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What Happened, What You Missed: August 23-27

FDA Fully Approves Pfizer/BioNTech COVID-19 Vaccine

On August 23, the Food and Drug Administration (FDA) fully approved the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older, but did not fully approve the vaccine for individuals ages 12 to 15, which is still only authorized for emergency use.  Full approval of the vaccine, which will be marketed as Comirnaty, is likely to spur additional companies and organizations to mandate employees to be vaccinated.  Just a few days later, Pfizer/BioNTech announced that it intends to submit a biologics license application (BLA) for a third dose of its vaccine to act as a booster shot.  Additionally, Moderna submitted a BLA for its COVID-19 vaccine this week, setting the stage for full FDA approval within the next few months.

New Data Shows J&J Booster Shot Increases Immune Response

Johnson & Johnson says data from a phase 2 clinical trial shows a second dose “booster shot” of its single-dose COVID-19 vaccine administered six to eight months after the first dose resulted in a nine-fold increase in antibodies compared to 28 days after the first dose.  The announcement comes amid concerns that the viral vector Johnson & Johnson vaccine may not be as effective as the mRNA vaccines offered by Pfizer/BioNTech and Moderna.  Last week, the Biden administration announced plans to make third-dose booster shots of the Pfizer/BioNTech vaccine to all eligible Americans by late September, but declined to make a final decision on whether recipients of the Johnson & Johnson vaccine should also receive booster shot.  Johnson & Johnson also announced that that it is working with FDA and other regulators regarding the need for booster shots.

Intelligence Report Inconclusive on Origins of COVID-19

According to news reports, an intelligence report delivered to President Joe Biden this week was inconclusive over whether COVID-19 originated naturally via human contact with an infected animal or originated in a laboratory.  In late May, Biden ordered the US intelligence community to produce a report within 90 days on the origins of COVID-19 after a hypothesis that the virus escaped from a laboratory gained traction.  While some scientists have called for all possibilities for COVID-19’s origin to be explored, many believe the most likely scenario is that the virus jumped from animals to humans.  Intelligence officials plan on publicly releasing a summary of the report in the coming days.

House Passes FY22 Budget Resolution after Democrats Reach Agreement

On August 24, the House narrowly approved a $3.5 trillion budget resolution for Fiscal Year (FY) 2022 along a party-line vote, following a period of deadlock between a group of moderate Democrats and party leadership that threatened to derail the budget resolution.  Earlier this month, nearly a dozen centrist-leaning Democrats including Reps. Josh Gottheimer (D-NJ) and Stephanie Murphy (D-FL) communicated that they would not support the budget resolution unless the House first voted on the Senate-passed bipartisan infrastructure bill.  Per their public agreement with the group of centrists, House leadership have committed to consider the bipartisan infrastructure bill by September 27.  House approval of the FY22 budget resolution sets the stage for Congress to advance a social spending bill in both chambers without any Republican support.

ICYMI: Washington Monument Could Reopen Soon

The Washington Monument has been closed since August 15, following a lightning strike that damaged the monument’s electronic access system that operates the door and the elevators.  Since then, the National Park Service has been awaiting replacement parts to get the electronic access system back in working order.  The parts finally arrived on August 25, and the National Park Service says it will begin installing and testing on Thursday in the hopes of reopening “as soon as possible.”

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What Happened to the Cancer Moonshot?

In his final State of the Union address in January 2016, then-President Barack Obama asked then-Vice President Joe Biden to lead the Cancer Moonshot initiative, a new national effort to accelerate research in cancer treatment.  Over the past five years, however, attention on the Cancer Moonshot has seemingly waned to the point that it barely pops up in the national discourse on health policy.  Is the Cancer Moonshot still around, and if so, what has it even accomplished?

Background

The Cancer Moonshot is far from being the federal government’s first push to deliver new cancer treatments.  The National Cancer Institute (NCI) was first established in 1937 to support cancer research.  Incorporated within the National Institutes of Health (NIH) in 1944, NCI remains the oldest center and has the largest budget among the other 27 centers and institutes of NIH. Decades later, President Richard Nixon signed the National Cancer Act of 1971 into law, which provided NCI with more autonomy within NIH and authorized $1.6 billion in funding for NCI over three years.  Additionally, the Orphan Drug Act of 1983 spurred many pharmaceutical companies to invest in drugs to treat rare diseases like cancer.

Beyond NCI,  the federal government has done little to invest large sums of money focusing on research into the prevention and treatment of cancer, which  has limited the progress in the war against cancer.  The overall death rate from cancer has only declined 5% since 1950, and new cancer drugs produced between 2003 and 2013 has only boosted overall survival by 3.4 months.  Given the technical and scientific difficultly of developing cancer treatments, a more concerted effort rather than a piecemeal approach may be necessary to deliver progress.

How the Moonshot Got Started

Shaped by his oldest son’s death from brain cancer in 2015, Biden declared after the 2016 State of the Union that the goal of the Cancer Moonshot was to double the rate of progress towards a cure for cancer. Shortly thereafter, Biden convened a Cancer Moonshot Task Force that established a BlueRibbon Panel charged with outlining research priorities to help the new initiative meet its goals.  Comprised of clinicians, scientists, cancer patients, and advocates, the panel issued a report in October 2016 that established seven working groups to identify research opportunities and offer recommendations on how the Cancer Moonshot can support those opportunities.  Since then, Congress authorized the Cancer Moonshot through enactment of the 21st Century Cures Act in December 2016, which set up the initiative within NCI and provided $1.8 billion funding over seven years.  For FY 2021, the Cancer Moonshot was appropriated $195 million.

Progress So Far

The Cancer Moonshot initiative uses its funding to invest in research that aligns with the initiative’s key priorities, such as generation of human tumor atlases, expanded use of early detection strategies, and establishing a network for direct patient engagement.  According to a midpoint progress update issued in January 2021, the initiative has so far funded over 240 research projects and more than 70 cancer science programs.  The Cancer Moonshot cites over a dozen projects on its website that have yielded progress, including:

  • The Immuno-Oncology Translational Network, whose research has led to insights into ovarian cancers responses to immunotherapy and the use of immunotherapy in certain types of head and neck cancers.
  • The My Pediatric and Adult Rare Tumor Network, which has developed a pipeline for biospecimen collection/analysis rare cancers and established several new specialized rare tumor clinics around the country.
  • The Fusion Oncoproteins in Childhood Cancers Consortium, whose researchers have developed several novel cancer models to study rare cancers and have made significant advances in understanding how each fusion affects the protein’s function and localization in the cell.

Room for Improvement

However, some scientists say Cancer Moonshot has the potential to deliver on greater progress.  To achieve this, a group of scientists proposed early this year in Lancent Oncology, a “Cancer Moonshot 2.0” that can meaningfully improve outcomes for cancer patients with a “scaled up, redoubled, and accelerated” approach.  Among the research areas suggested by the group include:

  • New database formats to capture biological data.
  • Non-invasive liquid biopsy approaches that can be used to screen high-risk individuals to identify precancers and early cancers.
  • Machine learning innovations that link the molecular structure of cancer pathways to more specific and effective drugs.
  • New drug delivery systems that target specific cancer vulnerabilities, such as bispecific antibodies and nanotechnologies.

While the Cancer Moonshot is still alive and kicking, the initiative may not be subject to as much attention when it was first conceived in 2016, likely due to less-than-stellar advancements and the domination of other issues in the public health discourse.  As difficult as cancer research may be, a redoubling of efforts and additional funding could pave the way for new treatments that exemplify the term “moonshot.”

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What Happened, What You Missed: August 16-20

Biden Administration Preparing to Make Booster Shots Available in September

On August 18, President Joe Biden announced his administration is preparing to offer a third dose of the Pfizer and Moderna mRNA vaccines by the week of September 20.  The administration wants the additional doses to function as a “booster shot” after new data has indicated that the efficacy of the Pfizer and Moderna vaccines decreases over time.  The administration also anticipates offering booster shots to individuals who received the single-dose Johnson & Johnson vaccine but is awaiting further information before making a final decision.  Before the administration can officially begin distribution of additional doses, the Food and Drug Administration and the CDC’s vaccine advisory committee must review and authorize booster shots.  The Biden administration’s decision has drawn criticism from health experts who say there isn’t sufficient data to justify booster shots, especially as most of the world’s population remains unvaccinated.

HHS to Mandate Vaccinations for Certain Long-Term Care Workers

President Biden also announced on August 18 that he is directing the Department of Health and Human Services (HHS) to require long-term care facilities to have their employees vaccinated in order to continue to receive funding from Medicare and Medicaid.  The announcement comes as vaccination rates for long-term care workers has lagged nationally, leaving elderly residents vulnerable to the virus.  According to data from the Centers for Medicare and Medicaid Services, just over 60% of nursing home staff is vaccinated, compared to nearly 83% of nursing home residents.  There have been mixed reactions from the nursing home industry regarding Biden’s announcement.  Both LeadingAge and the America Health Care Association (AHCA) have said the administration should require all health care workers to be vaccinated instead of singling out nursing homes, although LeadingAge does support requiring vaccination as a condition of employment for nursing home workers.  Additionally, AHCA has warned vaccination requirements could prompt some long-term care workers to flee to other industries.

KFF: Spending per Person for MA Enrollees Grew Higher, Faster Than Traditional Medicare

A report issued August 17 by the Kaiser Family Foundation (KFF) found the federal government spent $321 more per person for Medicare Advantage (MA) beneficiaries compared to those enrolled in traditional Medicare in 2019, resulting in an additional $7 billion in annual spending.  The report also found that spending per MA enrollee is growing faster compared to traditional Medicare, which could cause overall MA spending to double by 2029.  According to the report, several features of the MA payment system are contributing to rising costs, including how benchmarks for plan payments are set and the risk adjustment process.  The report’s release comes as the Biden administration looks to increase the solvency of the Medicare trust fund by reforming payments to privately managed plans like MA.

Pelosi Urges Moderate Democrats to Back $3.5 Trillion Budget Resolution

Speaker Nancy Pelosi (D-CA) sent a Dear Colleague letter to all House Democrats on August 17 urging the caucus to support passage of the $3.5 trillion Fiscal Year (FY) 2022 budget resolution when the House returns from recess on August 23.  Pelosi’s letter was a direct response to nine moderate House Democrats who in an August 13 letter threatened to block the FY 2022 budget resolution unless the $1 trillion bipartisan infrastructure bill is passed first.  In her Dear Colleague letter, the Speaker expressed that any delay in passing either measure could threaten a “once-in-a-generation opportunity” to enact policies that will help working families.

ICYMI: Washington Monument Closed after Lightning Strike

The Washington Monument remains closed after it was struck by lightning at 12:30 a.m. on August 15.  According to the National Park Service, the lightning strike damaged the monument’s electronic access system that operates the door and the elevators.  Work crews are waiting on parts before repairs can resume, and it remains unclear when the parts will arrive.  According to The Washington Post, lightning hits the Washington Monument several times a year, and last Sunday’s strike marks the second lightning hit in 2021.

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After 10 Years, How Is the CMS Innovation Center Doing?

  • Posted In CMS

The Center for Medicare and Medicaid Innovation (CMMI), also known as the CMS Innovation Center, just celebrated its tenth birthday last year.  Tasked to address growing concerns about rising costs, quality of care, and inefficient spending, CMMI is a powerful tool for innovation in the US health care system. (https://thelocopolo.com/)   After a decade, is CMMI delivering on its promise to innovate health care, or does the young agency still have much to accomplish?

All About CMMI

Created upon enactment of the Affordable Care Act (ACA) in 2010, CMMI is statutorily mandated to design, implement, and test new health care payment and delivery models for Medicare and Medicaid.  Managed by the Centers for Medicare and Medicaid Services (CMS), CMMI has launched over 40 new payment models since its inception, including accountable care organizations, medical homes models, and bundled payment models.  CMMI separately awards grants to state agencies, researchers, and other organizations for projects to design and implement new payment models with the same goals of improving care and lowering costs, and some of CMMI’s work includes multi-payer alignment models that impact patients with commercial insurance.

2020 Report to Congress

Released on August 4, the 2020 Report to Congress provides an in-depth look at the performance of CMMI models and serves as a key indicator of how the center is doing in its effort to address rising costs and boost quality.  While the report focuses on CMMI’s activities from October 1, 2018, to September 30, 2020, it also highlights some actions taken from September 30 to December 31, 2020.

In the 2020 Report, CMS estimated that over 27.8 million Medicare and Medicaid beneficiaries plus enrollees in commercial insurance plans have received care from over 500,000 health care providers or plans participating in alternative payment models under CMMI.  The 2020 Report analyzed a total of 38 active models within CMMI, including 11 new models announced since the 2018 Report and 27 active models that were launched prior to October 2018.

Summary of Findings

Unfortunately, only a handful of CMMI models met either goal of reducing costs or improving quality.   Furthermore, only the five following models delivered “statistically significant savings” to the Medicare Trust Fund according to the report:

Additionally, a few models led to improvements in quality but did not yield any noteworthy savings, including the Comprehensive End-Stage Renal Disease (ESRD) Care (CEC) Model and the Comprehensive Care for Joint Replacement (CJR) Model.

Saving money and raising quality aren’t the only metrics for a model’s success.  For CMS to consider permanently expanding a model for the federal health care entitlement programs, models must meet several additional criteria, including assurance from the CMS Office of the Actuary that a model’s expansion would not deny or limit coverage or provision of benefits under Medicare, Medicaid, and CHIP.   According to the report, only three models met the criteria:

How Can CMMI Improve?

While the 2020 Report to Congress does not explicitly offer recommendations on how to improve model performance, it does identify four issues that contributed to lower-than-expected model performance:

  • Selection bias created by voluntary models.
  • Benchmark inaccuracy.
  • Quality measure misalignment.
  • The need for greater data transparency.

These four issues identified in the report suggest a few ways CMMI models could produce better quality and provide for lower costs, mainly through mandatory model participation and more data transparency.  The idea of making more payment models mandatory is not a new idea.  In a July 2021 interview with Health Affairs, CMMI Director Liz Fowler explained that a shift towards mandatory models, which had already begun during the previous administration, will continue under the Biden administration and are likely to play a greater role in CMMI’s future.

The fact that CMMI models are underperforming is not lost on CMS leadership.  In a recent Health Affairs blog post, a few top agency officials including CMS Administrator Chiquita Brooks-LaSure and Fowler acknowledged only a handful of models have incurred savings and met the requirements to be expanded.  In addition to recounting a few recommendations from outside experts, such as MedPAC’s endorsement for streamlining and harmonizing models, Brooks-LaSure and Fowler offered several takeaways to inform how model performance could be improved.

  • CMMI needs to reevaluate how it designs financial incentives in order to boost meaningful provider participation.
  • Challenges in setting financial benchmarks have undermined models’ effectiveness, underscoring a need to ensure models are not resulting in overpayment and explore ways to improve or replace the current risk adjustment methodology.
  • Since providers find it hard to accept downside risk if they lack the tools to change care delivery, CMMI should help ensure providers have options for managing risk, such as support in transforming care, waivers, and data.

Despite dozens of underperforming models, CMS recognizes that the Innovation Center has room for improvement, and the agency’s leaders are keen on delivering a strategy that works.  Hopefully, through streamlining current models, implementing more mandatory models, boosting participation in voluntary models, improving financial incentives, and ensuring model participants have the tools they need to succeed, CMMI models could hopefully be in a better position to  both reduce costs and improve quality in time for the center’s 20th anniversary.

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What Happened, What You Missed: August 9-13

FDA Authorizes Third Vaccine Dose for Immunocompromised Patients

On August 12, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Pfizer and Moderna COVID-19 vaccines to allow immunocompromised people to get a third dose.  The Centers for Medicare and Medicaid Services (CMS) subsequently announced that Medicare beneficiaries would be able to receive the additional vaccine dose at no extra cost.  FDA’s announcement comes after a number of doctors said the two-dose regiment does not generate a sufficient level of protection in most people with compromised immune systems.  The Centers for Disease Control and Prevention (CDC) estimates that 2.7% of US adults are immunocompromised, including people undergoing cancer treatment and organ transplant recipients.  On August 13, CDC’s Advisory Committee on Immunization Practices will meet to discuss whether a third COVID-19 vaccine dose is needed for certain groups.

Biden Calls on Congress to Allow Medicare to Negotiate Drug Prices

President Biden publicly urged Congress on August 12 to enact legislation to allow Medicare to negotiate on drug prices as a key component of his vision for reducing the high cost of prescription drugs.  Other reforms Biden called for include establishing a cap on out-of-pocket drug costs for Medicare beneficiaries, building on efforts to help states and Tribes to import lower-cost drugs from Canada, and accelerating the development and uptake of generic and biosimilar drugs.  Immediately following Biden’s remarks, PhRMA President and CEO Stephen Ubl issued a statement saying the president’s proposals would undermine access to life-saving drugs and shift drug costs to patients.

Chamber of Commerce Files Lawsuit over Insurer Price Transparency Rule

On August 10, the US Chamber of Commerce filed a lawsuit in the US District Court Eastern District of Texas to challenge a rule finalized by the previous administration in October 2020 that requires insurers to post pricing information in a machine-readable format online.  In the suit, the Chamber contends that the rule violates the Administrative Procedures Act and that the administration lacks statutory authority to require prices to be listed in a machine-readable format.  According to the Chamber, the price transparency rule has the potential to reduce competition and boost prices consumers pay by requiring insurers to post information that’s otherwise considered confidential.  On August 12, the Pharmaceutical Care Management Association filed a similar lawsuit in the US District Court of the District of Columbia challenging the price transparency rule.

Senate Approves Bipartisan Infrastructure Bill, Kicks Off FY22 Budget Resolution Process

On August 10, the Senate voted 69-30 to approve a bipartisan $1 trillion infrastructure bill, moving forward a major component of President Biden’s agenda.  Passage of the infrastructure bill cleared the way for the Senate to adopt by a 50-49 vote its $3.5 trillion Fiscal Year (FY) 2022 budget resolution that contains key Democratic priorities around childcare, paid leave, climate change, and education.  The House is expected to return early from recess to approve the FY 2022 budget resolution during the week of August 23, which would unlock the budget reconciliation progress and allow the Senate to pass a final bill that only requires 50 votes.  The process to pass the larger measure could take months, however, and Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) have started to say  they will not support $3.5 trillion in spending.

AAP Calls for FDA to Accelerate EUA of COVID Vaccine for Kids under 12

In an August 5 letter, the American Academy of Pediatrics (AAP) urged the FDA to authorize the emergency use of COVID-19 vaccines for children under age 12 “as soon as possible” due to a rise in pediatric COVID-19 cases sparked by the Delta variant.  According to AAP, FDA should use the clinical trial data it already has collected on the Pfizer and Moderna vaccines to move forward on expanding the emergency use of the vaccine instead of waiting for six months of follow-up data due to “changes in the risk-benefit analysis” posed by the Delta variant.  AAP also noted that cases of myocarditis in adolescents and young adults are “extremely rare” and do not necessitate the collection of additional data to expand the EUA.

ICYMI: Congressional Staff Express Interest in Telework, Flexible Arrangements

Even though a number of congressional staffers have returned to in-person work in Washington, some staffers are calling for their bosses to consider making telework or hybrid work arrangements permanent.  According to some proponents, more telework opportunities could provide relief to employees with childcare responsibilities, help with employee retention, or provide opportunities to staff who can’t physically be in the Washington, DC area.

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