample. (6)
Previously, hospitals used either CC-49 (Product Replacement within Product Lifecycle) or CC-50 (Product Replacement for Known Recall of a Product) along with value code “FD” (Credit Received from the Manufacturer for a Replaced Medical Device). However, these two codes described only replacement devices and not a reduced cost for nonreplacement devices, the latter of which is often provided to Medicare beneficiaries as part of medical device trials.
Thus, CC-53 was created to fill the void by describing initially implanted medical devices that are not replacement devices. However, many in the industry have been critical of CMS for its lack of clarity about the new code, which adds to an already overflowing cache of device-related services that must be reported. (7)
Though certain states created local regulations surrounding coverage rules for patients in clinical trials, a provision generated by the Affordable Care Act (ACA) to the federal Public Health Service Act now prohibits denials of coverage and discrimination for services on or after January 1, 2014. (8)
Though it took effect last year, this improvement to limit discrimination against clinical trial patients is significant enough to warrant discussion in any article on regulatory complexity. It requires group health plans and health insurance issuers offering individual or group health insurance to provide coverage of routine patient costs associated with approved clinical trials.
Specifically, it prohibits health plans from denying participation in an approved clinical trial, nor can they deny, limit or impose additional conditions on coverage of routine patient costs for items or services furnished in connection with participation in the approved clinical trial. Finally, health plans are prohibited from discriminating against the patient on the basis of clinical trial participation. (9)
For clinical research, this guarantee of coverage for appropriate expenses is expected to boost enrollment by eliminating the justified concerns patients once had regarding insurance coverage. Participating in a clinical trial often results in an increased number of doctor’s visits, which without such protections could quickly erode coverage limits and send out-of-pocket costs soaring.
One notable item surrounds different levels of coverage per benefit plan. Each insurance plan depicts certain co-payments and deductibles specific to a participant’s level of coverage. It also includes the details for items, services, and/or procedures covered under each plan. Although the new regulations provide coverage guidelines, they do not overrule a participant’s individual plan. For example, if a certain item is never covered under the specific plan, that item would not be covered in a clinical trial visit.
Though statutory protections were already in place in 37 states, establishing a federal standard brings consistency to claims and billings for clinical trial organizations. It also helps patients better understand their financial obligations related to study participation.
The Role of Coverage Analysis
There are many other areas consistently up for debate in the clinical research world. This exacerbates the reality that all institutions that bill Medicare are susceptible to fraudulent billing; specifically, sites conducting clinical research in addition to standard practice. Because of the complexities associated with the CTP, and the lack of definitive clarification from Medicare, institutions conducting clinical research are left to interpret what a Medicare contractor might interpret when reviewing a clinical trial patient’s claim.
For this reason, it is advised that institutions take a proactive approach to the process of research billing compliance. Developing a Coverage Analysis (CA) prior to the start of a trial and in tandem with the development of other crucial study documents (e.g., Clinical Trial Agreement, budget, Informed Consent, etc.) is necessary to determine whether or not the clinical trial even qualifies for Medicare coverage. If so, one must know what items and services are billable to Medicare under the CTP.
The CA serves as the first line of defense for institutions to protect themselves against incorrectly billing Medicare and assists personnel on the back-end of research billing operations. Additionally, even though Medicare’s billing decisions are specific to Medicare beneficiaries, third-party insurance payors typically follow Medicare’s rules and regulations. Institutions need to contact their major payors to ensure they are following the approved coverage decisions.
There are three distinct steps to completing a CA: 1) Qualify, 2) Review, and 3) Justify. Understanding each component will give you a framework for performing a CA. Knowing whether items and services are billable to Medicare is key, as well as knowing what the sponsor has agreed to pay for, to avoid double billing.
Step 1: Qualify
The first step of the CA is to determine whether or not the study is a “qualifying clinical trial” based on the CTP. This step is the basis for the CA, because if the trial does not qualify, then the items and services are not billable to Medicare. However, institutions take liberty to interpret the coverage of a non-qualifying trial. Certain conservative institutions believe a non-qualifying status means no item or service performed under a protocol is “billable” to insurance, however, more risk averse institutions believe that items and services that would have been performed as standard of care are still covered within the non-qualifying trial.
To qualify for Medicare coverage, the clinical trial must meet four criteria:
- Fall within a Medicare benefit category: the majority of clinical trials will fall within Medicare’s list of 72 categories (e.g., drugs and biologicals, diagnostic tests, etc.), and the trial subject cannot be statutorily excluded per Medicare’s Benefit Policies.
- Have therapeutic intent: The trial must not be designed exclusively to test toxicity and disease patho-physiology. Typically, Phase II-IV trials will have therapeutic intent whereas Phase I trials often do not meet this criteria.
- Enroll patients with diagnosed disease: This appears self-explanatory, but it can spark debate about the definition of disease. Studies may also enroll healthy patients in order to have a proper control group, but at least one of the groups in the study must enroll patients with a diagnosed disease.
- Meet a “deemed” status: The study must possess the desirable characteristics of a sound clinical trial which are described in detail in the CTP. Some trials are presumed to meet the seven desirable characteristics and are considered “deemed.”
For a clinical trial to be “deemed” it must meet one of the following criteria:
- Funded by a governmental agency (e.g., NIH, DOD, CDC)
- Supported by centers or cooperative groups that receive funding from a governmental agency
- Conducted under an Investigational New Drug (IND) application reviewed by the FDA
- Exempt from having an IND under 21 CFR 12.2(b)(1)
Additional Medicare regulations apply to studies involving investigational medical devices, which are categorized by the FDA as either:
- Category A IDE (experimental)
- Category B IDE (non-experimental/investigational)
- Non-Significant Risk
- Humanitarian Use
Category A and B are considered “significant risk” devices and require IDE approval from the FDA. Humanitarian Use Devices are those that are expected to benefit less than 4,000 people in the U.S. per year and are typically regulated in a similar manner as Category B IDEs. (11) See new submission process listed above.
Step 2: Review
When it has been determined that a clinical trial qualifies for Medicare coverage, the next step is to review all relevant study documents and develop a billing grid in order to identify each item or service during the trial and the frequency at which each occurs. Study protocols typically have a schedule of events, but oftentimes these schedules do not include all of the potentially billable items (e.g., supportive medications, additional procedures, etc.). Therefore, a thorough review of the protocol is necessary to identify any hidden items and services that may generate a claim.
Once all items and services are added to the billing grid, other essential documents must be reviewed, such as the Clinical Trial Agreement/Grant and the Informed Consent form, to determine what the sponsor agrees to pay for during the trial. This analysis also allows the reviewer to assess whether there is conflicting language in any of the documents and what changes may be necessary to prevent double billing.
Step 3: Justify
The third and most involved portion of the CA includes determining which costs are “routine” per the CTP. (12)
- Routine costs are defined as: Items or services that are typically provided absent a clinical trial (i.e., conventional care)
- Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
- Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications
This process is the most time consuming of the three steps because it involves analyzing National and Local Coverage Determinations (NCDs and LCDs), Medicare policy manuals, FDA statutes, and approved clinical guidelines to determine what items and services are “conventional care.” It also involves determining which items and services are provided for the administration and monitoring of the investigational item, the prevention of complications, and any other reasonable and necessary services related to complications from the investigational item.
At some institutions, research personnel may consult with the study PI to determine which procedures are “standard of care” and which are for research purposes, but this can be a risky way to determine what is billable to Medicare. PIs are often unaware of Medicare’s rules regarding the CTP, and what may be one PIs standard of care is not necessarily conventional care or a routine cost in the eyes of Medicare.
Educating PIs is an important component of research billing compliance to ensure they understand the purpose of a CA and the reasoning behind any decisions made by the billing compliance professionals. Therefore, it may be necessary to consult the PI when justifying whether or not an item or service is billable, but ultimately any recommendation from the PI needs to be reinforced by Medicare-approved resources.
The three-step CA process should be conducted for every clinical trial that might bill Medicare or third-party payors. It is crucial that during this process the institution’s billing compliance professionals maintain an objective approach. Equally important is the proactive approach of educating PIs and research staff about the CTP and the purpose of CAs.
Although the process of conducting CAs is time-consuming and involves the training and cooperation of multiple personnel involved in the research billing process, it is essential to ensure compliance and to protect institutions.
1. Centers for Medicare and Medicaid Services: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies. Available at: http://www.cms.gov/ Medicare/Coverage/IDE/
2. Department of Health and Human Services Health Care Financing Administration: Medicare Carriers Manual Part 3 - Claims Process. Transmittal 1701. May 25, 2001. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/ downloads/R1704B3.pdf
3. Centers for Medicare and Medicaid Services. Medicare Benefit Policy Manual Chapter 14 -Medical Devices. Available at: http://www.cms.gov/Regulations-and-Guidance/ Guidance/Manuals/Downloads/bp102c14.pdf
4. Coding Strategies. Clinical Trial Number MLM Matters SE1344. Available at: http://www. codingstrategies.com/news/clinical-trial-number-mln-matters-se1344
5. U.S. National Institutes of Health. ClinicalTrials.gov. How to Register Your Study. Available at: https://clinicaltrials.gov/ct2/manage-recs/how-register
6. Centers for Medicare and Medicaid Services. “Implementation of New National Uniform Billing Committee (NUBC) Condition Code “53” - “Initial placement of a medical device provided as part of a clinical trial or a free sample.” MLM Matters. Medicare Learning Network. Available at: http://www.cms.gov/Outreach-and-Education/MedicareLearning-Network-MLN/MLNMattersArticles/downloads/MM8961.pdf
7. Calahan, M. “New Condition Code 53: What We Know and Don’t Know.” RACmonitor. March 4, 2015. Available at: http://www.racmonitor.com/rac-enews/1798-newcondition-code-53-what-we-know-and-don-t-know.html
8. American Society of Clinical Oncology. Insurance Coverage for Clinical Trial Participants. Available at: http://www.asco.org/insurance-coverage-clinical-trial-participants
9. Association of Community Cancer Centers. Coverage for Individuals Participating in Approved Clinical Trials under the Patient Protection and Affordable Care Act of 2010 (PPACA). Available at: https://www.accc-cancer.org/advocacy/pdf/PPACA-Coveragefor-Approved-Clinical-Trials.pdf
10. Burleigh A. “Medicare Coverage Analysis: Protecting your institution.” Compliance Today. Pp 25-29. May 2013. Health Care Compliance Association. Available at: http://www.hccainfo.org/Portals/0/PDFs/Resources/Compliance_Today/0513/CT_0513_Burleigh.pdf
11. U.S. Food and Drug Administration. FAQs about IDE. Available at: http://www.fda. gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ InvestigationalDeviceExemptionIDE/ucm051480.htm
12. Centers for Medicare and Medicaid Services: National Coverage Determination (NDA) for Routine Costs in Clinical Trials (310.1).