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

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

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.

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What Happened, What You Missed: January 23-27

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.

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What Happened, What You Missed: January 16-20

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.

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What Happened, What You Missed: January 9-13

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.

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

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.

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