Insights^

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

What Happened, What You Missed: May 30-June 3

White House: Kids under 5 Could Get Vaccinated as Soon as June 21

COVID-19 vaccinations for children under age five could start as soon as June 21, said White House COVID-19 Response Coordinator Ashish Jha on Thursday.  The Food and Drug Administration (FDA) is likely to approve Moderna and Pfizer’s vaccines for young kids after the agency’s vaccine advisory committee meeting on June 15, with the Centers for Disease Control and Prevention (CDC) issuing its recommendation shortly thereafter.  Jha said the administration will initially make 10 million doses of Pfizer and Moderna vaccines available to the states, and while the vaccination program is expected to take some time to ramp up, Jha expects that every parent should be able to schedule an appointment within weeks of approval.  According to an April 2022 poll from the Kaiser Family Foundation (KFF), 18% of parents say they will get their children under five vaccinated as soon vaccines become available, while 38% said they would “wait and see” before deciding.

CMS to Lower Part B Premiums in 2023

The Centers for Medicare and Medicaid Services (CMS) announced last Friday that seniors can expect lower Medicare Part B premiums for 2023.  The announcement follows a recent review of Part B premiums that determined CMS had overestimated the cost of Aduhelm, an expensive Alzheimer’s drug, in calculating its 2022 premiums.  In November 2021, CMS announced a 14% increase in Part B premiums – one of the highest ever increases – from $148.50 a month to $170.10.  However, Biogen made the surprise decision to lower its list price for Aduhelm in December 2021, setting the stage for CMS to subsequently review how the agency was pricing the Alzheimer’s drug.  CMS ultimately determined to lower Part B premiums in 2023 because it would have been too difficult to lower premiums or reimburse seniors mid-year.

Senate HELP Committee to Mark Up FDA User Fee Bill on July 8

The Senate Health, Education, Labor, and Pensions (HELP) Committee scheduled a markup for its bipartisan FDA user fee bill on June 8.   Initially released on May 27, the HELP Committee’s user fee bill includes several provisions that would improve the FDA’s oversight of cosmetics and dietary supplements, enhance regulation of laboratory-developed tests (LDTs), and reform the agency’s accelerated approval pathway.  The House Energy and Commerce Committee advanced its own FDA user fee reauthorization measure on May 18.  While the House bill has many commonalities with the Senate bill like changes to the accelerated approval pathway, it lacks the Senate bill’s provisions on LDTs and cosmetics and dietary supplements.

Medicare Trustees Report Shows Slightly Improved Outlook

According to the Social Security and Medicare Board of Trustees report released on Thursday, the Hospital Insurance (HI) Trust Fund for inpatient care will be unable to pay full benefits starting in 2028, two years later than reported last year.  However, the trustees warned that the HI Trust Fund still faces long-term financing shortfalls, thus necessitating “significant changes” to Medicare financing.  The trustees also concluded that the COVID-19 pandemic will not have any long-term effect on Medicare spending.  If the HI Trust Fund does become insolvent, the report projects that the program would be able to pay 90% of expected costs in 2028.

ICYMI: DC Gets Ready to Celebrate the Queen’s Platinum Jubilee

This month, Queen Elizabeth II is celebrating her platinum jubilee, which marks her 70th year on the throne as head of state of the United Kingdom.  Over the next few days, people in the Washington, DC area will have opportunities to join the British people in celebrating Her Majesty’s historic milestone.  Aside from an invite-only party hosted by the British embassy, the Fairmont in Georgetown will host a jubilee celebration on June 8, and the British Officers Club of Washington, DC will host a garden party with food and games at Lloyd House in Alexandria on June 18.  Meanwhile, numerous British pubs and restaurants like The Queen Vic and Brixton DC will host their own events throughout the upcoming weekend.

suzy-brooks-BabpEbkAy818-unsplash-1920x1440

People Injured by the COVID-19 Vaccine Need More Help from the Federal Government

No vaccine is perfect, and unfortunately, COVID-19 vaccines have caused serious adverse side effects in a tiny percentage of people.   For those whose side effects are severe enough to put them out of work or generate high medical bills, the federal government can provide benefits via the Countermeasures Injury Compensation Program (CICP).  This program is not to be confused with the National Vaccine Injury Compensation Program (VICP), which does not address caused by COVID-19 vaccines.  Examples of serious side effects from COVID-19 vaccines can include blood clots, long-lasting shoulder pain, and swelling of the tongue. 

However, the CICP is not up to snuff, and the majority of claims are not being addressed.  As public health officials continue to encourage Americans to get vaccinated against COVID-19, how can the government better serve those who face rare yet serious consequences from doing the right thing and getting their shots?

The CIPC, explained.  Created in 2010, the CICP was created to provide compensation for injuries resulting from any vaccination, medication, or other device that’s recommended to treat against a declared pandemic, epidemic, or security threat such as Ebola, Zika, and anthrax.

In March 2020, then-HHS Secretary Alex Azar issued a declaration to provide liability immunity for countermeasures like vaccines and treatments related to COVID-19.  He also directed the CICP to provide benefits to individuals who “sustain a serious physical injury or die” from a COVID-19 countermeasure.

In terms of coverage, the CICP provides $50,000 a year to replace lost wages and reimburse out-of-pocket medical expenses.  If a person dies, a next-of-kin can receive up to $370,376.  Those who are injured by a countermeasure can request compensation by filing a request and submitting medical records within one year from the date the countermeasure was administered.  CICP medical staff then process to review compensation claims, and those who feel their claims are unfairly rejected can review an appeal before an independent panel.

Unfortunately, many claims are not being address.  As of October 2021, over 1,300 countermeasure claims linked to COVID-19 vaccines remain pending before the CICP independent panel.  Since its creation over a decade ago, the CICP has only compensated 29 claims – none of which stem from the COVID-19 pandemic.

One of these unaddressed claims belongs to Cody Flint, an agricultural pilot from Mississippi who has been experiencing serious health issues after getting vaccinated for COVID-19 in February 2021.  Sen. Cindy Hyde-Smith (R-MS) shared Flint’s story to Health and Human Services (HHS) Secretary Xavier Becerra in a May 4th congressional hearing, where she remarked that CICP has shown a lack of urgency and transparency in addressing claims.

In response, Becerra didn’t provide any information on how CICP is addressing the backlog of claims.   Instead, he voiced agreement on the importance of providing transparency, and he explained he wants to make sure no one is “gaming the system” so that “those who really have medical issues to report are the ones who are receiving assistance.”

However, Becerra did seemingly acknowledge that many claims aren’t being addressed, saying “we’ve heard this story before,” and he promised to put a member of his staff in touch with the senator to provide further details.

Some lawmakers aren’t waiting around for the administration to take action on CICP claims, though.  Hyde-Smith is a cosponsor of the Countermeasure Injury Compensation Fund Amendment Act, which would update CICP’s adjudication framework and create a new commission to look at countermeasures specifically caused by COVID-19 vaccines.  Unfortunately, the backlog of CICP claims hasn’t captured the attention of many lawmakers so far.  The Senate bill has only garnered thee cosponsors as of this writing, and only one House bill has been introduced that would address CICP in some fashion.  Thus, it doesn’t seem like either measure has a shot at advancing in Congress anytime soon.

While the number of countermeasures arising from COVID-19 vaccines remains incredibly small, people who’ve legitimately suffered from countermeasures deserve compensation.  Although the federal government seems aware of the fact that the CICP claims backlog is nothing short of outstanding, without any additional commentary from top HHS officials like Becerra, it remains unclear if and when the administration will take action to address the backlog.   In the meantime, the best course of action for people impacted by countermeasures is to continue to advocate for changes at CICP, with the hope that more lawmakers will take notice and put pressure on the administration to get the program in order.

markus-spiske-DnBtFBnqlRc-unsplash-1920x1280

Inside the New Suicide Hotline Set to Launch This Summer

Everyone knows to dial 911 in case of emergency.  Soon, people experiencing a mental health crisis and are at risk of suicide will be able to dial 988 and get connected to a behavioral health counselor.  With the number of Americans reporting signs of anxiety and depression at an all-time higha new pathway for mental health care couldn’t come sooner.  However, concerns over the ability for states to respond to 988 calls and a lack of public awareness means the success of the new suicide hotline number isn’t guaranteed.

Background: The National Suicide Hotline Prevention Act established 988 as a universal telephone number for a national suicide prevention crisis hotline in October 2020.   Since states are tasked with fielding 988 calls, the law gives states the authority to impose and collect fees to operate 988 services.

988 isn’t the first attempt at a national suicide hotline.  First launched in 2004, the National Suicide Prevention Lifeline (800-273-8255) is a 24/7 service that connects callers experiencing a suicidal crisis to one of 160 crisis centers to receive immediate counseling and referrals to behavioral health professionals.  The Lifeline is still active – more than 2.1 million callers dialed 800-273-8255 in 2020, and the Lifeline will continue to remain in effect alongside 988.  However, there are several reasons why 988 is needed as an additional pathway for crisis intervention.

First, the demand for mental health services is greater than ever.  Cases of anxiety and depression have skyrocketed during the pandemic, and suicide deaths in the US totaled more than 46,000 in 2020, justifying the need for more resources.

Furthermore, the Lifeline was not adequately handling higher call volume spurred by the pandemic.   In 2021, callers abandoned about 17% of calls to the Lifeline before they received help due to extended wait times; additionally, 41% of text messages and 73% of online chats were also abandoned.  How well the Lifeline addressed higher call volume also varied by state.  In 2020, the state of Washington answered 74% of its calls, while Wyoming only answered 16% of its calls.

Finally, 988 is a simple number that’s easy to remember – just like 911.  Having more people remember and dial 988 would allow more opportunities to connect people experiencing a mental health crisis with the care they need.

988 is set to go live on July 16, 2022, and while the federal government won’t be operating the new hotline, agencies have been working to make sure states have the resources they need to start taking incoming calls on day one.  In December 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $282 million to grants to support 988 efforts, including $177 million to strengthen and expand the existing Lifeline network operations (including a network for Spanish speakers) and $105 million to build up staffing in states’ local crisis call centers.  In April 2022, SAMHSA doled out another nearly $105 million in grants to help states shore up their telephone infrastructure ahead of 988’s launch.

Despite hundreds of millions of dollars in federal assistance, states still may not have enough money to start fielding 988 calls once mid-July hits.  SAMHSA estimates that 988 could receive over 7.6 million calls in its first year, requiring $560 million in funding each year – which exceeds the amount of funding provided by federal agencies thus far.  While states do have the authority to fund hotline operations by imposing fees, only four states (Virginia, Nevada, Washington and Colorado) have passed legislation to do this, and many other states have been reluctant to impose fees on consumers amid widespread inflation.

On top of this, most people don’t even know about 988.  Public education on 988 has so far relied on states, which have done little to raise awareness.  A poll by the Trevor Project in April 2022 found that 69% of respondents were unaware of the forthcoming suicide hotline.

988 has great potential to provide people undergoing a mental health crisis to get the care they need.  But without enough money and clear communication, there’s a chance the new hotline might not live up to its expectations and otherwise preventable deaths by suicide could still continue to occur.

pexels-pixabay-163007-scaled

What Happened, What You Missed: April 18-22

DOJ Appeals Ruling on Transportation Mask Mandate

On Wednesday, the Department of Justice (DOJ) filed an appeal to the US District Court ruling that overturned a Centers for Disease Control and Prevention (CDC) requirement for masks to be worn on transit, airplanes, and other transportation-related settings.  After Judge Kathryn Kimball Mizelle ruled on Monday that the CDC had exceeded its statutory authority on the travel mask mandate, the CDC asked the DOJ to file an appeal.  Of note, the DOJ declined to include a motion for stay in its appeal filing meaning the federal government will not be able to reinstate the travel mask mandate unless the ruling is overturned.   Since the court’s ruling on Monday, multiple airlines, public transit agencies, and transportation providers have announced that they will no longer require passengers to wear masks.

CMS Proposes New Policies on Health Equity, Maternal Health

In a proposed rule issued on Monday, the Centers for Medicare and Medicaid Services (CMS) outlined new policies intended to improve health equity and maternal health.  The proposed rule calls for adding three health equity measures to the new Hospital Inpatient Quality Reporting (IQR) Program that focus on addressing social determinants of health and assessing how a hospital is advancing health equity through strategic planning and data collection.  To boost maternal health, the rule proposes creating a new birthing-friendly designation for hospitals and would add two maternal health-focused quality measures to the Hospital IQR Program.  Comments on the proposed rule are due on June 17, 2022.

Moderna: “Bivalent” Vaccine Booster Provides Stronger Protection

On Tuesday, Moderna announced that its modified COVID-19 vaccine booster generated strong protection against multiple COVID-19 variants.  The company modified its booster shot to be “bivalent,” meaning that it combines a formula targeted for the original COVID-19 strain and a formula focused on the Beta variant.  According to preliminary trial results, the bivalent vaccine shot demonstrated efficacy against the Omicron variant and other COVID-19 variants of concern.  Moderna is still testing another bivalent vaccine with a formula targeted to both original COVID-19 strain and the Omicron variant, and results on this version are expected later in the spring.  However, the trial results have yet to be reviewed independently by scientists.

Cook Political Report Shifts 8 House Races Toward GOP

Eight Democratic-held seats in the House of Representatives are less likely to remain in control of Democrats after this fall’s midterm elections, according to the latest 2022 midterm ratings by The Cook Political Report.  The updated ratings bring the total of Democratic-held seats that are in the “toss up” category or trending Republican to 27, exacerbating Democrats’ fears of a brutal midterm election this November.  The ratings shift is welcome news for the Republicans, who only need to win five seats in this fall to regain control of the House.  The new ratings comes as President Joe Biden’s approval ratings hit the lowest level of his presidency, stoking more fear among Democrats’ regarding their electoral prospects this fall.

ICYMI: US Army Parachute Plane Prompts Evacuation of Capitol

On Wednesday night, the US Capitol Police (USCP) briefly issued, then withdrew, an evacuation alert for the US Capitol Complex after the Federal Aviation Administration (FAA) allegedly failed to inform the USCP of an aircraft flying in the vicinity of the US Capitol.  The aircraft in question was a part of the US Army’s parachute team and was participating in a flyover at Nationals Stadium, which is less than one mile from the Capitol.  The following day, Speaker Nancy Pelosi (D-CA) slammed the FAA for not informing the Capitol Police of the flyover and committed to a congressional review of what went wrong.  Pelosi also noted that Capitol personnel are still reeling from the January 6, 2021, attack on the US Capitol.

waldemar-brandt-U1AAh1Sjl3w-unsplash-1920x1366

What Happened, What You Missed: April 11-15

Administration Extends PHE, Transportation Mask Mandate

On Tuesday, Secretary of Health and Human Services (HHS) Xavier Becerra issued a 90-day renewal of the public health emergency that was initially set to expire on April 16.  The renewal ensures that Medicaid coverage protections, telehealth services, and other waivers tied to the PHE will continue through at least July 15, 2022.  While the administration has declined to say how long the PHE will continue, Secretary Becerra has repeatedly stated that HHS would give 60 days’ notice before ending the PHE.  On Wednesday, the administration also announced a 15-day extension of the transportation mask mandate through May 3, 2022.  According to a press release, the administration is keeping the mandate in place as it assesses the impact for rising COVID-19 case numbers on severe disease and hospitalization.  In recent weeks, the airline industry has been lobbying the administration to wind down the transportation mask mandate, citing advanced air filtration systems on board aircrafts.

Pfizer to Seek FDA Authorization for Booster in Kids Ages 5-11

Pfizer announced on Thursday that it will soon ask the Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA) for a third “booster” dose of its COVID-19 vaccine for kids  five through 11.  The announcement comes after data from the phase 2/3 clinical trial, which revealed that a third dose administered six months after the initial two-dose regimen yielded enough antibodies to neutralize both the original COVID-19 strain and the Omicron variant.  While the results are welcoming news, scientists are concerned that Pfizer’s booster dose may only provide a few months of protection against infection.  For instance, antibodies generated from a booster dose of the Pfizer vaccine in adults wane after about four months. However, Pfizer has yet to make the data available to outside scientists for review.

CMS Proposes Pay Cut for Nursing Homes

On Monday, the Centers for Medicare and Medicaid Services (CMS) announced  a proposed rule that plans to decrease Medicare Part A payments to skilled nursing facilities (SNFs) by around $320 million in Fiscal Year (FY) 2023.  The payment cut is partially in response to a new payment system implemented in FY 2020 that ended up paying SNFs 5% more than initially anticipated.  The proposed rule also asked for feedback on how to code for residents in isolation, the quality reporting program, and how CMS should create minimum staffing requirements.  The deadline for stakeholders to submit feedback is June 10, 2022.

House Appropriators to Begin Marking Up FY23 Spending Bills in June

The House Appropriations Committee is reportedly planning to begin marking up its FY 2023 spending bills in June, which means the bills could be up for consideration on the House floor by July.  Tentatively, subcommittees are planning to mark up their 12 spending bills from June 13-22, while the full committee would hold its markups June 22-30.  Appropriations committee leaders have voiced a desire to reach agreements on spending bills much quicker than they did for FY 2022, which wasn’t finalized until an omnibus was signed into law last month.  During a March 31 subcommittee hearing, Chairwoman Rosa DeLauro expressed a desire to pass all appropriations bills “on time” so they can be signed into law by September 30, 2022.

ICYMI: Rabid Fox Bites 9 around US Capitol Complex

Last week, a rabid fox bit nine people around the US Capitol Grounds, including Rep. Ami Bera (D-CA).  While foxes are common in the Washington, DC metropolitan area, last Wednesday’s incident marks the first time a fox has been spotted in the US Capitol Complex since 2014.  Out of an abundance of caution, Rep. Bera and the other individuals bitten went on to get rabies and tetanus shots.  The Humane Rescue Alliance eventually captured and euthanized the fox after it tested positive for the rabies virus.

Administration Extends PHE, Transportation Mask Mandate On Tuesday, Secretary of Health and Human Services (HHS) Xavier Becerra issued a 90-day renewal of the public health emergency that was initially set to expire on April 16. The renewal ensures that Medicaid coverage protections, telehealth services, and other waivers tied to the PHE will continue through at least July 15, 2022. While the administration has declined to say how long the PHE will continue, Secretary Becerra has repeatedly stated that HHS would give 60 days’ notice before ending the PHE. On Wednesday, the administration also announced a 15-day extension of the transportation mask mandate through May 3, 2022. According to a press release, the administration is keeping the mandate in place as it assesses the impact for rising COVID-19 case numbers on severe disease and hospitalization. In recent weeks, the airline industry has been lobbying the administration to wind down the transportation mask mandate, citing advanced air filtration systems on board aircrafts. Pfizer to Seek FDA Authorization for Booster in Kids Ages 5-11 Pfizer announced on Thursday that it will soon ask the Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA) for a third “booster” dose of its COVID-19 vaccine for kids five through 11. The announcement comes after data from the phase 2/3 clinical trial, which revealed that a third dose administered six months after the initial two-dose regimen yielded enough antibodies to neutralize both the original COVID-19 strain and the Omicron variant. While the results are welcoming news, scientists are concerned that Pfizer’s booster dose may only provide a few months of protection against infection. For instance, antibodies generated from a booster dose of the Pfizer vaccine in adults wane after about four months. However, Pfizer has yet to make the data available to outside scientists for review. CMS Proposes Pay Cut for Nursing Homes On Monday, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule that plans to decrease Medicare Part A payments to skilled nursing facilities (SNFs) by around $320 million in Fiscal Year (FY) 2023. The payment cut is partially in response to a new payment system implemented in FY 2020 that ended up paying SNFs 5% more than initially anticipated. The proposed rule also asked for feedback on how to code for residents in isolation, the quality reporting program, and how CMS should create minimum staffing requirements. The deadline for stakeholders to submit feedback is June 10, 2022. House Appropriators to Begin Marking Up FY23 Spending Bills in June The House Appropriations Committee is reportedly planning to begin marking up its FY 2023 spending bills in June, which means the bills could be up for consideration on the House floor by July. Tentatively, subcommittees are planning to mark up their 12 spending bills from June 13-22, while the full committee would hold its markups June 22-30. Appropriations committee leaders have voiced a desire to reach agreements on spending bills much quicker than they did for FY 2022, which wasn’t finalized until an omnibus was signed into law last month. During a March 31 subcommittee hearing, Chairwoman Rosa DeLauro expressed a desire to pass all appropriations bills “on time” so they can be signed into law by September 30, 2022. ICYMI: Rabid Fox Bites 9 around US Capitol Complex Last week, a rabid fox bit nine people around the US Capitol Grounds, including Rep. Ami Bera (D-CA). While foxes are common in the Washington, DC metropolitan area, last Wednesday’s incident marks the first time a fox has been spotted in the US Capitol Complex since 2014. Out of an abundance of caution, Rep. Bera and the other individuals bitten went on to get rabies and tetanus shots. The Humane Rescue Alliance eventually captured and euthanized the fox after it tested positive for the rabies virus.

Subscribe to Us Now!

Be a DC insider by getting our updates straight to your inbox