Medicare Blog

who do i call at medicare with questions about approval for a clinical trial

by Zoey Mraz Published 2 years ago Updated 1 year ago
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Call 1-800-MEDICARE
For questions about your claims or other personal Medicare information, log into (or create) your secure Medicare account, or call us at 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.

Full Answer

Who do I call if I Have Questions about Medicare?

Do you have questions about your Medicare coverage? 1-800-MEDICARE (1-800-633-4227) can help. TTY users should call 1-877-486-2048. What should I have ready when I call 1-800-MEDICARE?

How do I talk to a real person at Medicare?

For specific billing questions and questions about your claim, medical records, or expenses, log into MyMedicare.gov, or call us at 1-800-MEDICARE (1-800-633-4227). TTY users call 1-877-486-2048.

Do clinical trials qualify for Medicare coverage?

Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development.

How do I contact Medicare about a claim?

For questions about your claims or other personal Medicare information, log into (or create) your secure Medicare account , or call us at 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048. What state do you live in?

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Who is responsible for approval of clinical trials?

As set forth in the 2019-CTRules and the Hdbk-ClinTrial, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India.

How do you get clinical trials approved?

Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy's safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.

What is the Medicare helpline?

(800) 633-4227Centers for Medicare & Medicaid Services / Customer service

What disqualifies you from clinical trials?

What is exclusion criteria? Exclusion criteria is a list of characteristics that disqualify a person from participating in a clinical trial. These characteristics can vary from demographic information like age, gender, or race to something as complex as comorbidities, organ dysfunction, or the use of other medications.

Is FDA approval required for clinical trials?

What Does FDA Require Regarding Certification? To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions.

How long does it take to register a clinical trial?

This process typically takes 2-5 days. Once your trial is successfully registered, the responsible party will receive an email with the trial's National Clinical Trials (NCT) number and the record will be viewable to the public.

How do I ask Medicare a question?

Call 1-800-MEDICARE For questions about your claims or other personal Medicare information, log into (or create) your secure Medicare account, or call us at 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.

How do I ask CMS a question?

Beneficiaries should call 1-800-MEDICARE (1-800-633-4227), TTY users should call 1-877-486-2048 for all of the following: General questions about the Shared Savings Program.

How can I contact Medicare by telephone?

(800) 633-4227Centers for Medicare & Medicaid Services / Customer service

Why do clinical trials have eligibility criteria?

Why Are Eligibility Criteria Necessary? Eligibility criteria are an important part of clinical trials. They help ensure that participants in a trial are alike in terms of specific factors, such as type and stage of cancer, general health, and previous treatment received.

Do you need health insurance to participate in clinical trials?

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.

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For specific billing questions and questions about your claims, medical records, or expenses, log into your secure Medicare account, or call us at 1-800-MEDICARE.

1-800-MEDICARE (1-800-633-4227)

For specific billing questions and questions about your claims, medical records, or expenses, log into your secure Medicare account, or call us at 1-800-MEDICARE.

What is Medicare approved amount?

Medicare-Approved Amount. In Original Medicare, this is the amount a doctor or supplier that accepts assignment can be paid. It may be less than the actual amount a doctor or supplier charges. Medicare pays part of this amount and you’re responsible for the difference. , depending on the treatment you get.

How do clinical studies work?

Clinical research studies (also called clinical trials) test how well different types of medical care work and if they’re safe, like how well a cancer drug works. Clinical research studies may involve diagnostic tests, surgical treatments, medicine, or new types of patient care. They may: 1 Study how well new treatments and tests benefit patients 2 Compare different treatments for the same condition to see which treatment is better 3 Study new ways to use existing treatments

Why is it important to participate in clinical trials?

Participating in clinical trials is of paramount importance because it allows new cures to pass the safety procedures, known as clinical trial phases, and to become available to the general population.

What is DoNotPay for Medicare?

DoNotPay is the fastest way of finding clinical trials covered by Medicare. You don’t have to waste your precious time looking for clinical studies by googling ‘clinical trials near me’ and deciding on what website to visit. To be done with the process in a heartbeat, do the following:

When was the 2000 clinical trial policy issued?

The Health Care Financing Administration (now the Centers for Medicare & Medicaid Services, or CMS) responded to the executive order with the clinical trial policy national coverage determination (NCD) issued on September 19, 2000 The 2000 policy may be found through the link below labeled, "2000 Clinical Trial Policy".

Why are clinical trials important?

Clinical trials are key to understanding the appropriate use of medical interventions of all types and informing payers about what services to cover. Only a very small percentage of American seniors participate in clinical trials, although the elderly bear a disproportionate burden of disease in the United States.

When did CMS change the CTP?

On July 19, 2007, CMS began a reconsideration of the 2000 CTP which proposed that the CTP be renamed the Clinical Research Policy and that a process be established that clinical research study sponsors/principal investigators must use to certify to CMS that their study meets the scientific and technical standards described in the proposed policy.

When did Medicare start paying for patient care?

On June 7, 2000, the President of the United States issued an executive memorandum 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.”. The Health Care Financing Administration (now ...

When was the 2000 CTP final decision issued?

We issued a final decision memorandum on July 9, 2007 that preserves the status quo of the 2000 CTP with the exception of the following changes: Clarification that items that are covered outside the trial are covered inside the trial.

Who do I submit to

Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage must submit a request for review and approval to CMS.

Claim Submissions

Effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QV modifier to identify the device.

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