Tag: FDA

Recall of Certain Medfusion 3500 and 4000 Syringe Infusion Pumps

Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Recalled Product Product Name: Medfusion Syringe Infusion Pumps Models, Product…

Medicare to Cover Free Over-the-Counter COVID-19 Tests

People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities.

This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).

This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries. There are a number of issues that have made it difficult to cover and pay for over-the-counter COVID-19 tests. However, given the importance of expanding access to testing, the Centers for Medicare & Medicaid Services (CMS) has identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries. This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. CMS anticipates that this option will be available to people with Medicare in the early spring.

Until then, people with Medicare can access free tests through a number of channels established by the Biden-Harris Administration. Medicare beneficiaries can:

  • Request four free over-the-counter tests for home delivery at covidtests.gov.
  • Access COVID-19 tests through healthcare providers at over 20,000 free testing sites nationwide. A list of community-based testing sites can be found here.
  • Access lab-based PCR tests and antigen tests performed by a laboratory when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional at no cost. In addition to accessing a COVID-19 lab test ordered by a health care professional, people with Medicare can also already access one lab-performed test without an order, also without cost sharing, during the public health emergency.

In addition:

  • Medicare Advantage plans may offer coverage and payment for over-the-counter COVID-19 tests as a supplemental benefit in addition to covering Medicare Part A and Part B benefits, so Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit.
  • All Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

For more information, please see these Frequently Asked Questions, https://www.cms.gov/files/document/covid-19-over-counter-otc-tests-medicare-frequently-asked-questions.pdf

Medicare to Cover Free Over-the-Counter COVID-19 Tests

People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through…

Medicare to Cover Free Over-the-Counter COVID-19 Tests

People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities.

This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).

This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries. There are a number of issues that have made it difficult to cover and pay for over-the-counter COVID-19 tests. However, given the importance of expanding access to testing, the Centers for Medicare & Medicaid Services (CMS) has identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries. This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. CMS anticipates that this option will be available to people with Medicare in the early spring.

Until then, people with Medicare can access free tests through a number of channels established by the Biden-Harris Administration. Medicare beneficiaries can:

  • Request four free over-the-counter tests for home delivery at covidtests.gov.
  • Access COVID-19 tests through healthcare providers at over 20,000 free testing sites nationwide. A list of community-based testing sites can be found here.
  • Access lab-based PCR tests and antigen tests performed by a laboratory when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional at no cost. In addition to accessing a COVID-19 lab test ordered by a health care professional, people with Medicare can also already access one lab-performed test without an order, also without cost sharing, during the public health emergency.

In addition:

  • Medicare Advantage plans may offer coverage and payment for over-the-counter COVID-19 tests as a supplemental benefit in addition to covering Medicare Part A and Part B benefits, so Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit.
  • All Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

For more information, please see these Frequently Asked Questions, https://www.cms.gov/files/document/covid-19-over-counter-otc-tests-medicare-frequently-asked-questions.pdf

New Waived Tests

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988).

The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows:

  • 81003QW, September 23, 2021. Teco Diagnostics Inc. Uritek TC-201 Urine Chemistry Test System;
  • October 7. 2021, Cardinal Health Strep A Dipstick – Rapid Test;
  • 80048QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood);
  • 80053QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood);
  • 80051QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood);
  • 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood);
  • 80069QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood);
  • 80048QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood);
  • 80053QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood);
  • 80051QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood);
  • 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood);
  • 80069QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood); and
  • 87880QW, November 10, 2021, Cardinal Health H. Pylori Rapid Test – Whole Blood/Serum Cassette (Whole Blood).

Some home health and hospice agencies perform tests that are considered waived under the CLIA which requires the home health agency or hospice to have a CLIA Certificate of Waiver.  Waived tests a home health or hospice agency may perform include, but are not limited to:

  • Blood glucose by glucose monitoring devices cleared by the FDA for home use
  • Prothrombin time home tests (PT/INR)
  • Dipstick or tablet reagent urinalysis
  • Flu test
  • Drug test

Performing these types of tests, and any included in the Tests Granted Waived Status Under CLIA table, requires the agency to have a current CLIA certificate of waiver.  An agency that obtains a sample and takes it to a laboratory for testing is not required to hold a CLIA certificate of waiver for that particular test, i.e. PT/INR where the agency’s personnel obtain a blood sample from the patient and take that sample to a laboratory for testing.

New Waived Tests

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 81003QW, September 23, 2021. Teco Diagnostics Inc.…

Biden Admin Issues Guidance to States on Required Medicaid and CHIP Coverage for COVID-19-Related Treatment

The Centers for Medicare & Medicaid Services (CMS) issued guidance to states about the statutory requirement for states to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs. This life-saving health care coverage, supported through the American Rescue Plan (ARP), includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.

In addition to issuing Medicaid and CHIP guidance, CMS recognizes and applauds the efforts that many private issuers have taken to waive cost sharing for COVID-19-related treatment in the commercial market. Along with today’s guidance, CMS encourages private health plans to continue to take steps to ensure consumers have coverage for treatment for COVID-19, including for long COVID, without cost barriers.

Continue reading “Biden Admin Issues Guidance to States on Required Medicaid and CHIP Coverage for COVID-19-Related Treatment” →

New Waived Tests

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 87801 QW, March 30, 2021, binx health…

Biden Admin Issues Guidance to States on Required Medicaid and CHIP Coverage for COVID-19-Related Treatment

The Centers for Medicare & Medicaid Services (CMS) issued guidance to states about the statutory requirement for states to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs. This life-saving health care coverage, supported through the…

Statement from HHS Secretary on COVID-19 Vaccine for 5-11-year-olds

Following the Centers for Disease Control and Prevention’s (CDC) recommendation to make 5-11 year old children eligible for COVID-19 vaccines after the Food and Drug Administration’s (FDA)’s authorization, HHS Secretary Xavier Becerra issued this statement on the landmark moment to increase children’s protection during this pandemic:

“This is another major milestone in our efforts to protect more children, their families, and our communities as we work to end the pandemic. We are following the data and science, and after a thorough review by FDA and CDC, we are ready to get millions of children vaccinated. Thanks to their rigorous, comprehensive and independent review of the data, we know that vaccination of younger children against COVID-19 proved to be safe and effective.

“As we deliver millions of doses nationwide, we are working with states, localities, pediatricians’ offices, children’s hospitals, pharmacies and other trusted health care providers for families to ensure equitable access to the vaccine for our nation’s kids. Looking toward winter and the holiday season, we have another significant opportunity to get ahead of this pandemic and protect kids ages 5-11 from what has become a cause of death in this age group. We know many families are trying to decide what is right for them, and we encourage anyone seeking additional information talk to a doctor or health care provider to get the facts. COVID-19 vaccines are the best way to protect yourself and those you love from COVID-19, and the Biden-Harris Administration will continue working every day to get as many people vaccinated and protected from COVID-19 as possible.”