Insights^

White House Orders HHS to Develop AI Safety Program

The Department of Health and Human Services (HHS) is tasked with establishing a safety program to document and address artificial intelligence (AI) harms and unsafe practices in health care, according to an executive order (EO) signed by President Joe Biden.  The EO attempts to strike a balance between recognition of the risk AI poses to Americans and acknowledgement of AI’s potential to improve health care delivery and develop new therapeutics.  Other health care components of the wide-ranging EO include the expansion of grants for AI research and a requirement for HHS to develop a strategy to determine whether AI tools are safe enough to use in health care settings.  While health care stakeholders have so far reacted positively to the EO and its unified approach to AI, questions remain on how the EO will be implemented.

HHS and CMS Publish Rule-a-Rama

In addition to last week’s End-Stage Renal Disease final payment rule, HHS and the Centers for Medicare and Medicaid Services (CMS) published a slew of payment rules for 2024.  CMS posted final rules for Home Health, Hospital Outpatient/Ambulatory Surgery Centers, and the Physician Fee Schedule, resolving months of lobbying efforts to impact payment and policy changes proposed by the agency earlier this year.   CMS also released details of the remedy for 340B-acquired drug payments for 2018 to 2022. Health care providers who commit information blocking could face additional penalties, according to a newly-proposed rule from HHS.

New Guidelines Urge More Smokers to Get Screened for Lung Cancer

5 million additional Americans who smoke or used to smoke should undergo annual screenings for lung cancer, according to updated guidelines from the American Cancer Society (ACS).  While previous guidelines said annual screenings are not necessary for people who quit smoking less than 15 years ago, the new guidelines say all former smokers should be screened annually, regardless of how long ago they quit.  ACS updated the guidelines in response to new research that found that the risk of lung cancer for former smokers remains elevated for at least 20-30 years compared to people who never smoked.  Cigarette smoking is responsible for 80% of lung cancer cases, which can usually be treated if detected early through screening.

Infant Mortality Rate Rises for First Time in 20 Years

A 3% bump in the US infant mortality last year marks the first time the rate has grown in two decades, according to new data from the Centers for Disease Control and Prevention (CDC).  All ethnic and racial groups saw rates grow, although the only statistically significant increases were observed among infants born to American Indian women and white women.  While the CDC did not provide a reason for the uptick in infant death, public health experts say it could be attributed to a rise in flu and RSV respiratory syncytial virus (RSV) cases last year as well as limited access to maternal care and abortions.  It remains unclear if the infant mortality rate’s increase is a temporary aberration or a sign of more pressing health care issues.

ICYMI: Romney Emcees Annual “Bipawtisan” Halloween Parade

In an era of historic partisan gridlock, dogs in costumes seem to be one of the few things left that are capable of bringing lawmakers from both parties together.  A few days ago, Sen. Mitt Romney (R-UT) hosted the widely attended Bipawtisan Howl-o-ween Dog Pawrade, which Sen. Thom Tillis (R-NC) launched in 2017 to encourage congressional pups and their owners to show off their costumes.  Tillis, the usual parade host, couldn’t participate this year after coming down with COVID-19.  Notable costumes from this year’s parade include a Chinese spy balloon from the Senate Foreign Relations Committee, a lobster from the office of Sen. Angus King (I-ME), and an astronaut from the office of Sen. Mark Kelly (D-AZ).

Odds of Shutdown Grow as Appropriations Gridlock Continues

The White House is urging Congress to agree to a short-term continuing resolution (CR) to keep the federal government open after the current fiscal year (FY) ends on September 30. To date, only the House has advanced an appropriations bill for FY 2024, although the Senate is considering moving forward on a package of spending bills as soon as next week. However, with little time remaining for a bipartisan, bicameral FY 2024 spending agreement, the Senate appears to be signaling that the upper chamber will address the looming appropriations deadline with a bipartisan CR of their own. However, widespread disagreements over spending among Republicans in the GOP-controlled House make the path forward on a bicameral CR increasingly tenuous, which raises the odds for a government shutdown in just over three weeks.

Health Affairs: 32% of HHS Appointees Leave for Private Industry

About one in three political appointees at the Department of Health and Human Services move on to positions in the private industry, according to a study published in Health Affairs. The study examined HHS appointee exits across three presidential administrations from 2004 to 2020. While Republicans were more likely to appoint individuals to HHS from industry than Democrats, political appointees from both parties departed for industry jobs at similar rates. The study’s authors noted that the 32% does represent the true extent of transitions to the private sector, as some non-profit roles support commercial interests. According to the study, appointees’ departures to industry shouldn’t be surprising given higher compensation in the private sector.

Moderna: New COVID-19 Vaccine Effective against BA.2.86

Moderna’s new COVID-19 vaccine that’s set to become available this fall offers a strong immune response to the BA.2.86 Omicron subvariant, according to data published by the company. Moderna’s new vaccine was initially developed to target XBB.1.5, which was the most prevalent Omicron subvariant in early 2023. BA.2.86 has 34 to 36 different mutations in the spike protein compared with XBB.1.5, which has sparked concerns that the new subvariant could evade protection from new vaccines. Fortunately, according to Moderna, its new shot induces aan 8.7-fold increase in neutralizing antibodies against BA.2.86. Additionally, a trio of studies introduced in the past week suggest that BA.2.86 is not as infectious as previous subvariants.

New CMS Model Aims to Address Chronic Diseases

The Centers for Medicare and Medicaid Services (CMS) launched the States Advancing All-Payer Health Equity Approaches and Development Model (AHEAD) Model on Tuesday, which aims to partner with states to address chronic disease, behavioral health, and other medical conditions. Participating states will work with CMS to redesign health care delivery to improve the total by improving the quality and efficacy of care delivery and reducing health disparities. The AHEAD Model hopes to incentivize better health outcomes by providing hospitals with a prospective payment stream via hospital global budgets. The model also intends to boost coordination across payers, providers, and community organizations in participating states. (https://flooringoutletandmore.com/) A Notice of Funding Opportunity (NOFO) will be released in late fall 2023.

ICYMI: Most Americans Want Age Cap for President

Some 76% of Americans say there should be a limit for how old someone can be to serve as president, according to a poll from The Economist/YouGov. The poll comes amid growing questions about the age and health of US politicians. For example, 81-year-old Senate Republican Leader Mitch McConnell (R-KY) recently froze up at a press conference, while 90-year-old Sen. Dianne Feinstein (D-CA) did not appear in the Senate for several months due to shingles and other health issues.

Administration Proposes New Medicare Drug Pricing Reforms

On Tuesday, the Centers for Medicare and Medicaid Services (CMS) announced a trio of drug pricing proposals that would standardize how much Medicare beneficiaries pay for certain generic drugs, explore new ways for Medicaid to pay for expensive cell and gene therapies, and test ways to pay for drugs approved without a proven clinical benefit.  The proposals stem from an executive order President Biden signed last year directing the administration to develop demonstrations that would complement the drug pricing provisions of the Inflation Reduction Act. Beyond the three proposals, CMS also called for more research to encourage adoption of biosimilars, data access to support price transparency, and access to cell and gene therapies under Medicare.

Administration Proposes Nursing Homes Disclose Connections to Private Equity

Nursing homes would have to disclose whether private equity firms or real estate investment trusts own or help operate facilities under a proposed CMS rule released on Monday.  The rule would require nursing homes to report such relationships during the Medicare and Medicaid enrollment process, which would enable government agencies and the public to more easily determine whether nursing home owners are private equity investors or real estate investment trusts.  In response, the American Health Care Association and National Center for Assisted Living (ACHA/NCAL) called the rule a “distraction from the real issues” facing nursing homes, like the underfunding of Medicaid and workforce shortages.

Feinstein Announces Retirement

Sen. Dianne Feinstein (D-CA), the Senate’s oldest member, announced her retirement on Tuesday.  A former mayor of San Francisco, Feinstein announcement came amid concerns regarding her age and mental acuity.  She is the first woman to have chaired the Senate Rules Committee and the only woman to have chaired the Select Committee on Intelligence. Since the announcement, Reps. Katie Porter (D-CA) and Adam Schiff (D-CA) have both announced their plans to run for Feinstein’s Senate seat, and Rep. Barbara Lee (D-CA) is widely expected to announce her own Senate run.

FDA Issues New Warnings on Aduhelm

The Food and Drug Administration (FDA) recently updated the label of Biogen’s Alzheimer’s drug Aduhelm following the death of a 75-year-old woman who experienced brain bleeding and swelling while taking the drug.  The new label calls on physicians to “inform patients that events of intracerebral hemorrhage” can happen infrequently when taking Aduhelm.  According to clinical trial data, 41% of Aduhelm-treated patients experienced brain bleeding and/or swelling, compared to 10% of patients on placebo.  Aduhelm received a controversial accelerated approval from the FDA in June 2021, despite mixed data on the drug’s clinical benefit for Alzheimer’s patients.  Aduhelm sales have remained low due to the drug’s high price tag and a decision from some major university hospital systems to not prescribe the drug.

ICYMI: UFO Fever Hits Washington…Again

Members of Congress and the general public has once again become enamored with unidentified flying objects (UFOs) after the Pentagon admitted to shooting down three such UFOs last weekend.  Details about the recent incidents remain sparse as earlier this week, Sen. Jim Risch (R-ID) said the craft was “smaller than a car,” and that one carried “a payload.”  However, other senators have been quick to clarify that the objects are not extraterrestrial in origin.  In recent years, UFO fascination in Congress has centered around reports of unidentified ariel phenomena (UAP) from US Navy personnel.

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 118^th Congress

Despite being dissolved at the end of 2022, the House Select Committee on the Modernization of Congress will live on in the 118^th 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.

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.