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Find our analysis on legislation, regulations, MedPAC meetings, and more. 

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

FDA Approves New Weight Loss Drug from Eli Lilly 

On Wednesday, the Food and Drug Administration (FDA) approved Eli Lilly’s diabetes drug tirzepatide for chronic weight management as public health undergoes a revolution in the treatment of weight loss.  Also known by its commercial name, Zepbound, the drug will be available to adults who are obese or overweight with at least one weight-related condition like high blood pressure.  Zepbound is the latest in new generation appetite-suppressing obesity drugs, following Novo Nordisk’s Ozempic in 2017 and Wegovy in 2021.  Eli Lilly estimates that Zepbound will be available in the US by the end of 2023 at a list price of $1,059.87. 

SFC Advances Bill to Lessen Impact of Medicare Payment Cuts 

Next year’s 3.4% cut to the Medicare Physician Fee Schedule (PFS) would be offset by 1.25% for one year, according to legislation unanimously advanced by the Senate Finance Committee on Wednesday.  Known as the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act, the bipartisan health care package contains other provisions to boost access to mental health and substance use disorder services for people enrolled in Medicare or Medicaid, address high drug costs for Medicare Part D beneficiaries, increase transparency around pharmacy benefit managers (PBMs), and other items. It is not yet clear when this package will advance through the Senate or be married up with similar legislation in the House. 

CDC: Newborn Syphilis Cases Reach 30-Year High 

Cases of congenital syphilis in the US reached a 3-decade height of 3,761 cases in 2022, according to new data from the Centers for Disease Control and Prevention (CDC).  While syphilis cases rose among all racial and ethnic groups, the CDC noted that infants born to Black, Hispanic, or American Indian/Alaska Native mothers were up to 8 times more likely to have newborn syphilis than infants born to white mothers.  The jump in cases comes amid a broader increase in sexually transmitted infections (STIs) nationwide, which public health experts attribute to a lack of access to testing and years of underinvestment in public health.  The data is additionally worrying since the only recommended treatment for syphilis in pregnant people is in short supply. 

Manchin Says He Won’t Seek Reelection in 2024 

Sen. Joe Manchin (D-WV) announced on Thursday that he won’t be seeking reelection next year, marking the end of a 14-year stint in the US Senate.  As next steps, the former West Virginia governor said he’ll be traveling the country to see if there’s interest in a “movement to mobilize the middle,” sparking concerns among Democrats that Manchin could seek a third party or independent bid for the White House in 2024.  Manchin’s retirement increases the already decent odds of the GOP retaking the Senate in next year’s elections due to the state’s strong Republican bend.  The centrist senator has been a key bipartisan swing vote for much of his Senate career, especially regarding President Joe Biden’s major legislative accomplishments like the American Rescue Plan Act and the Inflation Reduction Act. 

ICYMI: Interactive White House Museum Coming to Downtown DC 

The White House Historical Society has announced plans for a 33,000-square foot interactive museum – just a block away from the actual White House.   Dubbed “The People’s House: A White House Experience,” the museum will feature recreations and replicas of the Rose Garden and the Oval Office, along with various galleries and media to give visitors a sense of what it was like to be in the Executive Mansion at different points in history.  The museum is set to open in fall 2024. 

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What Happened, What You Missed: July 10-14, 2023

FDA Approves First OTC Birth Control Pill

The Food and Drug Administration (FDA) approved the first-ever over-the-counter (OTC) birth control pill for all women of reproductive age. Called Opill, the drug will be available without a prescription at pharmacies, grocery stores, and convenience stores, as well as online. Perrigo, the drug’s manufacturer, estimates that the drug will be available to consumers within the first few months of 2024. While Perrigo has pledged to make the drug “accessible and affordable,” the company has yet to disclose the pill’s price. Opill’s approval comes amid growing legal and legislative battles over women’s access to abortion services since the overturning of Roe v. Wade last year.

White House Outlines Plan to Fight Tranq

The White House released a National Response Plan to coordinate a whole-of-government response to address the risky combination of fentanyl and xylazine. Known as “tranq,” xylazine is an easily obtainable veterinary medicine that a growing number of drug dealers are cutting with fentanyl to extend a user’s high. A recent study found overdose deaths from xylazine-laced fentanyl increased by 276% between January 2019 and June 2022. The plan contains six areas of focus that address testing, data collection, supply reduction, research, and scheduling. Administration officials say the plan’s goal is to reduce the number of xylazine-related deaths by 15% in three of four US census regions by 2025.

Administration Proposes New Limits on Short-Term Plans

The Biden administration issued a proposed rule to reverse Trump-era policies that expanded the availability of short-term, limited-duration (STLD) plans. According to the rule, STLD plans would be limited from a maximum of three years to just three months, and STLD plan providers would be required to communicate to consumers what the plans do and do not cover. STLD plans do not have to meet the same requirements as Affordable Care Act (ACA) plans, such as coverage of pre-existing conditions and some essential health benefits like prescription drugs. Stakeholders have until September 11, 2023 to comment on the proposed rule.

CDC: More ER Visits Tied to Cannabis Use

A growing number of young people are going to the emergency room (ER) for marijuana-related emergencies, according to data from the Centers for Disease Control and Prevention (CDC). These ER visits occur when children and adolescents consume toxic levels of cannabis, which can result in confusion, vomiting, seizures, or difficulty breathing. The data found the sharpest rise in marijuana-tied ER visits among children under age 11, which increased 214% between 2019 and 2022. According to the CDC, pandemic-related stresses may have driven more children to consume cannabis products as a coping mechanism. The CDC recommends that adults safely and securely store marijuana products to help prevent unintentional ingestions among minors.

ICYMI: Climate Protesters Disrupt Congressional Softball Game

A group of protesters opposed to fossil fuels disrupted the Congressional Women’s Softball Game for 10 minutes, prompting several softball players to throw an impromptu dance party. Founded in 2009, the Congressional Women’s Softball Game pits lawmakers against journalists in a match to raise money for young survivors of breast cancer. The game resumed after Capitol Police told the protesters they would face arrest if they did not leave the field. Journalists prevailed over the lawmakers 15-9 in a game that raised a record $588,000.

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What Happened, What You Missed: July 3-7, 2023

FDA Fully Approves New Alzheimer’s Drug Leqembi

The Food and Drug Administration (FDA) granted full approval to Leqembi, setting up the stage for the Alzheimer’s treatment drug to become the first to receive broad coverage under Medicare. The announcement comes after months of lobbying by Alzheimer’s disease patients and advocates to make the drug more widely available through full approval. Developed by Eisai and Biogen, the drug slows the progression of Alzheimer’s disease by targeting amyloid plaques in the brain. However, Leqembi has faced controversy for its high $26,500 price tag that could lead to higher Medicare premiums, as well as reports of side effects like brain bleeding and swelling. CMS will require any physician who prescribes Leqembi to submit a patient’s medical information to a registry that will be used to evaluate the drug’s benefits or harms.

CMS Updates Guidance on Drug Price Negotiations

The Center for Medicare and Medicaid Services (CMS) recently issued revised guidance for the Medicare Drug Price Negotiation Program, likely in response to several lawsuits challenging the program. A component of the Inflation Reduction Act, the drug price negotiations are set to take course through next year. Since the IRA became law, the US Chamber of Commerce, Bristol Myers Squibb, Merck, and PhRMA have filed lawsuits against CMS that allege the program violates the First, Fifth and Eighth amendments of the Constitution. The new guidance offers relief for drug manufacturers who choose not to participate in the negotiation program by setting up a program for drugmakers to leave Medicare and avoid excise taxes.

Home Health Providers Sue CMS over Payment Cuts

The National Association for Home Care & Hospice (NAHC) filed a lawsuit against CMS that challenges a 3.925% payment cut for calendar year2023 that applies to home health providers. The lawsuit comes just days after CMS proposed a 2.2% cut in its calendar year 2024 Home Health Prospective Payment System proposed rule. The lawsuit alleges CMS put forth an invalid methodology to determine whether payment model changes are budget neutral. According NAHC, lower payments are forcing home care providers to close their doors, resulting in fewer patients receiving care. To address payment cuts, Sens. Debbie Stabenow (D-MI) and Susan Collins (R-ME) recently introduced legislation to take away some of CMS’s rate-setting authority.

JAMA: Maternal Mortality Rates Double

Maternal mortality rates have more than doubled between 1999 and 2019, according to a new study published by the Journal of the American Medical Association (JAMA). While the study found an increase in pregnancy-related deaths across all racial and ethnic groups, Black and Native American women were observed to have the highest death rates. Additionally, states in the South, the Midwest and the Great Plains saw the highest increases. Common causes of maternal death include mental health conditions, hemorrhages, hypertension, and blood clots. According to the study’s authors, increasing access to health care could prevent many pregnancy-related deaths.

ICYMI: It’s Summer Movie Season on the National Mall

“Summer Movies on the Lawn” officially returns next week with the screening of “Willy Wonka and the Chocolate Factory” (1971) on July 13. Started in 2017 by the Library of Congress, the summer movie series on the National Mall provides an opportunity for visitors to watch the National Film Registry in a scenic setting. The 2023 series will conclude on August 10 with the screening of “Jaws” (1975).

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What Happened, What You Missed: March 27-31, 2023

FDA Allows Narcan to Be Sold Over the Counter

On Wednesday, the Food and Drug Administration (FDA) approved Narcan, an opioid overdose-reversal drug, to be sold over the counter without a prescription. The announcement comes as opioid overdose deaths hover near record highs.  At a press conference, the Director of the White House Office of National Drug Control Rahul Gupta said businesses, such as restaurants, banks, and schools will be encouraged to purchase the drug. Narcan manufacturer Emergent BioSolutions said the spray will be available for online and over the counter purchase by the summer.

JAMA: Telehealth Linked to Fewer Opioid Overdoses

study published in the Journal of the American Medical Association (JAMA), found that the utilization of telehealth services for opioid use disorder during the COVID-19 pandemic reduced the odds for a fatal overdose among Medicare beneficiaries. The study determined that beneficiaries who started treatment during the pandemic and received telehealth services had a 33% lower risk of a fatal overdose. The study also found that fatal drug overdoses were 59% less likely among individuals who received medication to treat opioid use disorder and 38% less likely among those treated with buprenorphine in an office-based setting.

FDA Proposes Overhaul of Fast-Track Approval Process for Cancer Drugs

The FDA’s accelerated approval pathway could become more stringent, according to a draft guidance document released Tuesday. The accelerated approval pathway allows the FDA to approve a drug based on surrogate endpoints rather than a direct measure of a clinical benefit, which allows for drugs to receive an earlier approval. The draft guidance aims to strike a balance between speed and quality by requiring oncology drugs to go through randomized controlled trials (RTCs) that compare the effectiveness of an experimental drug against a conventional one.  The deadline for stakeholders to comment on the draft guidance is May 26, 2023.

Lawmakers Question Becerra on Coverage Determination for Alzheimer’s Drug

In multiple hearings to review the president’s proposed Fiscal Year (FY) 2024 budget, several Republican lawmakers voiced their criticism of a decision by the Centers for Medicare and Medicaid Services (CMS) to limit coverage of a class of Alzheimer’s drugs only to patients who are participating in relevant clinical trials. These drugs, which utilize amyloid plaque-blocking technology, have been marred with controversy due to their high cost and risk of side effects such as brain swelling and brain bleeding.  In response to the criticism, Health and Human Services Secretary Xavier Becerra repeatedly explained that FDA and CMS have different criteria for evaluating experimental drugs as mandated by law.

Most Doctors Say COVID-19 Misinformation a Problem

Seven in 10 doctors say misinformation about COVID-19 has made it harder to treat patients, according to a poll by the de Beaumont Foundation and Morning Consult.  A similar number of physicians surveyed said misinformation has negatively impacted patient outcomes.  The survey also found that 90% of physicians surveyed agreed on the benefits of COVID-19 vaccines.  Most doctors also noted that COVID-19 misinformation has seeped into other areas of health care, with two-thirds saying misinformation is common regarding weight loss, dietary supplements, mental health, and other vaccines.

Former Congressional Aide Launches Union Tracker for Senate Staff

former member of Minnesota Sen. Tina Smith’s staff launched a Senate Union Tracker earlier this month as a way to track which senators support collective bargaining protections for Senate staff and efforts to unionize among their own staff. Motivated by subpar pay and long hours during his time in the Senate, the former staffer hopes the tracker will help improve working conditions for those still working in the Senate.  Since the website launch, over a dozen Democrats have favorably voiced their support for unionization in the tracker.

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What Happened, What You Missed: January 2-6, 2023

House Report Criticizes FDA’s Approval of Alzheimer’s Drug

The Food and Drug Administration (FDA) inappropriately worked with the drug manufacturer Biogen for approval of the Alzheimer’s disease drug Aduhelm, according to a report from Democrats on two House committees.  Originally approved in July 2021, Adulhelm came under intense criticism for its uncertain clinical benefits, high list price, and potential for side effects like brain bleeding and swelling.  The report found the FDA’s interactions with Biogen were “atypical” – particularly through use of joint briefing documents – and failed to follow the agency’s own documentation protocol.  The report’s release precedes a highly anticipated January 6 announcement from the FDA on the approval of Lecanemab, another Alzheimer’s drug that uses a technology similar to Aduhelm that targets amyloid proteins in the brain.

OIG Report Calls for Better Part B Oversight

The Centers for Medicare and Medicaid Services (CMS) needs to conduct “robust oversight” to ensure that the agency makes appropriate payments for Part B-covered drugs, according to a new report from the HHS Office of the Inspector General (OIG).  Medicare spends about $40 billion every year on Part B drugs, and CMS uses manufacturer-reported average sales price (ASP) for the drug from quarterly sales to calculate provider payments.  However, due to incorrect or missing ASP data from manufacturers, CMS was unable to calculate an ASP-based payment amount for 8% of drug codes at least once between 2016 and 2020.  According to the report, CMS does not check the accuracy of the manual processes used to analyze ASP data.  The report also found that CMS does not incorporate its ASP data collection into watchdog reports.

SAMHSA: 25% of Adults Had A Behavioral Health Disorder in 2021

Roughly a quarter of US adults had a mental illness or substance use disorder in 2021, according to an annual survey released earlier this week by the Substance Abuse and Mental Health Services Administration (SAMHSA). The survey also found that 16% of the population, or 46 million people, met the criteria for a substance disorder in 2021, and only 6% of the 46 million actually sought treatment.  Additionally, the survey found that 22% of the population, or 61 million people, used illicit drugs in 2021, with the most commonly used drug being marijuana. The report echoes growing concerns on the prevalence of substance abuse and mental health issues across the nation.

NIH Launches Pilot Telehealth Program for COVID-19

On Thursday, the National Institutes of Health (NIH) launched the Home Test to Treat program, a new pilot program that will provide free COVID-19 health services like tests, telehealth sessions and at-home treatments in selected communities.  Later this month, local and state officials in Berks County, Pennsylvania, will be the first to pilot the program. Other communities around the nation will be selected to participate in this program based on need, socioeconomic factors, and access to health care.  The NIH is aiming to offer this service to up to 100,000 Americans over the next year.

Sen. Debbie Stabenow Announces Retirement 

Sen. Debbie Stabenow (D-MI) announced Thursday that she will not seek re-election and will leave the Senate at the end of her term on January 3, 2025, making her the first Senate Democrat to announce that she won’t be on the ballot in 2024.  Formerly a member of the Michigan state Senate and later a member of the US House of Representatives, Stabenow was first elected to the Senate in 2000.  Stabenow is the Senate Agriculture Committee’s top Democrat since 2011 and has been a longtime advocate for mental health care and tireless proponent for increasing domestic manufacturing.  Stabenow’s retirement announcement created an opening in a key swing state that is likely to attract strong interest from both parties.  According to reports, Reps. Debbie Dingell (D-MI) and Elissa Slotnik (D-MI) are already considering a run.

ICYMI: House Offices Reopened to Visitors

After nearly three years of pandemic and security-related restrictions, visitors on official business will no longer require a staff escort in the House office buildings and tourists will be able to access the gallery overlooking the House floor.  The removal of these restrictions was ordered by House Republicans, who now control the House with a slim majority in the 118th Congress.  The new Republican House majority also ordered the removal of metal detectors at the House chamber, which were first installed in the wake of the January 6, 2021, insurrection on the US Capitol.  For the time being, however, staff escorts are still required for visitors to Senate office buildings.

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