CMS

Implicit Bias Is CMMI’s Latest Problem to Tackle

by Matt Gontarchick

Advancing health equity is one of the five strategic objectives the CMS Innovation Center (CMMI) outlined in its Strategy Refresh back in November 2021.  It’s no surprise that health equity is becoming an increasingly important goal at CMMI as the Biden administration has made health equity a major priority since day one. 

However, CMMI has its work cut out for itself.  According to a July 2022 report, implicit bias is pervasive in at least three payment models, which signals challenges if CMMI is serious about advancing equity. 

Implicit bias is an involuntary bias that a person is unaware of.  Often times, negative attitudes and stereotypes can play a powerful role in shaping implicit bias, or “unconscious prejudice.”  Two top CMMI officials authored the report on implicit bias to analyze how implicit bias may be impacting beneficiary groups in payment models. 

In its analysis, CMMI only reviewed three models: the Comprehensive Care for Joint Replacement (CJR) Model, Kidney Care Choices (KCC) Model, and Million Hearts® Cardiovascular Risk Reduction Model.  CMMI selected these models because they represent a microcosm of CMMI models that vary by mandatory/voluntary status, financial methodology, and risk stratification. 

Overall, the report found that use of certain risk-assessment and screening tools, provider tools, and payment design and risk-adjustment algorithms has led to the exclusion of some beneficiaries from these models.  Here are some key findings:

  • The CJR Model tests bundled payment plans for participating providers that perform knee and hip replacements.  The report found beneficiaries receiving joint replacements were “less medically complex” than those receiving joint replacements at the same hospitals before model participation began.  The report also found that beneficiaries in the model are less likely to be dual-eligible, which indicates a lower socio-economic status.  It is also worth noting that Black Americans are likely to receive knee and hip replacements than White Americans. 
  • The KCC Model encourages nephrologists, dialysis facilities, and end-stage renal disease (ESRD) practices to focus on the total care of their patients and incentivizes kidney transplants for chronic kidney disease beneficiaries.  The analysis found that the model’s medical eligibility criteria may have inadvertently excluded Black American beneficiaries, despite the fact that Black Americans are over three times more likely to have ESRD. 
  • The Million Hearts Model provides financial incentives for practices to lower 10-year cardiovascular disease risk for the 30% of high-risk Medicare beneficiaries.  The evaluation found that despite being developed specifically for Black and White populations, the risk calculator used to predict risk scores underestimated risk among patients in other racial and ethnic groups that do not identify as White or Black as well as patients in lower-income households.   

CMMI acknowledged that its findings are “troubling” and underscore a need for a “more systematic evaluation of implicit bias in current and new models.”  As a next step, CMMI says it is working on a “step-by-step guide” to detect and address bias in current models and prevent bias from forming in future one.

While it’s encouraging to see CMMI has a plan to address implicit bias, the revelation that unconscious prejudice is prevalent in three key payment models only adds to the list of challenges CMMI needs to address.  According to an August 2021 report, only a handful of CMMI’s 40-plus models have met the center’s statutorily required goal of reducing costs or improving quality.  In addition to the Biden administration’s emphasis on health equity, the report’s findings likely catalyzed CMMI to lay out its strategic refresh in November 2021, which makes reducing costs and improving quality its “overarching goal.”  On top of CMMI’s difficultly of meeting its statutory obligations, the center now faces the challenge of addressing implicit bias, which may also be prevalent in additional payment models.

All in all, CMMI’s issues with reigning in costs, boosting quality, and stopping implicit bias could signal larger structural problems within the center.  Of note, CMMI’s problems are not lost on lawmakers, in May 2022, Sen. Cory Booker (D-NJ) and Rep. Terri Sewell (D-AL) introduced bicameral legislation to require the center to work with experts on health equity when developing and reviewing payment models.  

At least CMMI has acknowledged its challenges and is laying out plans to address them, including its strategic refresh and a forthcoming “step-by-step guide” on tackling implicit bias.  However, CMMI won’t be able to solve its problems overnight, and the center has a long way to go if it not only wants to achieve its statutory goals of bringing down costs and enhancing quality, but also take on new priorities like improving health equity.

Congress

Why ARPA-H Needs to Be Independent from NIH to Be Successful

by Matt Gontarchick

The nation needs more breakthrough medical treatments.  While the National Institutes of Health (NIH) is the government’s leading biomedical research agency, unfortunately, it takes a long time to turn NIH-supported research into cures.  To bridge this gap between research and innovation, Democrats are proposing an Advanced Research Projects Agency for Health (ARPA-H) with the hope that it will deliver breakthrough medical treatments quicker. 

For ARPA-H to be successful, its placement within the structure of the federal government may be key.  In a February 8 hearing by the Health Subcommittee of the House Energy and Commerce Committee, witnesses testified to make the case that for ARPA-H to be effective, it cannot be housed within the NIH – instead, ARPA-H must be an independent agency within outside the purview of the Department of Health and Human Services (HHS).

Democrats modeled ARPA-H after the Defense Advanced Research Projects Agency (DARPA), an independent research and development agency within the Department of Defense, that’s charged with the development of emergency technologies for use by the military.  According to former Assistant Secretary for Health Brett Giroir – a member of the witness panel and a former Director of Defense Science Office at DARPA – the independent status of DARPA was crucial in its ability to bring about innovations like cellular technology and the Global Positioning System (GPS).

During the hearing, members of the witness panel discussed several reasons why ARPA-H must be independent of NIH to be successful.

  • Culture.  Like DAPRA, ARPA-H would need to have a distinct culture, vision, and approach to problem solving to deliver breakthroughs.  This is only possible if ARPA-H is separate  from NIH – otherwise, the new agency will be unable to develop a culture distinct from NIH. 
  • Operations. Unlike NIH researchers, project managers at ARPA-H would follow timelines with specific deliverables that witnesses at the hearing suggested being publicly posted.  DARPA follows a similar model
  • Interaction with private sector.  Project managers at ARPA-H would be required to engage with the private sector to ensure that there is no overlap between research being conducted within the new agency and drug developers.  Witnesses at the hearing additionally suggested that ARPA-H hold listening sessions and/or engage with specific communities to ensure health equity is a focus at the new agency.

What comes next? House and Senate appropriators proposed funding for ARPA-H in Fiscal Year (2022) appropriations.  However, the new agency’s future is increasingly in doubt as lawmakers move to pass another continuing resolution to keep the government funded at FY 2021 levels through March 11 – which mean no funding for new initiatives like ARPA-H.  And it’s not just appropriations – for ARPA-H to become a reality, Congress needs to approve authorizing legislation, and there’s currently no timetable for when either of the bills that authorize ARPA-H will move forward. 

Administration

What Happened to the Cancer Moonshot?

by Matt Gontarchick

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.”

CMS

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

by Matt Gontarchick

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.  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.

Administration

ARPA-H, the Proposed Agency to Transform Biomedical Research

by Matt Gontarchick

The internet.  GPS.  The computer mouse.  These are some of the technological innovations made possible by the Defense Advanced Research Projects Agency (DARPA), a Defense Department agency tasked with advancing research and development of science and technology programs.  Now, the Biden administration wants to replicate DARPA’s success in biomedical research with a newly proposed entity called Advanced Research Projects Agency for Health (ARPA-H). 

What Is ARPA-H?

The Biden administration’s Fiscal Year (FY) 2022 budget request provided a $6.5 billion investment for APRA-H, which would be directed to drive “transformational innovation” in health research and speed application and implementation of health breakthroughs.  The initial focus of ARPA-H would be cancer, disabilities, and Alzheimer’s disease.  According to a concept paper provided by the White House, examples of projects that could be pursued by ARPA-H include:

  • mRNA vaccines to prevent most cancers.
  • Molecular “zip codes” that target drugs only to specific tissues and cell types, to eliminate serious side effects.
  • Highly accurate, inexpensive, wearable monitors for blood pressure and blood sugar that provide real-time data to patients and providers.
  • Holistic systems that eliminate racial disparities in maternal morbidity and mortality rates and premature births.
  • A process to design, test, and approve a vaccine against any newly emerging human virus in 100 days.

The National Institute of Health (NIH) further explains that ARPA-H will predominantly focus on “time-limited” projects with goals, metrics, and accountability.  It also states that the director of ARPA-H will be selected based on having a “proven innovation and partnership-building track-record,” and ARPA-H program managers will be recruited from industry, academia, or other sectors based on “scientific vision, judgement, and management skills.”

ARPA-H is also included in the Cures 2.0 discussion draft that was released by Reps. Diana DeGette (D-CO) and Fred Upton (R-CO).  However, the discussion draft is still a work in progress, and it contains far fewer details on the proposed agency than those provided by the Biden administration. 

How Would ARPA-H Advance Biomedical Research?

Ideally, ARPA-H would need many of the same authorities used by DARPA to accomplish its mission to delivery breakthroughs in biomedical research.  Key authorities would include:

  • The ability to hire individuals rapidly based on “a unique skill set” outside the typical civil services hiring system and pay those individuals a competitive wage, as well as the ability to recruit experienced program managers from the private sector. 
  • Broad, flexible funding authority that make it possible to mix and match the best ideas with minimal bureaucracy that allow for projects that can be funded for multiple years or don’t necessarily fit into one-year intervals.
  • Exemptions from the traditional review process for biomedical research, which can take up to 18 months or longer, to get from an idea to a scientific review before the actual work begins.

According to a July 26 Federal News Network interview with NIH Director Francis Collins, an ARPA-H with “some new authorities” could make a difference for experimental drugs that show a lot promise during clinical trials but fail to attract investment from pharmaceutical companies due to an experimental products being perceived as too risky or having a limited market share.  In these cases, Collins explained ARPA-H could chose to invest in certain experimental drugs and hand them over to the private sector when necessary.

The Structure of APRA-H

The Biden administration has stipulated that ARPA-H would be a “distinct division” within NIH, with a “unique culture and organization.”  However, some medical experts have argued ARPA-H should be a stand-alone entity within the Department of Health and Human Services (HHS), including a former chair from DARPA’s advisory committee, who suggested NIH’s approach to research and innovation is too time-consuming and bureaucratic.  In response, Collins told The Washington Post in mid-June that putting ARPA-H outside of NIH would be a big mistake because it would lead to “administrative duplications” and preclude the chance for ARPA-H program managers to develop synergy with their colleagues at NIH.  While the Cures 2.0 discussion draft has yet to define ARPA-H’s structure and home, Collins has said that DeGette and Upton are leaning towards having the new agency withing NIH.

Collins also threw cold water on the notion that ARPA-H could create internal jealously within NIH in his Federal News Network interview by countering that many NIH employees are excited about the prospect of a new research agency and that “unfriendly competitiveness” exists in other parts of the government.  It’s worth noting that the administration’s FY 2022 budget request includes a major increase in NIH funding rather than diverting away funds to create a new agency. 

Next Steps

APRA-H only becomes a reality when FY 2022 appropriations bills are signed into law, and the FY 2022 appropriations process has gotten off to a slow start.  The House passed an appropriations minibus for FY 2022 on July 31 that includes $3 billion for ARPA-H, while the Senate only began reviewing its FY 2022 spending proposals on August 2. , Notably, the proposals to create a new biomedical research agency been favorably viewed by members of both parties, meaning ARPA-H is unlikely to be cut from the legislation. However, given lawmakers’ slow progress on appropriations and long list of other items that require their attention in the next 60 days, all FY 2022 spending measures are unlikely to be finalized by the end of the FY 2021 on September 31.  This means NIH may not be able to take the first steps in building up ARPA-H until Congress finalizes the FY 2022 appropriations bills later in the fall or winter.

Once FY 2022 funding is squared away, Collins hopes to hit the ground running.  In his Federal News Network interview, the NIH director said he hopes to recruit 50-100 program managers for the agency’s first year, with results on research projects expected in the following one to two years as ARPA-H continues to “staff up and ramp up.”  Collins also projected to have 50-60 projects going at ARPA-H by the end of FY 2022, assuming all FY 2022 spending bills are enacted by December 2021.