Drugs

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

by Matt Gontarchick

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.

Administration

What Happened, What You Missed: January 30-February 3

by Matt Gontarchick

Biden Administration to End PHE in May 

The White House announced on Monday that the COVID-19 public health emergency (PHE) will officially come to an end on May 11.  Since it was first declared on January 31, 2020, the PHE has been renewed 12 times at 90-day intervals, with the most recent renewal being January 11, 2023. The end of the PHE will kick off a gradual unwinding of emergency measures and flexibilities related to the use of telehealth and a continuous coverage requirement for Medicaid. The PHE’s termination will also mean the end of free COVID-19 vaccines, tests, and treatments. By announcing the end of the PHE 101 days before May 11, the administration is honoring its commitment to provide 60 days’ notice prior to termination of the PHE. 

Surprise Bill Faces Lawsuit over IDR Process 

The Texas Medical Association (TMA) filed another lawsuit against the No Surprises Act – this time, over a 600% increase in administrative fees for parties seeking to enter the independent dispute resolution (IDR) process to resolve payment disagreements between health plans and out-of-network providers.  The Biden administration increased the $50 initial administrative fee to $350 to account for “increasing expenditures in carrying out the Federal IDR process,” likely due to the fact that more billing disputes have been directed to the IDR process than initially anticipated.  According to the TMA, the jump in administrative fees will disincentivize physicians’ ability to seek arbitration and disproportionally impact specialties with small-dollar claims, like radiology.  The TMA has filed three lawsuits against the No Surprises Act, and a district court ruling from one lawsuit compelled the administration to change its rules pertaining to the IDR process.  

Study: US Health Outcomes Worse Despite Higher Spending 

The US has some of the worst health outcomes among high-income countries despite having the highest health spending per person, according to a study from the Commonwealth Fund.  For example, the study found that the US had the lowest life expectancy at birth, the highest maternal and infant mortality rates, the highest suicide rates, and the highest death rates for avoidable or treatable conditions.  Some of the possible reasons for the poor health outcomes described in the study could be the lack of guaranteed health coverage in the US and the fact that the US has the lowest rate of practicing physicians and hospital beds per 1,000 population.  The study also noted that Americans see physicians less often than residents of other wealthy nations.  

Lawmakers Call for Drug Czar to Be Cabinet-Level Position 

55 bicameral, bipartisan lawmakers sent a letter to President Joe Biden on Thursday calling for the Director of the Office of National Drug Control Policy (ONDCP) to be elevated to a Cabinet-level position to better address the nation’s drug overdose epidemic.  Colloquially known as the “drug czar,” the position of ONDCP director was a Cabinet-level position until 2009 when then-President Barack Obama downgraded it.  Established under former President Ronald Reagan in 1988, the ONDCP coordinates with 19 federal agencies to lead US drug policy.  In the letter, the lawmakers urged President Biden to announce the reinstatement of the position to the Cabinet in the upcoming State of the Union address on February 7 due to a 60% increase in overdose deaths since 2019. 

ICYMI: Modernization Committee Lives On in 118th Congress 

Despite being dissolved at the end of 2022, the House Select Committee on the Modernization of Congress will live on in the 118th Congress as a subcommittee within the House Administration Committee as the the fate of the panel up until this week was in limbo due to a change in control of the House.  Like its predecessor, the new subcommittee consists of four members, equally divided between Republicans and Democrats.  Subcommittee leaders plan on building on the success of the select committee, which includes raising the pay ceiling for staff above what members earn and reviving a more transparent version of the earmarks process. 

Congress

What Happened, What You Missed: January 23-27

by Matt Gontarchick

Rep. Guthrie to Chair Health Subcommittee 

Rep. Brett Guthrie will chair the House Energy and Commerce Subcommittee on Health in the 118th Congress. Guthrie first became the Health Subcommittee’s top Republican at the start of the 117th Congress in January 2021, replacing Rep. Michael Burgess (R-TX), who sought to become the top Republican on the full Energy and Commerce Committee.  As chair of the Health Subcommittee, Guthrie’s likely priorities will be price transparency, the fentanyl epidemic, telehealth, medical product innovation, and exploring the business practices of pharmacy benefit managers (PBMs).  The Health Subcommittee will hold its inaugural hearing of the new Congress on February 1 to review legislation to address the fentanyl crisis.   

Bivalent Boosters Cut Risk of Infection by Half 

The new bivalent COVID-19 booster reduces the risk of symptomatic infection of the dominant Omicron XBB/XBB.1.5 subvariants by about 48%, according to new data from the Centers for Disease Control and Prevention (CDC).  Considered the most transmissible subvariant to date, XBB.1.5 is currently responsible for 49% of new COVID-19 infections nationwide.  The study found that the bivalent boosters were slightly more effective in preventing symptomatic infection in adults ages 18 to 49 than adults ages 50 and older.  However, most Americans are not benefitting from the added protection of a bivalent booster, as only about 15% of eligible Americans have received the new booster. 

HHS: Insulin Price Caps Mean Savings for Seniors 

1.5 million seniors in the US could save up to $500 per person annually thanks to new insulin price caps, according to a new report from the Department of Health and Human Services (HHS).  The report analyzed the impact of the $35 monthly insulin price cap in the Inflation Reduction Act, which went into effect for Medicare Part D beneficiaries on January 1, 2023.  According to the report, the average out-of-pocket cost per insulin fill for Part D beneficiaries in 2019 was $58 per insulin fill, while people with private insurance or Medicare coverage paid about $63 per fill.  The report also found that Medicare beneficiaries in Texas, California, Florida, North Dakota, Iowa, and South Dakota are likely to incur the most annual savings at $700-$800 per person.   

JAMA: Telehealth Didn’t Help with Opioid Treatment 

There was no significant difference in outcomes between people who sought treatment for opioid use disorder via telehealth or in-person via a clinician, according to a new study from the Journal of the American Medical Association (JAMA).  Since the start of the COVID-19 pandemic, emergency waivers have allowed people struggling with opioid addition to virtually receive prescriptions for treatments like buprenorphine.  One of the reasons why telehealth may not have resulted in better outcomes for substance use disorder patients is the limited access to broadband internet, particularly in low-income or rural communities.   

ICYMI: Diversity Lags among Congressional Staff 

While the 118th Congress is the most diverse in history, diversity amongst congressional staff is still playing catch-up, according to a report from the Joint Center for Political and Economic Studies.  The report found that only 18% of top congressional staffers are people of color, compared to 40% of Americans nationwide.  However, the report did note some recent areas of improvement, such as the fact that top staff working for returning members of Congress are more diverse than ever before.  Some of the obstacles preventing people of color from working in Congress include relatively low pay rates and the Washington, DC area’s high housing costs. 

Administration

What Happened, What You Missed: January 16-20

by Matt Gontarchick

Administration to Crack Down on Antipsychotics in Nursing Homes 

The Biden administration is getting ready to target the inappropriate use of antipsychotic medications in nursing homes, according to an announcement from the Centers for Medicare and Medicaid Services (CMS). The announcement is part of a larger initiative announced in October to strengthen oversight of the nation’s poorest performing nursing homes.  Starting this month, CMS will conduct targeted audits to determine whether nursing homes are accurately assessing and coding individuals with a schizophrenia diagnosis.  Nursing homes found to be regularly misdiagnosing residents will see changes to their rating in CMS’ nursing home rating system.  CMS will also start to make nursing home citations under dispute available to the public. 

Top White House COVID Official Steps Down 

Dr. David Kessler stepped down this week from his role as Chief Science Officer for the administration’s Covid-19 response.  His departure marks the end of a two-year stint at the White House that included oversight of the federal effort to develop and distribute COVID-19 vaccines and treatments.  In his role, Kessler was responsible for negotiating with drug companies to ensure that vaccines were available to anyone who wanted one.  Kessler is no stranger to public service, having served as Commissioner of Food and Drugs from 1990 to 1997.  The announcement of Kessler’s exit from the administration comes at a time when the federal government is working to shift COVID-19 vaccination from a government-run effort to one that will be managed by the private sector. 

Gallup: Most Americans Have Negative View of Health Care 

48% of Americans rate US health care quality as excellent or good, according to a new poll from Gallup.  The findings represent that for the first time since 2001, which was when Gallup began polling the public’s opinion on health care, that most Americans view health care quality as fair or poor.  The poll found that one of the key reasons that attitudes toward health care have declined is that Republicans’ faith in the health care system has deteriorated since former President Trump left office.  Another major reason respondents cited that health care quality declined was due to the high price of obtaining health care.  Views on health care in the US have gradually declined since their peak in 2012, when 62% of respondents viewed the health care system positively. 

Moderna’s Experimental RSV Vaccine Shows Promise 

Moderna’s experimental RSV vaccine was 83.7% effective at respiratory syncytial virus (RSV) in people ages 60 and older, according to data posted by the company on Monday.  No safety concerns were identified during the clinical trial of the vaccine, which uses the same mRNA technology as the company’s COVID-19 vaccine. The US is currently on the tail-end of a severe surge in RSV infections, which typically kill between 6,000 and 10,000 older adults every year and result in 60,000 to 120,000 hospitalizations.  A 37,000-person Phase III clinical trial is still ongoing, and the company plans on asking the Food and Drug Administration (FDA) to approve the vaccine by mid-year. 

Study Points to Benefits of Hybrid Immunity 

Hybrid immunity is more effective at protecting against severe COVID-19 cases and preventing hospitalization than immunity from infection alone, according to a study published in the Lancet.  The World Health Organization (WHO) defines hybrid immunity as protection in people who’ve been vaccinated for COVID-19 and have been infected with the virus either before or after vaccination.  The study found those with hybrid immunity were 42% less likely to get reinfected a year after their first two COVID-19 vaccine doses and 46% less likely six months after their first booster. While participants who had only been infected were 25% less likely to be reinfected with COVID-19.  The study’s authors recommended that mass vaccination should happen before case surges in the winter because immunity remains effective a year later. 

ICYMI: March for Life Rally Returns Today 

The March for Life returns to Washington, DC today, marking the first such rally of anti-abortion and pro-life advocates since the Supreme Court overturned Roe v. Wade last June.  Unlike previous years, this year’s march will partially go around the US Capitol instead of heading straight to the Supreme Court in order to send a message to lawmakers.  Organizers expect up 50,000 people to show up for the rally, which is similar to previous years.  Washington, DC area residents should be aware of road closures near the National Mall throughout the day.    

CMS

What Happened, What You Missed: January 9-13

by Matt Gontarchick

Number of ACA Marketplace Enrollees Reaches Record High 

A record-breaking 15.9 million people have enrolled for insurance coverage on the Affordable Care Act (ACA) marketplace through January 7, according to an announcement from the Centers for Medicare and Medicaid Services (CMS).  The new enrollment totals represent a 13% increase from the previous year.  In a press release, Health and Human Services (HHS) Secretary Xavier Becerra credited incentives in the Inflation Reduction Act (IRA) that expanded access to health care by lowering plan costs and offering more plan options for the enrollment boost.  The deadline to enroll in a plan on HealthCare.gov is January 15, although the deadline goes beyond Sunday in some states. 

Rep. Jason Smith Tapped to Chair Ways and Means 

Rep. Jason Smith (R-MO) prevailed over Reps. Adrian Smith (R-NE) and Vern Buchanan (R-FL) in his bid to chair the House Ways and Means Committee.  The committee’s jurisdiction over Medicaid and Medicare will give the Missouri congressman greater potential to affect health care policy.  Several factors helped Smith edge out his competitors, including his fundraising prowess and close relationship with Speaker Kevin McCarthy (R-CA). Known for his populist image, Smith has vowed to focus on rural health, telehealth, innovation, and price transparency.  He has also stated an interest in holding hearings to examine high health care costs.   

Medicaid Expansion Cause Post-Birth Hospitalizations to Decrease 

Medicaid expansion resulted in a 17% decline in postpartum hospitalizations in states that opted to expand the program, according to a new study from Health Affairs.  According to the data, the largest decrease in hospitalizations occurred during the first 60 days postpartum and a smaller decline in hospitalizations were observed for the period between 61 day and six months postpartum. Under the Consolidated Appropriations Act of 2023, the 12-month extended Medicaid postpartum coverage option has been made permanent. This has enabled 26 states and territories to expand Medicaid coverage for beneficiaries for up to one year postpartum. The results of the study are good news for the Biden administration, which is actively trying to improve maternal health. 

AHCA: 85% of Nursing Homes Face Staff Shortages 

Over eight in 10 nursing homes in the US are experiencing moderate to severe staffing shortages, according to a survey from the American Health Care Association (AHCA).  The survey also found that 96% of nursing homes are struggling to bring on additional staff.  Additionally, more than 60% of nursing homes said they’re worried about having to shut down due to the shortages.  To draw attention to the crisis, the ACHA launched a nationwide campaign to address staffing shortages that will help educate job seekers about opportunities in long-term care and help nursing homes recruit new employees. 

Porter, Lee Announce Bids for Senate 

Earlier this week, Reps. Katie Porter (D-CA) and Barbara Lee (D-CA) launched their campaigns for a Senate seat currently held by Sen. Dianne Feinstein (D-CA).  While the 89-year-old Feinstein filed paperwork in 2021 to run for re-election in 2024, the California senator has yet to publicly announce her bid for reelection.  Rep. Adam Schiff (D-CA) has also expressed an interest in running, although he has yet to make a formal announcement on his decision.  The likelihood of at least three House members seeking to represent California in the Senate will likely mean three competitive House races in the heavily Democratic San Francisco Bay Area and Los Angeles metropolitan area.   

ICYMI: Smoking Once Again Allowed in House Office Buildings 

House members are now allowed to use combustible tobacco products in their offices, according to new rules posted by the Speaker Pro Tempore on Tuesday.  While smoking is prohibited in nearly all office buildings in Washington, DC, the Capitol Complex is exempt from local rules.  However, smoking still remains off-limits on the House floor.  Since the rules were published earlier this week, noted cigar aficionado and new House Rules Committee Chairman Tom Cole (R-OK) has already been spotted smoking a cigar. 

FDA

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

by Matt Gontarchick

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

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

OIG Report Calls for Better Part B Oversight 

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

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

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

NIH Launches Pilot Telehealth Program for COVID-19 

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

Sen. Debbie Stabenow Announces Retirement  

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

ICYMI: House Offices Reopened to Visitors 

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

Congress

January 3: Who Will Be Sitting When the Music Stops? 

by Matt Gontarchick

A new era begins with a new Congress on January 3, 2023.  For the first time since 2007, Rep. Nancy Pelosi (D-CA) will no longer serve as the leader of House Democrats.  However, it remains unclear who will succeed Pelosi as Speaker, as several Republican House members are refusing to support Rep. Kevin McCarthy (R-CA), the current top Republican in the House.  For most other leadership positions and top committee spots, selections for the 118th Congress are expected to be non-controversial and generally follow lines of seniority. This blog post takes a look at who is expected to assume top leadership and committee roles in the new Congress, and why some selections have yet to be determined. 

Rep. Kevin McCarthy (R-CA), the Republican leader of the 116th and 117th Congress, was highly favored to be elected speaker in the new Congress, but the results of the 2022 midterm election changed the calculus.  A person needs a simple majority of all present and voting House members to be elected speaker, which amounts to  218 votes if all 435 representatives are present.  However, House Republicans’ narrow 10-seat majority in the House leaves McCarthy with little wiggle room when it comes to earning the support of his caucus.   

To get to 218 votes, McCarthy can’t afford to lose more than four votes from House Republicans, and currently,  five GOP House members are declining to support him.  Most of these five Republicans have different reasons for why they oppose McCarthy – some are critical of his leadership, while others say he lacks a strong policy agenda – which makes the situation tricky for McCarthy to address.  Other Republicans have signaled that they will support McCarthy if he agrees to change certain conference rules, such as allowing a “motion to vacate,” which gives any member the power to bring up a vote at any time to oust a speaker. McCarthy has yet to give in to this demand, although things could change as negotiations with the few remaining GOP holdouts continue. 

The vote for the speakership is set for Tuesday, January 3.  If McCarthy fails to reach 218 votes, several scenarios could play out.  First, House Clerk Cheryl Johnson could repeat a vote for the speakership until someone receives a majority, although this hasn’t happened since 1923.  Second, Republicans could adjourn the House to provide more time to negotiate and reach agreement on a candidate for speaker.  Either way, many Republicans anticipate that it could take multiple votes before a final candidate gets to 218. 

Uncertainty about who will be elected speaker has had a domino effect throughout the House Republican Conference, resulting in unanswered questions on who will chair several key committees in the House.  While the House Republican Conference Steering Committee met and selected chairs for most committees on December 7, decisions on who will lead several key committees were tabled until January, which includes the Ways and Means Committee.   

Of the three Republicans vying for the gavel of the Ways and Means Committee, Rep. Vern Buchanan (R-FL) is touting his business background, Rep. Jason Smith (R-MO) is taking a populist approach while emphasizing his ties to working class voters, and Rep. Adrian Smith (R-NE) is presenting himself as a top policy expert.  Whoever is elected chairman will have the opportunity to shape health care policy, due to the committee’s jurisdiction on Medicare.    

Jason Smith’s bid to lead the Ways and Means Committee complicates the situation for the Budget Committee, where he currently sits as the committee’s top Republican.  If the Missouri Republican succeeds in the competition to lead Ways and Means, Reps. Jodey Arrington (R-TX), Lloyd Smucker (R-PA), and Buddy Carter (R-GA) are the top candidates to chair the Budget Committee in the next Congress.   

The situation is similarly complicated for the House Homeland Security Committee, where several Republicans are seeking the gavel: Reps. Dan Crenshaw (R-TX), Mark Green (R-TN), Clay Higgins (R-LA), Dan Bishop (R-NC), and Scott Perry(R-PA).   The committee is expected to conduct oversight of the Biden administration’s border security policies in the next Congress.   

The House Education and Workforce Committee is also currently without a Republican leader in the new Congress.  The House Republican Conference currently bars members from leading a committee for more than three consecutive terms, regardless of which party has the majority.  GOP leadership granted Rep. Virginia Foxx (R-NC), the committee’s current ranking member, a waiver to serve as the committee’s top GOP member for a fourth term in the 118th Congress; however, an unexpected challenge for the gavel from Rep. Tim Walberg (R-MI) means a final decision on who will chair the committee won’t be made until January. Finally, since the speaker selects the chair of the House Administration Committee, it will remain unknow who will lead this committee until House Republicans settle on a speaker.   

Democrats in the House and Senate have already finalized most committee and leadership assignments for the 118th Congress, as have Senate Republicans.  However, House Republicans are sure to enter the new year in a state of uncertainty as disagreements over who will be second in presidential line of succession remain unresolved.  

House

Speaker: TBD 

Majority Leader: Steve Scalise (R-LA) 

Minority Leader: Hakeem Jeffries (D-NY) 

Minority Whip: Katherine Clark (D-MA) 

Committee Chairs and Ranking Members 

Agriculture: G.T. Thompson (R-PA) 

Ranking Member David Scott (D-GA) 

Appropriations: Kay Granger (R-TX) 

Ranking Member Rosa DeLauro (D-CT) 

Armed Services: Mike Rogers (R-AL) 

Ranking Member Adam Smith (D-WA) 

Budget: TBD 

Ranking Member Brendan Boyle (D-PA) 

Education and Workforce: TBD 

Ranking Member Bobby Scott (D-VA) 

Energy and Commerce: Cathy McMorris Rodgers (R-WA) 

Ranking Member Frank Pallone (D-NJ) 

Ethics: Michael Guest (R-MS) 

Ranking Member Susan Wild (D-PA) 

Financial Services: Patrick McHenry (R-NC) 

Ranking Member Maxine Waters (D-CA) 

Foreign Affairs: Michael McCaul (R-TX) 

Ranking Member Gregory Meeks (D-NY) 

Homeland Security: TBD 

Ranking Member Bennie Thompson (D-MS) 

House Administration: TBD 

Ranking Member Suzanne Bonamici (D-OR) 

Judiciary: Jim Jordan (R-OH) 

Ranking Member Jerrold Nadler (D-NY) 

Natural Resources: Bruce Westerman (R-AR) 

Ranking Member Raúl Grijalva (D-AZ) 

Oversight and Reform: Jim Comer (R-KY) 

Ranking Member Jamie Raskin (D-MD) 

Rules: Tom Cole (R-OK) 

Ranking Member Jim McGovern (D-MA) 

Science, Space, and Technology: Frank Lucas (R-OK) 

Ranking Member Zoe Lofgren (D-CA)  

Small Business: Blaine Luetkemeyer (R-MO) 

Ranking Member Nydia Velázquez (D-NY) 

Transportation and Infrastructure: Sam Graves (R-MO) 

Ranking Member Rick Larsen (D-WA) 

Veterans’ Affairs: Mike Bost (R-IL) 

Ranking Member Mark Takano (D-CA) 

Ways and Means: TBD 

Ranking Member Richard Neal (D-MA) 

Intelligence: Mike Turner (R-OK) 

Ranking Member Adam Schiff (D-CA) 

Senate

Top Leadership 

Majority Leader: Chuck Schumer (D-NY) 

Majority Whip: Dick Durbin (D-IL) 

Minority Leader: Mitch McConnell (R-KY) 

Minority Whip: John Thune (R-SD) 

Committee Chairs and Ranking Members 

Aging: Bob Casey (D-PA)  

Ranking Member Mike Braun (R-IN) 

Agriculture: Debbie Stabenow (D-MI) 

Ranking Member John Boozman (R-AR) 

Appropriations: Patty Murray (D-WA) 

Ranking Member Susan Collins (R-ME) 

Armed Services: Jack Reed (D-RO) 

Ranking Member Roger Wicker (R-MS) 

Banking, Housing, and Urban Affairs: Sherrod Brown (D-OH) 

Ranking Member Tim Scott (R-SC) 

Budget: Sheldon Whitehouse (D-RI) 

Ranking Member Lindsey Graham (R-SC) 

Commerce: Maria Cantwell (D-WA) 

Ranking Member Ted Cruz (R-TX) 

Energy and Natural Resources: Joe Manchin (D-WV) 

Ranking Member John Barrasso (R-WY) 

Environment and Public Works:  Tom Carper (D-DE) 

Ranking Member Shelley Moore Capito (R-WV) 

Ethics: Chris Coons (D-DE) 

Ranking Member James Lankford (R-OK) 

Finance: Ron Wyden (D-OR) 

Ranking Member Mike Crapo (R-ID) 

Foreign Relations: Bob Menendez (D-NJ) 

Ranking Member James Risch (R-ID) 

HELP: Bernie Sanders (I-VT) 

Ranking Member Bill Cassidy (R-LA) 

Homeland Security: Gary Peters (D-MI) 

Ranking Member Rand Paul (R-KY)  

Indian Affairs: Brian Schatz (D-HI) 

Ranking Member Lisa Murkowski (R-AK) 

Intelligence: Mark Warner (D-VA) 

Ranking Member Marco Rubio (R-FL) 

Judiciary: Dick Durbin (D-IL) 

Ranking Member Chuck Grassley (R-IA) 

Rules and Administration: Amy Klobuchar (D-MN) 

Ranking Member Deb Fischer (R-NE) 

Small Business: Ben Cardin (D-MD) 

Ranking Member Joni Ernst (R-IA) 

Veterans’ Affairs: Jon Tester (D-MT) 

Ranking Member Jerry Moran (R-KS) 

Congress

What Happened, What You Missed: December 19-23 

by Matt Gontarchick

Senate Advances $1.7 Trillion Omnibus Spending Bill 

The Senate passed a massive Fiscal Year (FY) 2023 spending package on Thursday by a 68-29 vote.  The legislation to fund the government through September 30, 2024, includes supplemental aid for natural disaster victims and the the war in Ukraine, as well as a bevy of policies related to electoral reform and how states can spend COVID-19 relief dollars.  Key health care items included in the bill are an extension of Medicare telehealth waivers through 2024, new requirements to improve clinical trial diversity, and a reduction in Medicare payment cuts that doctors are facing over the next two years. 

New Report Criticizes FDA’s Tobacco Oversight Operations 

The Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) operates in a “reactive state” and lacks clarity in its policies and processes, according to a new report from the Reagan-Udall Foundation.  While the report found that the CTP performs well when it comes to public health messaging and communication, the agency’s inconsistency of enforcing actions and lack of standard operating procedure has contributed to millions of tobacco products being sold without authorization.  Among the recommendations the report suggested are the creation of a detailed strategic agenda, the creation of an Office of Policy, and the establishment of an interagency task force to prioritize enforcement of tobacco laws. 

CDC: COVID-19 Caused US Life Expectancy to Drop 

A baby born in 2021 can expect to live two fewer years than a baby born in 2019, according to new data from the Centers for Disease Control and Prevention (CDC) on US life expectancy. The CDC attributed the drop to the COVID-19 pandemic, which exacerbated an existing substance abuse crisis by driving more vulnerable individuals to drug and alcohol misuse.  The new life expectancy of 76.4 years represents the lowest since 1996, having undone a quarter century of progress.  The CDC also released a report this week on drug overdose deaths which found that overdose deaths for all drugs have increased, except heroin. 

KFF: Public Support for Childhood Vaccine Requirements Wanes 

Public support for childhood vaccine requirements has declined since the start of the COVID-19 pandemic, according to a new survey from the Kaiser Family Foundation (KFF).  The survey found that 71% of adults say children should be required to get vaccinated for measles, mumps, and rubella (MMR) to attend school, which is down from 82% of adults in an October 2019 Pew Research Center poll.   Additionally, 28% said parents should be able to decide not to vaccinate their children, up from 16% in 2019.  The survey also found that about one-third of adults were concerned they will get seriously sick from COVID-19, although older adults and members of racial and ethnic minority groups voiced greater concern about becoming seriously ill. 

ICYMI: Modernization Committee Releases Its Final Report 

After four years of information gathering, the House Select Committee on the Modernization of Congress issued its final report that details what’s wrong with Congress and how to fix it.  Across 16 chapters, the report details more than 200 recommendations that aim to professionalize internships and fellowships, improve the retention of congressional staff, and modernize the legislative process.  The report also recommends that the committee continue its important work through the establishment of a new Subcommittee on Modernization within the House Administration Committee. 

Administration

What Happened, What You Missed: December 12-16 

by Matt Gontarchick

White House Revives Free COVID-19 Test Program 

The White House restarted a program to provide free COVID-19 tests to Americans via the US Postal Service, ahead of a possible winter surge as new cases and hospitalizations tick up.  The Biden administration initially began supplying COVID-19 tests by mail in January to address the Omicron surge, but the program was suspended in September due to a lack of funding.  The move is part of a broader COVID-⁠19 Winter Preparedness Plan that includes offering resources and assistance to states to get more Americans vaccinated and boosted, releasing a “winter playbook” for nursing homes and long-term care facilities, and monitoring for new variants.  Households can now order four tests at covidtests.gov, with shipments beginning next week. 

NBPP Proposes to Address Generic Drug Prices, Offer New Special Enrollment Period (SEP) 

The Department of Health and Human Services (HHS) proposed a number of new policies in its proposed 2024 Notice of Benefit and Payment Parameters (NBPP) rule, including one to require Affordable Care Act (ACA) marketplace plans to cover all generic drugs on a new, dedicated generic drug tier with lower cost-sharing.  According to HHS, the new policy would help prevent discriminatory benefit designs, improve access for prescription drugs, and reduce the risk of confusion for ACA plan enrollees.  Additionally, HHS proposed allowing ACA marketplaces to create a new special enrollment period (SEP) for people who lose Medicaid/CHIP benefits.  The proposed policy is likely a preemptive move to address coverage losses from Medicaid redeterminations once the COVID-19 public health emergency (PHE) comes to an end.  Stakeholders have until January 28 to comment on the proposed NBPP rule. 

Initial Data on Moderna’s Cancer Vaccine Show Promise 

Moderna’s mRNA cancer vaccine has resulted in a “clinically meaningful reduction” in the risk of death when used alongside an immunotherapy, according to early-stage clinical trial data released by the company on Tuesday.  Moderna stated in a press release the results amount to a “paradigm shift” in treating cancer by offering a new therapeutic that has significantly fewer side effects than existing treatments like chemotherapy and radiation therapy.  If approved, however, the cost of mRNA vaccines would be a major obstacle, as each treatment would be personalized to each patient. 

SAMHSA Proposes Buprenorphine Prescriptions via Telehealth 

In a notice of proposed rulemaking (NPRM) issued on Tuesday, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed nixing the in-person requirement to receive a buprenorphine prescription to treat opioid use disorder and allow the treatment to be prescribed via telehealth.  The change is likely intended to address a spike in opioid overdose deaths that began with the COVID-19 pandemic.  Since the start of the COVID-19 PHE, people suffering from opioid abuse have been able to get prescriptions for buprenorphine over audio-only or video telehealth via a temporary waiver.  According to a recent HHS study, people who took advantage of receiving a prescription over telehealth to treat opioid abuse experienced overall positive outcomes.   

ICYMI: Pelosi’s Portrait Unveiled at US Capitol 

An official portrait of Speaker Nancy Pelosi (D-CA) was unveiled in Statuary Hall of the US Capitol on Wednesday.  The portrait depicts the day she was first elected speaker on January 4, 2007.  Senate Majority Leader Chuck Schumer (D-NY) and former House Speaker John Boehner (R-OH) spoke at the unveiling ceremony, and former President Barack Obama delivered remarks via video.  The ceremony also included brief remarks in memory to the artist responsible for Pelosi’s and Boehner’s portraits, Ronald Scherr, who died last week at age 70.   

FDA

What Happened, What You Missed: December 5-9

by Matt Gontarchick

Report Calls for FDA to Break Up 

The Food and Drug Administration (FDA) should be split up to address problems plaguing the agency’s food oversight arm, according to a new report by the Reagan-Udall Foundation.  The agency asked the Reagan-Udall Foundation to analyze its operations in the wake of the infant formula crisis earlier this year.  According to the report, flaws in the FDA’s leadership structure and poor communication among agency officials has resulted in the agency’s food safety operations being consistently underfunded, understaffed, and underprioritized.  The report also suggested a less drastic measure that would create a deputy commissioner position with authority for overseeing food.  Any move to split up the agency would require approval from Congress. 

FDA Authorizes COVID-19 Boosters for Kids under 6 

On December 8, the FDA approved bivalent COVID-19 booster shots from Pfizer and Moderna for children six months to six years of age.  The announcement comes as children’s hospitals across the country are at capacity for kids suffering from a range of respiratory illnesses, including COVID-19, respiratory syncytial virus (RSV), and the flu.  However, the rules on who can get a shot when differ depending on whether the initial vaccine regimen came from Pfizer or Moderna.  Children under age six who have completed Moderna’s two-dose regimen can get their bivalent booster if it’s been at least two months since their last shot, while children under six who received the first two doses of Pfizer’s three-dose regimen can use the new bivalent booster for their third shot.  However, children who received all three initial vaccine doses from Pfizer aren’t yet eligible for a booster shot. 

ICER: Biggest Drug Price Increases Not Substantiated 

According to a report by the Institute for Clinical and Economic Review (ICER), price increases among seven of the ten drugs in 2021, which saw the largest increases from the year prior, were not supported by clinical evidence.  Out of the $805 million increase in drug spending from 2020-2021, Bausch Health’s Xifaxan, an antibiotic drug for traveler’s diarrhea, saw the biggest increase of nearly $175 million in spending, while Johnson & Johnson’s schizophrenia drug Invega Sustenna and Amgen’s osteoporosis drug Prolia were second and third with respective spending increases of $170 million and $124 million.  According to ICER, the report is intended to inform policymakers and lawmakers on policies they can pursue to address high drug prices.  However, the report acknowledged that the impact of the Inflation Reduction Act’s Medicare drug price negotiation on commercial payers remains uncertain. 

ACA Marketplace Enrollment Reaches 5 Million 

Nearly 5.5 million individuals from November 1 to December 3 selected a 2023 health plan through the federally facilitated and state-based marketplaces, according to the Centers for Medicare and Medicaid Services (CMS).  Roughly 80% of enrollees renewed their health care coverage, while the rest were new enrollees.  33 states currently use the federal marketplace for the 2023 open enrollment period, which runs through January 15, 2023.  CMS also reported that state-based exchanges will automatically renew coverage for about 2.9 million residents nationwide.  

 Top Ways and Means Republicans Make Their Case for Chairmanship 

With current Ways and Means Committee Ranking Member Kevin Brady (R-TX) set to retire soon with the end of the 117th Congress, three senior Republicans on the committee are making the case to succeed Brady and chair the committee in the next Congress.  As the Republican Steering Committee prepares to vote on who will get the chairman’s gavel in January, Rep. Vern Buchanan (R-FL) is touting his business background, Rep. Jason Smith (R-MO) is taking a populist approach while emphasizing his ties to working class voters, and Rep. Adrian Smith (R-NE) is presenting himself as a top policy expert.  Whoever is elected chairman will have the opportunity to shape health care policy, due to the committee’s jurisdiction on Medicare.   

ICYMI: Representatives Vie for New House Offices 

73 incoming House members were assigned their designated workspaces on Capitol Hill as a part of a biennial office lottery that took place late last week in the Cannon House Office Building.   While past lotteries followed the alphabetical order of members’ names, this year’s lottery was completely randomized.  The Rayburn House Office Building is usually seen as the most desirable office location, since the building is connected to the Capitol by the subway.  

FDA

What Happened, What You Missed: November 28-December 2 

by Matt Gontarchick

New Drug Shows Potential to Slow Alzheimer’s Disease  

The experimental drug lecanemab has the potential to slow the progression of Alzheimer’s disease, according to late-stage clinical trial data from drugmakers Biogen and Eisai.  While Phase 2 trial data released in the summer did not show a large difference between lecanemab and a placebo in Alzheimer’s disease patients over 12 months, newly released Phase 3 trial data found that the drug was associated with less cognitive decline after 18 months of use.  However, instances of patients experiencing brain swelling and brain bleeding have raised concerns over the drug’s safety.  The news follows controversy over the decision by the Food and Drug Administration (FDA) last year to approve another Alzheimer’s drug from Biogen, in spite of clinical trial data that showed the drug’s efficacy to be limited.   

Senate Panel Discusses Prior Authorization, Kids’ Mental Health 

Senators from both parties touted legislation to expand mental health integration into pediatric care in a Wednesday hearing from the Senate HELP Subcommittee on Children and Families that focused on how the pandemic has exacerbated mental health challenges facing adolescents.  Other bipartisan legislation discussed in the hearing would streamline transitions from high school to college for students with disabilities and increase Medicaid reimbursement for children’s mental health services.  Prior authorization reform was also a topic of discussion during the hearing, as several witnesses pointed out that long wait times and high administrative costs are preventing many teens from accessing mental health care services in a timely manner.   

HHS Proposes Changes to Privacy Records for Substance Use Disorder Patients 

Currently, a substance use disorder patient must provide consent every single time a health care provider needs to share the patient’s records.  However, a newly proposed rule from the Department of Health and Human Services (HHS) would allow providers to share a patient’s records multiple times after receiving a patient’s consent only once.  According to a press release, the new privacy rules would ensure individuals are not denied “life-saving care” due to concerns about records disclosure.  The rule would also increase coordination among providers of treatment for substance use, expand HHS enforcement authority under 42 CFR part 2, and update breach notification requirements to HHS.  Stakeholders have until January 31, 2023, to comment on the proposed rule. 

CDC: Deaths Linked to Substance Abuse Climb among Seniors 

Deaths associated with drug and alcohol abuse are steadily rising, according to new data from the Centers for Disease Control and Prevention (CDC).  According to the data, death rates from drug overdoses among people 65 and over have more than tripled since 2000, while alcohol-related deaths among seniors have jumped more than 20% from 2019 to 2020.  The CDC also noted that alcohol-related death rates are higher overall among men over the age of 65, with older men seeing death four times higher than women when considering seniors 75 and older.   The report additional found growing use of fentanyl and synthetic opioids among seniors. 

CDC to Start Wastewater Testing for Polio 

The CDC announced on Wednesday plans to begin wastewater surveillance for polio in select communities with low vaccination rates.  The CDC will use data from the surveillance program to assist with vaccination programs if necessary.  Communities in Michigan, New York, and Pennsylvania will be the first to adopt the wastewater testing programs, which will last for at least four months.  The CDC first hinted that it may begin wastewater testing program for polio in the summer when a single case of paralytic polio was found in Rockland County, New York.  The risk of polio to the public remains low because more than 92% of Americans were vaccinated during childhood. 

ICYMI: White House Celebrates 100th Lighting of National Christmas Tree  

President Joe Biden celebrated the 100th lighting of the National Christmas Tree on Wednesday in a ceremony that included performances from Shania Twain and Gloria Estefan.  During the ceremony to light the 27-foot white fir, President Biden emphasized the importance of national unity and called on Americans to reflect on their blessings. The lighting of the National Christmas Tree began as a tradition a century ago under President Calvin Coolidge.   

Congress

Health Care Issues Loom Large in Lame Duck

by Matt Gontarchick

The holiday rush commences today on Capitol Hill, with Congress back in session for the first time in several weeks. Following a midterm election that defied expectations, lawmakers face a lengthy to-do list to address this year’s unfinished business before a new Congress begins in January. Here are five items important to health care that lawmakers are likely to address in the coming weeks.

FY 2023 Appropriations

The current continuing resolution (CR) for Fiscal Year (FY) 2023 appropriations expires on December 16. With Republicans set to take control of the House with a narrow majority in January, Democrats will be keen to use their narrow majorities in the current Congress to complete work on a FY 2023 omnibus before the year’s end. While leading House and Senate appropriators have expressed an interest in completing an omnibus bill fully funding the government through FY 2023 by the December 16 deadline, factors such as the December 6 Senate runoff election in Georgia could delay negotiations a bit. With that in mind, Congress may need to enact a short-term CR ahead of December 16, perhaps even for a week, to ensure government funding continues while it presses on with negotiations on a final year end bill.

Although lawmakers could punt an omnibus spending bill into the next Congress, most have a preference for avoiding that outcome. Both top Senate appropriators Patrick Leahy (D-VT) and Richard Shelby (R-AL) are retiring, which adds pressure to make a bipartisan deal on their final spending bill. Contributing to the need to finish FY 2023 appropriations work in the current Congress is the fact that the next Congress will feature a narrow GOP majority, which will make it much harder to pass spending bills.

Medicare Cuts

Health care providers are facing several difficult Medicare cuts next year, most notably being a 4.5% cut to Physician Fee Schedule (PFS) reimbursement, a 4% cut in Medicare payments under the Pay-As-You-Go Act of 2010 (PAYGO) Act of 2010-mandated sequester, and an expiration of a 5% bonus payment for participation in alternative payment models. Congress is under intense pressure by health care providers to address all three in the forthcoming year end spending bill. In addition, funding for the Low-Volume Adjustment and Medicare-Dependent Hospital program was extended under the current CR and would need to be further extended. the Medicare-Dependent Hospital program, and the Low-Volume Adjustment.

FDA Reform

Members of both parties are eager to pass riders to the Food and Drug Administration (FDA) user fee reauthorization bill that were ultimately dropped from language that was included on the CR. . Some of the riders being debated are changes to the accelerated approvalof drugs, provisions to increase diversity in clinical trials, and regulation of diagnostic testing, cosmetics, and dietary supplements. These riders represent a number of bipartisan provisions that were included in either the House-passed user fee bill as well as the Senate Health, Education, Labor, and Pensions (HELP) Committee bill passed out of committee earlier this year, however, agreement between the two chambers could not be reached. .

Medicaid

December 16 is another important deadline, as it marks the expiration of matching federal dollars for the US territories’ Medicaid programs. On top of this deadline, Puerto Rican government officials are calling for more federal funding to address the damage from Hurricane Fiona. Furthermore, there is significant pressure by stakeholders, including the National Association of Medicaid Directors, on Congress to address the need for certainty around the end of the Medicaid continuous enrollment requirement per the public health emergency. In addition, several top Democrats are pushing to make 12 months of postpartum Medicaid coverage mandatory and permanent for states. Already over half of states have opted for the temporary extension of Medicaid postpartum benefits from 60 day to 12 months as made possible by the American Rescue Plan Act.

ARPA-H

Congress officially created the Advanced Research Projects Agency-Health (ARPA-H) in its FY 2022 omnibus, but specific details on the new agency remain unclear as work continues on authorizing legislation. While both the House and Senate bills to authorize ARPA-H contain many similarities, they differ in one key area – the Senate bill would make ARPA-H a part of the National Institutes of Health (NIH), while the House bill calls for making ARPA-H an independent agency within the Department of Health and Human Services (HHS). Despite differences on the structure of the new agency, Democratic leaders of the House and Senate health committee remain highly interested in finishing ARPA-H authorizing legislation this year.