Does Medicaid Cover Clinical Trials


Does Medicaid Cover Cpap

Is Medicaid Coverage Better or Worse than Private Insurance?

Many sleep study diagnoses are treated using therapies such as CPAP, particularly for beneficiaries experiencing severe and unambiguous obstructive sleep apnea. The use of CPAP is covered under Medicaid when prescribed by the attending licensed technician.

However, if the beneficiary has been utilizing CPAP therapy under a different insurance plan and is looking to switch to Medicaid, the issue requiring CPAP may be considered a preexisting condition. In this case, the beneficiary must first be found in accordance with all applicable policy guidelines. This typically includes an initial doctors visit, even in the event that you are currently using CPAP therapy or have in the past.

To find out more about how much your sleep study may cost you, talk to your doctor or health care provider.

Medicare And Medicaid Coverage

Medicare. The ACA does not affect Medicare coverage of clinical trial costs. Medicare has slightly different rules for covering clinical trials.

Medicare covers the following routine clinical trial costs:

  • Drugs, procedures, and services that Medicare would cover if you were not enrolled in the clinical trial.

  • Medical care needed for the treatment that the clinical trial is studying. For example, Medicare would cover medical care related to chemotherapy. But it would not cover the new chemotherapy drug.

  • Medical care related to health problems from the clinical trial. One example is the prevention and management of side effects.

Special rules apply for people enrolled in Medicare-managed care plans. These plans are also called Medicare Advantage plans.

If you are in one of these plans, traditional Medicare covers routine costs of the clinical trial. Then, the Medicare Advantage plan pays any difference in your out-of-pocket costs between traditional Medicare and the Medicare Advantage plan.

Medicare does not cover research-related costs.

Medicaid. The ACA clinical trials coverage rule does not apply to Medicaid plans. Federal law does not require states to cover clinical trials through Medicaid. But some states have laws that require Medicaid to cover clinical trials. Learn more about insurance coverage of clinical trials by state. Please note that this link takes you to a different ASCO website.

Clinical Trials Coverage And Billing Guide

On this page, view the below information.

Medicare may pay for items and services in clinical research studies under three policies:

  • Clinical Trial Policy
  • A National Coverage Determination that allows payment of routine items/services, and payment of the investigational item/service if it is normally covered outside of the trial and meets medical necessity requirements, in clinical trials that qualify for coverage. See the CMS Routine Costs in Clinical Trials NCD for details.
  • Coverage with Evidence Development
  • Medicare may issue an NCD that requires participation in certain clinical trials, longitudinal studies, or registries for coverage of an item/service and routine and related items/services.
  • See all CED studies on the CMS Coverage with Evidence Development webpage.
  • Investigational Device Exemption Policy
  • Medicare may cover certain items/services in Food and Drug Administration -approved IDE trials.
  • Trials initially approved by FDA before January 1, 2015, the Medicare Administrative Contractors review IDE studies to determine coverage.
  • Trials approved by FDA after January 1, 2015, view listing on the CMS Approved IDE Studies webpage. MACs may require additional information to facilitate claims payment.
  • Clinical Trials, Prospective Studies, and Registries Coverage

    Providers must ensure that their clinical trial claims contain the proper components when billing Medicare:

  • ICD-10 diagnosis code Z00.6
  • Must be reported on all clinical trial claims
  • Modifier Q0
  • Modifier Q1
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    Researchers Examine Insurance Coverage Of Clinical Trial Participation

    Research published in the August 1, 2017 issue of Cancer, looked at whether insurance denials persist after the implementation of the ACA clinical trial mandate for cancer patients. Investigators also explored the reasons used to deny coverage and any research-site factors associated with denials.

    The researchers deployed a survey to cancer research centers and community-based institutions to gather details on insurance denials of coverage for trial participation. Of the reasons provided to justify coverage denial, the most frequent explanations were:

  • Insurer claimed that the plan did not cover trial participation
  • Study site was out of the insurers provider network
  • Plan was grandfathered
  • Participation in a Medicare Advantage plan
  • Nearly 80% of trial sites reported not receiving a coverage response from the health insurer within 72 hours. Delays in coverage notification may have a significant effect on participation in trials with patients experiencing additional uncertainty, emotional distress, and concerns about disease progression/postponement of treatment.

    Insurance Coverage And Clinical Trials

    What does Medicaid cover? Federally

    Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

    • You must be eligible for the trial
    • The trial must be an approved clinical trial
    • The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan

    Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

    What are approved clinical trials?

    Approved clinical trials are research studies that:

    • Test ways to prevent, detect, or treat cancer or other life-threatening diseases
    • Are funded or approved by the federal government, have submitted an IND application to the FDA , or are exempt from the IND requirements. IND stands for Investigational New Drug. In most cases, a new drug must have an IND application submitted to the FDA in order to be given to people in a clinical trial.

    Which costs are not covered?

    Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. Often, the trial sponsor will cover such costs.

    Plans are also not required to cover the costs of out-of-network doctors or hospitals, if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial.

    • Reviewed:February 6, 2020

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    Costs Not Covered By Health Insurance

    It is important to know which costs you will need to pay before joining a clinical trial. Remember, health insurance companies and Medicare are not required to cover:

    • The cost of the treatment or procedure the clinical trial is studying

    • Any procedure only needed to collect data for the study

    Talk with the clinical trial research team about what your insurance plan may cover. And check if your insurance plan must meet the ACA clinical trial coverage requirements. You will usually talk about this with the research team during the informed consent process.

    How Much Does A Cpap Machine Cost With Medicare

    Medicare typically covers the most basic level of equipment, and it may not pay for upgrades. In the case where Medicare doesnt cover upgrades or extra features, youll need to sign an Advance Beneficiary Notice before you get the equipment.

    Your out-of-pocket cost for renting a CPAP machine and buying related supplies like masks and tubing is 20% of the Medicare-approved amount. The Part B deductible applies. In addition, you must consistently use the CPAP machine for 13 months in order for Medicare to cover the cost of renting it. After 13 months, you will fully own the machine.

    Medicare Advantage Plans set their own rates for DME coverage. Your plan may require you to secure approval before making an order, order from in-network providers, or use preferred DME brands. Your plan may reduce or deny coverage for the DME if you dont follow these rules.

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    Medicare Coverage For Clinical Trial Participants

    Medicare covers the routine patient costs for qualifying clinical trials. The Medicare National Coverage Determination, passed in the year 2000, clarified clinical trials coverage for beneficiaries enrolled in traditional Medicare fee for services coverage.

    Coverage of Phase 1 Trials

    The Medicare policy does not specify the phases of trials that are covered but instead states that a trial must have therapeutic intent. It is the position of ASCO and other leading cancer organizations that phase 1 cancer clinical trials have therapeutic intent and therefore should be covered by Medicare. In the past, ASCO has worked with other cancer organizations to provide information to assist research sites with coverage denials related to phase 1 participation. For assistance on this issue, please .

    Coverage for Medicare Advantage Plan Participants

    A persistent challenge remains for individuals enrolled in Medicare Advantage or private Medicare-managed care plans. The Centers for Medicare and Medicaid Services requires that these beneficiaries revert to FFS coverage if they enroll in a clinical trial. The Medicare Advantage plan is then required to reimburse beneficiaries for the difference in out-of-pocket cost sharing between FFS and their MA plan. ASCO is an opponent of this policy because it serves as a potential financial and bureaucratic disincentive for MA enrollees who want to participate in research.

    ASCO Policy Initiatives

    Additional Resources

    • Medicare Advantage Policies

    History Of Medicaid Coverage For Clinical Trials

    What You Need to Know about Medicaid Insurance and Dental Implants? | Dr. Parsa Zadeh

    In 2000, Medicare issued a national coverage decision on clinical trials, authorizing payment for routine patient care costs and medical complications associated with participation in a clinical trial.

    A brief from the Centers for Medicare andMedicaid states that routine costs for clinical trials are covered by Medicaid to the extent that they are covered in a state plan – leaving the responsibility for coverage with each individual state.

    In 2010, the Patient Protection andAffordable Care Act mandated that health plans cannot keep patients from joining a clinical trial, cannot limit or deny coverage of routine costs to patients who join an approved clinical trial and cannot increase costs because a patient joins aclinical trial.

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    Affordable Care Act Requirements For Private Insurance Coverage

    The federal health care reform lawthe Patient Protection and Affordable Care Act includes the requirement that private insurers cover the routine patient costs associated with participation in approved clinical trials. The following resources provide further information about the new requirement and ASCO’s ongoing work to inform the community about implementation of the law.

    Does Medicaid Cover Sleep Studies

    • If you might have a sleep disorder, your doctor could order a clinical sleep study to learn more. Find out whether Medicaid will cover any costs for a sleep study.

    If your doctor believes you’re exhibiting signs of sleep disorders, he may refer you to a polysomnography more widely known as a clinical sleep study. These studies require overnight evaluation to diagnose the severity of your symptoms and how they’re affecting your sleep continuity, cardiac functions and other factors. This may be in the form of a sleep lab study or a home test. Find out more about whether Medicaid covers sleep studies below.

    Also Check: Who Is Not Eligible For Medicaid

    User License Agreement And Consent To Monitoring

    End User Agreements for Providers

    Some of the Provider information contained on the Noridian Medicare web site is copyrighted by the American Medical Association, the American Dental Association, and/or the American Hospital Association. This includes items such as CPT codes, CDT codes, ICD-10 and other UB-04 codes.

    Before you can enter the Noridian Medicare site, please read and accept an agreement to abide by the copyright rules regarding the information you find within this site. If you choose not to accept the agreement, you will return to the Noridian Medicare home page.





    Consent to Monitoring

    Get A Second Clinical Evaluation

    New research investigates health care access for ...

    If Medicare covers your CPAP machine for the three-month trial period, you must undergo a second clinical evaluation to establish medical necessity for continued coverage. During the face-to-face evaluation, your doctor must document that your symptoms of sleep apnea have improved and that youve adhered to consistent CPAP therapy.

    If you fail the initial 12-week trial period, youre eligible to requalify for a CPAP device by taking an in-person clinical re-evaluation and repeating the sleep test in a facility-based setting.

    Also Check: Centers For Medicare And Medicaid Services Login

    Equity In Access To Clinical Trials In Medicaid

    The act authorizes the state medical assistance program to cover routine costs associated with phase I through phase IV clinical trials involving the prevention, detection, diagnosis, or treatment of life-threatening or debilitating diseases or conditions. The medicaid recipient’s treating physician must determine that the recipient has a qualifying disease or condition and that the recipient meets the selection criteria for the clinical trial. The clinical trial must be an approved clinical trial, as described in the act, and must be conducted by agencies and organizations specified in the act.

    As used in the act, “routine costs” include medically necessary items or services included under the medicaid program for a recipient, to the extent that the provision of such items or services to the individual outside the course of such participation would otherwise be covered under the medical assistance program, without regard to whether the recipient is participating in a clinical trial. Routine costs do not include items specified in the act, including the investigational item, device, or service itself items and services provided solely to satisfy data collection and analysis needed for the clinical trial and items, drugs, or services that would otherwise be provided by the clinical trial or provided for free to any individual participating in the clinical trial.

    Understand Your Explanation Of Benefits Forms

    EOB forms are sent to you by your insurance company. They list the cost of the treatments received and how much of the fee was paid for by the insurance company. It is possible that you will run into a plan that does not cover certain aspects of your trial that you feel are necessary.

    Whether its not covered within the ACA or your plan is grandfathered, you can argue your case.

  • Ask if the doctor will write a letter explaining why a certain test or procedure is required. Have that sent to your case manager.

  • If the company does not agree to cover it, in other words if your request is denied, you can then appeal the decision.

  • All denied insurance claims can be appealed. Heres a list of numbers to call if you need help with the appeal:

    • The Patient Advocate Foundation,

    • The National Coalition for Cancer Survivorship,

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    Data Element Definitions Templates And Checklists

    Data Element Definitions: These documents describe the registration, expanded access, and results data items that are entered via PRS.

    Protocol Registration Templates: Each template is a formatted summary of the data elements for each registration module, specific to the relevant study type. The templates are intended to help investigators understand and gather the data needed to complete each registration module.

    Simple Results Templates and Results Data Preparation Checklists:The templates are one-page formatted summaries of the relevant data elements for each results module, and the checklists provide an overview of the necessary data. The templates and checklists are intended to help investigators understand and gather the data needed to complete each results module.

    Which Clinical Trials Will Medicare Cover And How Do I Find One

    How Does Medicaid Help People with Low Income Pay Medical Bills?

    Your routine care costs are generally covered by Medicare if the clinical trial is funded at least in part by the federal government.

    Clinical trials automatically qualify to receive Medicare coverage of routine costs if:

    • Trials are funded by the Agency for Healthcare Research and Quality, National Institutes of Health, Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, the Department of Defense or the Department of Veterans Affairs.
    • Trials are supported by centers or cooperative groups that are funded by any of the organizations listed above.
    • Trials are conducted under an investigational new drug application reviewed by the Food and Drug Administration.

    You can visit to see a list of government and private studies across the country. The website provides details about a trials purpose, who can participate, locations and contact information.

    You can also join the National Registry of Research Volunteers at

    This initiative is funded by the National Institutes of Health to connect people who are searching for research studies with researchers looking for people to participate in their studies.

    It is a free, secure registry.

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    Do Medicare Drug Plans Pay For Clinical Trials

    Whether your Medicare Part D prescription drug plan will pay for a medication used in a clinical trial depends on their formulary. Often, experimental drugs aren’t covered or are classified as Tier 5 drugs that cost more out of pocket. If the study isn’t providing the drug for free, contact your insurance provider for information about potential costs.

    Revised Common Rule And Posting Of Clinical Trial Consent Forms

    A revised Federal Policy for the Protection of Human Subjects was issued in 2017 and became effective on July 19, 2018. The revised Common Rule ) requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form used in enrolling participants be posted on a publicly available Federal website within a specific time frame. In an , and were identified as the publicly available federal websites that will satisfy the consent form posting requirement.

    NOTE: No obligations to post such consent forms apply before January 21, 2019, the general compliance date for 45 CFR Part 46. For additional information on submitting Informed Consent Forms to, see Appendix A.1 of the Results Data Elements Definitions document.

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