Tag: FDA

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.”

FDA Approves First COVID-19 Vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, the first COVID-19 vaccine to move enjoy a status beyond emergency use status in the United States.

The Pfizer vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

William A. Dombi, President of the National Association for Home Care & Hospice (NAHC) hailed the approval, calling the coronavirus vaccines “safe and vitally important for us to move beyond the COVID pandemic.”

From the beginning of the public health emergency, NAHC has been at the forefront of COVID-19 education and advocacy. You can learn more about coronavirus and care in the home at the following pages:

About 85 million eligible Americans remain unvaccinated and the federal government hopes FDA approval will encourage many of them to now get vaccinated. Those who continue to reject vaccination may face considerable problems keeping or getting jobs, as well as gaining access to some public facilities and private businesses.

A June 2021 Kaiser Family Foundation poll found about 30 percent of unvaccinated Americans would be more likely to get vaccinated if a vaccine receives regulatory approval.

The Equal Employment Opportunity Commission approved some COVID vaccine requirements and incentives, as we reported in this space back in early June.

FDA approval of the Pfizer vaccine is likely to trigger a wave of vaccine requirements by cities, businesses, universities, health care systems and organizations, and more. The Veterans Administration became the first federal agency to require the COVID vaccine for employees, followed quickly by the Department of Defense, and the Department of Health & Human Services health care workers. The Pentagon vaccine requirement covers 1.3 million active duty troops and comes into effect after approval of the first vaccine, which has just occurred.

California has come close to a vaccine mandate for health care workers, while Oregon has created a vaccine mandate for schoolteachers and staff in public schools from kindergarten through 12th grade.

United Airlines recently announced it will require all employees to show proof of vaccination within five weeks of FDA approval of a vaccine.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

According to Pfizer, it showed the FDA data from 44,000 clinical trial participants in the United States, South America, European Union, Turkey, and South Africa, demonstrating the vaccine is 91 percent effective in preventing infection.

As NAHC Report reported on Wednesday, August 18, the Biden Administration has developed a plan to begin offering COVID-19 booster shots this fall, subject to an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines, and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.

The National Association for Home Care & Hospice has strongly communicated to HHS how important it is that shipments of booster vaccines be sent directly to home care providers, so that safe and efficient booster vaccinations of the elderly and disabled – the most at-risk population – can take place in the home. NAHC will continue to make this case and we will keep our members up to date on this critically important topic.

“We look forward to working with the Administration to get vaccines to a very vulnerable group of individuals who, in many cases, are homebound and cannot otherwise secure the life-saving Covid vaccines and booster shots,” said NAHC President Bill Dombi, in response to the news.