Category: Drugs

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. 

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.

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.

Pfizer Says Three Vaccine Doses Are Effective Against Omicron

Pfizer announced on Wednesday that three doses of its COVID-19 vaccine – two initial doses plus a booster dose – neutralized the Omicron variant at levels comparable to what two doses against earlier variants like Alpha and Delta.  While the preliminary data cited by Pfizer says two doses offer significantly less protection against infection from Omicron, the company is confident that two doses will still offer strong protection against hospitalization and death from the new variant.  While Pfizer’s announcement is encouraging, their findings on the effectiveness of their vaccine against Omicron has yet to be peer-reviewed or published in a scientific journal. Also, researchers are still studying how well vaccines work against the variant in the real world.

Surgeon General: American Youth Are Facing Mental Health Crisis

In an advisory issued on December 7, US Surgeon General Vivek Murthy stated that American youth are facing a mental health crisis.  In addition to the COVID-19 pandemic, which has exacerbated existing mental health problems, the advisory cites other sources of stress including gun violence, climate change, racism, and social conflict.  In an interview, Murthy said the US cannot wait until the end of the pandemic to address the mental health crisis.  Some of the advisory’s recommendations include addressing economic and social barriers that contribute to poor mental health, ensuring every child has access to high-quality, affordable mental health care, and recognizing that mental health is a crucial component of overall health.

Nunes Resigns from Congress to Lead Trump’s New Media Company

On December 6, Rep. Devin Nunes (R-CA) announced he will resign from Congress at the end of 2021 to become the CEO of the Trump Media & Technology Group, which is a recently formed media company that former President Donald Trump founded.  His announcement comes amid a redistricting process in California, where draft maps were likely to change his congressional district from majority Republican to majority Democratic.  Nunes (pronounced NEW-ness), who has represented California’s San Joaquin Valley in Congress since 2003, is the second highest-ranking Republican on the House Ways and Means Committee, and he would have been poised to chair the powerful committee if the GOP retakes the House majority next year.  California Governor Gavin Newsom, a Democrat, will call a special election to fill the remainder of Nunes’ term once he officially steps down.

Senate Clears Bill to Raise Debt Ceiling by Simple Majority

On Thursday night, the Senate passed a bill in a 59-35 vote that would allow Senate Democrats to raise the debt ceiling by a simple majority vote.  Thursday’s vote is the result of a one-time agreement between Senate Majority Leader Chuck Schumer (D-NY) and Republican Leader Mitch McConnell (R-KY) to tweak Senate rules and allow the Senate to advance the measure without any GOP votes.  Next week, the House and Senate plan to pass another bill that will actually raise the debt ceiling by at least $30 trillion to prevent the federal government from defaulting on its debt obligations.  Of note, last night’s bill would also avert billions of dollars in looming Medicare cuts to providers. 

ICYMI: RIP Senator Bob Dole

Earlier this week, former Sen. Bob Dole (R-KS) passed away in his sleep at the age of 98.  The former Senator was a decorated World War II veteran, served in both chambers of Congress for a total of 36 years, served as the Republican Majority leader, and was a presidential candidate in 1996.  During his tenure in Congress, Sen. Dole worked across the aisle to advance Social Security, protect the disabled, and reworked the Supplemental Nutrition Assistance Program, amongst many other issues. He was laid in state at the US Capitol on Thursday where President Biden and congressional leaders paid their respects to honor his memory. President Biden in his remarks stated, “America has lost one of our finest patriots [and Dole] too was a giant of our history, and that’s not hyperbole.” A formal departure from the Capitol will be held early Friday morning ahead of a funeral at Washington National Cathedral and ceremony at the World War II Memorial.

FDA Authorizes Third Vaccine Dose for Immunocompromised Patients

On August 12, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Pfizer and Moderna COVID-19 vaccines to allow immunocompromised people to get a third dose.  The Centers for Medicare and Medicaid Services (CMS) subsequently announced that Medicare beneficiaries would be able to receive the additional vaccine dose at no extra cost.  FDA’s announcement comes after a number of doctors said the two-dose regiment does not generate a sufficient level of protection in most people with compromised immune systems.  The Centers for Disease Control and Prevention (CDC) estimates that 2.7% of US adults are immunocompromised, including people undergoing cancer treatment and organ transplant recipients.  On August 13, CDC’s Advisory Committee on Immunization Practices will meet to discuss whether a third COVID-19 vaccine dose is needed for certain groups.

Biden Calls on Congress to Allow Medicare to Negotiate Drug Prices

President Biden publicly urged Congress on August 12 to enact legislation to allow Medicare to negotiate on drug prices as a key component of his vision for reducing the high cost of prescription drugs.  Other reforms Biden called for include establishing a cap on out-of-pocket drug costs for Medicare beneficiaries, building on efforts to help states and Tribes to import lower-cost drugs from Canada, and accelerating the development and uptake of generic and biosimilar drugs.  Immediately following Biden’s remarks, PhRMA President and CEO Stephen Ubl issued a statement saying the president’s proposals would undermine access to life-saving drugs and shift drug costs to patients. 

Chamber of Commerce Files Lawsuit over Insurer Price Transparency Rule

On August 10, the US Chamber of Commerce filed a lawsuit in the US District Court Eastern District of Texas to challenge a rule finalized by the previous administration in October 2020 that requires insurers to post pricing information in a machine-readable format online.  In the suit, the Chamber contends that the rule violates the Administrative Procedures Act and that the administration lacks statutory authority to require prices to be listed in a machine-readable format.  According to the Chamber, the price transparency rule has the potential to reduce competition and boost prices consumers pay by requiring insurers to post information that’s otherwise considered confidential.  On August 12, the Pharmaceutical Care Management Association filed a similar lawsuit in the US District Court of the District of Columbia challenging the price transparency rule.

Senate Approves Bipartisan Infrastructure Bill, Kicks Off FY22 Budget Resolution Process

On August 10, the Senate voted 69-30 to approve a bipartisan $1 trillion infrastructure bill, moving forward a major component of President Biden’s agenda.  Passage of the infrastructure bill cleared the way for the Senate to adopt by a 50-49 vote its $3.5 trillion Fiscal Year (FY) 2022 budget resolution that contains key Democratic priorities around childcare, paid leave, climate change, and education.  The House is expected to return early from recess to approve the FY 2022 budget resolution during the week of August 23, which would unlock the budget reconciliation progress and allow the Senate to pass a final bill that only requires 50 votes.  The process to pass the larger measure could take months, however, and Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) have started to say  they will not support $3.5 trillion in spending. 

AAP Calls for FDA to Accelerate EUA of COVID Vaccine for Kids under 12

In an August 5 letter, the American Academy of Pediatrics (AAP) urged the FDA to authorize the emergency use of COVID-19 vaccines for children under age 12 “as soon as possible” due to a rise in pediatric COVID-19 cases sparked by the Delta variant.  According to AAP, FDA should use the clinical trial data it already has collected on the Pfizer and Moderna vaccines to move forward on expanding the emergency use of the vaccine instead of waiting for six months of follow-up data due to “changes in the risk-benefit analysis” posed by the Delta variant.  AAP also noted that cases of myocarditis in adolescents and young adults are “extremely rare” and do not necessitate the collection of additional data to expand the EUA.  

ICYMI: Congressional Staff Express Interest in Telework, Flexible Arrangements

Even though a number of congressional staffers have returned to in-person work in Washington, some staffers are calling for their bosses to consider making telework or hybrid work arrangements permanent.  According to some proponents, more telework opportunities could provide relief to employees with childcare responsibilities, help with employee retention, or provide opportunities to staff who can’t physically be in the Washington, DC area. 

Moderna Becomes Second Vaccine Maker to Recommend Third Dose

On August 5, Moderna said a third dose of its COVID-19 vaccine will likely be necessary as a “booster shot” this winter as immunity gradually declines.  The company is currently testing three candidates that could be used as a third dose to boost immunity against rising COVID-19 variants such as Delta.  Moderna also announced that its vaccine is 93% effective six months after the second dose, even against the Delta variant.  Moderna’s calls for a third dose came one week after Pfizer released data that showed a third dose of its vaccine increased antibody levels against the Delta variant.   Amid growing interest in a third vaccine dose, the World Health Organization notably called for wealthy nations to hold off on distribution of third doses to their populations and instead focus on distribution to low-income countries where vaccination rates remain low.

HHS Inspector General to Review FDA’s Accelerated Approval Process

On August 4, the Department of Health and Human Services Office of the Inspector General (OIG) announced it will review the accelerated approval pathway used by the Food and Drug Administration (FDA) to review drugs that treat serious conditions and fill an unmet medical need.  The review was sparked by FDA’s use of the accelerated approval process for Alzheimer’s disease drug Aduhelm, which spurred scientific disputes within FDA as well as allegations of an “inappropriately close relationship” between FDA and the pharmaceutical industry.  Acting FDA Commissioner Janet Woodcock asked OIG to review the process used to approve Aduhelm in mid-July, and she has since pledged full cooperation with OIG’s pending investigation.

Vote on Infrastructure Bill Could Come This Weekend

Senate Majority Leader Chuck Schumer (D-NY) is hoping to hold a procedural vote to end the debate on a $550 billion bipartisan infrastructure bill as soon as Saturday after Senators failed to reach an agreement on Thursday night.  The Senate spent most of Thursday waiting for a Congressional Budget Office score that projected the measure will add $265 billion to the federal deficit over 10 years.  The Senate is out of session on Friday, and several Senators will be using their day-long break to attend the funeral of former Sen. Mike Enzi (R-WY).   If the Senate clears the bipartisan infrastructure bill when it reconvenes on Saturday, Senate Democrats will immediately pivot to working on a budget resolution with instructions for reconciliation that include the “human infrastructure” pieces.

Former Michigan Senator Carl Levin Has Died

Carl Levin, Michigan’s longest-serving US Senator, died on July 29 at age 87.  Elected to the Senate in 1979 after practicing law and serving on the Detroit City Council, Levin helped set military priorities as Chairman of the Armed Services Committee and investigated corporate behavior as Chairman of the Permanent Subcommittee on Investigations.  Throughout his six terms in the Senate, the liberal Michigan Democrat was known for his defense of Senate traditions and tenacity in uncovering corruption.  Levin hailed from a political family – his brother, former Rep. Sander Levin (D-MI), chaired the powerful House Ways and Means Committee, and his nephew, Rep. Andy Levin (D-MI), currently represents a district north of Detroit.

CMS Finalizes 2022 Payment Rates for Acute Care Hospitals

A final rule issued by the Centers for Medicare and Medicaid Services (CMS) on August 2 provides for a 2.5% increase in hospital reimbursement rates under Medicare’s Inpatient Prospective Payment System (IPPS) for Fiscal Year (FY) 2022.  The rule also includes a $1.1 billion decease in disproportionate share hospital payments from FY 2021 and adds a Maternal Mortality measure to the hospital quality reporting program.  Furthermore, the final rule contains several provisions related to the COVID-19 public health emergency, namely a new requirement for hospitals to post vaccination rates among employees as well as authorization of additional payments for COVID-19 diagnostics and therapies.  The final rule goes into effect on October 1, 2021. 

ICYMI: DC Area Athletes Rack Up Medals in Tokyo Olympics

So far in the 2020 Summer Olympics in Tokyo, US athletes who hail from the Washington, DC area have been winning big.  Maryland natives Katie Ledecky, Chase Kalisz, and Andrew Wilson have all won gold medals in swimming events, while Maryland triathlete Katie Zaferes has earned the silver and bronze medals in two separate triathlon events.  Additionally, Noah Lyles of Alexandria, Virginia won a bronze medal in the men’s 200-meter race, while Lucas Kozeniesky of Fairfax County Virginia narrowly missed a gold medal in the mixed 10m air rifle event.  Of note, several athletes hailing in the region are still competing in track, soccer, basketball, and wrestling events.

CDC Panel Recommends Continued Use of J&J Vaccine, Despite Risks

On July 22, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) agreed the federal government should continue to recommend Johnson & Johnson’s COVID-19 vaccine amid concerns of side effects.  According to the panel, the benefits of the single-dose vaccine outweigh the risk of Guillain-Barre, a rare neurological disease.  However, two members of the panel felt the risk of Guillain-Barre should be conveyed to potential recipients of the J&J vaccine, noting that two highly effective mRNA vaccines are available as alternatives.  ACIP convened just days after New York University researchers released a study that found the J&J vaccine is only 33% effective against the Delta variant, a significant decrease from the 66% efficacy observed against the original COVID-19 strain in clinical trials.

NEJM: Pfizer, AstraZeneca Vaccines Still Highly Effective against Delta Variant

A study published in the New England Journal of Medicine (NEJM) on July 21 found two doses of Pfizer’s COVID-19 vaccine is 88% effective against the Delta variant, compared to 94% against the Alpha variant.  The same study found two doses of the AstraZeneca vaccine is 67% effective against Delta, a small decrease from a 75% efficacy rate with Alpha.  The release of the NEJM study findings come after a pair of studies released earlier this month found the Pfizer vaccine has varying degrees of efficacy against the Delta variant. Those studies include a research published by the Israeli Health Ministry on July 5, which found a double dose of the Pfizer vaccine to be only 64% effective against Delta, while an analysis posed on June 14 by Public Health England found two Pfizer doses to be at least 90% effective.

Major Hospital Groups Back Vaccination Mandates

On July 21, the American Hospital Association and America’s Essential Hospital separately issued statements urging its member hospitals to require vaccination for all employees.  According to both organizations, vaccines help protect not only health care workers but also patients and their communities.  The announcement comes as hospitals nationwide see a rise in COVID-19 patients who are unvaccinated and growing number of hospitals and health systems mandate their employees be vaccinated.

Details of Bipartisan Infrastructure Bill Could Come as Soon as Monday

A bipartisan group of 22 Senators are hashing out the final details of a $579 billion infrastructure bill that could be released as soon as Monday, July 26.  Senators previously attempted to begin debating the bipartisan infrastructure bill on Wednesday as a way to push negotiations forward, but Senate Republicans mounted a filibuster, saying more time is needed to finalize details and resolve differences.  Since Wednesday’s failed vote, Senators have tentatively agreed to delay a Medicare rule that eliminates Part D drug rebates that drug makers offer to pharmacy benefit managers in exchange for participation on their formularies as a way to partially pay for the infrastructure bill.  Remaining sticking points include how much spending should be directed to public transit and assurances that the Drinking Water and Wastewater Infrastructure Act will be fully funded.

ICYMI: No Smithsonian Tickets? No Problem!

Starting on July 19, visitors to all open Smithsonian museums will no longer need timed-entry passes for general admission.  The two exceptions to the new policy are the National Zoo and the National Museum of African American History and Culture, which already required timed-entry tickets before the pandemic.  Other currently shuttered museums, like the Air and Space Museum and Smithsonian Castle, are also set to reopen later this month.