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

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 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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What Happened, What You Missed: June 6-10

Moderna Says Its Omicron-Specific Booster Is Effective

Moderna announced on June 8 that a new vaccine candidate offers strong protection against the Omicron vaccine compared to the company’s original vaccine.  The latest vaccine is bivalent, meaning it targets both the original iteration of COVID-19 and the Omicron variant.  While Moderna is seeking authorization from the Food and Drug Administration (FDA) for its vaccine to be used in an anticipated booster campaign this fall, it remains unclear how effective the new vaccine candidate is against new Omicron subvariants like BA.4 and BA.5, which are quickly gaining ground in the United States.  However, the company is confident the new vaccine will prove effective against newer subvariants, especially compared to vaccines that are currently available.

Appropriations Season Kicks Off in the House Next Week

House Appropriations Committee markups for the 12 Fiscal Year (FY) 2023 appropriations bills are scheduled to begin on Wednesday, June 15, and conclude on Thursday, June 30, according to a schedule released by Chairwoman Rosa DeLauro (D-CT) on Thursday.  DeLauro has expressed a desire to pass all FY 2023 appropriations bills “on time” so that that they can be signed into law by September 30, 2022.  However, given the upcoming midterm election and lawmakers’ focus on campaigning, the most likely outcome by the end of September will be a stopgap funding bill through Election Day.

Lawmakers Make Tepid Progress on Gun Control Legislation

This week saw minor steps forward on advancing gun control legislation in Congress as the House Committee on Oversight and Government Reform met Wednesday to hear from victims and survivors of the Uvalde shooting.  Shortly after Wednesday’s hearing, the House passed a wide-ranging package that includes limits to magazine sizes and a “red flag” process that allows law enforcement to temporarily seize firearms from potentially dangerous owners, although the package has no chance of being considered in the Senate.  Meanwhile, Senate negotiators are hoping to finalize an agreement by the end of the week that would set standards for gun storage and incentive states to create red flag laws.  However, it remains unclear if House and Senate leaders can reach a final agreement.

FTC Launches Investigation into PBMs

On Tuesday, the Federal Trade Commission (FTC) launched an investigation into the business practices of pharmacy benefit managers (PBMs).  Specifically, the investigation will focus on how vertically integrated PBMs impact prescription drug prices and affordability.  As a part of the investigation, the FTC is requiring six of the country’s largest PBMs – CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics, and MedImpact Healthcare Systems to furnish five years of records regarding their business practices.  The investigation will explore, amongst other areas,  fees PBMs charge unaffiliated pharmacies and the impact of rebates and fees drug manufacturers have on formulary design.

ICYMI: Temporary Memorial on National Mall Honors Live Lost to Gun Violence

Visitors to the National Mall will have a chance to view an installation consisting of 45,000 flowers to memorialize the number of Americans who die each year from gun violence.  The memorial was created by the Giffords organization, which partnered with the organization responsible for the COVID-19 flag memorial installation.  The memorial will be open for public viewing through Saturday, June 11, which coincides with a March for Our Lives rally in DC to protest against gun violence.

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What Happened, What You Missed: March 21-25

Moderna to Seek EUA for COVID-19 Vaccine for Children under Age 6

Moderna announced on Wednesday that it will ask the Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for its COVID-19 vaccine “as soon as possible.” Moderna’s initial data demonstrated that the vaccine is 44% effective at preventing infection from the Omicron variant in children ages 6 months to under 2 years and about 38% effective for children 2- to 5-years-old. Importantly, none of the children who participated in the trial developed severe disease.  The announcement is promising news for parents of young children and toddlers who’ve been previously disappointed by setbacks on vaccine development for this age group.  It’s unclear when the FDA advisory panel will hold a meeting to discuss approving vaccines for children under age 6.

Fauci: Surge Unlikely Despite Uptick in Infections

According to recent data from the Department of Health and Human Services (HHS), COVID-19 cases have increased in nine states in the past 14 days, with the most growth in Arkansas, New York, and Connecticut.  The uptick in cases is largely driven by the more transmissible Omicron variant BA.2, which the Centers for Disease Control and Prevention estimates accounts for more than one-third of COVID-19 cases nationwide and more than half of cases in the Northeast.  Despite the growth of BA.2, nationwide COVID-19 cases still saw a 19% decrease over the past 14 days.  While White House Chief Medical Advisor Anthony Fauci has acknowledged that the more transmissible subvariant is likely to cause case numbers to grow and he believes another major surge resulting in high levels of hospitalization is unlikely.

Airlines Push Administration to Drop Mask Mandates

Leaders of 10 major commercial and cargo airlines sent a letter to President Joe Biden on Wednesday urging his administration to end the federal transportation mask mandate as well as pre-departure COVID-19 testing requirements for international flights.  According to the letter, declining hospitalization and death rates from COVID-19, the high level of immunity in the US, and the widespread availability of effective vaccines have rendered federal travel restrictions that were put in place two years ago unnecessary.  Several British airlines dropped mask mandates in the past few weeks, despite a recent rise in COVID-19 cases in the United Kingdom.  Current federal travel mandates are set to expire on April 18, and CDC is still reviewing how best to proceed.

HHS Doles Out $413 Million in New Provider Relief Fund Payments

On March 22, HHS announced more than $413 million in Provider Relief Fund payments to over 3,600 providers across the country.  This recent distribution is part of the fourth round of Phase 4 payments, which targeted  smaller providers that took on a higher percentage of financial losses during the pandemic.  To date, HHS has delivered $12 billion in Phase 4 funds to over 82,000 providers nationwide.  Providers will have until the end of June 2023 to use this latest round of payments.  Despite the additional payments, providers are still calling for more financial relief.  On Wednesday, LeadingAge sent a letter to congressional leaders urging $28 billion in additional Provider Relief Fund support citing continued  COVID-19 expenses on aging services providers.

ICYMI: Cherry Blossoms Hit Peak Bloom in DC

On Monday, Washington’s famous cherry blossoms hit peak bloom – the eighth earliest peak bloom since records were first taken in 1921.  Peak bloom is defined when 70% of the cherry trees’ buds are flowering. The March 21 peak bloom coincides with the National Cherry Blossom Festival, which runs this year from March 20 to April 17.  The cherry blossoms’ peak bloom is expected to pass this weekend due to cooler temperatures and windy conditions, so be sure to check them out before it’s too late.

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Can Lawmakers Pass Comprehensive Drug Pricing Reform This Year?

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. (Ambien online)   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.

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