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.

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.  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.

The White House is not giving up hope on Congress passing legislation this year to allow Medicare to negotiate on drug prices, according to a White House domestic policy advisor who spoke at  AHIP’s National Conference on Health Policy and Government Health Programs in March.  But if a recent Senate Finance Committee hearing is any indication, the odds of this proposal passing in Congress this year are slim to none.

A Brief History of Recent Drug Pricing Proposals

Allowing Medicare to negotiate with drug manufacturers on prices has been a cornerstone of Democrats’ drug pricing proposals for some time now.  Negotiation was a major health care provision of the Build Back Better Act and President Biden reiterated the need for negotiation in his State of the Union on March 1.

Republicans have never been receptive to negotiation over fears that it would amount to price controls and leave pharmaceutical companies with fewer resources to develop new drugs.  However, in 2019, there was a sense of cautious optimism that a bipartisan compromise on drug pricing policy could be reached. That year, Sens. Ron Wyden (D-OR) and Chuck Grassley (R-IA) introduced a sweeping bipartisan measure that would cap out-of-pocket drug costs under Part D once a beneficiary hits a certain threshold.  But this legislation fell apart after then-Senate Majority Leader Mitch McConnell (R-KY) said he had no interest in bringing the bill up for a vote in the Senate, prompting Wyden to withdraw his support.

The Drug Pricing Debate in 2022

As the 2022 midterm elections approach, many Democrats believe their window of opportunity to pass comprehensive drug pricing reform is rapidly closing.  Despite this, Democrats don’t seem to be in any mood to compromise.  During the March 16 hearing of the Senate Finance Committee, Democrats were unanimous in their support for lowering drug prices through negotiation, which the committee’s Republican members continually opposed.

Instead, committee Republicans including Ranking Member Mike Crapo (R-ID) voiced support for the Lower Costs, More Cures Act, which would establish an annual out-of-pocket cap of $3,100 for Medicare Part D enrollees – similar to the Grassley-Wyden bill – and allow certain patients to pay in monthly installments.  But Democrats on the Finance Committee didn’t seem interested in half-measures.  For instance, Wyden said out-of-pocket caps would simply “pass higher prices to someone else, like taxpayers.”

It’s not as if Democrats are completely opposed to the idea of price caps.  During the hearing, Sen. Raphael Warnock (D-GA) touted his bill to cap copayments for insulin at $35 a month – a proposal Biden endorsed in his State of the Union.  However, Republicans seem opposed to this stand-alone measure, even though it’s similar to the Lower Costs, More Cures Act provision that would make permanent the Center for Medicare and Medicaid Innovation model that enables Part D enrollees who take insulin to limit out-of-pocket costs to $35.  During the hearing, Sen. Pat Toomey (R-PA) suggested rising insulin costs over the years have contributed to “tremendous innovation” of insulin products.

What happens next? Warnock said he wants to get his insulin pricing cap bill to the Senate floor by Easter.  The chances of this bill passing don’t look good at the moment and barring a break in the logjam between Democrats and Republicans on negotiation, progress on overall drug pricing reform doesn’t seem likely, either.  Both parties seem entrenched on their preferred legislative solutions to tackle high drug prices to the point that relatively bipartisan proposals like the Grassley-Wyden bill of 2019 wouldn’t stand a chance in passing.

But if Congress can’t do it, maybe the administration can, according to some Democrats.  Seemingly having lost hope in Congress to deliver on major Democratic policy proposals, many Democratic lawmakers are urging President Biden to sidestep Congress and take whatever executive actions necessary to lower the cost of prescription drugs.  On March 17, the Congressional Progressive Caucus issued a list of recommendations for executive action that includes drug pricing, among other issues.

However, the Biden administration has yet to comment on which specific actions it could take, and any new executive orders on drug pricing could be subject to change – either in the courts or by the next administration.   Therefore, any serious attempt at drug pricing reform this year may still only be through Congress, no matter how slim the odds may be.