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What Happened, What You Missed: March 13-17, 2023

VA to Cover Controversial New Alzheimer’s Drug

The Department of Veterans Affairs (VA) has agreed to cover new Alzheimer’s disease drug Leqembi for patients with early-stage Alzheimer’s, making the VA the first and largest health program in the nation to cover the drug.  Developed by Biogen and Esai, the monoclonal antibody treatment is considered controversial because around one-fifth of patients who participated in a clinical trial experienced brain bleeding or brain swelling.  The Food and Drug Administration (FDA) initially approved the drug in January and has since updated its warning label to encourage physicians to warn patients of the side effects.  It appears the VA will remain the only health program to cover the drug, as the Centers for Medicare and Medicaid Services (CMS) has communicated that it wants more evidence about the effectiveness of the Leqembi before making a coverage decision.

JAMA: Mortality Rates for Kids, Teens on the Rise

Following years of progress against pediatric deaths, the all-cause mortality rate for people ages one to 19 years increased by about 10% each year between 2019 and 2021, according to a new study from the Journal of the American Medical Association (JAMA).  Firearms are the leading cause of death for children and adolescents, and they account for nearly half of the increase in all-cause mortality in 2020.  Drug overdoses and automobiles were the second and third leading causes of death.  To turn the tide, the study calls for the enactment of sensible firearm safety laws as well as new efforts to address social inequities, segregation, and structural racism.

Maternal Mortality Rates Rose in 2021

The deaths of pregnant women in the US rose last year, according to new data from the Centers for Disease Control and Prevention (CDC) as deaths of pregnant women reached a six-decade high. The report found that 1,205 people died of maternal causes in the U.S. in 2021, which represents a 40% increase from the previous year.  The report also found significant racial disparities in the maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is over two-and-a-half times the rate for White women, at 26.6 per 100,000.

FDA Approves Pfizer’s COVID-19 Booster for Kids under 5

The FDA authorized Pfizer’s Omicron booster shot for children under five years of age who were previously vaccinated with the company’s initial three-dose vaccine regimen.  Since December, children under five who completed two doses of Pfizer’s original vaccine have been eligible to receive the Omicron booster as their third shot, or last dose in their initial vaccination series. The FDA noted that children who received the Omicron shot as their third dose aren’t eligible for the bivalent booster right now, but they should still be protected against severe complications from COVID-19.

KFF: Non-Profit Hospitals Had Estimated $28M Tax Exemption in 2020

Non-profit hospitals received $28 million in tax subsidies but only provided $16 billion in charity care, according to a new analysis from the Kaiser Family Foundation (KFF).  The findings come amid questions from lawmakers over whether nonprofit hospitals provide enough benefits to their communities to justify their federal, state, and local tax exemptions.  Some non-profit hospitals have also come under scrutiny for taking aggressive steps to collect unpaid medical bills, such as suing patients over unpaid medical debt.  According to the analysis, the nearly $28 billion tax exemption is equivalent to about 43% of net income generated by nonprofit hospitals in 2020.

ICYMI: White House Welcomes Special Visitors for St. Patrick’s Day

Irish pubs in Washington, DC aren’t the only institutions making special plans for St. Patrick’s Day.  Today, Irish Taoiseach Leo Varadkar will meet with President Joe Biden to commemorate the 25th anniversary of the Good Friday Agreement, a peace agreement that saw the end of the Troubles in Northern Ireland.  Additionally, Irish singer and former One Director member Niall Horn will appear in a special performance at the White House today.

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What Happened, What You Missed: February 27-March 3, 2023

Eli Lilly to Cut Price of Insulin

Drugmaker Eli Lilly will reduce prices for its most commonly prescribed insulins by 70%, according to a press release issued by the company on Wednesday.  Eli Lilly also announced that it would expand its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month.  The high price of insulin has come under increased scrutiny in recent years, as evident by President Biden’s comments on insulin prices in his most recent State of the Union address.  While Congress enacted a $35 monthly cap on insulin prices for Medicare recipients, the new law does not apply to people with diabetes that have commercial insurance coverage.  However, the impact of Eli Lilly’s reduced prices appears to be limited.  The lower prices will only apply to the drugmaker’s older insulin products, and most people who require insulin use products from other drug manufacturers like Novo Nordisk and Safoni.  At the moment, it’s unclear if other insulin manufacturers will follow suit with Eli Lilly.

Colorectal Cancer Rates Among Young People on the Rise

Amid an overall decline in colorectal cancer cases, the number of new colorectal cancer cases among younger Americans is growing, according to a new report from the American Cancer Society.  Adults under the age of 55 comprise about 20% of new colorectal cancers, and the report says that the portion of Americans under age 55 has increased from 11% in 1995 to 20% in 2019.  Cancer experts say the rise in colorectal cancer cases could be attributed to environmental changes and dietary habits such as high consumption of ultra-processed foods. The report also found that more people are surviving colorectal cancer, with the survival rate at least five years after diagnoses increasing from 50% in the mid-1970s to 65% in 2018.

FDA Panel Endorses RSV Vaccines for Seniors

A Food and Drug Administration (FDA) advisory panel voted this week to recommend respiratory syncytial virus (RSV) vaccines by Pfizer and GlaxoSmithKline (GSK) for adults ages 60 and older.  While most of the panel agreed the vaccines are effective, some members were concerned about the vaccines’ relationship with nervous system disorders like Guillain-Barré syndrome.  The FDA granted priority review status to both vaccines from Pfizer and GSK, which reduces the approval timeline by four months. The end of the review period is expected to be May 2023 for both shots.  There is currently no vaccine for RSV in either adults or children, although vaccine for infants may be available by fall 2023.

Slotkin Announces Bid for Stabenow’s Senate Seat

Rep. Elissa Slotkin (D-MI) announced on Monday that she’s running for the Senate seat being vacated by Sen. Debbie Stabenow (D-MI).  Her decision to run for the battleground Senate seat leaves an open House seat in a competitive district that Democrats will have to defend.  While Slotkin is the first Democrat to announce her campaign, two Republicans – Michael Hoover and Nikki Snyder – have already declared their candidacy.  First elected to Congress in 2018, Slotkin worked as a Central Intelligence Agency analyst before serving as a senior Defense Department official from 2012 to 2014.  Within 24 hours of her announcement, Slotkin’s campaign raised $1.2 million.

ICYMI: Lawmakers Prevail over Lobbyists in Congressional Hockey Challenge

Members of Congress triumphed over lobbyists for the fifth consecutive time in the Congressional Hockey Challenge on Wednesday night.  Due to the House being out of sessions, Reps. Tom Emmer (R-MN), Dean Phillips (D-MN) were one of the few members of Congress who played for the Lawmakers, as the majority of the team’s roster consisted of current and former congressional aids.  The match took place at the MedStar Capitals Iceplex, the Washington Capitals’ practice facility in Arlington. (Zolpidem)   Nearly all proceeds from the game are directed towards hockey related organizations like the Professional Women’s Hockey Players Association and the Fort DuPont Ice Hockey Club.

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What Happened, What You Missed: February 20-24, 2023

Multiple Problems Plague Primary Care in America

Primary care across the nation is in a dire state, according to a new report from the Milbank Memorial Fund and the Physicians Foundation.  Among the most concerning findings is an increase in the percentage of adults who don’t have a usual source of care, and the fact that too few primary care physicians are being trained in community settings.  According to the report, a major contributing factor to these problems is inadequate investment in primary care.  For example, average spending on primary care for all insurance types declined from 6.2% in 2013 to 4.6% in 2020, which is far below average spending in other wealthy nations.

FDA Begins Review of Babies’ RSV Vaccine

The Food and Drug Administration (FDA) granted priority review for a vaccine to protect infants up to six months of age from respiratory syncytial virus (RSV), according to an announcement from Pfizer.  The priority review status means the agency will try to review the application within six months instead of the standard 10.  There are currently no RSV vaccines available for infants, and the FDA offers priority review for drugs that promise “significant improvements” over existing drugs.  If deemed effective, the Pfizer’s RSV vaccine could be available for infants ahead of a likely RSV season next winter.

FDA Issues First Fines to E-Cigarette Manufacturers

The FDA fined four electronic cigarette manufacturers over their alleged sales of unauthorized products on Wednesday, marking the first time the agency has issued civil money penalty complaints against tobacco product manufacturers for allowing products to go to market without federal approval.  According to a press release, the FDA has sent more than 550 warning letters since the start of 2021 to companies that manufacture, sell, or distribute new tobacco products without being allowed. Most of the companies that received warning letter have taken their products off the market and are now complying with FDA regulations.

Poll: High Costs Is America’s Number 1 Public Health Worry

Reducing high drug and health costs was the top public health priority for 50% of Americans, according to a new poll from Axios-Ipsos.  In comparison, 14% said reducing gun deaths and another 14% listed research into cures and treatment for major diseases as a top priority for government intervention.  When asked to name the number one threat to public health, over a quarter of respondents said opioids and fentanyl, 21% cited obesity, 17% listed gun violence, and 12% said cancer.  Additionally, a large majority of respondents said the country is not prepared to handle another pandemic.  The poll was conducted in February and included over 1,200 adults.

ICYMI: Cicilline to Resign from Congress in June

Rep. David Cicilline (D-RI) announced earlier this week that he will officially leave Congress on June 1, 2023.  A member of the Foreign Affairs and Judiciary committee, the 61-year-old Cicilline has been elected to seven terms in Congress.  Prior to entering Congress, he served in the Rhode Island state legislative and as mayor of Providence.  Cicilline is leaving to Congress to lead the Rhode Island Foundation, which supports community programs in the Ocean State through grants and investments.  His retirement will trigger a special election in the heavily Democratic 1st Congressional District.

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What Happened, What You Missed: February 13-17, 2023

Administration Proposes New Medicare Drug Pricing Reforms

On Tuesday, the Centers for Medicare and Medicaid Services (CMS) announced a trio of drug pricing proposals that would standardize how much Medicare beneficiaries pay for certain generic drugs, explore new ways for Medicaid to pay for expensive cell and gene therapies, and test ways to pay for drugs approved without a proven clinical benefit.  The proposals stem from an executive order President Biden signed last year directing the administration to develop demonstrations that would complement the drug pricing provisions of the Inflation Reduction Act. Beyond the three proposals, CMS also called for more research to encourage adoption of biosimilars, data access to support price transparency, and access to cell and gene therapies under Medicare.

Administration Proposes Nursing Homes Disclose Connections to Private Equity

Nursing homes would have to disclose whether private equity firms or real estate investment trusts own or help operate facilities under a proposed CMS rule released on Monday.  The rule would require nursing homes to report such relationships during the Medicare and Medicaid enrollment process, which would enable government agencies and the public to more easily determine whether nursing home owners are private equity investors or real estate investment trusts.  In response, the American Health Care Association and National Center for Assisted Living (ACHA/NCAL) called the rule a “distraction from the real issues” facing nursing homes, like the underfunding of Medicaid and workforce shortages.

Feinstein Announces Retirement

Sen. Dianne Feinstein (D-CA), the Senate’s oldest member, announced her retirement on Tuesday.  A former mayor of San Francisco, Feinstein announcement came amid concerns regarding her age and mental acuity.  She is the first woman to have chaired the Senate Rules Committee and the only woman to have chaired the Select Committee on Intelligence. Since the announcement, Reps. Katie Porter (D-CA) and Adam Schiff (D-CA) have both announced their plans to run for Feinstein’s Senate seat, and Rep. Barbara Lee (D-CA) is widely expected to announce her own Senate run.

FDA Issues New Warnings on Aduhelm

The Food and Drug Administration (FDA) recently updated the label of Biogen’s Alzheimer’s drug Aduhelm following the death of a 75-year-old woman who experienced brain bleeding and swelling while taking the drug.  The new label calls on physicians to “inform patients that events of intracerebral hemorrhage” can happen infrequently when taking Aduhelm.  According to clinical trial data, 41% of Aduhelm-treated patients experienced brain bleeding and/or swelling, compared to 10% of patients on placebo.  Aduhelm received a controversial accelerated approval from the FDA in June 2021, despite mixed data on the drug’s clinical benefit for Alzheimer’s patients.  Aduhelm sales have remained low due to the drug’s high price tag and a decision from some major university hospital systems to not prescribe the drug.

ICYMI: UFO Fever Hits Washington…Again

Members of Congress and the general public has once again become enamored with unidentified flying objects (UFOs) after the Pentagon admitted to shooting down three such UFOs last weekend.  Details about the recent incidents remain sparse as earlier this week, Sen. Jim Risch (R-ID) said the craft was “smaller than a car,” and that one carried “a payload.”  However, other senators have been quick to clarify that the objects are not extraterrestrial in origin.  In recent years, UFO fascination in Congress has centered around reports of unidentified ariel phenomena (UAP) from US Navy personnel.

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What Happened, What You Missed: February 6-10, 2023

Judge Dismisses Lawsuit to Block States from Importing Drugs

On Tuesday, US District Court Judge Timothy Kelly dismissed a lawsuit from PhRMA that sought to block states from importing prescription drugs from Canada.  In his 26-page opinion, Kelly ruled that the plaintiffs were unable to prove that drug companies would face a “concrete risk of harm” from allowing drugs to be imported.  Additionally, Kelly explained that the drug industry lacked standing to file the lawsuit because there is no guarantee that the federal government will approve any state plans on drug importation.  The ruling comes amid growing concern about the rising cost of prescription drugs.  Over the years, many older Americans have traveled to Canada to purchase lower-cost drugs, while others have turned to online websites to purchase Canadian drugs.

PPE Manufacturers Launch New Lobbying Group

On Thursday, nine manufacturers of personal protective equipment (PPE) and health care supply chain stakeholders launched the American Medical Manufacturers Association (AMMA) to lobby for domestic production of PPE.  Most PPE used in US hospitals is currently manufactured in China, making it more vulnerable to supply chain disruptions and export restrictions, as was the case at the start of the COVID-19 pandemic.  To make American-made PPE more affordable, the AMMA will advocate for federal tax credits at a much higher reimbursement rate for hospital systems that purchase American-made equipment.

Survey: Most Hospitals Not Complying with Price Transparency Rule

Only about 25% of hospitals are fully complying with a federal price transparency rule, according to a new survey of 2,000 large hospitals from the Patient Rights Advocate.  Implemented at the start of 2021, the Hospital Transparency Rule requires all hospitals to post their prices online in an accessible and searchable format.  While the survey found that most hospitals had posted their files online, the survey’s authors did not deem these hospitals to be fully compliant because the files were incomplete or not clearly associated with a plan or person.  However, the survey did show an increase of compliant hospitals from a previous survey in August 2022 where only 16% of hospitals were considered fully compliant.  Lawmakers from both parties have expressed an interest in exploring hospitals’ compliance with price transparency rule in the new Congress.

CDC Adds COVID-19 Shots to Immunization Schedules for Children, Adults

On Thursday, the Centers for Disease Control and Prevention (CDC) added COVID-19 vaccines to its immunization schedules for children, adolescents, and adults.  Changes to the schedules also include new recommendations on influenza and pneumococcal vaccines, as well as new vaccines for measles, mumps, and rubella (MMR), and for hepatitis B.  The inclusion of COVID-19 vaccines on the schedules normalizes the vaccines by being considered another routinely recommended vaccine.  However, the updated schedules do not mean schools will require COVID-19 vaccines, as school vaccination requirements are determined by state or local jurisdictions.

IMCYI: Labor Advocates Call for Senate Staff to Unionize

Amid an uncertain future for House staffer unions, the Congressional Workers Union (CWU) is urging Senate leaders to hold a vote later this month on whether to allow Senate staffers to unionize.  According to the CWU, if the Senate does not hold a vote by March, two Senate offices will voluntary take steps to seek voluntary recognition.  The House started allowing offices to unionize last year when the chamber was controlled by Democrats, but the new Republican majority in the House has since banned staff unions.  For unions to become a reality in the upper chamber, the Senate would have to approve an authorizing resolution.  However, given the 60-vote filibuster threshold, any successful resolution would require GOP support, and so far, no Senate Republicans have voiced their support for such a move.

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