FDA Recalls Ellume At-Home COVID Tests

Posted on by lad3

The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume, indicating the test kits may produce “false positives” due to a manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA. Earlier this year, the Biden administration cut a $231.8 million deal with Ellume to boost the availability of the tests in the U.S. market.

Ellume says it has corrected the manufacturing problem and the FDA says it is continuing to monitoring the company’s efforts.

Federal Judges Offer Mixed Ruling Concerning 340B Drug Program

Posted on by lad3

Fierce Healthcare reported on November 8, 2021, that drug manufacturers cannot unilaterally restrict sales of 340B drugs to contracted pharmacies, but they do not have to provide discounts either, according to two separate rulings by federal judges. The lawsuits were filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics in response to a Biden administration warning to drug makers to walk back restrictions imposed in summer 2020.

Read more.

CMS Releases Guidance on Mandatory Coverage of COVID-19 Treatment

Posted on by lad3

CMS released guidance on the American Rescue Plan’s requirement that state Medicaid and CHIP programs cover COVID-19-related treatments without cost-sharing. Beginning Mar 11, 2021, state Medicaid programs are required to cover treatments for COVID-19, including specialized equipment and therapies, preventive treatments and treatments for “long COVID-19.” States must also cover the treatment of conditions, without cost sharing, that may seriously complicate the treatment of COVID-19 (like cardiovascular diseases, chronic lung diseases, and cancer) if these services are already included in the state plan or a waiver.

To ensure that all state plans reflect the statutory requirements, states must submit a Medicaid state plan amendment attesting to coverage of these treatments without cost-sharing.

OSHA ETS to Minimize COVID-19 Transmission in the Workplace

Posted on by lad3

On Thursday, November 4, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) with the goal of minimizing COVID-19 transmission in the workplace. The ETS is for employees of large employers (100 or more employees).

Who is covered by the ETS? The ETS applies to employers in all workplaces that are under OSHA’s authority and jurisdiction, including the health care industry. However, this standard does not apply in settings where employees provide health care services or health care support services when subject to the requirements of the CMS health care ETS.

Are remote workers subject to the requirements? The ETS does not apply to employees who do not report to a workplace where other individuals are present. However, even though the employee does not report to the workplace, the individual counts toward the count of employees.

When is this rule effective? The ETS is effective immediately upon publication in the federal register. The deadline to be vaccinated from COVID-19 is January 4, 2022. By that point, workers must be fully vaccinated, completing a two-dose regimen of either Pfizer or Moderna vaccines, or the single-dose Johnson & Johnson vaccine.

Do you have to be vaccinated to comply with this regulation? No, you do not. However, if an employee decides to not be vaccinated by January 4, 2022, the employee must provide weekly test results to their employees at their own expense. Additionally, workers who remain unvaccinated will be required to wear a mask at work.

Information an employer must supply. The ETS requires employers to provide employees information in understandable language and literacy about: 1) information about the requirements of the ETS and workplace policies and procedures; 2) the CDC document “Key Things to Know About COVID-19 Vaccines,” 3) information about protections against retaliation and discrimination; and 4) information about laws that provide for criminal penalties for knowingly suppling false statements or documentation.

Is this rule being challenged in court? Yes, on Friday, November 5, 2021, 26 states filed suit challenging the ETS regarding COVID-19 vaccination and testing requirements issued by OSHA. In response, a federal appeals court halted the vaccine mandate for businesses. Timeline for when this rule will be litigated remains unclear, but that this time there has been no change to the January 4, 2022, effective date.

National Association of Chronic Disease Directors Announces Launch of the Center for Advancing Healthy Communities

Posted on by lad3

The National Association of Chronic Disease Directors (NACDD) announces the launch of its Center for Advancing Healthy Communities (CAHC), which will work to foster healthy communities for all by advancing health equity and eliminating social barriers.

“Despite incredible advances in the health field, disparities across our country are profound. Access to healthy living opportunities should be available to everyone,” said John W. Robitscher, MPH, NACDD’s CEO. “Through this Center, we are committed to making public health programs in communities across states and territories more effective, more equitable, and more inclusive.”

Led by Jennie Hefelfinger, MS, the Center’s efforts will leverage best practices and evidence-based programming to impact food and nutrition security, physical activity and the built environment, tobacco cessation, obesity, social connectedness, chronic disease-related mental health, and equity/social justice. It will build upon successful NACDD-led projects such as Building Resilient Inclusive Communities, the Walkability Action Institutes, Worksite Wellness, and more.

At Center launch, programs and team members include: 

“We want to make every community healthier and stronger. Over the years, we’ve learned that the best way to accomplish this is to work together; to listen, to share, to nurture, and to work collectively to maximize the impact of each program,” said Hefelfinger. “We are excited to launch this Center, which will coordinate programs that logically work together, provide thought leadership to our partners, and continue to advance the mission of NACDD.”

CAHC will provide technical assistance and training for program implementation while expanding capabilities and resources, promoting healthful policy and environmental change, and collaborating to foster mutually beneficial partnerships.

“Our team of public health professionals at NACDD has been implementing chronic disease prevention and health promotion programs for more than 30 years,” Robitscher said. “Not only do we know how to make the programs effective, but we know where the opportunities are to integrate programs, share best practices, and make public health more impactful.”

Visit https://chronicdisease.org/the-center-for-advancing-healthy-communities/ to learn more.

The Community Health Literacy Assessment

Posted on by lad3

A community health assessment identifies a community’s health status, needs, and issues through partner engagement and data collection and analysis. This information can help organizations develop a community health improvement plan and justify how and where resources should be distributed.

Historically though, community health assessments have not collected data on community health literacy measures. Researchers at the Herschel S. Horowitz Center for Health Literacy at the University of Maryland developed the Community Health Literacy Assessment (CHLA) to help bridge this gap.

Visit Community Health Literacy Assessment to learn more about this resource.

CMS Publishes 2022 Physician Fee Schedule (PFS)

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The annual Physician Fee Schedule (PFS) final rule announces policy changes which sets the rates for Medicare payments made under the PFS, and updates for the Quality Payment Program (QPP) for Calendar Year 2022 has been released/published.

The annual Physician Fee Schedule (PFS) final rule announces policy changes which sets the rates for Medicare payments made under the PFS, and updates for the Quality Payment Program (QPP) for Calendar Year 2022 has been released/published.  Please review the following links for further information on those items.

Should you wish to contact CMS QPP directly please use the following below information.

  • By Phone: Monday – Friday 8 a.m. – 8 p.m. ET 1-866-288-8292 (TRS: 711)
  • By Email: QPP@cms.hhs.gov

USDA Invites Applications for Grants to Improve Access to Healthy Foods While Creating Jobs for People Living in Underserved Rural Areas

Posted on by lad3

Agency to Host Informational Webinar on Wednesday, Nov. 17

U.S. Department of Agriculture (USDA) Under Secretary for Rural Development Xochitl Torres Small has announced that USDA is inviting applications for at least $4 million in grants to improve access to healthy foods while creating jobs for people in underserved rural areas.

USDA is making the grants available under the Healthy Food Financing Initiative Targeted Small Grants Program. Through this program, USDA is partnering with the Reinvestment Fund, the National Fund Manager, to provide the funding. Qualified grantees include grocery stores and food distributors that are working to improve access to healthy foods in underserved areas. These awards are expected to create and preserve quality jobs and revitalize low-income communities. The funding is authorized by the 2018 Farm Bill.

To apply, applicants must submit a letter of interest by Tuesday, Dec. 7, 2021. If invited to apply, applicants must submit a full application. Additional information on how to apply is available at www.investinginfood.com.

USDA and the Reinvestment Fund are hosting an informational webinar on Wednesday, Nov. 17 at 1 p.m. Eastern Time for interested parties to learn more about the program. To register, visit https://register.gotowebinar.com/register/4101009465716687631.

For more information, please contact help@investinginfood.com.

If you’d like to subscribe to USDA Rural Development updates, visit our GovDelivery subscriber page.

CMS OMH Celebrates National Rural Health Day

Posted on by lad3

Throughout the month of November, the Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH) is recognizing National Rural Health Day, November 18, and highlighting the unique health needs of rural communities.

Despite comprising the vast majority of the land area in the U.S., rural areas only contain about 19% of the U.S. population (or approximately 60 million people). People who live in America’s rural areas face unique barriers to health care – including longer travel distances to receive care, a shortage of health care providers, lack of broadband internet access, etc. These can contribute to worse health outcomes for this population. In comparison to their people in urban communities, people who live in rural America are at a greater risk of death from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke. Black, Asian or Pacific Islander, White, and Hispanic populations that live in rural areas have also been shown to receive generally worse results for clinical care.

Existing health disparities can also be seen in COVID-19 vaccination rates between those who live in rural areas and those who live in urban areas. While 46% of adults in urban communities received their COVID-19 vaccine between December 2020 and April 2021, only 39% of adults living in rural areas were vaccinated during that same time period.

During November, we’re placing a spotlight on the work being done within CMS OMH and across all federal agencies to help address these disparities. Below are resources that you can share to help improve the health of rural Americans.

COVID-19 Vaccine Webinar for Rural Communities

On Monday, November 15, CMS OMH, along with representatives from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, will host a webinar to discuss federal COVID-19 resources, health care workforce mandates, health care coverage related to the COVID-19 vaccine, and more.

Resources

CMS recognizes that more than 57 million Americans live in rural areas, and face several unique challenges.  And those challenges can differ dramatically among the different kinds of rural areas across the country.  Rural residents tend to be older and in poorer health than their urban counterparts, and rural communities often face challenges with access to care, financial viability, and the important link between health care and economic development.

Contact RuralHealth@cms.hhs.gov for any questions or inquiries related to rural health policies and programs.

Rural America is Losing its Pharmacies

Posted on by lad3
The Washington Post

Batson’s Drug Store seems like a throwback to a simpler time. The independently owned pharmacy in Howard, Kan., still runs an old-fashioned soda counter and hand-dips ice cream. But the drugstore, the only one in the entire county, teeters on the edge between nostalgia and extinction.

Julie Perkins, pharmacist and owner of Batson’s, graduated from the local high school and returned after pharmacy school to buy the drugstore more than two decades ago. She and her husband bought the grocery store next door in 2006 to help diversify revenue and put the pharmacy on firmer footing.

But with the pandemic exacerbating the competitive pressures from large retail chains, which can operate at lower prices, and from pharmaceutical middle men, which can impose high fees retroactively, Perkins wonders how long her business can remain viable.

She worries about what will happen to her customers if she can’t keep the pharmacy running. Elk County, with a population of 2,500, has no hospital and only a couple of doctors, so residents must travel more than an hour to Wichita for anything beyond primary care.

“That’s why I hang on,” Perkins said. “These people have relied on the store from way before I was even here.”

Corner pharmacies, once widespread in large cities and rural hamlets alike, are disappearing from many areas of the country, leaving an estimated 41 million Americans in what are known as drugstore deserts, without easy access to pharmacies. An analysis by GoodRx, an online drug price comparison tool, found that 12% of Americans have to drive more than 15 minutes to reach the closest pharmacy or don’t have enough pharmacies nearby to meet demand. That includes majorities of people in more than 40% of counties.

Read more.