Alex Costa

What Happened, What You Missed: July 4-8

Posted In FDA

FDA Allows Pharmacists to Prescribe Paxlovid

Authorized state-licensed pharmacists can now prescribe the COVID-19 antiviral Paxlovid to eligible patients, according to a revised emergency use authorization (EUA) from the Food and Drug Administration (FDA). The revision will increase access to the medication, which has been a priority of the Biden administration for the past few weeks. While Paxlovid has shown to be 89% effective in reducing the risk of hospitalization, use of the drug has been lower than expected due to complex eligibility requirements and reduced testing. The FDA has recommended that pharmacists refer patients for clinical evaluation if not enough information is available to assess possible drug interactions or renal and hepatic function.

BA.5 Becomes Dominant Omicron Subvariant in US

Omicron subvariant BA.5 comprises 53.6% of COVID-19 cases in the US, making it the nation’s dominant strain according to data from the Centers for Disease Control and Prevention (CDC). A similar subvariant, BA.4, makes up 17% of cases. Scientists estimate that BA.4 and BA.5 are about three times less sensitive to neutralizing antibodies from existing COVID-19 vaccines than the original Omicron subvariant BA.1, although current vaccines still offer strong protection against hospitalization and death from BA.4/5 infection. Due to waning vaccine protection, the FDA has recommended that vaccine manufacturers update their shots to specifically target BA.4/5 ahead of a fall booster campaign.

Senate Dems Release Updated Drug Pricing Proposal

On Wednesday, Senate Democrats released legislative text for an updated drug pricing proposal as part of an attempt to revive the reconciliation bill, Build Back Better that failed to move forward last year. While the text overall matches last year’s initial agreement, key changes include moving the implementation date for drug price negotiations from 2025 to 2026 and requiring Medicare to negotiate prices on as many drugs as possible in order to prevent future Republican administrations from interfering with negotiations. While there are no agreements on a broader reconciliation package, Senate Majority Leader Chuck Schumer (D-NY) has said that if a deal can be made, a bill could be considered on the Senate floor before August recess.

FDA Weighing Vin Gupta as New Advisor

According to reports, the FDA is considering tapping Dr. Vin Gupta, a pulmonologist and medical analyst for NBC, as a senior advisor to lead the agency’s communications strategy. The FDA’s decision to consider onboarding a communications expert is likely a response to the criticism over the agency’s messaging on baby formula and COVID-19 vaccines. Currently a chief medical officer at Amazon, Gupta his risen in prominence as a health commentator over the last two years of the COVID-19 pandemic and helped advise the Biden campaign and transition team on the pandemic response. If hired, Gupta would be responsible for reforming the FDA’s image as well as guiding the agency’s messaging on vaping and nicotine.

ICYMI: The Reflecting Pool Isn’t a Swimming Pool

Earlier this week, people were spotted taking a dip in the Reflecting Pool on the National Mall in Washington, DC, probably as a respite to the brutal humidity that’s been lingering around the region. Yesterday, the National Park Service erected a fence around most of the Reflecting Pool – seemingly as a way to keep swimmers out. This week’s escapades weren’t the first time people have used the Reflecting Pool for something other than its intended purpose – in 2018, some people took to ice skating on the pool during a particularly cold winter.

The Medicare Trustees Report Is Still Bad News

Posted In MEDICARE

The Medicare Hospital Insurance (HI) Trust Fund will become insolvent in 2028, according to the latest report by the Medicare Board of Trustees in June 2022. Last year’s report projected the HI Trust Fund’s insolvency date to 2026, which means the fund now has just two additional years of breathing room.

In brief, the HI Trust Fund funds Medicare Part A, which reimburses providers for inpatient hospital services, hospice care, and skilled nursing facility and home health care services and is funded primarily through payroll taxes. In contrast, a separate account known as the Supplementary Medical Insurance (SMI) Trust Fund funds physicians and other outpatient services under Part B and prescription drugs under Part D and is funded through general tax revenue and the premiums enrollees pay.

Better-than-expected recovery in economic growth, pay, and employment convinced the Medicare trustees to push out the HI Trust Fund’s insolvency date by two years. The trustees also noted in their report that the COVID-19 pandemic isn’t expected to have a serious impact on Medicare’s finances.

New projections that the HI Trust Fund will become insolvent two years later than initially expected isn’t the good news it seems to be. In fact, the HI Trust Fund is in a world of trouble. As the trustees noted in their report, there is much uncertainty on the economy, population demographics, and access to health care that indicate serious problems with the HI Trust Fund’s estimates on future expenditures, and there may be cause for concern regarding the report’s projected insolvency date.

For example, the trustees made the economic projections that were included in the report back in February 2022 – right before COVID-19 cases started to shoot up again and inflation began to climb. An analysis from the Committee for a Responsible Federal Budget says the trustees’ estimates appear to “understate inflation and overstate real economic growth.” If inflation and poor economic growth is persistent into next year, the report might estimate a sooner insolvency date in their 2023 report.

Furthermore, the HI Trust Fund still faces a massive shortfall to the tune of a $350 billion deficit over the next 10 years. The trustees project there will be a shortfall of 0.7% of payroll, or 0.3% of Gross Domestic Product (GDP). This means either a 24% payroll tax or a 15% spending cut is required to prevent the fund from becoming insolvent.

Additionally, Medicare spending is expected to quickly increase. According to the report, Medicare spending is projected to grow from 3.9% of GDP to 6% by 2040 before hitting 6.5% around 2070. Medicare Advantage (MA) is cited as a primary driver of rising spending, as MA plans are argued to be more expensive than traditional Medicare. On top of this, an aging population is driving overall health care spending higher, which includes the kind of inpatient services that Part A pays for. High spending means addressing the HI Trust Fund’s finances – whether by upping payroll taxes or cutting spending – is only going to get harder down the road.

There is some disagreement on how dire the situation is for the HI Trust Fund’s finances. Even if the HI Trust Fund were to be depleted in the next few years, it would still pay roughly 90% of its current level. However, this is far from an ideal scenario. Insolvency essentially means Medicare Part A payments to providers would be reduced to levels that could only be covered by incoming tax revenues. By only being able to pay nine-tenths of current program expenditures, an insolvent HI Trust Fund would affect providers by either delaying payments for all providers or having Medicare reimburse at a decreased rate for Part A care. Either scenario could result in many seniors potentially losing access to care.

Thus, the HI Trust Fund going insolvent is a big deal, and lawmakers will have to get their act together at some point to shore up Medicare’s finances. It is important that lawmakers act sooner rather than later to bolster the trust fund by reducing spending, increasing revenues, or some combination of both. Acting sooner would also boost the public’s trust in Medicare and stabilize the fund, heading off scenarios where providers face declining reimbursement and beneficiaries could lose access to care.

What Happened, What You Missed: June 27-July 1

Posted In ADMINISTRATION

FDA Wants COVID-19 Boosters to Target Omicron Subvariants

The Food and Drug Administration (FDA) told drug manufacturers on Thursday that any new COVID-19 vaccines to be used in a fall booster campaign should be tailored to target the Omicron BA.4 and BA.5 subvariants as well as the original COVID-19 strain in order to provide the broadest possible level of protection. The agency’s proclamation follows Wednesday’s announcement that the administration has reached an agreement with Pfizer to purchase 105 million vaccines doses for a fall booster campaign. In a press release, Pfizer announced that its updated doses are planned to be delivered as soon as late summer 2022. While it remains possible that BA.4 and BA.5 will be overtaken by newer subvariants by fall, scientists and regulators are hopeful that the new shots will provide much better protection against symptomatic infection than the vaccines that are currently available.

Health Sector Leaders Commit to Halve Carbon Emissions

61 of the largest US hospital and health sector companies signed on to a Biden administration agreement to reduce greenhouse gas emissions by 50% by 2030. Known as the Health Sector Climate Pledge, the agreement calls private entities in the health care sector to mitigate the effects of climate change and increase their climate resilience. Major commitments include two of the five largest US private hospital and health systems, Ascension and CommonSpirit Health, large drug manufacturers like Pfizer and AstraZeneca, and major associations like the America’s Essential Hospitals and the American Association of Medical Colleges (AAMC). According to the White House, the health care sector contributes 8.5% of the total US carbon emissions.

White House Lays Out Monkeypox Vaccination Strategy

The Department of Health and Human Services (HHS) will send nearly 300,000 vaccines over the next few weeks as part of a new monkeypox outbreak response strategy announced Tuesday. The administration is immediately providing 56,000 doses from the National Strategic Stockpile (NSN) to communities most at-risk of monkeypox, with a combined 1.6 million doses expected to become available over the next few months. The Centers for Disease Control and Prevention (CDC) has counted about 300 cases of monkeypox nationwide, although the actual number is estimated to be much higher. The virus has been disproportionately spread among men who have sex with men, although health officials stress that everyone should be informed on the risks of the virus.

Ketanji Brown Jackson Sworn In as Newest SCOTUS Justice

Ketanji Brown Jackson was sworn in as the 116^th Supreme Court justice on Thursday, making her the first Black woman to serve on the high court. A federal judge since 2013, Jackson is now the fourth woman serving on the nine-member court – the highest number of female justices ever to serve concurrently. President Joe Biden initially nominated Jackson in February as his choice to relace outgoing Justice Stephen Breyer, who formally announced his retirement in a letter on Wednesday. Justice Jackson will have to decide on a number of consequential cases next term regarding affirmative action, religious freedom, and independent legislature theory.

ICYMI: Smithsonian Folklife Festival Returns to National Mall

If you’re in Washington, DC over the long weekend, there’s more to do than just watch fireworks. The Smithsonian Folklife Festival returned to the National Mall last week after two years of virtual events. Visitors will have until Monday, July 4 to catch this year’s festivities, which explore the culture of the United Arab Emirates. Over the weekend, festivalgoers will have the opportunity to make their own fragrance, learn about the symbolism of henna, craft their own pottery, and cook slabs of marinated goat or lamb.

Is Wearable Health Tech Poised to Play a Bigger Role in Washington?

Posted In TELEHEALTH

High costs. Disparities. Limited accessibility. Everyone agrees that there are a lot of things wrong with the US health care system right now. Fortunately, lawmakers, administration officials, and stakeholders are beginning to coalesce around wearable health technology as a possible solution because of its potential to tackle many health care problems. For example, wearable tech can address:

High health care costs by allowing clinicians to monitor patients and intervene before a health condition becomes worse, thereby saving the health care system money.
Health disparities by helping practitioners monitor and treat conditions like hypertension, which are more prevalent in communities of color.
Limited access to health care providers in rural areas by allowing practitioners to remotely track patients without worrying about geographic constraints.

Given the obvious benefits of wearable tech, what are policymakers and providers doing to promote it?

Congressional Action

The House Republican Healthy Future Task Force Modernization Subcommittee issued its recommendations for modernizing the health care system on June 1. A key policy area focuses on development of patient-centered technologies – i.e., wearable tech – while protecting privacy and allowing interoperability.

There have been legislative proposals on wearable tech, too. Last year, Rep. David Schweikert (R-AZ) introduced the Advanced Safe Testing at Residence Telehealth (A-START) Act to advance the use of wearable technology. It would work by establishing Medicare Advantage, Medicaid, and Veteran Affairs demonstration programs to test the efficacy and potential use of modern telehealth tools like wearable tech by allowing patients access to these tools approved by the Food and Drug Administration (FDA).

Administration Action

While the Biden administration does not seem to have a specific initiative to promote the use of wearable health technology, review of wearable tech has been a regular practice of the federal government for several years. In 2016, for instance, the FDA issued guidance on regulating “general wellness products” that help monitor health, nutrition, and fitness. Additionally, the FDA issued numerous emergency use authorizations (EUAs) for wearable devices during 2020 to help patients access providers during the COVID-19 public health emergency (PHE).

However, the promise of wearable tech is not lost on the Biden administration. During an April 28 congressional hearing, Health and Human Services (HHS) Secretary Xavier Becerra agreed with Rep. Schweikert that wearable tech can help reduce health care costs. If the momentum on crafting policy around wearable tech on Congress continues, lawmakers probably wouldn’t have a tough time finding allies in the White House.

Stakeholder Action

Health care providers are getting on board with wearable tech, too. In May, a group of health care providers, drug manufacturers, and universities launched the Digital Health for Equitable Health (DHEH) Alliance. Initial members of the group include the American Cancer Society, Otsuka Pharmaceuticals, and the Howard University College of Medicine. The new organization’s goal is to promote digital health policies like wearable tech to eliminate health disparities and barriers to high quality care. However, the DHEH Alliance has yet to announce a specific policy agenda.

What Happens Next?

Wearable health technology may be starting to gain ground, but current proposals pertaining to wearable tech are still in their infancy. First, there’s not a lot of legislation introduced around this topic, aside from Rep. Schweikert’s bill and the GOP task force’s recommendations. Second, wearable tech doesn’t seem to be a prominent part of the administration’s agenda, even though a top administration official agrees on the promise of the use of these health tools. Third, industry stakeholders who want to promote wearable health tech have yet to assemble a policy agenda on how they plan to reach their goals.

It’s also worth noting that none of the currently proposed policies address the important issue of how wearable health technology will be reimbursed. This is related to the broader argument of how the government will pay for health technology services like telemedicine after the COVID-19 PHE ends.

Thus, proponents of wearable tech shouldn’t expect movement on current proposals in the near-term, as Congress will probably be occupied with appropriations and other must-pass items through the end of 2022. However, things could change next year.

Republicans are widely expected to take control of at least one branch of Congress in this fall’s midterm election, and in anticipation of their victory, GOP lawmakers have been busy crafting an agenda that steers clear of large, sweeping packages that will be difficult to pass, like another attempt at repealing and replacing the Affordable Care Act (ACA).

Instead, Republicans in Congress are likely to use their majority to advance smaller, less-controversial health care policies that stand a better chance at becoming law, like the House Republican Healthy Future Task Force Modernization Subcommittee’s recommendations on health care technology. With Republicans likely in control of the House and/or the Senate in the next Congress, momentum on wearables tech could be poised to surge.

What Happened, What You Missed: June 20-24

Posted In FDA

Moderna Says Updated Vaccine Effective against Omicron Subvariants

Moderna announced on Wednesday that an updated version of its COVID-19 vaccine provides strong protection against a symptomatic infection of the Omicron subvariants BA.4 and BA.5, which are rapidly spreading worldwide. The updated vaccine candidate is bivalent, meaning it targets both the original version of COVID-19 and the Omicron variant. The World Health Organization (WHO) labeled BA.4 and BA.5 as “variants of concern” as they are better able to evade immune defenses from previous infections and the current available vaccines. Moderna is currently manufacturing the bivalent vaccine doses with the hope that they could be employed as a booster in the fall and winter, when experts say COVID-19 cases could spike.

Administration Approves Waiver to Expand Insurance Options in Colorado

Up to 10,000 people in Colorado will soon have access to lower health insurance premiums, according to the Section 1332 Innovation Waiver that the Biden administration approved on Thursday. The Department of Health and Human Services (HHS) estimates that a combination of additional federal funding and more competition between insurers will allow the Colorado Option to lower premiums by 15% for individuals, families, and small businesses by 2025. Colorado is also working to establish premium reduction targets for insurers as a way of attracting new consumers to the state’s individual marketplace. Of note, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urged Congress to pass legislation that extends the Affordable Care Act (ACA) premium tax subsidies during a press call on the waiver’s approval.

House Passes Bill to Authorize New Biomedical Research Agency

The House passed (336-85) an amended bill to establish the Advanced Research Projects Agency for Health (ARPA-H) as a new biomedical research agency on Wednesday evening. While the Fiscal Year (FY) 2022 omnibus provided $1 billion in funding for the new agency, separate authorizing legislation is required to fill in key details on the structure and organization of ARPA-H. Notably, the legislation establishes ARPA-H as an independent agency within HHS, which differs from the administration’s preference of housing the new agency within the National Institutes of Health (NIH). To ensure bipartisan support, key amendments to the original legislation include capping administrative costs at 15%, limiting the number of program offices to six in order to address concerns over “mission creep,” and the removal of the requirement that the ARPA-H director be confirmed by the Senate. While members of both parties are eager to make ARPA-H a reality, it remains unclear when the Senate will vote on authorizing legislation.

Senate Passes Gun Safety Legislation

On Thursday night, the Senate approved bipartisan gun safety legislation by a 65-33 vote, clearing the way for a vote in the House later today. Known as the Bipartisan Safer Communities Act, the bill expands background checks on gun buyers 21 and younger to include their mental health and juvenile justice records. It would also expand current law to prevent people from buying guys if they have previously abused a current or former romantic partner and incentivize states to create laws to seize guns from people who are deemed a danger to the community. Additionally, the measure includes millions of dollars for mental health, school safety, and crisis intervention programs.

ICYMI: Smithsonian Selects 4 Possible Sites for New Museums

The Smithsonian has narrowed down its choices to four possible locations for the future National Museum of the American Latino and the Smithsonian American Women’s History Museum. These four site locations include the Arts and Industries Building, a section of undeveloped land north of the Reflecting Pool, an undeveloped lot next to the National Museum of African American History and Culture, and an undeveloped section of land along Maine Avenue SW and the Tidal Basin. To decide on a final location for each museum, all four sites will go through an evaluation process to determine environmental impact, accessibility, and other factors.

Insights^

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

What Happened, What You Missed: July 4-8

The Medicare Trustees Report Is Still Bad News

What Happened, What You Missed: June 27-July 1

Is Wearable Health Tech Poised to Play a Bigger Role in Washington?

What Happened, What You Missed: June 20-24

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