Sachit Verma, MD, MBA, FAPCR
Medicare Coverage Analysis (MCA) is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third-party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors.
Medicare Coverage Analysis – Why it Matters
- Minimize the potential errors in research billing: It diminishes the risk of improper or inappropriate billing. The False Claims Act targeted at “fraud” violations may be triggered by inaccurate billing. There is a decrease in risk of noncompliance by abiding with federal regulations and by avoiding harmful audits results. By sending bills to agencies inappropriately, the institution and the individuals risk paying civil and criminal penalties and exclusion from participation. If the OIG discovers improper billing, they can exclude institutions from Medicare or Medicaid or other federal programs.
- Provide a template for budget development and negotiation: It can lead to potential loss of revenue due to improper budgeting, i.e., financial gain or loss associated with a particular study (budgeting), justifies payments to the institutions, strengthens the budget development process and further creates efficiency in budget negotiations. It maximizes recovery of study related cost by getting reimbursed for items and services not standard of care.
- Patient Dissatisfaction and undue financial burden: There can be “double billing” for billing CMS or third-party payers for items that have already been paid by a sponsor. You can have unhappy patients who are under financial burdens as they are receiving these incorrect or additional bills on services, which ultimately affects the reputation of the institution. This may be an indicator of billing problems and process problems. Therefore, there is a need to assess and evaluate trends and to recognize these issues by getting the sequence right from the Medicare Coverage Analysis assessment at the beginning of a study.
- Promote and Streamline Billing compliance: Medicare Coverage Analysis helps coordinate billing and administrative activities and downstream communication to the billing staff and other member of the research team, thereby reducing the number of hours spent reviewing charges and providing the road map. It streamlines billing compliance.
Medicare Rules and Regulations
In 1965- Congress passed legislation establishing the Medicare and Medicaid programs as Title XVIII and Title XIX, respectively, of the Social Security Act.
President Clinton issued an executive memo July 7, 2000, directing the Secretary of Health and Human Services to “explicitly authorize [Medicare] payment for routine patient care costs…and costs due to medical complications associated with participation in clinical trials.” A formal NCD was then issued by CMS on September 19, 2000.
CMS began reconsideration of the clinical trial policy July 10, 2006, and published a Memorandum on July 9, 2007, that maintained the status quo of the September 2000 Clinical trial policy with the following exception. One – added clarification that investigational items covered in clinical trial if covered outside the clinical trial in regular clinical care (i.e. post marketing trial) and Two- allowed for expansion- i.e. coverage for items and services provided in clinical trials that gather data to support coverage known as coverage with evidence development (CED) process (that basically includes the data collection and reporting as a condition of coverage so that CMS can make future determination of that particular item).
The Medicare Program’s July 9, 2007, version of the Clinical Trial Policy provided much of the framework for research billing compliance.
In an Oct 17, 2007, decision – CMS Maintained the status quo of the July 9, 2007, clinical trial policy and closed the reconsideration with a final decision memorandum.
CMS released an updated guidance document on November 20, 2014, that describes coverage with evidence development (CED). CMS, as part of the national coverage determination (NCD) may determine coverage of an item or service only in the context of a clinical study.
NCD 310.1- Coverage of Routine cost- Clinical Trials Policy (CTP)
In order to support patient enrollment in clinical trials and the advancement of drug sciences, CMS implemented National Coverage Determination (NCD) 310.1 Clinical Trial Policy: “Coverage for Routine Costs in Clinical Trials” which states – “Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.”
Conditions for Qualifying Clinical Trials (QCT)
A qualifying clinical trial must meet All of 3 (Necessary requirements) and be a 4. Deemed Trial.
- Medicare Benefit Category: The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., drugs and biologicals, physicians’ service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
- Therapeutic Intent: The trial must have therapeutic intent. Does the trial provide some form of clinical efficacy such as progression free survival, shrinkage of tumor, or improved quality of life? It cannot be designed exclusively to test toxicity or disease pathophysiology.
- Patients Enrollment with Diagnosed Disease: The trial of therapeutic intervention must enroll patients with diagnosed disease rather than healthy volunteers.
- The trial must be “deemed” to meet CMS’ seven desirable characteristics of a clinical trial.
A clinical trial is deemed to automatically meet the seven desirable characteristics if it is:
• Funded by NIH, CDC, AHRQ, CMS, DOD, and VA
• Supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA
• Conducted under an investigational new drug application (IND) reviewed by the FDA
• Drug trials that are exempt from having an IND under 21 CFR 312.2 (b)(l)
Medicare Coverage Analysis Process and Procedure
Requirement is to gather protocol related documents from the sponsor and thoroughly review all these documents to do the Medicare Coverage Analysis which includes: Protocol, draft sponsor ICF, Investigator Brochure, Pharmacy manual, draft sponsor budget, IND information for drug trials, FDA, CMS letters for device trials.
It is important to consider the type of study whether, therapeutic drug trial, device study, registry, retrospective chart review, observational data collection, outcome study, quality of life etc. Then apply the criteria for qualifying clinical trial and perform the QCT analysis and prepare the billing grid.
Key consideration while performing Medicare Coverage Analysis
a. Understand all items and services being provided as part of the protocol schedule of assessment that involves data collection, Evaluation and Management, Local versus Central Labs, Tests and Procedures, Imaging, Scans, Biopsies, Drugs, Supportive and concomitant medications etc. and capture those in the billing grid with various billing determinations and designations.
b. Medicare Coverage Analysis assessment requires a knowledge base, skill and quality time and effort in actually doing it and a responsibility to provide accurate information to clinical team, research staff, and principal investigators, to always have clear understanding and organizational approach and buy-in from all the stakeholders.
c. Dissect the protocol in and out while covering relevant sections: Table of events, Calendar, Study design, Number of Arms, Study population with inclusion and exclusion criteria, Study methodology, Description of Study Treatments, Procedures, Length of Study, Study Objectives. Study Endpoints including primary, secondary, tertiary, exploratory, safety and efficacy, Adverse Events, and discontinuations.
d. There must be documentation of supporting rationale and justifications such as National treatment guidelines, Imaging criteria, Appropriate Use Criteria, National coverage determinations (NCD) as well as local coverage determination (LCD), Medicare’s Policy manuals, FDA status, Drug labels, which must be evaluated when determining coverage.
e. Include modifiers, Q0 and Q1, CPT codes on to the study grid and ensure accurate trial information is entered into the Clinical Trial Management System (CTMS).
f. Identify clinical research items and services that can or cannot be billed to third party payors and insurance.
g. Bill for the little thing as detailed in the protocol.
h. Determine which items and services are “conventional care.” Remember standard of care (SOC) is not a Medicare concept. What they are looking for is the routine cost.
i. Evaluating which items and services are required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent) and clinically appropriate monitoring of the investigational item or the prevention of complications.
j. American Society of Clinical Oncology recommends universal screening for hepatitis B for patients that undergo cancer therapy. “All cancer patients anticipating systemic anticancer therapy should be screened for hepatitis B through three tests. hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), IgG, and antibody to hepatitis B surface antigen (anti-HBs)—prior to, or at the beginning of, systemic anticancer therapy”. While developing your coverage analysis especially for Oncology protocols this must be kept in mind. Institutions can add them as standard items in their screening and if it is still limited by NCD 210.6, then this needs to be reimbursed.
k. It is critical to think about each element of history and physical exam (whether medically appropriate) in your analysis in the context of E&M evaluation whether it is a new patient or an established patient and type of settings. This also involves the medical decision making early in the encounter and that it is coded appropriately. Make sure the diagnosis code is specified and corresponds to the service in the claims (linking ICD-10 to the appropriate CPT code with primary diagnosis). “Medical Necessity” still drives the level of service because CMS and the payers consider it to be the “overarching criterion” in selecting a level of service. The quality of E&M documentation is crucial for provider reimbursement and to help clarifying that why it was medically necessary to perform that service or procedure.
l. NCD 310.1 pays for routine cost during qualifying clinical trial but when it comes to screening labs there are two relevant definitions or criteria that apply – one is conventional care and the second is the monitoring of and assessing of complications from side effects of the study drug. For example:
1. If the study drug causes changes in the cardiac arrhythmia i.e., abnormal electrical conduction of the heart in patients who are receiving them, then tests could be considered medically necessary to ensure patient safety, particularly if the drug class is known to be associated with abnormal cardiac dysfunction. So requested EKG is often required during work up for these patients and is billable.
2. Language regarding routine screening and asymptomatic patient is quite common and normally clearly limiting. It is important to know that if a test and procedure is routinely performed in the clinical setting it, may still be limiting or non-covered by Medicare. One common example is lipid testing (National Coverage Determination (NCD) for Lipid Testing (190.23). “Routine screening and prophylactic testing for lipid disorder are not covered by Medicare. While lipid screening may be medically appropriate, Medicare by statute does not pay for it. Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.” Please remember the language all other Medicare rules apply. CMS interprets these provisions to prohibit coverage of ‘screening’ services, that included the laboratory test services e.g., PTT, lipid panel, EKG furnished in the absence of signs, symptoms, or personal history of disease or injury, or those who don’t fall under Medicare benefit category. Actual coverage for services is limited to “reasonable and necessary,” based on the diagnosis or treatment of complication arising from the provision of an investigational item or service
Medicare Coverage Analysis assessment is an essential element of a billing compliance program. You can demonstrate a good faith effort of trying to determine billable vs. non-billable tests and procedures, minimize the potential of billing errors, ensure the effectiveness of corrective action in your internal audit, and intended outcomes, with the help of thorough and detailed Medicare coverage analysis.
1. “Medicare Clinical Trial Policies,” retrieved Aug. 1, 2022, from https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies
2. “National Coverage Determination (NCD) for Routine Costs in Clinical Trials,” retrieved June. 1, 2022, from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1
3. Jessica P. Hwang, Jordan J. Feld, Sarah P. Hammond, et al. Hepatitis B Virus Screening and Management for Patients With Cancer Prior to Therapy: ASCO Provisional Clinical Opinion Update. Journal of Clinical Oncology 2020 38:31, 3698-3715.
4. “National Coverage Determination (NCD) for Lipid Testing (190.23),” retrieved June.1, 2022, from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=102