Administration

How Is ARPA-H Shaping Up?

by Matt Gontarchick

The Advanced Research Projects Agency for Health (APRA-H) has come a long way since the Biden administration first proposed a new biomedical research agency back in April 2021.  Since then, Congress and the administration have started laying the foundation for the new agency.  The Fiscal Year (FY) 2022 appropriations omnibus provided $1 billion in funding for the nascent agency and directed the president to appoint an ARPA-H director.  In congressional hearings last spring on the administration’s FY 2023 budget request for the Department of Health and Human Services (HHS), Secretary Xavier Becerra offered a few more details, like the administration’s preference to make ARPA-H a part of the National Institutes of Health (NIH).

There are still more questions than answers about what ARPA-H could one day look like.  However, more details have come into focus in recent weeks as authorizing legislation for ARPA-H progresses through Congress and the administration makes new decisions about ARPA-H personnel.

A New Acting Deputy Director

While the search for a permanent director remains under way, the administration has at least made headway in naming a temporary member of the new agency’s leadership team.  On May 25, HHS Secretary Becerra appointed Adam H. Russell, DPhil, to be ARPA-H’s acting deputy director.  With experience managing research projects at the Defense Advanced Research Projects Agency (DARPA), Russell is tasked with building out the administrative structure of the new agency and hiring initial staff until the president appoints a permanent director.  It remains unclear if Russell is under consideration for a permanent role either as director or deputy director.

The ARPA-H Director: Appointment or Confirmation?

When the administration finally taps someone to permanently lead ARPA-H, will the appointment require Senate confirmation?  Recently, Rep. Anna Eshoo (D-CA) revised her ARPA-H authorizing legislation to require the Senate to confirm the ARPA-H director.  The Senate’s legislation on ARPA-H and previous versions of Eshoo’s bill did not address whether the individual appointed by the president would require confirmation.  The House is set to vote on the bill  during the week of June 20, while a Senate panel already approved its ARPA-H bill in March.

The Continued Debate over Placement within NIH

To date, the question of whether APRA-H should be an independent agency within HHS or a part of the organizational structure of the National Institutes of Health (NIH) remains unsettled.  The Senate’s legislation aligns with the administration’s preference of placing the new agency within NIH, which Becerra explained over multiple congressional hearings would allow ARPA-H to focus on developing breakthroughs from day one by delegating administrative functions to the parent agency.  However, Eshoo and other lawmakers have been firm in their stance that ARPA-H must be independent to successfully carry out its mission, and her bill maintains this position. 

Where Will the ARPA-H Headquarters Be?

While certain lawmakers and the administration have yet to agree on whether the Senate should confirm the ARPA-H director and the placement of e the organization, there is a universal agreement that the new biomedical research agency should not be physically located on the NIH campus in Bethesda, Maryland.  Over the past few months, several states have been jockeying to be selected as the home base for the new agency.   Members of the Texas and Massachusetts congressional delegations have recently sent letters to the administration urging their states to be considered as the location for ARPA-H due to their existing infrastructure in medical research and life sciences. 

In Massachusetts, business and academic leaders have joined public officials on efforts to lure ARPA-H to the Bay State.  Several members of the Ohio congressional delegation are also urging the administration to select Cleveland as the new ARPA-H home, and other states vying for the headquarters include California, North Carolina, and Maryland.  However, the administration has yet to announce a timeline for its headquarters selection process or provide any details on how a location will be chosen. 

When Will We Know More about ARPA-H?

Once the House votes on ARPA-H legislation during the week of June 20, stakeholders will have to keep an eye on the Senate.   While minor differences around the provision of whether the Senate confirms   the ARPA-H director seem reconcilable, other issues like whether to place ARPA-H within NIH will continue to garner significant debate.  Until a final agreement can be reached, further details on ARPA-H will probably be sparse, as the administration will likely hold off on major announcements on items like personnel and a headquarters location until legislation is close to the finish line. 

Congress

What Lawmakers Talked About during the HHS FY23 Budget Hearings

by Matt Gontarchick

Xavier Becerra made the rounds on Capitol Hill recently in his capacity as Secretary of Health and Human Services (HHS) to testify on the Biden administration’s Fiscal Year (FY) 2023 budget request for HHS.  Beyond the secretary’s submitted testimony – which was virtually the same for every hearing – here is a countdown of the top five health-related topics on lawmakers’ minds that were discussed across seven congressional hearings on the HHS budget request.

5. Ending the PHE

In a few hearings, lawmakers questioned Becerra on when the administration plans to unwind the COVID-19 public health emergency (PHE), which is currently set to expire on July 16, 2022.  Each and every time, Becerra reiterated the administration’s commitment to providing 60 days’ before ending the PHE in order to give states and health care providers time to prepare.  In recent weeks, the administration has given no indication that it will simply let the current PHE expire in two months.  Since May 16, 2022 marked exactly 60 days before the current PHE expiration date, the administration is all but certain to renew the PHE for another 90-day period come July.

4. Telehealth Waivers

One reason why lawmakers are so interested in how long the PHE will last is because several emergency health care flexibilities are tied to the end of the PHE.  These flexibilities include several Medicare telehealth waivers that waive geographic site originating requirements and allow coverage of audio-only services, among other items.  During the hearings, Becerra repeatedly thanked lawmakers extending temporary telehealth waivers for 151 days – 5 months –  beyond the end of the PHE in the Fiscal Year (FY) 2022 omnibus. 

Members were also strongly supportive of extending at least some of the telehealth waivers permanently. Some of the telehealth benefits lawmakers cited include increased access to health care in rural areas and relief for the health care workforce shortage.  Becerra voiced agreements on telehealth’s many benefits during the hearings, and he urged lawmakers to work with the administration on developing legislation to make the temporary telehealth authorities permanent.  Fortunately, members are already hard at work and a bipartisan group of House members have already introduced legislation to permanently expand coverage of audio-only telehealth and remove geographic restrictions on originating sites.

3. No Surprises Act

Members from both parties across multiple committees criticized the secretary for not following congressional intent in implementing the No Surprises Act because the rulemaking process establishes the Qualifying Payment Amount (QPA) as the presumptive out-of-network rate in the independent dispute resolution (IDR) process.  They argued that doing so tips the scale in favor of insurers during the IDR process. During the hearing, authors of the No Surprises Act like House Ways and Means Committee Chairman Richard Neal (D-MA) said members went to great lengths to ensure that the legislation established a level playing for all factors to be considered in the IDR process.   

In February 2022, a district court ruling struck down provisions of the No Surprises Act that gave weight to the QPA.  Becerra assured members during the hearings that the administration’s final rule on the No Surprises Act will heed the court’s ruling, although he declined to provide a timeline  on when  the rule will be released.  The secretary also said that HHS is working with the Department of Justice (DOJ) on whether to appeal or accept the ruling.  Additionally, Becerra was confident that the new rule will protect patients from surprise medical bills. 

2. 988 Suicide Hotline

988 will officially become the new suicide hotline on July 16, 2022, and members were curious to see how the administration is ensuring the hotline will work from day one.  States and territories will be responsible for operating the actual hotline, and Becerra explained that the administration is providing states with funding to make sure they can onboard enough counselors and behavioral health professionals to take incoming calls.  In the event that existing state call centers are overwhelmed, Becerra told lawmakers that HHS is working to set-up back-up call centers.  As the launch date approaches, Becerra assured the congressional committees that HHS is “keeping tabs” with states on call center preparation, although he noted that some states will be in a better position than others to take calls right away once the new hotline goes live this summer.

1. ARPA-H

The FY 2022 omnibus established the Advanced Research Projects Agency for Health (ARPA-H) as the newest biomedical research agency within HHS.  While members were unanimous in their support of the new agency, some including Reps. Rosa DeLauro (D-CT) and Anna Eshoo (D-CA) were critical of the administration’s decision to house ARPA-H within the organizational structure of the National Institutes of Health (NIH).  DeLauro, Eshoo, and others had been advocating for ARPA-H to be an independent agency within HHS because they felt this arrangement would help cultivate an independent culture within the new agency that would best facilitate the development of new cures.  Additionally, some members including Sen. Jerry Moran (R-KS) and Rep. Tom Cole (R-OK) were concerned that the administration’s was proposing additional FY 2023 funding for ARPA-H at the expense of additional funding for existing research projects at NIH.

Becerra assured lawmakers that the placement of ARPA-H was purely administrative, and he explained that having NIH assume functions like accounting and human resources would allow ARPA-H to focus on developing breakthroughs from the get-go.  To further point to the new agency’s independence, he said the ARPA-H director would report to the secretary – not the NIH director – and he added that ARPA-H would not be “physically housed” within the NIH campus. 

Becerra additionally told the congressional panels that ARPA-H will be operational once a director is appointed.  While the secretary said the search for a director is currently underway, he was unable to provide a timeline. 

Congress

What Will ARPA-H Look Like?

by Matt Gontarchick

There’s a new federal agency in town.  The Fiscal Year (FY) 2022 omnibus appropriations bill officially created the Advanced Research Projects Agency for Health (ARPA-H), which the Biden administration first proposed last year to drive “transformational innovation” in health research.  However, the omnibus bill is scant on details, and lawmakers have much to decide about the structure of the new agency.

What’s in the spending bill? Beyond appropriating $1 billion in funds to the new agency through September 30, 2024, the FY 2022 omnibus bill allows the ARPA-H director to use those funds to make awards in the form of “grants, contracts, cooperative agreements, and cash prizes.”  Notably, the bill gave the Department of Health and Human Services (HHS) 30 days to decide whether the new agency would be independent or part of an existing institution, like the National Institutes of Health (NIH).

The issue of whether to make ARPA-H an independent agency within HHS or house the new agency within the NIH has been the subject of debate for months.  Public health experts who testified before a congressional panel on February 8 unanimously agreed that ARPA-H would need to foster an independent culture to be successful in delivering biomedical breakthroughs, and most witnesses and lawmakers felt that housing the ARPA-H within NIH would make it impossible to cultivate its own identity and operating structure. 

Since then, more details about ARPA-H have come into focus.  In a March 31 congressional hearing, HHS Secretary Xavier Becerra announced that ARPA-H would be placed within NIH.  However, Becerra did offer key details that suggests the administration wants to help foster an independent culture within the new agency.  For example, he said the ARPA-H director will be under the supervision of the HHS secretary, not the NIH director.  Additionally, Becerra clarified that ARPA-H would not be “physically housed” within NIH.  According to Becerra, the reason for the new agency’s placement within NIH is to allow ARPA-H to focus on research from the get-go while NIH handles all the administrative work like human resources and legal functions.  

However, the makeup and structure of ARPA-H won’t be up to the Biden administration.  That’s the job of Congress where a trio of authorizing bills are under consideration that flesh out the details of ARPA-H. The bills – the Cures 2.0 Act plus the House and Senate versions of the ARPA-H Act – propose similar requirements on the new agency, such as:

  • Presidential appointment of the APRA-H director for one five-year term, with the option to extend for one additional term.
  • Establish goals for delivering biomedical breakthroughs by prioritizing high-risk, high-reward innovations and identifying potential areas of health research advancement that industry stakeholders aren’t currently addressing due to technical or financial reasons.
  • Collaboration with other HHS entities like the Food and Drug Administration (FDA).

There’s one key area where the bills differ – the Cures 2.0 Act calls for APRA-H to be a part of NIH, while both versions of the ARPA-H Act say the new agency should be independent within HHS.  The House Energy and Commerce Subcommittee on Health held a legislative hearing on March 17 to review both the Cures 2.0 Act and the ARPA-H Act, and currently, House leadership supports the ARPA-H Act, which increases the odds the new agency will ultimately be independent from the NIH. 

As lawmakers continue their work, stakeholders outside of Washington are focusing on a different question: the specific location of ARPA-H.  While Becerra told lawmakers back in March that the new agency wouldn’t physically be a part of the NIH campus in Bethesda, Maryland – neither the FY 2023 omnibus bill nor the three authorizing bills say anything about where ARPA-H should be headquartered.  Currently, cities in California, Massachusetts, North Carolina, and Texas are lobbying to become the location of the new biomedical research agency.

Congress is in recess until the week of April 25, and neither chamber has indicated when it will markup and vote on their respective authorizing bills on APRA-H.  Until the finish line is in sight, conversations over the makeup of ARPA-H – and whether it should be a part of the NIH – are likely to continue. 

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

Collins Leaves Big Shoes to Fill at NIH

by Matt Gontarchick

Francis Collins announced plans to retire from his role as Director of the National Institutes of Health (NIH) on October 5.  This is a big deal for the Biden administration, as this leaves another crucial leadership position vacant, as the administration still has not nominated a Commissioner for the Food and Drug Administration (FDA).

Brief background: The Staunton, Virginia native first came to NIH in 1993 to serve as Director of the National Human Genome Research Institute, a role he held for 15 years.  Under his leadership, the institute made landmark discoveries of disease genes and contributed to the international Human Genome Project, which for the first time fully mapped all genes of the human genome.  Collins was later nominated to lead NIH under then-President Barack Obama and was confirmed by the Senate in 2009.

Why is he retiring?  Even though a public health emergency is still ongoing, Collins told reporters that his “hour-to-hour oversight” is no longer as necessary now that three vaccines are out and case numbers are declining nationwide.  According to reports from Politico, Collins initially wanted to quit last winter, but National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci convinced him to stay on a little while longer.

It wasn’t a spur of the moment decision.  Collins said he had been thinking about retirement for the past 3-4 months.  By making the decision now, Collins hopes to facilitate a smooth transition for the next NIH director.

Who’s taking over?  Principal Deputy Director Lawrence Tabak, number two at NIH, is most likely to serve as acting director in the interim.  But it’s unclear if he’s in the running for the top job – Collins said in an October 5 interview that he wants a woman to succeed him.  The only certainty is that Fauci won’t be the next NIH director – he’s already said no to the role.

Whoever takes over will have big shoes to fill.  During his decade-plus at the helm of NIH, Collins:

And whoever becomes the next NIH director has plenty of challenges to look forward to, including:

  • Leading the agency though the next (and hopefully final) phase of the pandemic.
  • Shaping the development of the Advanced Research Projects Agency, or ARPA-H.
  • Overseeing clinical trials for COVID-19 treatments.
  • Defending the administration’s public health policies and handling of the  pandemic on Capitol Hill. 

It’s also worth noting that Francis Collins is a bit of a Renaissance man.  Here are some of his other accomplishments outside of leading the world’s largest medical agency.

Collins won’t be the NIH director anymore, but he isn’t leaving NIH.  In fact, he’s planning to return to his laboratory at the National Human Genome Research Institute. 

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.