Insights^

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 117^th 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.

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 100^th Lighting of National Christmas Tree 

President Joe Biden celebrated the 100^th 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.

Becerra Authorizes FDA to Issue EUAs for Monkeypox Tests

Health and Human Services (HHS) Secretary Xavier Becerra issued an emergency declaration on Wednesday to allow the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) for monkeypox tests.  The announcement comes one month after HHS declared monkeypox to be a public health emergency.  According to Becerra, the declaration will help propel the government’s response to monkeypox by expanding access to testing.  In a separate announcement, the FDA issued its first EUA for a monkeypox test to Quest Diagnostics.  While the US is currently conducting more than 80,000 tests per week, some experts warn confusion over where patients get tests could be limiting access to monkeypox tests.

White House Pushes for COVID-19 Funding in CR

The Biden administration is pushing Congress to include $22.4 billion in a continuing resolution (CR) to help the domestic fight against COVID-19.  Due to dwindling funds, the administration has already announced it will no longer send free COVID-19 tests to people’s homes, and federal funding for COVID-19 vaccines is likely to end soon.  Additionally, the White House has communicated that it has no objection to attaching the reauthorization of FDA user fees to a CR, although the administration declined to offer its outright support for the proposal.   However, the likelihood that either proposal makes it into a CR is uncertain, as congressional appropriations leaders are currently hashing out whether to include Democratic energy policies in a stopgap spending measure.  Even if Congress is able to quickly pass a CR later this month, lawmakers could become embroiled in another appropriations fight later this year when the CR is expected to end.

Study: Private Equity-Owned Practices Leave Patients with Higher Bills

Physician practices acquired by private equity firms were associated with higher spending and more patient visits, according to a study published by the Journal of the American Medical Association.  The study found an average increase of 20%, or $71, in charges per claim, and 11%, or $24, in amount allowed per claim.  Private equity-owned practices were also reported to have about 26% more unique patients.  According to a press release by the study’s authors, the higher billing could be due to either more efficient documentation of services or up-coding/up-charging to insurance companies.   The study only examined dermatology, gastroenterology and ophthalmology medical practices purchased by private equity.

Federal Judge Rules HIV Drug Coverage Requirement Violates Religious Freedom

On Wednesday, US District Judge Reed O’Connor ruled that requiring employers to provide the HIV prevention drug PrEP violates their religious freedom, potentially jeopardizing the mandatory coverage of preventative health care services under the Affordable Care Act (ACA).   According to the Texas employers behind the suit, the provision violates the Religious Freedom Restoration Act by forcing people to pay for coverage that conflicts with their faith and values.  The ruling is not the first time O’Connor has challenged the ACA – in 2018 he ruled the entire health care law to be unconstitutional, which the Supreme Court overturned in 2021.  It was not immediately clear what kind of impact the ruling will have beyond the employers challenging the ACA provision.

ICYMI: Portraits of Barack and Michelle Obama Unveiled at White House 

Former President Barack Obama and former First Lady Michelle Obama returned to the White House this week for the unveiling of their official portraits.  President Obama’s photo-realistic portrait was painted by Robert McCurdy and Michelle Obama’s portrait was painted by Sharon Sprung.  The portrait unveiling is a long tradition that goes back to 1978 when President Jimmy Carter invited his immediate predecessor, Gerald Ford, back to the White House. Wednesday’s unveiling event would have traditionally been held during the Trump presidency, although both parties mutually declined to participate according to sources.

FDA Authorizes Boosters Tailored to BA.5

On Wednesday, the Food and Drug Administration (FDA) authorized bivalent COVID-19 booster shots from Pfizer and Moderna that target both the original COVID-19 strain and the Omicron BA.4/5 subvariants.   The Centers for Disease Control and Prevention (CDC) is widely expect to sign-off on the boosters today, which means pharmacies could start administering doses after Labor Day weekend.  According to the FDA, it may take up to two months before data is available on how effective the updated boosters are at preventing infection.  So far, the federal government has secured 171 million doses from Pfizer and Moderna.

House Democrats Consider CR through December 16

According to news reports, House Democratic leaders are working on a continuing resolution (CR) that would extend current government funding levels through December 16.  The current fiscal year ends on September 30, and House Democrats are hoping to bring their CR to the House floor for consideration during the week of September 12.  While negotiations over stopgap spending bills have typically been contentious, lawmakers may be more willing to cut a deal sooner rather than later this month due to an eagerness to return to the campaign trail ahead of November’s midterm elections.   Of note, a CR could include a reauthorization of FDA user fee programs, which are also set to expire at the end of September.

CDC: Life Expectancy in US Dropped to 76 Years in 2021

Life expectancy in the US fell from 79 years in 2019 to 76.1 years in 2021, according to data from the CDC.  The decline marks the first time life expectancy dropped two consecutive years in nearly a century.  According to the CDC, the decline in life expectancy can be attributed to the COVID-19 pandemic and increases in unintentional injuries, namely drug overdoses.  While a drop in life expectancy was observed in all 50 states, the CDC found that Southern states saw the biggest declines, as well as Indiana, Missouri, New Mexico, Ohio, and Oklahoma.

HHS Issues $20M in Grants on Maternal and Infant Health

On Monday, the Biden administration took a major step in carrying out its Blueprint for Addressing the Maternal Health Crisis by announcing investments of over $20 million to improve maternal and infant health.  According to a press release from the Department of Health and Human Services (HHS), the awards include $9 million to the State Maternal Health Innovation Program, $4 million to the Rural Maternity and Obstetrics Management Strategies Program, $3 million to 19 Healthy Start programs to reduce maternal health disparities, and $4.5 million to the Catalyst for Infant Health Equity Program.

ICYMI: Fencing Around Supreme Court Removed

Metal fencing that had surrounded the Supreme Court building for the past few months finally came down earlier this week.  The fences were initially erected in May after a draft decision to overturn Roe v. Wade leaked, which prompted protests in front of the court building.  However, the building itself remains closed, and the court has yet to comment on when the building will reopen to the public.

On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss.  This rule was 5 years in the making – why now?

Background

While FDA has regulated hearing aids for decades, the agency had previously only focused on assuring safety and effectiveness of prescription hearing aids.  In 2017, Congress stepped in and passed a law to require the agency to issue rules for over-the-counter devices. Lawmakers were hoping establishing a new category of hearing aids would address:

• Cost:  Lack of competition in the market means hearing aids can cost between $2,000 and $7,000 per pair.

• Coverage:  Most commercial insurance plans and Medicare don’t cover the cost of hearing aids for people with mild to moderate hearing loss because they’re not considered an essential medical device – or in other words, they’re considered “elective.”
• Access:  Additionally, getting hearing aids requires a prescription from an audiologist or other specialist.  Buying devices in a retail setting or online would provide more options for consumers.

A Rule that Was Years in the Making

It’s taken a long time for the idea of over-the-counter hearing aid sales to go from initial concept to final rule.  Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) got so fed up with the agency dragging its feet that they introduced legislation to require FDA to issue rulemaking on OTC hearing aids.  Even though the bill was signed into law as part of the FDA Reauthorization Act of 2017, it still took the agency 5 years to finalize the rule.  Why?

COVID.  Yes, the needed change in focus of the agency to address COVID was a no-brainer, but President Trump signed the bill 2+ years before the virus struck….

Change in administration.  Yes there was a change in administration but it took President Biden until July 2021 to issue an executive order directing his own agency to issue rule making.

So why the delay?  It turns out that balancing stakeholder concerns was complicated.  When FDA issued the proposed rule in October 2021, the agency received more than 1,000 comments from the public.  Here is where the rule ended up:

• Output levels:  Lowers the maximum sound output to reduce the risk from over-amplification of sound
• Volume control:  Requires all OTC aids have a user-adjustable volume control
• Label and packaging language:  Simplifies phrasing so safety concerns can be easily understood

• State authority:  Retains authority by States to require an audiological evaluation for minors and other previously granted State exemptions applicable to non-OTC hearing aids

What’s Next? 

The final rule goes into effect in 60 days, which is the date that over-the-counter hearing aids can officially be marketed.  Already, Best Buy has announced that it plans to have hearing aids available in 300 of its 1,000 stores by the fall.

Even though Congressional Democrats weren’t able to get Medicare coverage for hearing aids signed into law, the rule signals real financial relief and a step toward health equity for millions.  Good news for consumers makes for good politics…right ahead of the November 8^th elections.