Last Friday, the U.S. House of Representatives voted to dramatically expand investment and access to apprenticeships with the passage of the National Apprenticeship Act of 2021 under the leadership of Rep. Bobby Scott. This legislation had been passed in November in the last Congress, however, the Republican Senate Majority failed to take up the bill for a vote. With Democrats now in the majority, there is renewed hope that the country’s underfunded and outdated apprenticeship system can finally be modernized to meet our 21st-century workforce needs.
The reauthorization of The National Apprenticeship Act is estimated to create nearly one million high-quality apprenticeship opportunities and includes provisions that target opportunities for key groups, such as young adults, childcare workers, and veterans. The bill also aims to increase apprenticeships in industries that do not require a four-year degree for well-paid jobs, such as healthcare, IT, and financial services.
For the more than 10 million workers who have lost jobs or been laid off, there is no guarantee that their jobs will be there once our country returns to normal. Some estimate thatat least 3.7 million Americans will not have jobs to return to. Many will have to reinvent themselves and apprenticeships can play a critical role in helping workers get back to work better after the pandemic.
As policymakers consider how to help American workers weather the Covid recession, PPI strongly supports an increase in public investment in apprenticeships and work-based “career pathways” training programs that connect workers, including those laid off during the pandemic, to well-paying careers. We look forward to its progress in the Senate Health Education Labor and Pensions Committee under Senator Patty Murray, and we encourage the Senate to pass this important workforce legislation.
Senator Amy Klobuchar, the incoming chair of the U.S. Senate Judiciary Committee’s Antitrust Subcommittee, just released a draft of the Competition and Antitrust Law Enforcement Reform Act of 2021, which includes a slew of antitrust-related initiatives.
In comments on this new legislation, Alec Stapp, director of technology policy at the Progressive Policy Institute, said:
“Senator Klobuchar’s proposed antitrust legislation includes many urgently needed provisions to ensure the federal government is safeguarding competition in every sector of the economy. According to one recent analysis, appropriations for our two federal antitrust agencies have fallen by 18% since 2010. Antitrust enforcers desperately need more resources to police anticompetitive conduct across the economy and bring cases when necessary. Antitrust cases are notoriously expensive and require high-level legal talent — this is not an area the government should be skimping on.”
“The package also includes new transparency and data collection requirements that would be hugely beneficial for better understanding the state of competition and antitrust enforcement in the U.S. Proposed competition studies on institutional investors’ cross-ownership and the role of monopsony power in labor markets are long overdue. Furthermore, a series of Congressional hearings focused on monopoly power in various sectors of the economy, including healthcare and agriculture, would help shed light on the size and scope of the problem we face. Lastly, a requirement for parties to a merger settlement to provide post-merger data is a common-sense idea that would allow enforcers to learn from past decisions and update their analytical methods for future cases.”
“While there is much to like in this batch of proposals, there is also much reason for caution. While certainly not perfect, the current set of antitrust institutions is much improved from what prevailed from the early 20th century until the 1970s, when almost every merger was presumed illegal and most behavior by large firms was inherently suspect. Under the current standard, enforcers need to show evidence of market power, anticompetitive conduct, and consumer harm. The problem with the proposed bill is that it would drastically lower the bar for antitrust liability and might inadvertently criminalize pro-competitive conduct. A prohibition on “conduct that materially disadvantages competitors” would essentially degrade antitrust law to a “know it when you see it” standard for anticompetitive conduct. In reality, lots of corporate conduct is ambiguous at first glance. Enforcers need to do the work of economic analysis and fact-finding to determine whether it’s pro-competitive or anti-competitive. We shouldn’t short circuit that process.”
If you would like to speak to Alec Stapp you can reach him at astapp@ppionline.org or (480) 628-3863.
Some Democrats want to seek political revenge for the Republicans’ unapologetic use of their power over the past decade to engineer a conservative judiciary. Since October, they have been calling on President Biden to expand and pack the Supreme Court and federal judiciary with liberal judges. Biden has wisely resisted these calls and is setting up a commission to provide thoughtful ways to repair the partisan damage done to the courts over the past decade.
When it comes to reforming the courts, Democrats need to tread carefully. Our criminal and civil justice systems are keystones of our economic and political liberty; they keep order and facilitate the peaceful resolution of disputes. Neither system is perfect, but these objectives are unachievable if there is a belief among enough Americans that cases are decided by partisan politics, not justice.
The good news is that Biden has entrusted this effort to two highly respected lawyers, former White House Counsel Bob Bauer and former Deputy Assistant Attorney General Cristina Rodriguez. The persistent guidepost for their work must but ensuring the impartiality of the courts. Their big challenge, therefore, is putting this political genie back in the bottle.
On Tuesday, February 2nd our Deputy Director Curtis Valentine moderated an engaging conversation on the rights of all parents to choose where their children attend school entitled “Parent Choice…is it a Civil Right?” The all-star panel of experts in civil rights and education included George Parker (formerly with Washington Teacher’s Union), Lakisha Young (The Oakland REACH), Shavar Jeffries (Democrats for Education Reform), and T. Willard Fair (Urban League of Greater Miami).
With an audience of parents, educators, advocates, and policy makers, the panel debated the connection between parent choice and the promise of a quality education. As America celebrates Black History Month, our project celebrates those who fight for the civil rights of all parents, especially the right to a quality public education for their children.
PPI President Will Marshall welcomes Representative Suzan DelBene of Washington State’s First District to this episode of the PPI Podcast. The two discuss the Republican party’s identity crisis, the issue of Marjorie Taylor Greene, and the need for the GOP to come to the table on a broad relief package.
They also talk about DelBene’s involvement in the New Democrat Coalition, the House’s largest ideological caucus focused on a solutions-oriented approach to bipartisan legislation for economic growth and progress. Will Marshall hits on the importance of purple districts like DelBene’s, and she highlights the necessity of proving governance still works.
PPI President Will Marshall welcomes Representative Suzan DelBene of Washington State’s First District to this episode of the PPI Podcast. The two discuss the Republican party’s identity crisis, the issue of Marjorie Taylor Greene, and the need for the GOP to come to the table on a broad relief package.
They also talk about DelBene’s involvement in the New Democrat Coalition, the House’s largest ideological caucus focused on a solutions-oriented approach to bipartisan legislation for economic growth and progress. Will Marshall hits on the importance of purple districts like DelBene’s, and she highlights the necessity of proving governance still works.
President Biden’s nominee for Education secretary appeared before the Senate’s education committee today. Miguel Cardona was asked about his stance on issues such as federal support for student civil rights and charter schools. The most pressing questions were centered on the pandemic: Under what circumstances should schools reopen? How much federal aid is needed? How should standardized testing be managed after months of lost learning?
Cardona’s answers are critical to families whose schools have been shuttered for nearly a year. But it’s Cardona’s leadership skills that senators should be most focused on. How strongly will Cardona advocate for America’s children, particularly when adult interests such as teacher unions push in the opposite direction? The secretary of Education doesn’t have authority to open or close schools; that falls to states and localities. But he does have a bully pulpit, and he should use it forcefully to support state and local officials struggling to reengage kids in learning.
Previous Education secretaries under Democratic presidents have forcefully used their voices to support education reforms. Richard Riley’s “America Reads Challenge” during the Clinton administration and Arne Duncan’s “Race to the Top” competition during the Obama administration come to mind. The challenges of this moment are even more daunting.
WASHINGTON, D.C. – A new report co-authored by the Progressive Policy Institute’s Caleb Watney and Doug Rand and Lindsay Milliken of the Federation of American Scientists, highlights a significant opportunity for the Biden Administration to boost entrepreneurship and create up to a million new jobs through a little-known immigration rule.
For the United States in particular, foreign-born entrepreneurs have made up an extraordinary share of our most successful companies and technological achievements. To encourage the vitally important flow of immigrant entrepreneurs, and to accommodate the growing need for an entrepreneur-specific pathway into the country, the Department of Homeland Security (DHS) adopted the International Entrepreneur Rule (IER) in early 2017.
The rule was quickly put on hold by the incoming Trump Administration but was never removed from the Code of Federal Regulations. According to the new report, with support from the Biden Administration, the IER could quickly become an essential pathway to attract and retain foreign-born entrepreneurs who seek to build their businesses within the United States.
Publicize the International Entrepreneur Rule and credibly signal to stakeholders that the IER will receive agency attention and resources
Issue new guidance documents to agency adjudicators to clarify evidentiary standards and make it reasonably straightforward for investors to prove they meet qualifying criteria
Issue new guidance directing U.S. Citizenship and Immigration Services (USCIS) and U.S. Customs and Border Protection (CBP) to grant beneficiaries the full initial 30 months of parole, absent extraordinary circumstances
Issue future rulemaking to improve the IER based on feedback from stakeholder groups
Pursue a long-term legislative solution to stabilize immigration pathways for entrepreneurs
Co-author Caleb Watney, the director of innovation policy at PPI, had this to say about the findings and key proposals: “Countries all over the world are competing to attract the best talent to their shores. Unlike Canada, Australia, and the United Kingdom, the United States has no statutory immigration pathway designed for entrepreneurs. The International Entrepreneur Rule is a powerful tool to help solve this gap and should be embraced by the Biden Administration to increase U.S. dynamism, economic growth, and job creation. Now is the time to build back better and ensure the United States’ place as the best place to start a new business and to welcome brilliant entrepreneurs from across the globe.”
Authors: Caleb Watney, Lindsay Milliken, and Doug Rand
Entrepreneurship is the engine of long-term economic growth and dynamism. For the United States in particular, foreign-born entrepreneurs have made up an extraordinary share of our most successful companies and technological achievements. To encourage the vitally important flow of immigrant entrepreneurs, and to accommodate the growing need for an entrepreneur-specific pathway into the country, the Department of Homeland Security (DHS) adopted the International Entrepreneur Rule (IER) in early 2017.
The rule was quickly put on hold by the incoming Trump Administration, but was never removed from the Code of Federal Regulations. With support from the new Biden Administration, the IER could quickly become an essential pathway to attract and retain foreign-born entrepreneurs who seek to build their businesses within the United States.
Using the DHS estimate that 2,940 entrepreneurs per year would come to the country through the IER, after adjusting for expected business failure rates, we project these entrepreneurs would produce approximately 100,000 jobs over ten years if they produce only the minimum number required for parole extension. If they mirror the average job growth of firms their age, we project more than 160,000 jobs over ten years. If 50 percent of them are high-growth STEM firms, we project more than 300,000 jobs over ten years.
If the number of yearly entrepreneurs is larger than DHS projected, job growth could be considerably higher:
This paper proposes the following recommendations for the new administration, both immediate and longer-term:
Publicize the International Entrepreneur Rule and credibly signal to stakeholders that the IER will receive agency attention and resources
Issue new guidance documents to agency adjudicators to clarify evidentiary standards and make it reasonably straightforward for investors to prove they meet qualifying criteria
Issue new guidance directing U.S. Citizenship and Immigration Services (USCIS) and U.S. Customs and Border Protection (CBP) to grant beneficiaries the full initial 30 months of parole, absent extraordinary circumstances
Issue future rulemaking to improve the IER based on feedback from stakeholder groups
Pursue a long-term legislative solution to stabilize immigration pathways for entrepreneurs
Introduction
More than half of America’s billion-dollar startups were founded by immigrants, and 80 percent have immigrants in a core product design or management role. Though immigrants make up only 18 percent of our workforce, they have won 39 percent of our Nobel Prizes in science, comprise 31 percent of our Ph.D. population, and produce 28 percent of our high-quality patents. To be clear, this is not because immigrants are inherently smarter than the average native-born worker, but instead because of strong selection effects wherein many of the talented and entrepreneurial people from many countries are the individuals most likely to emigrate in search of new opportunities.
Importantly, global competition for this population of international entrepreneurs is heating up rapidly. Countries like Canada, Australia, and the U.K. have adopted versions of a startup visa to create a dedicated pathway for international entrepreneurs, while other countries like China have elaborate talent recruitment programs to try and bring back talented students and workers who are living internationally.
In contrast to this global trend, the United States does not have a statutory startup visa category, and trying to use traditional pathways such as the H-1B visa can be very difficult for an entrepreneur, if not impossible. Other pathways for highly skilled immigrants, including the O-1, EB-1, and EB-2 visas, rely on a strong record of prior accomplishments and are not a good fit for entrepreneurs whose potential accomplishments lie in the future. Entrepreneurs like Steve Jobs or Bill Gates had little track record of success before founding Apple and Microsoft; if they had been born in another country, it is unlikely that traditional employment-based U.S. immigration pathways would have let them start their respective firms here. This inability to recognize prospective success is one of the core deficiencies in our immigration system that the IER was designed to address.
Unfortunately, much damage has been done to the United States’ reputation as the prime destination for the world’s inventors and technical practitioners over the last four years. It is vitally important that under the new administration, we begin attracting this valuable global talent again and opening pathways for their legal residence. The IER has the advantage of already existing⸺quite literally⸺in the federal rulebook, and so it can be revived immediately. For policymakers looking to quickly re-establish the United States as the top stop for international entrepreneurs, strengthening the IER should be an appealing first step.
The Biden administration has made it clear that immigration makes the U.S. a stronger, more dynamic country. Nowhere is this more obvious than with international entrepreneurs who very directly grow the pie of economic opportunity for native-born Americans. The political moment is ripe for action on immigration with public support for increasing immigration at record highs⸺ high-skill immigration is especially popular receiving support from 78 percent of the U.S. population.
Importantly, this proposal is complementary with the wide array of immigration proposals already being pursued by this administration. The IER operates through parole authority that does not impact existing visa caps for other programs, and not needing legislation or immediate regulatory action to operate means the IER is low-hanging fruit from an administrative perspective.
A Brief Primer on the International Entrepreneur Rule
The IER was finalized at the end of the Obama Administration as a way for the federal government to attract entrepreneurs to launch innovative startups in the United States. It is a federal regulation that was developed by DHS, rooted in the DHS Secretary’s statutory authority to grant parole on a case-by-case basis for “urgent humanitarian reasons or significant public benefit.” (In the context of immigration law, “parole” simply means temporary permission to be in the United States; it has nothing to do with “parole” in the context of criminal law.)
The Secretary’s discretionary parole power has historically been used for those with serious medical conditions who must seek treatment in the United States, individuals who are required to testify in court, individuals cooperating with law enforcement agencies, and volunteers who are assisting U.S. communities after natural or other disasters. Recipients of this temporary parole, however, do not have an official immigration status. They are merely permitted to stay in the United States for an amount of time determined by DHS, after which they must leave the country.
With the International Entrepreneur Rule, DHS first articulated its use of parole for individuals who could provide a “significant public benefit” by starting innovating businesses with high potential for growth in the United States. In the rule, DHS outlined the requirements for the types of entrepreneurs and startups that would be considered eligible for entry into the United States with parole. To be considered for parole, entrepreneurs must:
Have “recently formed a new entity in the United States that has lawfully done business since its creation and has substantial potential for rapid growth and job creation”;
Possess at least 10 percent ownership in the entity at the time of adjudication;
Have “an active and central role in the operations and future growth of the entity, such that his or her knowledge, skills, or experience would substantially assist the entity in conducting and growing its business in the United States”; and
Meet one of these thresholds:
Raise at least $250,000 from qualified U.S. investors with established track records;
Win at least $100,000 in grants or awards from federal, state, or local government agencies; or
Provide other “reliable and compelling” evidence that the startup will deliver a “significant public benefit.”
Up to three entrepreneurs per startup can qualify for IER parole. If an entrepreneur (or entrepreneurs) and their startup meet these requirements, DHS may grant them parole for up to 30 months. After this period, the entrepreneur can apply for a single extension of parole for at most another 30 months, if the startup continues to provide a “significant public benefit” as proven by increases in capital investment, job creation, or revenue.
It is important to note that U.S. Citizenship and Immigration Services (USCIS) processes IER applications and U.S. Customs and Border Protection (CBP) officially grants IER parole at a port of entry. When an IER petition is approved, USCIS recommends that CBP grant the beneficiary entry into the United States for a certain amount of time up to 30 months. Then CBP can decide whether to follow that recommendation, or grant entry for a shorter period.
While the IER is not a typical immigration pathway, it fills a gap for entrepreneurs that more common immigration statuses cannot satisfy. Other statuses have lengthy processing times or backlogs which are incompatible with launching a startup (H-1B and EB-2), require a significant amount of personal wealth (EB-5), necessitate establishing the business in another country first (L-1, E-1, and E-2), or require the entrepreneur to already be at the top of their field (O-1 and EB-1), which is uncommon for most startup founders.
The IER is currently the only path to work in the United States that was designed specifically for attracting talented startup entrepreneurs, and should be reimplemented swiftly so it can achieve its full potential. In addition, the IER gives U.S. investors a strong interest in ensuring that the entrepreneurs are successful and that they integrate well while in the United States. Qualified investor organizations are highly motivated to put their money into strong teams with a high capability to execute.
A Rocky Start: Key Takeaways from the Last Four Years
Unfortunately, implementation of the IER has had a host of issues. On January 17, 2017, the final rule for the IER was published in the Federal Register, just days before President Trump was inaugurated. It was supposed to come into effect on July 17 of that year. On July 11, however, DHS delayed the effective date with the stated intention of rescinding the IER completely, thus dissuading potential applicants from taking advantage of it. The Trump Administration was against any expansion of parole authority and directed its energy to reducing immigration levels to an unprecedented extent.
In December 2017, however, the U.S. District Court for Washington, DC ordered DHS to stop delaying and to begin accepting IER applications. It did so, grudgingly, warning applicants that the administration still sought to eliminate the program.
Then, in May 2018, DHS issued a proposed rule in the Federal Register to formally rescind the IER, creating even more confusion and casting another cloud over the program. Even though this rescission rule was never finalized and therefore never took effect, the contentious early history of the IER stunted its potential and convinced an untold number of entrepreneurs to look elsewhere to start their businesses.
For those few who nevertheless chose to pursue entrepreneurship in the United States via the IER, the application process was grueling. Attorney Elizabeth Goss, one of the few immigration lawyers in the country who had a client approved for IER parole thus far, notes that many of the difficulties she faced during the application process were likely related to the unfamiliarity DHS had with implementing the rule. The two biggest pain points were the difficulty of obtaining investment history information from her client’s investors and the discretionary nature of IER parole length.
First, in order to be approved, the applicant must provide proof that their investors are “qualified” as defined in the IER. This includes having the investor organization prove that it has invested in startup entities worth no less than $600,000 over a five-year period and that at least two of these startups created at least five full-time jobs and generated at least $500,000 in revenue with an average annualized revenue growth of at least 20 percent—all information that is not commonly shared with outside parties.
Next, after compiling all of the necessary evidence and fielding requests for additional information from the agency, Goss’ client was only granted a year-long parole by CBP instead of the full 30 months. The entire application process itself took one year.
Former USCIS Deputy Chief of the Adjudications Law Division Sharvari Dalal-Dheini, who observed the initial implementation of the IER within the agency, echoed some of Goss’ points about the difficulty of obtaining IER parole. She agreed that the standards in the IER regulations are very high and have likely dissuaded potential entrepreneurs from applying. In particular, the requirements to be considered a qualifying investor are restrictive, as the investor organization must be majority-owned by U.S. citizens or permanent residents. It is not uncommon, however, for high-profile investor organizations to have foreign investors.
That said, many groups have strongly advocated for the IER, noting that there is no other adequate pathway for startup entrepreneurs. Greg Siskind, another leading immigration lawyer, explained in a public comment that IER parole is no less risky than holding a nonimmigrant work visa, at least as long as USCIS has rescinded its policy of deference for prior determinations for status renewals. He also outlined how other immigration pathways are inadequate for startup entrepreneurs, a summary of which can be found in the table below.
Table 1: A comparison of alternative pathways for startup entrepreneurs and their drawbacks
Potential pathway for entrepreneurs
Requirements
Reasons pathways are not adequate for startup entrepreneurs
L-1 – Intracompany transferee (temporary status)
The business must be operating both inside and outside the U.S. for a year.
The executive, manager, or specialized knowledge employee must be employed abroad full-time for one year prior to transfer to the U.S.
The startup must be founded in another country and expand to the U.S., negating the benefits of starting a business in the U.S.
The entrepreneur must already have significant funding and a founder already in the U.S.
H-1B – Specialty occupation worker (temporary status)
Employers must be able to pay the candidate the prevailing wage according to the geographic area in which the business is located.
The number of H-1Bs is capped at 85,000 per year.
H-1B holders must legally be an “employee” who does not have sole decision-making authority, which can be difficult to structure as a startup founder.
Startup founders regularly underpay themselves to ensure more money goes to the business.
Startups often lose money in the first few years, making it difficult to prove that the business would be able to pay an employee the prevailing wage.
O-1 – Extraordinary ability or achievement (temporary status)
This status is reserved for those with extraordinary abilities “sustained by national or international acclaim.”
Current standards used to judge “extraordinary ability” are very high and create a bias towards those with very documentable awards/accomplishments, typically not recognizing investor funding.
This may help a small number of accomplished entrepreneurs, but renders many young professionals with innovative ideas ineligible.
E-1 and E-2 – Treaty traders and investors (temporary status),
These visas are only available for the countries which have signed certain treaties with the U.S.
To be eligible, investments must be made by those from the same country in which the business started.
The founder must have at least 50 percent ownership of the business.
This excludes entrepreneurs from many countries that do not have treaties with the U.S., including India, China, and Russia, among others.
It is common for startups to have founders from more than one country, or also have an American founder, rendering them ineligible.
It is necessary to give small portions of ownership to investors in each funding round, quickly making it very difficult for a startup founder to maintain at least 50 percent ownership.
EB-1 – First preference, employment-based (permanent residency)
One type of EB-1has requirements that are similar to O-1s in that beneficiaries must “demonstrate extraordinary ability.”
EB-1s for “multinational managers or executives” are for those who have been employed outside the U.S. for at least one year with a business that has been active in the U.S. for at least one year.
Many early-career entrepreneurs will not meet the extraordinary ability requirements.
The executive/manager pathway for EB-1s is inadequate as well, because the startup would have to be founded in a different country, negating the economic benefits of its launch in the U.S.
EB-2 – Second preference, employment-based (permanent residency)
Beneficiaries must have an advanced degree or 10 years of work experience
National Interest Waivers (NIWs)—which remove the requirement for a lengthy labor-market test—are only granted to those with exceptional ability and whose employment would “greatly benefit the nation.”
This high level of work experience may work for some founders but does not allow those earlier in their careers or without advanced degrees to benefit.
NIW adjudications also take up to a year, which is too long for an entrepreneur looking to launch a startup.
EB-3 – Third preference, employment-based (permanent residency)
Approval requires an individual labor certification from the Department of Labor.
Founders cannot obtain an individual labor certification because they have ownership or control over the business and cannot conduct a typical market test for the position.
EB-5 – Immigrant investor program (permanent residency)
To be eligible, the beneficiary must invest at least $900,000 or $1.8 million (depending on the location) and create or preserve at least 10 full-time jobs for U.S. workers.
Only entrepreneurs who are independently wealthy would qualify for an EB-5, which is rare.
Processing times can also extend to over two years, with consular processing taking another six months, which is too long to wait to found a startup.
The Road Ahead: Getting the Most Out of the International Entrepreneur Rule
The IER, if allowed to work properly, fills an important gap in the immigration system. The Biden Administration has an opportunity not only to revive the IER but to address some of the implementation difficulties of the last several years and make the program more effective. There are three levels of changes that can be made to strengthen the IER:
Improve marketing and outreach to make it clear to practitioners and stakeholders that the IER is available and workable.
Implement non-regulatory changes such as improving program operations and issuing updated policy guidance to make evidentiary standards clearer.
Solidify the program through new regulations, such as adding a more durable qualified investor status.
Program marketing and outreach improvements
At the broadest level, for the IER to live up to its full potential, it needs the credible backing of the administration, publicly committing to the rule and its improvement based on feedback from the broader community. Immigration lawyers play a vital role in guiding their clients through the labyrinthine process of navigating various immigration channels and they are unlikely to recommend their clients pursue the IER unless they believe that it is a “real” program with well-articulated standards and a reasonable processing timeline.
This can be achieved in a number of ways. First, vocal support and recognition of the program by the White House and high-ranking administration officials will raise the profile of the IER and indicate that the program will be actively administered and improved over time.
Second, DHS can make a concerted effort to market the program, highlight the IER specifically as an option for qualified candidates, compare the different pathways for legal residence for talented international students, and be sure to circulate such information with U.S. colleges and universities where many potential entrepreneurs will be studying.
With the IER being a relatively new program, it is likely to face additional implementation barriers that are difficult to anticipate beforehand. Accordingly, it will be important to create and maintain real-time feedback mechanisms that allow external stakeholders to flag unnecessary bureaucratic hurdles or improperly targeted eligibility criteria. One option for facilitating feedback would be to use an existing DHS council under the Federal Advisory Committee Act (FACA) to get real-time implementation suggestions from such stakeholders as immigration lawyers, venture capital firms, and international student groups—for example, the Homeland Security Academic Advisory Council (HSAAC). Questions regarding the optimal investment size minimum, the structure of qualified investment groups, and the process for U.S. border entry will be better addressed with the buy-in and input of the communities that are most impacted by them.
Guidance documents and operational improvements
Given the fairly wide scope for agency discretion in the administration of the IER, there are many ways of improving implementation simply by issuing new guidance documents and streamlining operations, among other subregulatory actions that do not require altering existing regulations.
As described above, past applicants to the IER program were approved by USCIS but granted entry by CBP for a shorter period of time than the full 30 months. This increases uncertainty for future applicants and makes it much more difficult for an entrepreneur to launch a startup and cultivate its success prior to the parole period ending. In addition, to obtain a renewal IER status, the startup must meet stringent requirements, and shortening the amount of time the entrepreneur has to satisfy those requirements adds a significant burden—dissuading future applicants and forcing entrepreneurs with innovative ideas out of the country prematurely. This could be mitigated by issuing internal guidance that directs USCIS and CBP to grant beneficiaries the full 30 months of parole, absent extraordinary circumstances.
In addition, one of the biggest pain points during the application process is proving that an entrepreneur’s investors are qualified. Often the information that is required is not publicly available or is proprietary. For Goss’ client, it took an entire year to gather the right information to satisfy the investor requirements. USCIS could simplify the process, making it clearer what documentation is necessary, and making it easier for investing organizations to provide information without compromising sensitive financial data in certain cases. In addition, once an investing organization has proven to USCIS that it is qualified, it should be allowed to refer back to its previous documentation for future IER approvals for a period of time (e.g. three years). This would encourage more U.S. investors to become willing participants in the IER program, since the bureaucratic hurdles would be viewed as more a one-time cost rather than a recurring issue.
An alternative approach to streamline the process of verifying qualified investor status would be to look to the “accredited investor” process adopted by the Securities and Exchange Commission (SEC) for private placements. Rather than have investors submit sensitive financial data to the SEC, the agency allows investors to submit a sworn affidavit that indicates the investor meets the standards for accreditation under penalty of perjury. This process is much simpler for investors and the SEC alike, and would surely save DHS both time and resources.
Lastly, DHS could issue further clarification on what would satisfy the “alternative evidence” standard for IER eligibility. If an entrepreneur does not have $250,000 in investor funds or $100,000 in government grants or awards, they can still qualify for IER parole if they can prove that their startup has “significant potential for rapid growth and job creation.” USCIS guidance in a Policy Memorandum could encourage adjudicators to place particular weight on evidence that the startup will:
Be headquartered and creating jobs in a rural area or region with high unemployment;
Commercialize new technologies in high-priority industries for the nation, such as cybersecurity, biotechnology, and artificial intelligence;
Tackle societal issues such as racial or economic disparities; or
Create not just a sufficient number of jobs to satisfy the minimum requirements of the IER, but also jobs that are sufficiently high-paying or high-quality as measured by salary or necessary skills.
Regulatory improvements
While guidance documents can be a useful near-term tool to improve the functioning of the IER and allow flexibility for the agency, ultimately the program will have more stability if long-term changes are established in regulation.
First, new rulemaking should be used to formalize guidance once the agency has worked out more definitive and objective standards around a more durable definition of “qualified investor” and evidentiary standards for “rapid growth and job creation.” Increasing stakeholder certainty in the long-term viability of the rule will be key to its uptake and success.
Second, new rulemaking should be used to help bridge the gap between the IER and existing immigration pathways for permanent residence. It would be a perverse outcome if successful entrepreneurs were forced out of the country after their parole term concluded. Policymakers should identify natural “bridge” statuses for individuals on the IER to graduate into, and make the operation of a growing U.S. business an explicit criterion for eligibility. For instance, the EB-2 green card overlaps well with the skill sets and purpose of the IER, as it is meant for a “foreign national who has exceptional ability.” Almost by definition, the successful launch of a growing U.S. business should demonstrate exceptional ability. Modifying the EB-2 and National Interest Waiver rules, as described in Table 1, to explicitly include entrepreneurship as a qualifying criterion will provide a natural on-ramp to permanent residence and the continued long-term operation of the entrepreneur’s business.
The role of Congress
Finally, it is important to note that while the IER is a promising tool for making the United States a welcoming home to international entrepreneurs in the immediate term, even with all the proposed changes above, it may not be sufficient. The uncertainty around long-term permanent resident status in the United States, which cannot be granted through parole alone, and uncertainty around future political changes to (or suspension of) the program could prevent the IER from being maximally effective. Over the longer term, Congress should pass more enduring startup visa legislation, expand the number of green cards available, and reform existing immigration pathways such that they would be more suitable for an international entrepreneur seeking to start a firm in the United States.
In fact, not one but two statutory pathways for entrepreneurs were already passed by the Senate in its bipartisan 2013 comprehensive immigration bill. Congress should consider reintroducing these pathways, updating them with the best parts of the IER while maintaining DHS’ flexibility. Such changes include:
Removing the 2013 bill’s requirement for applicants to submit a business plan, which DHS adjudicators are unlikely to have adequate time and expertise to review—unlike professional investors with “skin in the game”;
Allowing a simplified process to evaluate the qualifications of the startup’s investors, with deference to previous approvals;
Providing a more explicit way for adjudicators to account for the value of a startup being accepted into an exclusive accelerator program as evidence of its potential for rapid growth; and
Granting DHS the flexibility to adjust investment and revenue thresholds to account for changing industry standards.
In addition to these changes, Congress should make a point to gather stakeholder feedback on the details, particularly on the definition of a qualified investor, to ensure that no legitimate investors are barred from participating.
What is the potential impact of a fully implemented IER?
Baseline job creation estimate
We have developed a few baseline estimates as to the number of jobs that could be created through the IER by using a similar methodology as the one used by the Kauffman Foundation in their earlier paper estimating the job impacts of a statutory Startup Visa.
To begin with, we use the DHS estimate that the IER will attract 2,940 entrepreneurs per year with one founder for each firm. However, starting a business is difficult, and some percentage of firms will fail each year. Using the Business Employment Dynamics (BED) dataset from the U.S. Bureau of Labor Statistics, we can see the percentage of firms starting in 2010 that survived from year to year among the “Professional, scientific, and technical services,” category which we believe to be the closest analogue for the types of firms likely created under the IER.
Then, we can create an estimate for the total number of surviving entrepreneurs that remain in the country that entered through the IER and add the addition of a new entrepreneur class that joins each year.
Finally, we can apply a simple job creation rate under a number of scenarios. Under the most conservative scenario, we estimate the number of jobs created if surviving firms create only the required 5 jobs over a 30 month period to satisfy the terms of the program and be eligible for parole renewal. We then assume no further job growth while the firm survives.
In the second scenario, we estimate job growth under the assumption that each of these firms mirrors the average job creation rate of a U.S. firm its age so long as it survives. To estimate this we used the BED dataset and the average employment of firms at age 1, age 2, age 3, and so on starting in 2010.
Finally, we consider the scenario in which 50 percent of these firms are in STEM fields and have a corresponding higher rate of job growth. We use the estimate of Vivek Wadhwa from a prior Kauffman study, which found that the average immigrant technology or engineering startup in their sample from 2006 – 2012 had 21.37 employees. The other 50 percent of firms are assumed to mirror the average U.S. job creation rate for a firm that age. Fundamentally, this third scenario is trying to capture the idea that while the average US firm begins to slow down the rate of job creation after the first several years, the types of entrepreneurs and investors likely to make use of the IER are those disproportionately in the” high-growth young firm” category that will sustain fast rates of job growth overtime.
The table below shows these three scenarios applied to the projected entrepreneur population:
After 10 years, the IER could bring in more than 13,000 new businesses and create more than 300,000 jobs in the United States. While this projection is already promising, the IER has the potential to contribute even more to the economy.
Reasons for optimism
The above job creation projections are all based on the assumption by DHS that a fully implemented IER will attract 2,940 entrepreneurs per year—but there is good reason to expect a much higher level of uptake. Entrepreneurs, investors, and local communities are all responsive to potential opportunities, and if they perceive that the IER program is workable and stable for the immediate future, they are likely to adapt their own practices to better utilize this pathway.
➤ Venture capitalists
For instance, firms and individuals that have a proven track record of investing in international entrepreneurs through the IER may begin to specialize in such cases and seek out promising potential entrepreneurs from around the world and encourage them to apply for IER status in the first place. Today a few groups like Unshackled Ventures specialize in finding, investing in, and bringing international entrepreneurs to the United States through the limited immigration pathways that already exist. With a dedicated path to entry for international entrepreneurs, many more such firms would likely come to exist. Similarly, major venture capital groups with significant foreign investment may reorganize their structure to ensure that their U.S. investment arms are majority-owned and controlled by U.S. citizens and permanent residents, thereby satisfying the eligibility requirements for qualified investors under the IER.
➤ State and local governments
States and local governments frequently award competitive research grants on a wide range of R&D and business development topics, and would likely expand these efforts if they also entailed a legal path to residence for international entrepreneurs. Legislative proposals like the Economic Innovation Group’s “Heartland Visa”—largely endorsed by the Biden presidential campaign—would have Congress create a new immigration pathway to promote regional economic development through state- and city-sponsored visas. Essentially, a pilot version of this proposal could be pursued immediately through the IER as states and localities that award at least $100,000 to promising international entrepreneurs could thereby ensure the creation of a new startup in their region.
➤ International students
In addition, international students studying here would know ahead of time that a path exists for those starting a successful business, and could organize their studies and plans accordingly. This could end up having a very large impact, given the startling finding that foreign-born STEM PhDs are not currently founding or working for U.S. startups at the rate we would expect given their stated career interests.
Economists Michael Roacha and John Skrentny found that immigration barriers are a significant deterrent in these PhD graduates’ ability to realize their startup career interests, compelling them to either leave the country or work at larger U.S. firms where visa pathways are more well-established.
“Foreign PhDs are as likely as U.S. PhDs to apply to and receive offers for startup jobs, but conditional on receiving an offer, they are 56 percent less likely to work in a startup. This disparity is partially explained by differences in visa sponsorship between startups and established firms and not by foreign PhDs’ preferences for established firm jobs, risk tolerance, or preference for higher pay. Foreign PhDs who first work in an established firm and subsequently receive a green card are more likely to move to a startup than another established firm, suggesting that permanent residency facilitates startup employment. These findings suggest that U.S. visa policies may deter foreign PhDs from working in startups, thereby restricting startups’ access to a large segment of the STEM PhD workforce and impairing startups’ ability to contribute to innovation and economic growth.”
This is further evidence that America has a latent population of foreign-born entrepreneurial talent that could be effectively unlocked by creating better pathways for them to stay in the United States while launching or working for a startup.
In short, the prior estimate of IER leading to 100,000 – 300,000 jobs over 10 years, generated by fewer than 3,000 startups per year, is likely a lower bound. Consider that angel investors in the United States fund about 63,000 startups per year, most of them in STEM fields. Roughly one quarter of tech startups have at least one foreign-born founder, who was able to stay in the United States, thanks to an immigration pathway not designed for entrepreneurs.
With a permanent, predictable pathway for international entrepreneurs, it is reasonable to expect far more than 3,000 additional founders to choose the United States over other alternatives, leading to significant job creation in the aggregate. If we instead adjust the number of incoming immigrant entrepreneurs to 5,000, more than 500,000 jobs could be created over 10 years. And if 10,000 immigrant entrepreneurs came each year, more than a million jobs could be created over 10 years.
It is also worth remembering that today’s startup can become tomorrow’s industry-shaping giant. Among America’s first four trillion-dollar companies, one was co-founded by an immigrant (Google), two were founded by the children of immigrants (Amazon and Apple), and one is run by an immigrant (Microsoft). These four companies alone employ over 676,000 people in the United States.
The bigger picture
In addition to the direct job gains, adding more international entrepreneurs could help reverse the decades long decline in American economic dynamism. Fewer American firms are being started, fewer firms are exiting, and the resulting slowdown has coincided with a slowdown in productivity growth.
Stimulating the U.S. economy with more international entrepreneurs would very directly increase the number of firms started in the country, but increased competition could also force U.S. incumbents to become more nimble and adopt new technologies and products to survive and thrive.
As concern continues to build on both the right and the left that the United States may be losing its status as the world’s leader in science and technology, one of the easiest ways to solidify this lead would be to allow international entrepreneurs to build their companies in the United States rather than in competitor nations. For emerging technologies like artificial intelligence, drones, quantum computing, and biotechnology, this is especially important.
Conclusion
Countries all over the world are competing to attract the best talent to their shores. These efforts include developing an environment that supports the establishment and growth of promising startups. The United States, however, has no statutory immigration pathway designed for entrepreneurs. To address this unnecessary handicap, DHS established the International Entrepreneur Rule in 2017 to welcome foreign-born entrepreneurs with innovative ideas with high growth potential. Unfortunately, the IER was never fully implemented by an administration determined to eliminate it.
IER has survived, however, and now is the time to strengthen it. This paper provides a suite of recommended improvements to bolster the IER and ensure that the United States is better positioned to attract international entrepreneurs. Tens of thousands of entrepreneurs and subsequent economic growth are at stake. The IER is a valuable tool in the economic toolbox—not only for the federal government but for states and localities as well—which can attract entrepreneurs to settle throughout the United States. It should be fully implemented and reinforced. The United States has a renewed opportunity to solidify its reputation as the best place on Earth to start and grow a new company.
Donald Trump reportedly plans to defend himself in the Senate impeachment trial by rehashing his bogus “stolen election” claims. To debunk this noxious myth, the prosecution has a new witness it can call: Trump’s own pollster.
Tony Fabrizio oversaw polling for the former president’s 2020 campaign. He’s just issued an unsparing post-mortem on how Trump actually lost to Joe Biden. The story has nothing to do with fraudulent voting and everything to do with Trump’s compulsive mendacity and inept response to the coronavirus pandemic.
Based on an analysis of exit polls from 10 key battleground states, five that flipped to Biden, and five that held for Trump, Fabrizio found “massive swings against POTUS” among independent voters. “Racially, POTUS suffered his greatest erosion with White voters, particularly White Men in both state groups,” the report says.
In the five states that flipped to Biden (Pennsylvania, Wisconsin, Michigan, Arizona, and Georgia), Trump’s margin among white voters fell from 23 percent in 2016 to 15 percent in 2020, with white men defecting at a higher rate than women. Trump also lost ground with white voters in the five battleground states he won in 2016 (Florida, Iowa, North Carolina, Ohio and Texas), albeit by smaller margins.
Fabrizio’s findings shred Trump’s fantasies about being cheated out of victory by a Democratic-deep state-media conspiracy, especially his allegations of ballot-stuffing in big cities with many black voters. They spotlight the truth that would shatter Trump’s fragile ego if he tried to face it: He blew a winnable race by convincing many white voters that he couldn’t be trusted to tell them the truth and couldn’t competently manage the pandemic.
Ironically, this conclusion also could prove discomfiting to the progressive left. Many activists have convinced themselves Biden won the election thanks to a tsunami of minority turnout. However, Fabrizio’s analysis suggests that wasn’t the decisive factor in these 10 pivotal states. On the contrary, he notes that Trump made double-digit gains with Hispanics while slightly exceeding his 2016 performance with black voters.
In the states that flipped, Trump lost ground (-8 points) among voters over 65, while older voters in the other five states stayed with him. But the ex-president’s most dramatic losses came among college-educated whites, who shifted 14 points toward Biden in the states that flipped and 18 points in those Trump held. So what happened?
The short answer: coronavirus. Voters in all 10 states said combatting the pandemic was a higher priority than handling the economy. Those who picked Covid as their top issue favored Biden by 73–26 in the flipped states and nearly the same margin in the states Trump held.
Conversely, Trump’s strength was the economy, even though the election occurred amid the worst recession since the Depression. Voters gave Trump better marks for handling the economy, 51–47 in the flipped states and 54–43 in the states he held.
In a sign of how badly Trump misjudged the public temper on Covid, mask mandates won overwhelming support (3–1) from voters in all 10 states. And while Trump was in negative territory on handling Covid in all the states, the man he itched to fire — Dr. Anthony Fauci — “garnered nearly a 3–1 positive job approval on the handling of CV overall with Fauci detractors voting overwhelmingly for POTUS while Fauci supporters voted for Biden by wide margins, especially in “Flipped’ states,” according to the report.
After Covid, the issue of character seemed to weigh most on voters’ minds. Asked which candidates were “honest and trustworthy,” they chose Biden by a crushing 18-point margin in the flipped states, while Trump narrowly edged Biden out (52–48) in the five states he won twice. Conservative pundits who dismissed Trump’s constant and well-documented lying as inconsequential or “performative” missed the demoralizing effect it had on a significant chunk of the people they considered his “base.”
Finally, the Fabrizio report makes clear that Trump’s defeat was very much a personal one. It notes that in all 10 states the 2020 electorate was more Republican than in 2016. That’s why Republicans overperformed in Congressional and state contests even as Biden was trouncing Trump nationally by more than seven million votes. Trump probably helped boost Republican turnout, but there is cosmic justice in the fact that he was one of the few Republican candidates who didn’t benefit from it.
We don’t yet know whether Trump has read Fabrizio’s report. That’s another benefit of the ex-president’s exile from Twitter. But it’s another piece of damning evidence, from a source Republicans will find hard to dismiss, that Trump is lying about a stolen election simply to hide his shame over blowing his reelection.
President Biden met with 10 Republican senators on Monday to discuss their proposed $600 billion alternative to his $1.9 trillion American Rescue Plan. Both the White House and Sen. Susan Collins described the meeting as a productive exchange of ideas and the start of continued talks. But some Democrats believe these discussions are doomed from the start and want Biden to focus on passing his plan through reconciliation – a complicated process that allows budgetary legislation to pass with just 51 votes instead of the 60 required to bypass the filibuster on all other legislation. Although Democrats are right to move forward with reconciliation, there are several reasons why it makes sense for Biden to pursue the talks further and seek common ground beyond just a platonic ideal of “bipartisanship.”
Four Ways the Pharma Sector is Performing Well, Four Big Problems, and Three Straightforward Solutions
In this paper we summarize the state of today’s pharma sector with four ways it is performing well and four big problems.
Then we propose three key policy proposals that the Biden Administration can use to address the problems:
A cap on out-of-pocket costs, including co-pays, similar to legislation proposedin 2018, should dramatically improve Americans’ experiences with drug pricing.
A shift to point-of sales rebates should benefit consumers and align their incentives with actual net prices.
Building on the successful rapid creation and testing of the Covid vaccines, President Biden should convene a high- level “Biopharma Regulatory Improvement Commission” to accelerate pharma innovation and deployment in order to boost health and cut costs.
EXECUTIVE SUMMARY
The U.S. pharmaceutical industry is one of the nation’s crown economic jewels. It is also one of its knottiest policy problems. The pandemic performance of U.S. pharma companies, working in concert with global partners, has been nothing less than outstanding. Producing multiple safe and efficacious vaccines in less than a year is a testament to the expertise and capabilities of the industry.
On the other hand, Americans have a deeply held distrust of the pharma industry. A Gallup survey taken in summer 2020 still showed the pharmaceutical industry at the bottom of the American approval list, ahead of only the federal government. True, that’s a gain over the previous year, when it was literally rock bottom, but it still isn’t good.
In this paper, we identify four ways that the U.S. pharma sector is performing well, and four big problems (Summary Table 1). Some of them are surprising, in a positive sense. For example, despite all of the headlines about cost pressures, overall spending on pharmaceuticals has been slowly dropping as a share of GDP. Pharma manufacturers revenues, net of discounts and rebates, fell from 1.75 percent of GDP in 2010 to 1.66 percent in 2019 (based on IQVIA Institute data). Also surprisingly, household out-of-pocket expenses for prescription drugs, including Part D premiums, fell from 0.36 percent of GDP in 2010 to 0.32 percent in 2019 (based on national health expenditures data from the Centers for Medicare and Medicaid).
On the negative side, a small portion of Americans have huge out-of-pocket prescription drug bills. In 2018, roughly 1 percent of Americans paid more than $2,000 in out-of- pocket drug expenses, not including Part D premiums (based on our analysis of Medical Panel Expenditure Survey data).
Equally worrisome, most Americans face sharply rising out-of-pocket drug costs as they age. This “prescription escalator”—the result of a steep age-usage curve and per-prescription copays— has the effect of increasing individual spending by 5-6 percent per year, even if underlying drug prices are flat.
How can President Joe Biden address these problems, while taking advantage of the good features of the U.S. system? To address the political and human toll of the current system of pharma insurance, Biden should support legislation to cap out-of-pocket drug payments. That’s the best way to control the low but real possibility of huge out-of-pocket payments. It’s also the best way to get a handle on the “prescription escalator”—the sharp rise in out-of- pocket payments as Americans age.
Second, Biden should preserve the recently finalized Medicare Part D Rebate Rule that replaces drug rebates with point-of-sale consumer discounts. Discounts paid directly to consumers at the point of sale, rather than rebates paid retrospectively to insurers or pharmacy benefit managers, would significantly lower out-of-pocket costs, clarify the true cost of prescription medications, and allow consumers and physicians to make better cost-benefit trade-offs. The would also be a good launching pad towards the introduction of new legislation to enact similar changes in the commercial market. Together, these changes would fix the opaque rebate system and could create the conditions for list prices to come down.
Third, Biden should take a page from the successful Covid vaccine effort. U.S. businesses and government agencies have spent almost $2 trillion since 1995 on biotech and other health-related R&D, and this knowledge was mobilized quickly to generate new vaccines and therapies. Still, in the normal course of business it would have taken years rather than months to bring the new technology to bear. What’s needed is a high-level “Biopharma Regulatory Improvement Commission” to identify the regulatory and financial impediments to faster useful biopharma innovation, without sacrificing safety at all.
INTRODUCTION
The U.S. pharmaceutical industry is one of the nation’s crown economic jewels. It is also one of knottiest policy problems faced by Washington. The pandemic performance of US. pharma companies, working in concert with global partners, has been nothing less than outstanding. The production of multiple safe and efficacious vaccines in less than a year is a testament to the expertise and capabilities of the industry.
On the other hand, Americans have a deeply held distrust of the pharma industry. A Gallup survey taken in summer 2020 still showed the pharmaceutical industry at the bottom of the American approval list, ahead of only the federal government. True, that’s a gain over the previous year, when it was literally rock bottom, but it still isn’t good.
President Joe Biden comes into office with a comprehensive plan for dealing with what he calls “runaway” drug prices, including establishing an independent review board to assess the value of new drugs, and limiting list price increases for all brand, biotech, and “abusively priced” generic drugs to the rate of inflation.
But Biden’s plan may be aiming at the wrong targets. The two best aggregate measures of the economic burden of pharma spending— overall net spending on pharmaceuticals as a share of GDP and household out-of-pocket drug spending, including Part D premiums, as a share of GDP—have been trending down, not up.
Proposals to restrain list prices are not likely to accelerate these aggregate declines. List prices are important, but because of rebates and discounts they do not directly correlate payments to manufacturers or with out-of-pocket spending by households.
While proposals to restrain list prices may be helpful for patients lacking insurance, and among those in plans with high deductibles and coinsurance, list prices do not typically reflect the price that most patients pay out of pocket due to the impact of rebates and discounts on plan benefit designs.
True, an increasing share of prescriptions are reimbursed by means of co-insurance, which apparently sets the out-of-pocket cost for a drug as a fixed percentage of the list price for that drug. But even then, remember that insurance companies control that apparently fixed percentage and can easily raise it any time they want. As a result, lowering the list price of a drug might or might not decrease the out-of-pocket cost, depending on how the insurance company adjusts the cost-sharing arrangements.
The real problem lies in the way the drug reimbursement system has evolved over the years, exposing Americans to co-pays that seemingly shift randomly from year to year, a small portion of Americans have huge out- of-pocket prescription drug bills, which is bad enough. Most Americans face sharply rising out-of-pocket drug costs as they age (“the prescription escalator”). In some ways the drip- drip of drug co-pays is a form of psychological torture.
To address the political and human toll of the current drug reimbursement system, Biden must support legislation to cap out-of-pocket drug payments. One model is the Capping Prescription Costs Act of 2018, introduced
by Sens. Elizabeth Warren (D-Mass.) and Ron Wyden (D-Ore.) which set caps for prescription drug copays at $250 per month for individuals and $500 per month for families. That’s the best way to control the low but real possibility of huge out-of-pocket payments. It’s also the best way to get a handle on the “prescription escalator”— the sharp rise in out-of-pocket payments as Americans age.
Equally important, Biden should support the implementation of the Medicare Part D rebate safe harbor final rule and propose follow-on legislation that would encourage point-of-sale discounts in the commercial market as well. These discounts would finally reach consumers directly (instead of insurers or pharmacy benefit managers). From an economic perspective, this approach has several virtues. It can lead to a substantial reduction in out-of-pocket costs at the point of sale, clarify the true cost of prescription medications, allow consumers and physicians to make better cost-benefit trade- offs. Importantly, it would ensure that patient coinsurance is based off of net prices (vs list prices), which is far easier for everyone to understand.
Finally, Biden should learn a lesson from the successful Covid vaccine effort. The mRNA vaccines from Pfizer and Moderna show
that with the right motivations, advanced biotechnology that might have otherwise languished on the shelf can innovate and createbeneficial medicines.
What we need now is a focused effort to get most useful drug innovations out of the almost $2 trillion that businesses and government agencies have spent in the U.S. on health- related R&D since 1995. With the successful Covid vaccine effort as a role model, what’s needed is a high-level “Biopharma Regulatory Improvement Commission” to identify the regulatory and financial impediments to useful innovation.
THE FACTS: HOW THE PHARMA SECTOR IS PERFORMING WELL
Before addressing policy changes, we must understand what’s working and what isn’t about the sprawling system of drug innovation, spending, and reimbursement. The common belief is that drug spending is out of control. But a reality-based analysis, based on solid statistics, paints a very different picture.
Let’s briefly go through each of these:
» Positive Fact #1:
Overall net spending on pharmaceuticals has been slowly dropping as a share of gross domestic product (GDP).
Net spending on pharmaceuticals is defined as the net amount that drug manufacturers receive for their products, after accounting for rebates and other price concessions. The difference between drug spending calculated with list prices vs net prices is huge and growing. In 2019, for example, the IQVIA Institute estimated that the net revenue received by manufacturers of $356 billion was 47 percent below drug spending valued at list prices, $671 billion. By comparison, this gap between net revenues and spending valued at list prices was only about 37 percent in 2014 and 34 percent in 2010.
Net revenues as a share of gross domestic product (GDP) are a good measure of the burden of pharmaceutical spending on the overall economy, representing the amount paid to manufacturers. Since 2010, net manufacturer revenue has increased by 36 percent, compared to a 48 percent increase in overall gross domestic product. As a result, net manufacturer revenue as a share of GDP fell from 1.75 percent of GDP in 2010 to 1.66 percent in 2019.
What this information tells us is that the overall burden of drug spending on the economy— consumers, private companies, government, hospitals, insurance companies, wholesalers, pharmacy benefit managers—has been falling slightly. But analyzing the impact on any particular market participant is very difficult, because the discounts and rebates are so opaque.
» Positive Fact #2:
The combination of Medicare Part D and the Affordable Care Act (ACA) has slightly reduced household out-of-pocket (OOP) expenses for prescription drugs as a share of GDP.
You wouldn’t know it from all the Congressional hearings that feature Americans having trouble paying for drugs. But on average, the drug cost burden on households has been falling over time, measured as a share of household income or GDP. That’s true, even if we include Medicare Part D premiums when calculating out-of-pocket spending, since from the perspective of Part D participants their premiums also come out of their pockets.
Based on the latest CMS data, released in December 2019, household out-of-pocket expenses for prescription drugs, including Part D premiums, fell from 0.36 percent of GDP in 2010 to 0.32 percent in 2019. Other data sources, such as the Consumer Expenditure Survey from the Bureau of Labor Statistics, show roughly the same pattern.
These figures measure the average burden on households. As we will see later, there are outliers who have to pay much more. But at least the aggregate data is positive.
» Positive Fact #3:
Pharma industry spending on R&D has slightly risen as a share of GDP.
One of the great paradoxes of the U.S. health care system is the poor perception many Americans have of the pharmaceutical industry. Nevertheless, pharma companies have been taking on more of the financial burden and risk-taking associated with drug research and development over the past decade, even while public sector funding has stagnated. Since 2010, federal and state spending on health-related R&D, mostly through NIH, has only risen by 7 percent, from $35.2 billion in 2010 to $37.6 billion in 2019.
The pharma industry spending on R&D items such as pre-clinical drug development and clinical trials has skyrocketed, from $57.3 billion in 2010 to $89.8 billion in 2019, according to figures from the Bureau of Economic Analysis (BEA). This corresponds to an increase of 57 percent, faster than the 48 percent gain in GDP over the same period. As a result, pharma industry spending on R&D rose from 0.38 percent of GDP in 2010 to 0.42 percent in 2019 (based on BEA data).
» Positive Fact #4:
The U.S. pharma industry was able to develop safe and efficacious vaccines within a year
Using a variety of different approaches, pharma firms in the United States and around the world were able to create safe and effective vaccines in less than a year. First out of the gate were Pfizer and Moderna with their mRNA-based vaccine technologies, never before successfully used for a vaccine. However, other vaccines using more familiar technologies are not far behind.
But the big advantage of mRNA vaccine technology is that it can be quickly adjusted to new variants of Covid. Moreover, now that the technology has been shown to be effective, it has the potential to quickly create vaccines against other viral scourges, such as influenza and HIV. So the silver lining from the Covid cloud is that it may have opened up new avenues for dealing with disease.
WHERE THE PROBLEMS ARE
We certainly don’t want to leave the impression that the pharma sector and pharma pricing are free of blame. An honest approach also tells us where four big problems are, as shown in Table 2.
» Negative Fact #1:
A small portion of Americans have huge out-of-pocket prescription drug bills.
One staple of the drug price debate are congressional hearings that highlight heartbreaking stories of people who can’t afford to pay for their medicines. Are these people reflective of a broader problem?
The answer is yes and no. In fact, our analysis of 2018 MEPS data suggests that over 3 million Americans paid more than $2000 in out-of- pocket drug expenses in 2018, not including Part D premiums. That’s about 1 percent of the population, but it’s still an unacceptably high number that need to be addressed by policymakers.
Consider the high cost of insulin, a product with huge rebates. Indeed, rebates for insulin products often reach as much as 70 percent of the list price, so the net price after rebates is much lower than the list price. However, those rebates are typically paid to the health insurance company or the prescription benefit managers (PBM), rather than to the consumer.
As a result, patient coinsurance is often based on the list price, while high manufacturer rebates are collected by insurers. At the same time, benefit designs that place even higher out-of-pocket burdens on patients continue to grow, exacerbating affordability challenges for patients.
» Negative Fact #2:
Most Americans face sharply rising out-of- pocket drug costs as they age.
In addition to the small but significant fraction of the population with high out-of-pocket costs, the widespread anger of Americans at drug companies is fueled by what we call the “prescription escalator.”
It turns out that the use of medicines can rise steeply as people age. For example, in 2018, individuals between the ages of 35 and 44 filled an average of 7.2 prescriptions, including refills, compared to an average of 12.2 prescriptions for those between the ages of 45 and 54 and 18.1 prescriptions for those between the ages of 55 and 64. This 150 percent increase in the number of prescriptions as people age corresponds to an equivalent rise in prescription drug spending, since the structure of health insurance generally charges co-pays for each prescription. This “prescription escalator”—the result of a steep age-usage curve and per-prescription copays—has the effect of increasing the typical individual’s spending by 5-6 percent per year, even if underlying drug prices are flat.
Indeed, even if underlying drug prices are flat, most Americans see their drug spending rise year after year much faster than other types of medical spending. As a result, the share of out- of-pocket spending going to drugs increases as Americans age, making it seem like drug costs are more of a burden.
» Negative Fact #3:
The complicated and opaque system of rebates and discounts means that costs to patients and providers are only tenuously connected to list prices.
We have decent measures of how much consumers pay for drugs through various surveys. We also have good measures of how much pharma manufacturers receive in net revenues, because that number is reported on financial statements. But the flows of money back and forth through PBMs, insurance companies, and hospitals are much more opaque. The rebates and discounts are not simply a percentage of the price. Sometimes they are tied to volume, sometimes to the efficaciousness of the drug, and sometimes they are mandated by law. Much of the time, they are not public.
However, it’s clear that list prices bear only the slightest resemblance to the actual net costs. On an aggregate level, between 2014 and 2019 spending at list prices rose at an annual rate of 7.1 percent, far faster than GDP growth. Meanwhile, actual net outlays by payers only rose at a 4.1 percent annual rate, equal to the rate of GDP growth (based on data from the IQVIA Institute).
The lack of connection between list and net prices makes it very hard for consumers, doctors and policymakers to understand the true cost of drugs.
» Negative Fact #4:
Misaligned regulatory and financial incentives may be holding back pharmaceutical innovation.
Before the Covid pandemic, there was a sense among economists that the enormous spending on biopharma basic and applied research had underperformed. The promise of biotech had been cheaper, faster drug development and a raft of new cures. Instead, the cost of drug development had soared, and only 14 percent of drugs that enter clinical trials get approved.
There are three leading hypotheses, all of which may have some degree of truth:
The intricacies of medicine and the human body are more complicated than first thought.
The desire for profits could be diverting biopharma firms from truly important drug development.
Excessive or misdirected regulation could be raising drug development costs and slowing down biotech innovation.
Facing pressure from the pandemic, regulators and manufacturers were able to work together to greatly accelerate the pace of Covid-19 vaccine development, innovating to bring new technologies into the market without compromising drug safety and efficacy testing. Companies developed vaccines and tested them, even while building manufacturing facilities. The government issued fixed-price contracts for millions of doses to transfer risk to Washington, which could bear it.
As everyone knows, the process produced several successful vaccines. This implies that the full capabilities of private and public R&D are not being utilized in the current regulatory and financial structure.
IMPLICATIONS FOR POLICY
Americans deal with a very complicated reimbursement scheme for drugs, where the list price has very little connection with either the net price that manufacturers receive, or the out-of-pocket expenses paid by patients. Some out-of-pocket costs are set as a percentage of the list price in terms of co-insurance, but that’s variable as well, since the insurance companies can adjust the co-insurance percentage when they set up their plans each year.
To meaningfully improve prescription drug affordability, President Biden should pursue reform of plan benefit designs that directly reduces out-of-pocket costs for consumer. Capping out-of-pocket costs, for example, is both relatively simple and delivers significant political bang for the buck.
One particular model is the Capping Prescription Costs Act of 2018, introduced by Sens. Elizabeth Warren (D-Mass.) and Ron Wyden (D-Ore.) which set caps for prescription drug copays at $250 per month for individuals and $500 per month for families. That’s the best way to control the low but real possibility of huge out-of-pocket payments. It’s also the best way to get a handle on the “prescription escalator”—the sharp rise in out-of-pocket payments as Americans age.
How expensive would this or a similar program be? Suppose our target was to hold annual out-of-pocket costs down to $2000 per year for individuals. Based on our analysis of 2018 MEPS data, that cap would cost $2.4 billion annually for people 65 and over, less than 3 percent of total expenditures by Medicare Part D, the prescription drug benefit program, net of rebates.
As a complementary effort, President Biden should preserve the recently finalized Medicare Part D Rebate Rule that replaces drug rebates with point of sale consumer discounts. Such discounts would be paid directly to consumers rather than to insurers or pharmacy benefit managers. Such a program would have several effects. First of all, the rebates on expensive drugs would actually benefit the patients taking those drugs. That’s what Americans really want.
Point-of-sale consumer discounts would also clarify the true cost of prescription medications and allows consumers and physicians to make better cost-benefit trade-offs. And it would largely address the problems associated with the disconnect between list and net prices. An opaque system does not foster good decision- making. Finally, the Medicare Part D Rebate Rule could also serve as a launching pad towards similar legislation in the commercial market.
Finally, Biden should help regulators and companies learn the right lesson from the successful Covid vaccine effort. The biopharma sector had an enormous stockpile of knowledge and manufacturing know-how that mobilized quickly to generate new vaccines and therapies. The government supported the effort with funding and fixed-price contracts to buy hundreds of millions of doses of the still-yet unproven vaccines. While there are issues with distribution, the development and production worked as well as could be expected.
Still, under the usual regulatory framework and business decision-making it would have taken years rather than months to bring the new technology to bear. The FDA has its usual step-by-step procedures which tend to discourage disruptive but potentially beneficial innovations. Pharmaceutical manufacturers, which invest huge amounts in R&D, are naturally attuned to the regulators and the need to focus on drugs that will get through the approval process.
Biden should appoint a high-level “Biopharma Regulatory Improvement Commission” to identify the regulatory and financial impediments to faster useful biopharma innovation. PPI has in the past proposed a new approach to improve regulations without sacrificing consumer and worker protection. Such legislation has been introduced several times in Congress.
What Biden needs now, though, is a commission that is narrowly focused on finding a way to accelerate biopharma innovation, without sacrificing an ounce of safety. At the end of the day, the best way to reduce the cost of medications may be to improve the ease of innovation.
For those concerned about nicotine addiction and tobacco consumption, a ban on flavored tobacco might sound like a good idea. But as Nkechi Taifa explains in this week’s PPI Podcast, such bans are going to almost entirely fall onto minority communities.
Several states are considering or have already banned flavored tobacco. Nkechi Taifa agrees with Crystal Swann that in time a time when we are rolling back the war on drugs in favor of a public health approach, we should be doing the same with tobacco.
For those concerned about nicotine addiction and tobacco consumption, a ban on flavored tobacco might sound like a good idea. But as Nkechi Taifa explains in this week’s PPI Podcast, such bans are going to almost entirely fall onto minority communities.
Several states are considering or have already banned flavored tobacco. Nkechi Taifa agrees with Crystal Swann that in time a time when we are rolling back the war on drugs in favor of a public health approach, we should be doing the same with tobacco.
It’s been less than a week since President Biden took office, but Washington’s tribal gladiators already are arming for mortal combat. Fortunately, pragmatic Democratic lawmakers are working to help Biden avert a relapse into political paralysis.
Senate Republicans are bewailing Biden’s $1.9 trillion American Rescue Plan to end the pandemic and help jobless workers and small businesses tread water until it’s over. Though few complained when his predecessor broke the trillion-dollar deficit barrier – despite a then surging economy – Republicans now profess to be shocked by the “colossal waste” (Sen. Pat Toomey) of Biden’s “massive spending” package (Sen. Rick Scott).
Such hypocrisy is galling, and it has tripped the progressive left’s hair-trigger outrage alarm. Activists who didn’t support him in the first place fret that Biden is too eager to compromise in the name of the national “unity” he movingly invoked during his inauguration. They insist he waste no time in pressuring Senate leadership to kill the filibuster so Democrats can steamroll Republicans, at least for the next two years.
Everyone should take a deep breath. President Biden is anything but a political naif. Having been on the receiving end of Sen. Mitch McConnell’s deeply unpatriotic strategy of total obstruction for eight years, he doesn’t need lectures from sectarians in his own party about how rabidly partisan the other side can be.
But Biden understands he was elected to save our democracy from an unhinged demagogue, not to join Republicans in fomenting intractable enmity between red and blue America. He also knows from bitter experience that one-party rule is inherently unstable and fuels political paranoia and extremism.
WASHINGTON, D.C. — A new brief released today from the Progressive Policy Institute (PPI) commends President Biden’s bold vision to ease student debt burdens. The brief calls on the Administration to help borrowers in more meaningful ways by fixing America’s broken financing model for higher education, and investing in non-college pathways to good jobs.
Key highlights from the brief:
More than 1/5 households hold a student loan, up from 1/10 in 1989.
Millennials, who are already saddled with lower wages and lingering economic pains from the Great Recession, hold $497.6 billion in outstanding loans.
Education debt is a generational/equity crisis. Borrowers are more likely to be lower-income, Black, and less likely to have generational wealth, making them more likely to default, which can lead to further worsening of poverty and the racial wealth gap.
Biden has faced calls to cancel $50,000 in education debt for borrowers but the evidence suggests that this could be regressive and benefit many high-income households who don’t need relief.
Education debt relief should not be a one-time fix. President Biden and Congress need to meaningfully address America’s broken financing model for higher education and invest in non-college pathways to good jobs.
The policy brief calls for the Biden Administration to take important key steps, including:
Auto-enrollment in income-based repayment as opt-out for new and existing loans.
Modernize the Public Service Loan Forgiveness Program to reward national or community service for our public servants and create incentives for public service.
Accelerate attainment of credentials by making the process for earning college credit through Advanced Placement (AP), International Baccalaureate (IB) programs, and college courses taken in high school at community colleges, more transparent and accessible.
Veronica Goodman, PPI’s Director of Social Policy and author of the brief, said this:
“President Biden and Congressional Democrats have a rare opportunity to move fixing America’s broken higher education financing model to the center of the nation’s agenda.
They should follow targeted education debt relief with bold progressive reforms aimed at two critical national goals: Lowering college costs and thereby reduce the need for borrowing, and boosting public investment in the skills and career prospects of the majority of young Americans who do not get college degrees.”