Tag Archives for U.S. Food and Drug Administration

US Senate Special Committee on Aging holds its First Hearing on Menopause

Published in RINewsToday on September 21, 2026

For generations, menopause was a health issue that many women were expected to deal with on their own, quietly. Last week, the U.S. Senate Special Committee on Aging took the issue into the public discussion, holding the first congressional hearing devoted exclusively to menopause.

The Sept. 16 hearing brought congressional attention to an issue affecting millions of American women navigating perimenopause, menopause and post-menopause. Approximately 2 million more women enter menopause each year.

Menopause affects women differently, but the symptoms can upend daily life. Women may experience hot flashes, vaginal dryness, insomnia, migraine headaches, brain fog, heart palpitations, mood changes, and changes in metabolism. For some, these symptoms become debilitating, disrupting daily and work routines and quality of life.

Senate Aging Committee Chairman Rick Scott (R-FL) and Ranking Member Kirsten Gillibrand (D-NY) convened the hearing, titled “Half the Country, Zero Hearings: Meeting the Moment to End the Menopause Care Gap in America,” to examine what lawmakers call the nation’s “menopause care gap.”

Medical experts, researchers, and women’s health advocates testified about the lack of research, physician training, and access to treatment.

The Senate Aging Committee hearing was a critical step in elevating this issue to determine what’s needed to improve medical research, training, and care for women experiencing menopause,” said Gillibrand in her opening statement.

“Menopause affects half of the population. For generations, women have been told to suffer in silence. I’m done with this silence,” she said.

Even though women in midlife make up a significant portion of the U.S. population, Gillibrand called menopause “one of the most under-researched, undertreated, and under-discussed” health issues in the nation. She pointed to estimates that less than 1% of federal women’s health research funding goes to menopause.

Gillibrand also noted that about 80% of OB-GYN residents report feeling ill-prepared to discuss menopause or its symptoms. The result, she said, is that many women seeking medical care are left without adequate treatment.

Menopause care also carries an economic cost. Gillibrand cited a Mayo Clinic study estimating that menopause costs the U.S. economy $26.6 billion annually, including $1.8 billion in lost work time.

“There’s simply no excuse for the lack of resources and information to help every woman navigate menopause and the challenges that come with it,” said Scott in his opening statement.

Scott cautioned that there is no “one-size-fits-all solution.” Instead, he called for women to have access to reliable information, qualified health care providers, and treatment options that allow them to make informed decisions about their health.

Scott also pointed to hormone replacement therapy as a safe treatment option for many women, while noting that lack of education and access can make it difficult for women to obtain appropriate treatment.

“We also need providers who have the most up-to-date training and who can clearly discuss treatment options with their patients,” said Scott, pointing to the shortage of health care providers as another barrier to care.

Scott and Gillibrand also announced that they sent a bipartisan letter requesting the Government Accountability Office to examine how the federal government both coordinates and funds menopause research and care. The senators say the report could help identify remaining gaps in research, education and treatment.

More Research Needed

Federal funding for research advancing menopause care is inadequate, Dr. Jean Wactawski-Wende, a SUNY Distinguished Professor who has conducted women’s health research for more than four decades, charged.

“In 1985, the National Institutes of Health put forward a study…the report said we’re not doing enough research on women…I’d argue we are now 35 years later, and we have not come all that far,” she told the committee.

“Clinical trials are the gold standard of evidence, and we do not have enough of those trials in women, especially in postmenopausal women,” added Wactawski-Wende.

She identified four areas needing greater attention: increased federal research on women’s health throughout the lifespan; chronic disease in aging women; better education and clinical care after menopause; and greater attention to healthy behaviors throughout life.

Dr. Lynne M. Coslett-Charlton, a board-certified gynecologist who has practiced in Northeastern Pennsylvania for 27 years, pointed to the U.S. Food and Drug Administration’s recent changes to warning labels for menopausal hormone therapy as a major shift in women’s treatment.

Coslett-Charlton also voiced concern that women might get menopause advice from social media influencers instead of from qualified clinicians. This could, in turn, lead them to buy unregulated supplements and products.

She noted that the American College of Obstetricians and Gynecologists has increased its educational efforts to steer patients toward safe, evidence-based, and medically appropriate care. Coslett-Charlton and ACOG also support passage of the Advancing Menopause Care and Midlife Women’s Health Act.

Training Doctors to Treat Menopause

Jennifer Weiss-Wolf, executive director of NYU Law’s Birnbaum Women’s Leadership Center, urged Congress to make telehealth part of the solution. She told lawmakers that virtual care could help connect women, particularly those in areas without specialists, to providers knowledgeable about menopause.

But telehealth has its own barriers, she cautioned, including poor internet connectivity and inadequate insurance coverage. Weiss-Wolf also warned that physician education about menopause must improve.

“For those who started residency after 2002 — statistically that amounts to more than half of all practicing OB-GYNs in the U.S. today — the majority have not had meaningful or even any menopause training,” she said.

Weiss-Wolf called for modern clinical trials that include millennial and Gen X women, with racial, ethnic and geographic diversity. She also urged researchers to use technology better to collect data and track symptoms.

She called on lawmakers to pass three federal bills to increase research and attention to women’s health: the Advancing Menopause Care and Midlife Women’s Health Act; the Service Women and Veterans Menopause Research Act; and the Hormone Health Data and Research Act.

“I Want to Feel Like Myself Again”

“When I ask patients what they hope to get from their care, I often hear, ‘I want to feel like myself again,’” said Dr. Suzanne Silverman Fenske, an obstetrician-gynecologist and integrative medicine practitioner who has practiced in New York City for nearly two decades.

“They want their energy back, relief from anxiety, and a sense of control over a body that suddenly feels unfamiliar,” she said, adding that she

Fenske told the Senate panel that before menopause, a woman’s risk of chronic disease is generally lower than a man’s. After menopause, that risk increases. She pointed to heart disease, hip fractures and urinary sepsis among the serious health problems facing older women.

Fenske also raised an issue that receives far less attention — how physicians are reimbursed for treating menopausal women.

“There is not much incentive for physicians to take care of menopausal women,” she told lawmakers.

Fenske said low insurance reimbursement makes it difficult for independent physicians to spend the necessary time with menopause patients. Large hospital networks may be better able to absorb those costs, she said, while smaller independent practices cannot.

Like the other witnesses, Fenske highlighted the lack of minimum standards for menopause education in medical residency programs.

Fenske offered lawmakers a striking comparison: OB-GYN residents are required to complete at least 200 vaginal deliveries, but there is no comparable minimum requirement for menopause education.  She called on Congress to push Medicare and the Departments of War and Veterans Affairs to make menopause education part of accreditation standards.

Black Box Warning Changes and Challenges

Menopause treatment has received renewed federal attention under Health and Human Services Secretary Robert F. Kennedy Jr., who announced in November 2025 that the FDA would begin removing its strongest “black box” warnings about cardiovascular disease, breast cancer and probable dementia from hormone replacement therapies, including estrogen. The first six revised labels were approved in February 2026, reflecting the administration’s position that overly broad warnings had discouraged women from seeking effective symptom relief. The change does not mean hormone therapy is risk-free: treatment remains an individual decision, with the FDA emphasizing initiation of systemic therapy before age 60 or within 10 years of menopause. The boxed warning about endometrial cancer remains for systemic estrogen-only products. On September 3, the FDA said it was working with manufacturers to increase estrogen patch supplies after rising demand made them harder to find.

Rhode Island No. 1 in U.S. Menopause Workplace Protections

On June 24, 2025, Gov. Dan McKee signed into law legislation (S 0361), introduced by Sen. Lori Urso (D-Dist. 8, Pawtucket), to support women experiencing menopause under the state’s fair employment statute—making Rhode Island the first state to enact such workplace protections explicitly. Rep. Karen Alzate (D-Dist. 60, Pawtucket, Central Falls) introduced a companion bill (H 6161), which passed by concurrence.

Rhode Island law already prohibits workplace discrimination based on pregnancy, childbirth, and related conditions. This includes requiring employers to provide reasonable accommodations and protecting individuals from being denied employment opportunities or promotions—or terminated—because of these conditions. The new law adds menopause to this list of protected health conditions.

“Menopause is a difficult and personal subject that has been stigmatized in this country,” said Sen. Urso in a statement announcing the bill’s passage. “But as something that affects half our population, it’s time we recognize it as a workforce issue—especially as our workforce ages along with our population. The current lack of protections contributes to inadequate retirement savings and lost leadership opportunities for women and poses an economic challenge for employers facing workforce shortages and the loss of experienced employees,” she says.

“Menopause is not something women choose to experience, and its effects on the mind and body can significantly impact daily life and job performance,” said Rep. Alzate. “Women should not have to risk being penalized or discriminated against at work due to a naturally occurring biological transition,” she says.

Rhode Island’s new law is paving the way for workplaces that actually support women experiencing menopause—and it sets a great example for the rest of the country to follow.

A Final Note…

For the millions of women now going through menopause — and the millions more who will follow them — the Sept. 16 hearing put an issue long discussed quietly in doctors’ offices and among women themselves squarely before Congress.

Whether the hearing ultimately results in more federal research, better physician training, and improved access to care will depend on what lawmakers do next. But after generations of silence, menopause finally received its first congressional hearing.

To read Scott and Gillibrand’s correspondence to GAO on the federal government’s role in Menopause research and education, go to Gillibrand Scott GAO Letter on Menopause

To watch the Sept. 16 Senate Aging Committee hearing, go to Half the Country, Zero Hearings: Meeting… | Senate Committee On Aging.

To read about RI’s new Menopause law, go to Rhode Island First in Nation to Add Workplace Protections for Women Experiencing Menopause – Herb Weiss

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Medicare slow to fix equity issue for seniors’ access to at-home COVID test kits

Published on Feb. 7 in Rhode Island News Today

Today home test kits were made available in a variety of ways – but, for Medicare recipients, it was a different story, being forced to go thru a different purchasing and payment process than those having private insurance, or no insurance. That process required the oldest and most at-risk population to take more than several steps, put up their own money, do a lot of paperwork, to seek reimbursement.

The White House made changes in testing so that at-home tests are now fully covered by health insurances. Those insured can pick up their test kits in a store and have them paid for at the time of purchase by their insurance, at no cost to the person. They aren’t required to visit their physician or get a prescription to obtain the free test. They have a limit of 8 test kits per month.

But, when the program began, this was not the plan for those insured through the government’s Medicare and Medicare Advantage plans.

Red Tape… Upfront Charges for COVID-1

Jane, a 65-year old Medicare beneficiary from Warwick went through the steps to get a kit after a relative she had seen found out she was exposed to COVID.  Before Medicare announced easing up on the purchasing process of COVID-19 test kits, she expressed frustrations to this writer about the regulatory hoops she faced because she was on Medicare – purchasing the test kits and getting reimbursed for the upfront charges. “First, I had to request a prescription from my physician and say that I had either been exposed to someone who had COVID, or I was having symptoms, myself,” recalls the frustrated Medicare beneficiary.  “Once my physician sent the prescription over to CVS, I was notified that it would take a couple of days before I could pick up the kits and that I would only be given two kits per prescription”, she fumed, knowing that sometimes it takes 4 or 5 days of testing to test positive, but was only eligible to receive two, and she might have to go through the whole process again in a few days.

“Three days later CVS finally left me a message saying these kits were in. I used the drive-up window for pickup and the cashier asked me for $46,” Jane remembered.  “When questioning this charge, a pharmacist came to the window to assist and told me that I had to pay for the kits upfront and then seek reimbursement,” she added.

Paying for the kits, Jane went home, and called Blue Cross, her Medicare supplement company and was told she needed to request a copy of the prescription which took hours to finally request with the back and forth phone calls to her busy doctor’s office. It was almost two weeks later she finally got a copy of the receipt detailing her $46 payment for the kits. She was then able to upload the copy of the prescription and a copy of her receipt to a BCBS reimbursement screen on her computer (or she could have printed the form out and mailed the whole package in). At press time, Jane is still waiting for her reimbursement, being told it will take from 4 to 6 weeks to receive a check.

It’s better late than never, says Jane, when she heard that Medicare would now cover free over-the-counter COVID-19 tests. “Not everyone can put out $46 and wait two months to get it back, home health tests were made available in a variety of ways – but, for Medicare recipients, there was a different process. More concerning was all the steps I had to take to complete the process they had originally intended for us to do. How many people would really complete all those steps?” she says. “We talk a lot about equity, but seniors need equitable healthcare processes, too.”

Just days ago, the Centers for Medicare & Medicaid Services (CMS) announced that beneficiaries 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, estimated to be in April. Under the new CMS 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). A prescription will not be required.

CMS Unveils New Medicare Benefit

According to CMS, 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. This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries.

CMS’s announcement follows last month’s announcement that the Biden-Harris Administration would be requiring commercial health insurance companies to cover at-home COVID tests for free.

Until the new benefit kicks in, Medicare beneficiaries can access free tests through a number of channels established by CMS, too. Now, they can request four free over-the-counter tests for home delivery at covidtests.gov. Or beneficiaries can access COVID-19 tests through health care providers at over 20,000 free testing sites nationwide. Many cities and towns are also giving out free test kits at drive-up handout programs as the state receives supplies.

CMS’s Feb. 3 statement noted that Medicare beneficiaries can also 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, says CMS.

In addition, CMS says that 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. Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit.

Finally, all Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

“AARP applauds today’s announcement that will guarantee access to at-home over-the-counter COVID-19 tests at no cost for Medicare’s 64 million beneficiaries and we thank [Health and Human Resources]Secretary Becerra and CMS Administrator Brooks-LaSure for their diligence in addressing this issue. Expanded access to no-cost testing will help protect seniors who have been hit hardest by the pandemic and ensure they can remain connected with their loved ones and community.,” says AARP Executive vice president and Chief Advocacy and Engagement Officer Nancy LeaMond in a statement issued with CMS’s Feb. 3rd announcement of the new Medicare benefit.

“Every American should have an easy way to get at-home COVID tests. We know that people 65 and older are at much greater risk of serious illness and death from this disease – they need equal access to tools that can help keep them safe. The cost of paying for tests and the time needed to find free testing options are barriers that could discourage Medicare beneficiaries from getting tested, leading to greater social isolation and continued spread of the virus, adds LeaMond.

Successfully Advocating the Seniors

Last month, Senators Sherrod Brown (D-OH) and Debbie Stabenow (D-MI) along with 17 of their  Senate colleagues including Rhode Island Democratic Senators Reed and Sheldon Whitehouse wrote to HHS Secretary Becerra and  CMS Administrator Brooks-LaSure urging them to expand Medicare coverage of free at-home rapid COVID-19 testing.

Aging groups also joined the Senators in pushing Medicare to offer the new testing kick benefit.  “It is clear that regular testing is a crucial part of managing the spread of COVID-19. That’s why AARP has been calling for coverage of at-home tests, says AARP’s LeaMond, noting that the nation’s largest aging advocacy group “will continue to watch for details about when and how at-home COVID tests are made available to those in Medicare.”

Thankfully CMS quickly heeded their calls.

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 (PDF)

Stay tuned for free N95 masks to be made available to all coming up soon.

It’s time. Staff vaccinations required for nursing homes as 10 RI facilities see new COVID cases

Published in Rhode Island News Today on August 24, 2021

With the COVID-19 Delta variant spiking across the country especially among the unvaccinated, last Wednesday, President Joe Biden announced at an afternoon address at the White House that the U.S. Department of Health and Human Services will require nursing homes to require all workers to be fully vaccinated against COVID-19 as a condition for those facilities to continue receiving federal Medicare and Medicaid funding.

According to federal data, of the 1.6 million nursing home workers across the  nation, about 540,000 — 40 percent of the work force — are unvaccinated.  

Since the spread of the Delta variant, there has been a rise in the number of COVID-19 cases, especially in those states that have low rates of vaccinated workers. Both the U.S. Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) data confirm a strong relationship between the increase of COVID-19 cases among nursing home residents and the rate of vaccination among nursing home workers.

These new emergency federal regulations, crafted  by CDC and CMS, would apply to nearly 15,000 nursing home facilities, which employ approximately 1.6 million workers and serve approximately 1.3 million nursing home residents.

Rhode Island Gov. Dan J. McKee, along with other states, has already taken a similar step to protect nursing home residents by requiring all staff to be vaccinated and the new federal mandate will ensure consistent and equitable standards throughout the country. 

At a COVID-19 update held at the state the state capitol in early August, McKee called for the new vaccine mandate (as a term of employment) to take effect on Oct. 1st.

On August 23rd, Pfizer’s vaccine was fully approved by the FDA. Approvals of Moderna, Johnson & Johnson and booster shots are expected to follow soon.

According to CMS, the new mandate is a key component of protecting the health and safety of nursing home residents and staff by ensuring that all nursing home staff receive COVID-19 vaccinations. Over the past several months, millions of vaccinations have been administered to nursing home residents and staff, and these vaccines have shown to help prevent COVID-19 and have proven to be effective against the Delta variant.

“Keeping nursing home residents and staff safe is our priority. The data are clear that higher levels of staff vaccination are linked to fewer outbreaks among residents, many of whom are at an increased risk of infection, hospitalization, or death,” said CMS Administrator Chiquita Brooks-LaSure in a statement announcing the new vaccine mandate.  “We will continue to work closely with our partners at the CDC, long-term care associations, unions, and other stakeholders to advance policies that keep residents and staff safe. As we advance these new requirements, we’ll work with nursing homes to address staff and resident concerns with compassion and by following the science,” she said.

CMS says that it’s requiring all nursing home staff to be vaccinated is in keeping with the federal agency’s authority to establish requirements to ensure the health and safety of individuals receiving care from all providers and suppliers participating in the Medicare and Medicaid programs. About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.

Last May, CMS issued new regulations that require Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to educate residents, clients, and staff about COVID-19 vaccination and, when available, offer a COVID-19 vaccine to these individuals. These regulations also mandate that LTC facilities report weekly COVID-19 vaccination data for residents and staff to the CDC’s National Healthcare Safety Network (NHSN).

CMS will continue to analyze vaccination data for residents and staff from the CDC’s National Healthcare Safety Network (NHSN) data as an additional method of compliance monitoring and in keeping with current practice, as well as deploy the Quality Improvement Organizations (QIOs)—operated under the Medicare Quality Improvement Program—to educate and engage nursing homes with low rates of vaccinations.

CMS strongly encourages nursing home residents and staff members to get vaccinated as the Agency undergoes the necessary steps in the rule-making process over the course of the next several weeks. CMS expects nursing home operators to act in the best interest of residents and their staff by complying with these new rules, which the Agency expects to issue next month.  CMS also expects nursing home operators to use all available resources to support employees in getting vaccinated, including employee education and vaccination clinics, as they work to meet this staff vaccination requirement.

Rhode Island Long Term Care Facilities with new cases in the last 14 days (as of 8/14/2020):

These RI nursing homes are on the RI Dept. of Health list with increased cases –

Alpine – Coventry – 5-9 cases

Avalone – Warwick – less than 5

St. Antoine – North Smithfield – less than 5

Woonsocket Health – Woonsocket – less than 5

All America Assisted Living – Warwick – less than 5

Anchor Bay – Johnston – less than 5

Smithfield Woods – Smithfield – less than 5

Sunrise House – Providence – less than 5

Bridge at Cherry Hill – Johnston – 5-9

Tockwotton – Providence – less than 5

AARP Strongly Supports Biden’s Vaccine Mandate in Nursing Homes 

In response to the Biden Administration directing all nursing homes that receive Medicare or Medicaid funds to require vaccinations for all staff, Nancy A. LeaMond, AARP Executive Vice President and Chief Advocacy & Engagement Officer, stated:  

“The Administration’s announcement today requiring vaccinations for nursing home staff is a significant step in the fight against this pandemic. Around 30% of COVID deaths have been among residents and staff in nursing homes and other long-term care facilities, even though they represent less than 1% of the population. As the new variants are emerging, facilities cannot let preventable problems be repeated. Increasing vaccination rates in nursing homes is one of the most common sense and powerful actions we can take to protect the lives of vulnerable older adults.”

The AARP Public Policy Institute, in collaboration with the Scripps Gerontology Center at Miami University in Ohio, created the dashboard to provide snapshots of the virus’ infiltration into nursing homes and impact on nursing home residents and staff, with the goal of identifying specific areas of concern at the national and state levels in a timely manner.

Don’t Just Single Out Nursing Homes 

“We appreciate the Administration’s efforts to increase COVID-19 vaccinations in long term care. Unfortunately, this action does not go far enough. The government should not single out one provider group for mandatory vaccinations. Vaccination mandates for health care personnel should be applied to all health care settings. Without this, nursing homes face a disastrous workforce challenge,” warns Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) 

“Focusing only on nursing homes will cause vaccine hesitant workers to flee to other health care providers and leave many centers without adequate staff to care for residents. It will make an already difficult workforce shortage even worse. The net effect of this action will be the opposite of its intent and will affect the ability to provide quality care to our residents. We look forward to working with the Administration in the coming days to develop solutions to overcome this challenge,” says Parkinson.

The full Nursing Home COVID-19 Dashboard is available at www.aarp.org/nursinghomedashboard. For more information on how COVID is impacting nursing homes and AARP’s advocacy on this issue, visit www.aarp.org/nursinghomes.