Insights^

Eli Lilly’s New Obesity Drug Shows Promise

A new obesity drug from Eli Lilly helped patients lose 24% of their weight, according to phase 2 clinical trial results posted this week. Known as retatrutide, the drug is a weekly injection that imitates certain digestive hormones that help patients feel “full” and thus decreases their appetite. The clinical trial included 338 adults who were obese or overweight and had either received retatrutide injection or a placebo treatment. The results suggest retatrutide could be more effective than Mounjaro (tirzepatide), another Lilly drug that led to 21% weight loss in trials. The company is currently requiring patients participate in a phase 3 clinical trial.

CDC: Overdose Deaths from Xylazine-Laced Fentanyl on the Rise

Overdose deaths from fentanyl combined with xylazine increased by 276% between January 2019 and June 2022, according to data from the Centers for Disease Control and Prevention (CDC). However, CDC noted that the timing and scale of increase in detection of xylazine overdoses might be due to both increased frequency of testing and increased presence in the drug supply. Known as “tranq,” xylazine is an easily obtainable veterinary drug that used as a sedative and pain reliever. In recent years, drug dealers have been cutting fentanyl with xyzaline to extend a user’s high. In April 2023, the White House Office of National Drug Control Policy designated fentanyl combined with xylazine as an emerging threat.

CMS Proposes Pay Increase for Dialysis Providers

Dialysis providers could get a 1.6% payment bump from Medicare next year, according to a proposed rule for the end-stage renal disease (ESRD) Prospective Payment System (PPS). The rule contains a number of proposals related to ESRD payment policies, including a request for information (RFI) on the potential creation of a new payment adjustment that would increase payment to geographically isolated ESRD facilities. The rule also proposes a requirement on reporting of “time on machine” data, which is the the amount of time that a beneficiary spends receiving an in-center dialysis treatment. Stakeholders have until August 25, 2023 to comment on the proposed rule.

KFF: 1.5M Have Lost Medicaid Coverage since April

1.5 million people have lost Medicaid coverage in 25 states and the District of Columbia since the disenrollment process began in April, according to data from the Kaiser Family Foundation (KFF). Many states have yet to begin the disenrollment process in earnest, and KFF projects that up to 17 million people could lose their coverage. Additionally, 73% of disenrollments are due to technical reasons, such as a state Medicaid office being unable to contact an enrollee or a failure to verify income. The federal government’s options for addressing the coverage losses are limited, given that states are largely responsible for administering the program. However, the Department of Health and Human Services (HHS) did provide new flexibilities for states earlier this month intended to address disenrollment, such as allowing managed care firms to complete Medicaid renewal forms for an enrollee.

ICYMI: First-Ever Thai Festival Comes to National Mall

For the first time ever, the Thai Embassy is hosting a festival on the National Mall to celebrate 190 years of diplomatic relations between Thailand and the US. Visitors can sample various food vendors and enjoy cultural activities including Muay Thai demonstrations, Thai massages, and dance lessons. The festival is scheduled for Sunday, July 2.

Merck Sues HHS over Drug Pricing Law

Pharmaceutical company Merck filed a lawsuit on Wednesday against the Department of Health and Human Services (HHS) over Medicare’s plans to negotiate drug prices in the Inflation Reduction Act (IRA). According to the lawsuit, Merck says the IRA violates a Fifth Amendment clause that prohibits the government from taking private property for public use without proper compensation. The company also claims that the program violates the First Amendment by forcing them to convey that they agree with the negotiation process. The Biden administration has since expressed that it will win the lawsuit.

CDC: Blood Donations Show Widespread COVID-19 Immunity

Nearly all Americans had some level of COVID-19 immunity, according to a new study from the Centers for Disease Control and Prevention (CDC). The study looked at blood donations from people ages 16 years and older for COVID-19 antibodies from July through September 2022. CDC researchers found that 96% of blood donors had antibodies, with about 23% from infection alone and 26% from just vaccination. The remaining 48% had hybrid immunity from both infection and vaccination. The study found that vaccinated people had lower levels of infection, which points to the fact that vaccines still provide some level of protection against infection. The study also found that donors ages 65 and older were less likely to have hybrid immunity, which is probably due to the fact that seniors had earlier access to vaccines.

Charity Care Drops in Non-Profit Hospitals

Spending for charity care in non-profit hospitals has dropped despite higher profits, according to a new study in Health Affairs. While the mean operating profits for non-profit hospitals grew from $43 million in 2012 to $58.6 million by 2019, charity care spending dropped slightly during that time period, from $6.7 million to $6.4 million. Non-profit hospitals are required to provide charity care for their tax-exempt status. The study echoes previous analyses that found non-profit facilities spend less on charity care than for-profit facilities. Hospital groups contend that the community benefits that non-profit hospitals provide more than justify their tax-exempt status.

FDA First Rapid COVID-19 Test via Traditional Review Process

The Food and Drug Administration (FDA) approved on Tuesday the first rapid antigen, over-the-counter COVID-19 with the traditional premarket approval process, rather than through emergency use authorization (EUA). Manufactured by Cue Health, the test identified 93% of positive and 99% of negative samples in people with COVID-19, according to clinical trial data. The FDA says the authorization represents a new era of consumer access to COVID-19 tests. In a statement, a top FDA official said the authorization is part of a broader effort to expand the development and availability of over-the-counters tests for a variety of medical conditions.

ICYMI: UK PM Throws First Pitch at Nats Game

UK Prime Minister Rishi Sunak was the guest of honor at Nationals Park on Wednesday night as part of a trip to strengthen economic ties between his nation and the US. He threw the first pitch in a game that saw the Washington Nationals lose to the Arizona Diamondbacks 6-2. The following day, Sunak joined President Joe Biden at the White House to announce the Atlantic Declaration, a new framework for economic co-operation between the two nations. Biden and Sunak also discussed the importance of AI regulation.

CDC Approves Second Omicron Booster for Seniors & Immunocompromised

The Centers for Disease Control and Prevention (CDC) updated its guidelines on Wednesday to allow an additional COVID-19 booster dose for adults who are 65 years or older and immunocompromised adults at least four months from their last dose. The move comes two days after a Food and Drug Administration (FDA) advisory panel voted to authorize an additional booster for high-risk groups. The CDC’s updated guidance also recommends that the original monovalent mRNA COVID-19 vaccines be no longer used in the US. Also, the United Kingdom and Canada already are offering spring booster shots for high-risk populations.

White House to Nominate NCI Director to Lead NIH

Reports indicate that the White House is poised to nominate National Cancer Institute (NCI) Director Monica Bertagnolli to lead the National Institutes of Health (NIH) in the coming days. A surgical oncologist by training, Bertagnolli has earned the respect of top Biden administration officials since taking the reins of NCI in October 2022. The NIH has been without a permanent director since longtime chief Francis Collins stepped down in December 2021. Since then, Larry Tabak has been serving as acting director. Bertagnolli would be the second female NIH leader if confirmed by the Senate. The next NIH director will face a slew of challenges, including responding to congressional inquiries into the agency’s role in the COVID-19 pandemic, advancing the pace of innovation, and ensuring that the agency can continue to invest in biomedical research amid a tough budgetary environment.

mRNA Vaccines Show Promise in Treating Skin Cancer

An individually tailored vaccine combined with an immunotherapy drug has been shown to reduce a patient’s risk of reoccurrence or death from a deadly type of skin cancer, according to phase 2 clinical trial results posted by Moderna and Merck. All 107 melanoma patients who participated in the trial had their cancerous tumors removed in surgery but were at a high risk of recurrence. The trial found that the vaccine decreased patients’ risk of recurrence or death by 44% compared to treatment with the immunotherapy alone. mRNA vaccine technology, which was widely used to immunize people against COVID-19, works by sending messenger RNA into cells to instruct them to build proteins that trigger an immune response that fights off future disease. Merck and Moderna expect to begin a phase 3 trial later this year, and if the results show the mRNA technology to be effective, the treatment could be approved for patients within three years.

CMS Finalizes ACA Plan Policies, Health Equity Standards

Released on Monday, the 2024 Notice of Benefit and Payment Parameters (NBPP) finalizes a number of rules pertaining to Affordable Care Act (ACA) plans. Some of the more notable changes included increasing the number of nonstandard plans insurers can offer per region from two to four and adding a new special enrollment period for people who lose Medicaid eligibility. To boost health equity, the NBPP permits navigators and other assisters to conduct door-to-door outreach and enrollment assistance, which the administration hopes will improve access to coverage for underserved populations that face barriers to getting insured.

McCarthy Seeks Support for Debt Limit Plan

A proposal from Speaker Kevin McCarthy (R-CA) would increase the current $31.4 trillion statutory borrowing limit by $1.5 trillion or suspending it through March 31, 2024 by capping topline Fiscal Year (FY) 2024 discretionary spending at the FY 2022 level. While the proposal is intended to bring the Biden administration and congressional Democrats to the negotiating table, both have since communicated that the proposal is a non-starter. Although McCarthy’s leadership team is confident that his proposal will win the support of congressional Republicans, it remains uncertain if the proposal can garner 218 votes in the House, especially among moderate GOP members in the Problem Solvers Caucus who are putting forth their own bipartisan debt limit plan.

ICYMI: Rare Gem Goes On Display at the Smithsonian

Yesterday, the Smithsonian’s National Museum of Natural History put on public display the “Lion of Merelani,” which is one of the most finely detailed colored gemstones in the world. Known as a tsavorite, the original crystal was found in northern Tanzania in 2017 before being cut into a gem by Victor Tuzlukov in 2018. According to the Smithsonian, the gem is the largest precision-cut tsavorite in the world and the largest tsavorite gem. A private donor gifted the tsavorite to the National Gem Collection, which contains 350,000 mineral specimens and 10,000 gems.

NIH Rejects March-In Rights Petition for Pricey Prostate Cancer Drug

The National Institutes of Health (NIH) rejected a petition to force drugmakers Pfizer and Astellas to lower the price of their prostate cancer drug Xtandi using its “march-in” authority, according to a letter the agency sent to the petitioners on Tuesday. March-in rights, which have never been used before, allow the federal government to forcibly relicense a patent that resulted from any amount of federal funding if an original patent holder does not make the product available to the public on reasonable terms. According to the letter, NIH declined the petition because Xtandi is already widely available, and the agency also noted that a lengthy administrative process and remaining patent life would render authorization of march-in right an ineffective means of lowering the drug’s cost. The same day, the federal government also announced an interagency effort to review the criteria used for determining march-in rights.

Administration Proposes Major Changes to Organ Transplantation System

On Wednesday, the Health Resources and Services Administration (HRSA) announced a new initiative to break up the private nonprofit overseeing the Organ Procurement and Transplantation Network (OPTN) by seeking more contracts to operate the system.  In a statement, HRSA said the move is intended to bring more accountability and transparency to the OPTN.  The announcement follows years of bipartisan scrutiny of the United Network for Organ Sharing (UNOS), which holds the sole federal contract to oversee the country’s organ procurement organizations and transplant centers.  HRSA also called on Congress to more than double annual program funding to $67 million, remove the appropriations cap on OPTN contracts, and expand the scope of eligible contractors.

Biden Signs Bill to Release DOE’s COVID-19 Origin Report

President Joe Biden signed legislation earlier this week to require the Office of the Director of National Intelligence to declassify information within 90 days on any possible links between a lab in China and the origins of the COVID-19 pandemic. However, US intelligence agencies will still retain the right to redact information to protect sources and methods. The push to enact legislation to release classified information on the origins of the pandemic comes after the Energy Department concluded with “low confidence” that the virus is likely the result of an accidental laboratory leak at the Wuhan Institute of Virology. Of note, the US intelligence community is split about the origin of COVID-19.

FDA Panel Sends Mixed Message About Biogen’s ALS Drug 

A Food and Drug Administration (FDA) advisory panel voted against recommending full approval of Biogen’s experimental amyotrophic lateral sclerosis (ALS) drug for a rare and aggressive form of the disease.  However, the panel voted unanimously to support “conditional accelerated approval” of the drug since the data suggests the drug could be effective in reducing a protein that is associated with disease severity. Conditional accelerated approval allows for faster approval of drugs for serious conditions that fill an unmet medical need. The agency will make a final decision on the drug by April 25^th.

North Carolina Poised to Expand Medicaid 

North Carolina Governor Roy Cooper (D) is expected to sign legislation to expand Medicaid coverage for hundreds of thousands of residents into law in the coming days after state lawmakers gave the legislation final approval on Thursday.  This makes North Carolina the latest state with a Republican-controlled legislatures that has moved to expand Medicaid after years of opposition. Voters in South Dakota approved expansion in a referendum in November, and advocates in Alabama are urging state lawmakers to take advantage of federal incentives to expand Medicaid.  There are 2.9 million traditional Medicaid enrollees in North Carolina, and advocates have estimated that expansion could help 600,000 adults.

ICYMI: Potential Pay Cuts for Congressional Staff Sound Alarms

Historically underpaid staffers in the House of Representatives have been earning more since the passage of the Fiscal Year (FY) 2022 omnibus, which provided the largest increase to the Members Representational Allowance (MRA) since 1996 and set a minimum salary for staffers at $45,000.  However, an agreement among House Republican leaders to cut spending to FY 2022 could lead to cuts in the MRA and reverse progress in improving staffers’ pay.  Some advocates and staffers say higher pay is essential for reducing turnover on the Hill – especially among senior staff – and ensuring that congressional staff come from more diverse socio-economic backgrounds.

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 25^th 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.