Administration

Key Primary Races to Watch in August 2022 (8/2/2022) 

by Matt Gontarchick

The long 2022 primary season isn’t over yet.  Starting today, 15 states will hold primary elections over the next 30 days, and the results of some races will be more impactful than others.  By the beginning of September, American voters are sure to have a clearer idea of the importance of political dynasties, and more importantly, how much influence former President Donald Trump wields over the GOP electorate.   

Michigan Democrats: Levin v. Stevens (August 2) 

Michigan lost a congressional seat in the 2020 Census.  The state’s new congressional map is the product of an independent commission, and while the commission has been successful in avoiding partisan gerrymandering, it wasn’t enough to stop a race between two incumbents.  Both Rep. Andy Levin (D-MI) and Rep. Haley Stevens (D-MI) could have opted to run in the new 10th Congressional District, which leans slightly Republican and contains suburban communities northeast of Detroit.  But instead, both Democratic incumbents chose to seek reelection in the 11th Congressional District, which features a more Democratic-leaning electorate in the suburb’s northwest of Detroit.   While Levin resides in the new district, Stevens’ current district includes much of the new one she’s running in. 

Both Levin and Stevens first entered Congress at the start of 2019, meaning they have been incumbents for the same length of time.  However, Levin has one possible advantage in the form of name recognition.  His father, Sander Levin, served in the House before retiring in 2019, and his uncle, Carl Levin, served in the Senate from 1979 to 2015.   

Missouri Republicans: Greitens v. Schmitt (August 2) 

Eric Greitens was elected Governor of Missouri in 2016, but he resigned in 2018 following allegations of sexual misconduct and violations of campaign finance laws.  Having secured Trump’s endorsement back in 2016, Greitens threw his hat in the ring as a Trump-friendly candidate in the 2022 Republican primary to replace the retiring Sen. Roy Blunt (R-MO) amid a crowded field consisting of Missouri Attorney General Eric Schmitt, Rep. Vicky Hartzler (R-MO), and Rep. Billy Long (R-MO).  While Trump has yet to formally endorse a candidate in the race, he has positively commented on Greitens as recently as July 8.  However, Greitens’ initial lead in the polls seems to have has fallen after allegations of domestic abuse became public and the release of a controversial ad about hunting “Republicans-in-name-only,” or RINOs.  

Currently, one poll has Greitens in third place behind Schmitt and Hartzler, while another has all three candidates tied for first.  As voters in Missouri head to the polls, many Republicans including members of the former president’s inner-circle are currently divided over whether to support Greitens or Schmitt.  However, given Trump’s 15-point victory margin in Missouri two years ago, whichever GOP Senate candidate prevails on Tuesday is all but certain to win in November. 

Arizona Republicans:  Brnovich v. Masters (August 2) 

Arizona State Attorney General Mark Brnovich led the polls for months as the Republican candidate in the primary race for the Senate.  However, Brnovich began to lose ground after former President Trump criticized the attorney general for not supporting him during the 2020 election audit of Maricopa County.  In June, Trump endorsed Blake Masters, bringing the 35-year-old venture capitalist to first place in the polls.  A critic of the validity of the 2020 presidential election, Masters has been also questioning whether the results of the 2022 midterm election will be legitimate, which some Republicans worry could backfire and dissuade some GOP voters from showing up at the polls this November.  Whoever secures the Republican Primary will take on freshman Sen. Mark Kelly (D-AZ) this fall in a race that the Cook Political Report currently rates as a “toss-up.”  But the nomination of a hardcore Trump loyalist and election skeptic like Masters to the GOP ticket could turn off moderate and independent voters, leaving Kelly with a slight edge in November. 

Wyoming: Cheney v. Hageman (August 16) 

Rep. Liz Cheney (R-WY) was a rising star in the Republican Party, having been elected House GOP Conference Chair in August 2019.  However, Cheney lost her leadership position in May 2021 after drawing the ire of House Republicans for her criticism of former President Donald Trump.  Since then, Cheney has only doubled down on her criticism of Trump by serving as the Vice Chair of the January 6th Committee.   

Wyoming voters picked Trump over then-candidate Joe Biden in 2020 by a 40-point margin, so it’s no surprise that Cheney is trailing the Trump-endorsed attorney Harriet Hagemen by nearly 20 points in the GOP primary.  Cheney’s current situation is a sharp contrast from 2020, when she won reelection with 70% of the vote.  Cheney could theoretically find a narrow pathway to victory if she secures the votes of independents and Democrats over the coming days, but a landslide loss would mean the former president is still capable of commanding influence in states that strongly lean red.   

The Rest of Primary Season 

After August 31, only four states have primaries left: Massachusetts’ primary is scheduled for September 6, while Delaware, New Hampshire, and Rhode Island have their primary elections on September 13.  Given the number of consequential primaries in August, however, voters won’t have to wait until the end of the month to get a sense of what the midterm election in November will look like – and how much of an influence the former president has on the GOP. 

Medicare

Fixing Medicare’s Insolvency Requires Both the Administration and Congress – So Where Are They?

by Matt Gontarchick

The 2022 Medicare Trustees Report was full of grim news – namely, that the Hospital Insurance (HI) Trust Fund is projected to hit insolvency by 2028.  Given the serious implications insolvency could have on access to care, stakeholders have been begging Congress and the administration to do something.   

However, Washington has avoided serious attempts to address the HI Trust Fund’s insolvency for years, primarily because the most obvious fixes would be unpopular among voters.  Since the payroll taxes predominantly finance the HI Trust Fund, lawmakers could opt to raise payroll taxes to add more years to the fund.  Unfortunately, higher payroll taxes would mean less take-home pay for employees and would put pressure on employers, which sounds like a sure-fire way to anger the electorate.  Inflation and general concerns over cost-of-living issues would also exacerbate the impact of higher payroll taxes on workers. 

Lawmakers could also maximize existing revenue streams by cutting Medicare spending, but this would spark political backlash from the health care sector.  The pandemic has stretched hospitals’ operating margins even thinner and reducing already-low Medicare reimbursement rates would make life even more difficult for providers.  Medicare could shift costs to beneficiaries in the form of higher deductibles and co-payments, but this would once again be political damaging as seniors will then have to grapple with the combined effects of higher health care costs and inflation.

The federal government could also incur Medicare savings by making the program more cost effective, but that’s no easy task.  During a series of congressional hearings of the Fiscal Year (FY) 2023 budget request for the Department of Health and Human Services (HHS), Secretary Xavier Becerra repeatedly said value-based payment models could be used to save Medicare dollars and extend the HI Trust Fund’s solvency.  Unfortunately, these payment models haven’t had much of effect on Medicare’s finances.  Out of the 40 payment models launched by HHS over the past 10 years, only five have delivered “statistically significant savings.”  Even if all value-based payment models were to start immediately reducing costs, it would likely take years for these savings to make a serious dent on Medicare’s finances.

Congressional Action in Sight?

The urgency of addressing Medicare Part A’s finances isn’t lost on members of Congress.  During Becerra’s appearances before congressional committees last spring, Republican lawmakers repeatedly questioned the secretary about the administration’s plans for addressing the HI Trust Fund’s pending insolvency.  In response, Becerra repeatedly told lawmakers that they will have to work with HHS to develop legislation to improve the outlook for the HI Trust Fund. Rep. Adrien Smith (R-NE), one of the GOP members to question Becerra about the HI Trust Fund, penned a June 2022 op-ed that underscored the need for “bipartisan action” to shore up Part A revenue.

It’s not that Congress hasn’t taken action in the past.  There is a statutory requirement for the administration to submit a report to Congress when more than 45% of Medicare hospital spending is projected to come from general revenue – not the HI Trust Fund – within seven years.  However, as both Smith and Becerra confirmed in the recent HHS budget hearings, the Biden administration has no plans to meet this requirement. 

Fortunately, a viable proposal to address the HI Trust Fund has emerged in recent days.  On July 7,  Senate Democrats reached an agreement to extend the solvency of the HI Trust Fund to 2031 by closing a Net Investment Income tax (NIIT) loophole involving pass-through businesses.  Primarily targeting high-income earners, the proposal to close the tax loophole was first put forth by the Biden administration back in 2021 as a part of its Fiscal Year (FY) 2022 budget request.   Senate Democrats are reportedly including this proposal in a broader reconciliation package to secure the support of Sen. Joe Manchin (D-VW), whose decision to withdraw support from last year’s package caused it to fall apart. 

The proposal from Senate Democrats is getting attention in the House, too.  On July 11, Rep. Lloyd Doggett (D-TX) introduced legislation that would similarly close the NIIT loophole.

However, the proposal is still in its infancy at this point, and it doesn’t have a strong likelihood of becoming law.  The Senate Parliamentarian has yet to complete the review of the new reconciliation proposal, and as last year has shown, delicate negotiations on a new reconciliation bill could collapse at any point.  However, as the Senate attempts to revive a reconciliation bill and the comments made during recent congressional hearings show that lawmakers are definitely concerned about Part A’s finances and recognize the importance of taking action before it’s too late.  

Public Health

How Is the Federal Government Doing on Health Equity?

by Matt Gontarchick

Equity has been a cornerstone of the Biden administration since day one.  On his first day in office, President Joe Biden signed an executive order (EO) to advance racial equity across the federal government in many areas – including health. 

Policies to promote health equity are crucial to addressing health disparities, which affect populations with a lower socioeconomic status, rural communities, people with cognitive and physical disabilities, and communities of color.  For example, African Americans and Hispanic Americans are less likely to have health insurance coverage and more likely to have chronic health conditions than non-Hispanic whites. 

As the nation wraps up celebrating its second Juneteenth – a holiday paramount to the cause of racial equity – what steps has Congress and the administration taken since the president’s inauguration to advance health equity?

Health Equity and COVID-19

The EO called for the creation of the administration’s COVID-19 Health Equity Task Force, whose mission was to ensure that elements of the COVID-19 response, including the mass vaccination campaign, prioritized equity.  The task force ultimately played a pivotal role in the administration’s response to COVID-19 by addressing barriers to vaccinations like the need to take time off work and lack of transportation to vaccination centers. This ultimately led to the administration to advocate for paid leave to allow people to get vaccinated and reimburse their transportation costs to vaccination sites. 

Released in November 2022, the task force’s final report  coalesced around several key actions: investing in local community-based efforts, putting more resources into collecting data on health-related concerns by race and ethnicity, and increasing representation of people of color in the health care system.   The task force also recommended that the White House create a “permanent health equity structure” to coordinate health equity efforts across the executive branch, although the administration has yet to address this.

American Rescue Plan Act of 2021

Enacted in March 2021, the American Rescue Plan Act did much more than providing COVID-19 aid – it also made key investments in health equity by closing gaps in access to medical care, investing in community health, and addressing social determinants of health.  Funding provided by the law has since gone on to bolster initiatives like a $90 million investment to support data driven approaches to reducing health disparities. 

Health Equity Strategy at CMS

The Centers for Medicare and Medicaid Services (CMS) adopted an action plan on health equity in April 2022, which the agency outlined as a continuation of the administration’s drive to improve health equity.  Some of the goals laid out in the plan include increased outreach to individuals about the Affordable Care Act (ACA) marketplaces, promoting culturally and linguistically appropriate services, and gathering more data factors like ethnicity, language, income, and sexual orientation.

One of the ways the action plan has manifested is through the CMS Innovation Center (CMMI), which added “advancing health equity” as one of its five strategic objectives in 2022 .   

Legislation on Deck

Since the American Rescue Plan became law, lawmakers have been working on several bills aimed at improving health equity.  Examples include:

  • The Advancing Maternal Health Equity under Medicaid Act (H.R. 6612) – Provides a 90% federal matching rate for Medicaid maternal health care expenditures that exceed 2021 levels.
  • The Rural Health Equity Act (S. 3149) – Establishes the Office of Rural Health within the Centers for Disease Control and Prevention (CDC) to serve as the primary point of contact within the CDC on rural health matters and coordinate public health research on issues affecting rural populations.
  • The Pursuing Equity in Mental Health Act (S. 1795/H.R. 1475) – Directs the federal government to award grants to establish inter-professional behavioral health care teams in areas with a high proportion of racial and ethnic minority groups.

What could happen next?  Although the window of opportunity for Congress to advance any sort of health equity legislation before the midterm elections is rapidly closing, the administration has yet to carry out many of the recommendations listed in the COVID-19 Health Equity Task Force’s report. This means there are still plenty of opportunities for the Biden administration to make strides on health equity over the next two years.

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

FDA User Fee Process: The Clock Is Ticking

by Matt Gontarchick

September 30, 2022.  That’s the date the Food and Drug Administration’s (FDA) user fee programs for drug products and medical devices are set to expire.  Given the “must-pass” nature of user fee reauthorization, lawmakers and FDA stakeholders are using this moment to advance other FDA-related reforms pertaining to the accelerated approval process, promoting clinical trial diversity, competition in drug markets, and other areas.  While the House and Senate user fee packages are fundamentally similar, there are some differences between the two.  For instance, the Senate package includes policies related to dietary supplements, diagnostic labs, and cosmetics; the House does not.  Given the differences between the packages and the pressure to get a signed bill before the August recess, stakeholders would be keen to watch the legislative process unfold.

A Brief History of the FDA User Fee Process

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) authorized the FDA to collect user fees from companies that submit applications for drug products.  Since then, Congress has added additional user fee programs for other products like medical devices, generic drugs, and biosimilars.  Congress reauthorizes user fee bills every five years, and the reauthorization process marks an important opportunity for lawmakers to consider FDA-related policies as well as overall FDA performance. 

Since FDA depends on user fees to operate, failure to reauthorize user fee programs would catastrophically disrupt FDA operations by triggering massive layoffs of career staff who review new drugs and devices and monitor drug safety.   As a result, the timelines for new drug products to reach patients and providers would increase exponentially.   

Although current authority for the user fee programs expires at the end of Fiscal Year (FY) 2022, Congress typically passes reauthorization bills in the summer preceding the September deadline to avoid disrupting FDA operations. With that in mind, the House and Senate are on the clock to pass a legislative package over the next couple of months before the FDA starts handing out pink slips.

What’s in the House and Senate Bills?

The House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee have already released their own respective user fee reauthorization bills that would reauthorize fees that drugs, biosimilars, and medical device companies must pay the agency for review of their products.  Both bills appear to move forward with fee levels that were negotiated between FDA and industry groups prior to their release. 

Additionally, both bills set out to reform the FDA’s accelerated approval program, which allow the agency to approve drugs more quickly for serious conditions that fill an unmet medical need.  In exchange, drug manufacturers must complete post-approval trials to confirm those clinical benefits – something the FDA has not consistently ensured. 

Both the House and Senate bills would allow the FDA to require manufacturers to start post-approval studies prior to accelerated approvals, give the FDA more control over study design and deadlines, and create a mechanism for the agency to pull drugs off the market.  The bills also would clarify that post-approval studies could rely on real-world evidence (RWE) to confirm that drugs are effective.  Notably, the Senate bill differs from the House bill in that it would create an interagency coordinating council that would periodically review accelerated approvals.

Additionally, both bills set out to promote drug competition through better access to generic and biosimilar drugs, albeit through different paths.  For instance, the House bill contains provisions that would streamline the generic approval process in certain types of cases, while the Senate bill addresses exclusivity for interchangeable biosimilar products.

Outside of fee proposals, changes to the accelerated approval process, and access to generic and biosimilar drugs, both bills contain several notable differences.  For example, the House bill includes provisions aimed at improving diversity in clinical trials by requiring trial sponsors to submit diversity action plans with details on how the sponsors intend to enroll a diverse group of trial participants.  Other provisions would require the FDA to submit reports on diversity action plans and to hold public workshops on improving trial diversity. While the Senate bill does not contain such a provision, another Senate HELP Committee-approved bipartisan bill, the PREVENT Pandemics Act, does include policy intended to promote clinical trial diversity.

Among the Senate’s user fee package proposals are provisions that would enhance the regulation of laboratory-developed tests (LDTs) by allowing the FDA to regulate LDTs based on the level of risk associated with them, similar to how the agency regulates medical devices.  The Senate bill would also expand the FDA’s ability to regulate dietary products by requiring dietary supplement companies to list their products with the agency, which would theoretically improve the FDA’s ability to enforce consumer protections.  Furthermore, the Senate bill contains a slew of provisions aimed at boosting regulation of cosmetics.  These include requirements for cosmetics manufacturers to register their products with the FDA, new labeling requirements, and the establishment of good manufacturing practice regulations.

What Comes Next?

The House Energy and Commerce Committee voted in favor of its user fee package in the Health Subcommittee on May 11 and the full committee on May 18 with a vote on the House floor scheduled for June 7.   Over in the Senate, the HELP Committee is scheduled to mark up its user fee package on June 14, along with legislation to improve access to mobile health clinics. 

Congress has always addressed the user fee reauthorization legislation ahead of the expiration deadline (September 30), and leaders from both House and Senate committees with jurisdiction over the FDA have publicly stated that they don’t want to hold up the reauthorization process.  However, substantive differences between the House and Senate versions of the reauthorization bill combined with a highly partisan climate have the potential make passing user fee legislation more difficult than in previous years. 

Additionally, the Senate HELP Committee has also voted in favor of its PREVENT Pandemics Act, another top priority of Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), who is retiring at the end of this year, for enactment.  Likewise, a priority of House Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-CA) will be enactment of her bipartisan House legislation creating the Advanced Research Project Agency for Health (ARPA-H).  It remains unclear if/how these policy priorities and user fee reauthorization packages will come together and form one bill to be signed by the President before the expiration of the current user fee programs. As the summer unfolds, stakeholders would keen to monitor the reconciliation process to see which provisions and changes make it into the final reauthorization bill.

Congress

What Will the FY 2023 Appropriations Cycle Look Like?

by Matt Gontarchick

House and Senate appropriators are poised to introduce their Fiscal Year (FY) 2023 spending bills, kicking off weeks and months of negotiations and hearings.   The FY 2023 appropriations cycle notably follows a lengthy FY 2022 cycle that wasn’t resolved until March 2022.  As lawmakers grapple with the midterm elections, retirements, and economic concerns in the coming months, how likely will the new appropriations cycle spill over into the next calendar year?

What We Currently Know

So far, top congressional appropriators are saying they want FY 2023 appropriations to wrap up in the current calendar year.  In a March 31 hearing, House Appropriations Committee Chairwoman Rosa DeLauro (D-CT) expressed a desire to pass all appropriations bills “on time” so they can be signed into law by September 30, 2022.  But her Republican counterpart, Ranking Member Tom Cole (R-OK), had a more sobering take, saying Congress is unlikely to finish its work on FY 2023 appropriations until the end of the current calendar year.

There are only a handful of other indications as to how the FY 2023 appropriations cycle will pan out.  On April 28, Democratic and Republican leaders of the House and Senate Appropriations committees met to discuss topline spending levels for FY 2023.  While it remains to be seen what came out of the meeting, the dollar figures each side offers will indicate how contentious appropriations negotiations might shape out to be this summer.  For instance, the administration proposed a $1.6 trillion budget for FY 2023, with funding allocations roughly equally divided between defense and non-defense spending.  If Democrats start their negotiations with the president’s budget request, their push is likely to fall flat, as Republicans and some centrist Democrats have been eager for more defense spending. 

There aren’t many more details about timelines, either.  In the House, the Appropriations subcommittees are reportedly expected to markup their 12 spending bills between June 13 and June 22, with the full committee to follow its markups from June 22 through June 30.  However, all dates are currently tentative, and the committee won’t confirm official dates until a final notice is sent out.

The Senate Appropriations Committee has yet to announce its own tentative timeline, although Senate appropriations hearings always follow appropriations hearings in the House.  This means subcommittee and full committee markups in the Senate will probably be scheduled throughout July and August. 

Which Factors Will Impact FY 2023 Appropriations?

Unfortunately for lawmakers, they’re heading into a new appropriations cycle with many distractions and extenuating circumstances that don’t often come together all at once.  Here are some key factors that will determine whether lawmakers will wrap up the new appropriations cycle before 2022 ends

The Midterm Elections

A “wave” election that could likely see control of the House shift from one party to another is typically a strong indicator of a long appropriations season.  Due to both historical trends and President Joe Biden’s low approval ratings, Republicans are generally favored to regain a majority in the House in the 2022 midterm election this November.  The closest comparison to the 2022 election so far is 2010, when low approval ratings over the Obama administration’s handling of the economy helped flip 63 House seats to the GOP, causing the Democrats to lose control of the chamber.  As a result, Congress didn’t finalize FY 2011 spending bills until March 2011.  2018 saw another wave election, with then-President Donald Trump’s unpopularity supercharging Democratic turnout to help the party flip 41 seats, allowing Democrats to retake the House.  If 2010 and 2018 are any indication, a long FY 2023 appropriations season is likely to coincide with the 2022 midterm elections.

Retirements of Top Appropriators

Some of the current lawmakers who won’t be on the ballot for the 2022 midterm elections include Senate Appropriations Committee Chairman Patrick Leahy (D-VT) and Ranking Member Richard Shelby (R-AL), who will both be retiring at the end of the 117th Congress.  Their pending retirements might incentivize both to reach deals on spending bills sooner rather than later.   Additionally, Sen. Susan Collins (R-ME), who is widely favored to replace Shelby as the Appropriation Committee’s top Republican, has indicated she’d prefer finishing FY 2023 appropriations in 2022 to ensure she can start the new Congress “with a clean slate.”

Inflation

Inflation is at a 40-year high, which could spur lawmakers to reach a final agreement on FY 2023 sooner instead of relying on a series of continuing resolutions (CRs) into next year.  When inflation is at a more typical level like 2% per year, federal agencies can generally make do under a CR and find money in their budgets to ensure there are no interruptions in services or operations.  However, if inflation persists near its current level of 8.5% through September, agencies will have a difficult time operating under a CR as they struggle to accommodate rising prices with budgets frozen at FY 2022 levels. 

With a mix of incentives for and against reaching a budget deal, it’s hard to say when a final FY 2023 spending agreement will be signed into law.  However, election season is busy enough for lawmakers, and with a historic and contention midterm election season almost in full swing, there’s little likelihood Congress will reach an agreement on appropriations before Election Day on November 8. 

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

Current Members of Congress Who Used to Be Interns

by Matt Gontarchick

Everyone gets their start somewhere.  For some members of Congress, their careers kicked off at the bottom of the totem pole, by serving as interns for other members of Congress.  Below is a list of key current members whose experience with the legislative branch started with answering phones and other administrative duties.

Speaker Nancy Pelosi (D-CA)

The only woman to serve as speaker of the House of Representatives was exposed to politics at an early age, with her father serving as a Democratic Congressman from Maryland, and later, as Mayor of Baltimore.  Pelosi herself first dipped her toes in the political waters when she interned for Sen. Daniel Brewster (D-MD) while pursuing a Bachelor of Arts (BA) in political science at Trinity College in Washington, DC.

Majority Leader Steny Hoyer (D-MD)

Also serving as an intern in Sen. Brewster’s office alongside the future speaker was the future majority leader, Steny Hoyer.  At the time, Hoyer was finishing up a BA in government and politics from the University of Maryland, College Park.  Just a few years later in 1966, Hoyer was elected to the Maryland State Senate.

Rep. Eric Swalwell (D-CA)

Hoyer isn’t the only University of Maryland alumnus serving in Congress.  While studying for his BA in government and politics, the California native interned with Rep. Ellen Tauscher (D-CA) in 2001 and 2002.  Swalwell has stated that his experience interning on Capitol Hill during the September 11 terrorist attacks cemented his desire to pursue public service. 

Sen. Marco Rubio (R-FL)

While studying at the University of Miami School of Law, Rubio interned for Rep. Ileana Ros-Lehtinen (R-FL), a fellow Cuban American who retired from Congress only a few years ago.  Rubio also worked on the 1996 presidential campaign of Sen. Bob Dole (R-KS) while in law school.

Sen. Mark Warner (D-VA)

While attending George Washington University in the mid-1970s, Warner interned for Sen. Abraham Ribicoff (D-CT).  Shortly after graduating, Warner took a job with then-Rep. Chris Dodd (D-CT) and went on to manage Dodd’s senatorial campaign while studying in law school.

Sen. Kirsten Gillibrand (D-NY)

Like Pelosi, Gillibrand was born into a political family.  Her father was a staffer for Sen. Al D’Amato (D-NY), and her maternal grandmother founded the Albany Democratic Women’s Club.  While studying at Dartmouth College, Gillibrand interned in D’Amato’s Albany office. 

Congress

A History of Annual Congressional Sporting Events

by Matt Gontarchick

Many Americans love sports, and members of Congress are no different.  A few times a year, lawmakers from both parties gather to play games in a variety of sports with the goal of raising money for charities.  Here are some of the games where Representative and Senators have the chance to take a break from the usual grind of Washington and bring out their inner athlete.

Congressional Baseball Game

Founded in 1909 by a Pennsylvania representative who once played baseball professionally, the Congressional Baseball Game is the oldest of the lawmaker-centric sporting events.  In the game, which has been played at Nationals Park since 2008, Democrats and Republicans form different teams and play against one another.  Congressional staffers, lawmakers’ families, and even some presidents attend the game, which raises money for four charities: the Boys and Girls Clubs of Greater Washington, the Washington Nationals Dream Foundation, the Washington Literacy Center, and the US Capitol Police Memorial Fun.

Congressional Football Game

Started in 2004, the Congressional Football Game features members of Congress and former National Football League players facing off against the US Capitol Police.  An Arizona representative led the effort to start the annual tradition as a way to honor the memory of two Capitol police officers who died in a shooting in 1998.  The Congressional Football game raises money for three charities: the US Capitol Police Fund, Our Military Kids, and Advantage 4 Kids.

Congressional Women’s Softball Game

Sen. Susan Collins (R-ME), Sen. Kirsten Gillibrand (D-NY), Rep. Debbie Wasserman Schultz (D-FL) and several other female members of Congress started the Congressional Women’s Softball Game in 2009.  Each year, a team consisting of female lawmakers plays against women of the Washington, DC press corps.  The game primarily raises money for the Young Survival Coalition, which supports women under 40 who are diagnosed with breast cancer. 

Congressional Soccer Match

Founded in 2013, the Congressional Soccer Match consists of separate teams formed by Democratic and Republican lawmakers that play against one another with help from some former professional soccer players.  Nearly all lawmakers who participate in the annual event are members of the Congressional Soccer Caucus.  The US Soccer Foundation hosts the annual match, which raises funds for several charity programs that help children in underserved communities.

Congressional Hockey Challenge

The Congressional Hockey Challenge began in 2009 from a weekly pickup match consisting of congressional staff and lobbyists.  Each year, members of Congress, congressional staff, and administration officials face off against lobbyists, and proceeds from the annual match go towards the Fort Dupont Cannons, USA Warriors Hockey, Capital Beltway Warriors, the Tampa Warriors, and the Professional Women’s Hockey Players Association.

Congress

Members of Congress Related to Celebrities

by Matt Gontarchick

Most members of Congress aren’t household names, but quite a few have people in their family who are, particularly in the world of film and television.  Here are some notable celebrity-lawmaker connections. 

Rep. Fred Upton (R-MI)

The Michigan congressman’s niece is model and actress Kate Upton.  Kate was born in her uncle’s hometown of St. Joseph, MI but later moved with her family to Florida when she was seven years old.  She rose to fame after appearing in the Sports Illustrated Swimsuit Issue in 2011, and since then, she’s appeared in prominent publications like Vogue and Vanity Fair.  Kate is also a successful actress who has appeared in several hit comedy films including Tower Heist and The Layover.  In 2016, Rep. Upton hosted his niece and gave her  a tour of the US Capitol – along with her husband, Houston Astros pitcher Justin Verlander.

Senate Majority Leader Chuck Schumer (D-NY)

Comedienne and actress Amy Schumer and the Senate Majority Leader are first cousins, once removed.  Both Schumers have appeared publicly together to advocate on issues like gun violence, and in 2016, Amy attended a White House press conference with her uncle when then-President Barack Obama announced new actions on gun control.  However, both cousins were largely estranged from one another during Amy’s childhood, and the senator and the comedienne didn’t start to develop a relationship until Amy’s fame started to grow in 2009.

Sen. John Hickenlooper (D-CO)

The freshman Colorado senator’s cousin is filmmaker George Hickenlooper.  His feature-length documentary, 1991’s Heart of Darkness: A Filmmaker’s Apocalypse, explored the chaotic production of the 1979 Vietnam War film Apocalypse Now.  George’s final film was the 2010 comedy-drama movie Casino Jack, which focused on the corruption scandal surrounding lobbyist Jack Abramoff.  The film notably featured actor Kevin Spacey in the titular role, and George’s cousin John even had a brief cameo in the film.  Sadly, George Hickenlooper died in his sleep at the age of 47 on October 29, 2010, just a month after the film’s release.

Speaker Nancy Pelosi (D-CA)

The speaker’s daughter is filmmaker Alexandra Pelosi, who has filmed, produced, and directed 14 films to date.  Pelosi’s first film was the Emmy-nominated 2002 documentary Journeys with George, which chronicled George W. Bush’s first presidential campaign.  Since then, Pelosi has gone on to receive critical acclaim for a host of other documentaries, including Citizen USA: A 50 State Road Trip, which explored the citizenship process for immigrants, and Meet the Donors, which looks at the influence money has  in politics. 

Former Rep. Mike Capuano (D-MA)

A US Representative from Massachusetts who served from 1999 to 2019, Capuano’s famous nephew is actor Chris Evans.  After playing supporting role in films like 2001’s Not Another Teen Movie and 2005’s Fantastic Four, Evans rose to worldwide fame for his portrayal of the titular role in 2011’s Captain America: The First Avenger.  Since then, Evans has appeared as Captain America in several Marvel Cinematic Universe films, and he’s acted in critically acclaimed films like 2013’s Snowpiercer and 2019’s Knives Out.  Notably, Evans told Esquire in 2016 that he’s considered getting into politics someday, and in 2019, he met with several Democratic senators on Capitol Hill for A Starting Point, new political venture aimed at addressing partisanship and distrust.

Sen. Bernie Sanders (I-VT)

Actor, comedian, writer, and filmmaker Larry David and the former presidential candidate are third or fourth cousins.  Neither man was aware of their relation until historian and literary critic Henry Louis Gates Jr. revealed the family connection in a 2017 episode of Finding Your Roots.  David has played Sanders in multiple episodes of Saturday Night Live since 2016.  Both men were born in Brooklyn, New York City and trace their ancestry back to Ashkenazi Jewish immigrants from Poland.

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. 

Drugs

Can Lawmakers Pass Comprehensive Drug Pricing Reform This Year?

by Matt Gontarchick

The White House is not giving up hope on Congress passing legislation this year to allow Medicare to negotiate on drug prices, according to a White House domestic policy advisor who spoke at  AHIP’s National Conference on Health Policy and Government Health Programs in March.  But if a recent Senate Finance Committee hearing is any indication, the odds of this proposal passing in Congress this year are slim to none.

A Brief History of Recent Drug Pricing Proposals

Allowing Medicare to negotiate with drug manufacturers on prices has been a cornerstone of Democrats’ drug pricing proposals for some time now.  Negotiation was a major health care provision of the Build Back Better Act and President Biden reiterated the need for negotiation in his State of the Union on March 1.

Republicans have never been receptive to negotiation over fears that it would amount to price controls and leave pharmaceutical companies with fewer resources to develop new drugs.  However, in 2019, there was a sense of cautious optimism that a bipartisan compromise on drug pricing policy could be reached. That year, Sens. Ron Wyden (D-OR) and Chuck Grassley (R-IA) introduced a sweeping bipartisan measure that would cap out-of-pocket drug costs under Part D once a beneficiary hits a certain threshold.  But this legislation fell apart after then-Senate Majority Leader Mitch McConnell (R-KY) said he had no interest in bringing the bill up for a vote in the Senate, prompting Wyden to withdraw his support.

The Drug Pricing Debate in 2022

As the 2022 midterm elections approach, many Democrats believe their window of opportunity to pass comprehensive drug pricing reform is rapidly closing.  Despite this, Democrats don’t seem to be in any mood to compromise.  During the March 16 hearing of the Senate Finance Committee, Democrats were unanimous in their support for lowering drug prices through negotiation, which the committee’s Republican members continually opposed. 

Instead, committee Republicans including Ranking Member Mike Crapo (R-ID) voiced support for the Lower Costs, More Cures Act, which would establish an annual out-of-pocket cap of $3,100 for Medicare Part D enrollees – similar to the Grassley-Wyden bill – and allow certain patients to pay in monthly installments.  But Democrats on the Finance Committee didn’t seem interested in half-measures.  For instance, Wyden said out-of-pocket caps would simply “pass higher prices to someone else, like taxpayers.” 

It’s not as if Democrats are completely opposed to the idea of price caps.  During the hearing, Sen. Raphael Warnock (D-GA) touted his bill to cap copayments for insulin at $35 a month – a proposal Biden endorsed in his State of the Union.  However, Republicans seem opposed to this stand-alone measure, even though it’s similar to the Lower Costs, More Cures Act provision that would make permanent the Center for Medicare and Medicaid Innovation model that enables Part D enrollees who take insulin to limit out-of-pocket costs to $35.  During the hearing, Sen. Pat Toomey (R-PA) suggested rising insulin costs over the years have contributed to “tremendous innovation” of insulin products.

What happens next? Warnock said he wants to get his insulin pricing cap bill to the Senate floor by Easter.  The chances of this bill passing don’t look good at the moment and barring a break in the logjam between Democrats and Republicans on negotiation, progress on overall drug pricing reform doesn’t seem likely, either.  Both parties seem entrenched on their preferred legislative solutions to tackle high drug prices to the point that relatively bipartisan proposals like the Grassley-Wyden bill of 2019 wouldn’t stand a chance in passing.

But if Congress can’t do it, maybe the administration can, according to some Democrats.  Seemingly having lost hope in Congress to deliver on major Democratic policy proposals, many Democratic lawmakers are urging President Biden to sidestep Congress and take whatever executive actions necessary to lower the cost of prescription drugs.  On March 17, the Congressional Progressive Caucus issued a list of recommendations for executive action that includes drug pricing, among other issues. 

However, the Biden administration has yet to comment on which specific actions it could take, and any new executive orders on drug pricing could be subject to change – either in the courts or by the next administration.   Therefore, any serious attempt at drug pricing reform this year may still only be through Congress, no matter how slim the odds may be.