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Demystifying the HHS Waiver Process


The ‘J’ exchange visitor program permits researchers, scholars, professors, medical trainees, and others to come to the United States to participate in a sponsored program. According to the U.S. Department of State, the J-1 program is designed to promote the interchange of persons, knowledge, and skills in the fields of education, arts, and sciences.[1] Since the purpose is the exchange of information, knowledge, and skills, many exchange visitors are required to return to their home country at the completion of their program, to share their newly acquired information, knowledge, or skills.[2] Yet in many instances, those with a two-year home requirement are reluctant to return and if it can be established that their continuing presence is in the interest of a U.S. government agency, they may not have to.

There are only a handful of U.S. Interested Government Agencies (IGA) that have a formal application process to initiate a waiver recommendation. These include, inter alia, the National Science Foundation,[3] the Department of Defense,[4] the Department of Energy,[5] and the Department of Health and Human Services.[6] Waivers submitted to these IGAs are given technical review by relevant experts in the field. Therefore, such applications require a sophisticated level of scientific and technical information demonstrating why the exchange visitor’s (EV) continued presence in the United States is in the interest of that IGA. As a result, it is often difficult for advocates or institutions, who are not necessarily scientific experts, to advise on these petitions or provide effective guidance and assistance.

The purpose of this article is to evaluate the IGA waiver process via a review of the Department of Health and Human Services (HHS) Exchange Visitor Waiver Review Board’s (the Board) procedure.  The hope is that this evaluation will afford insight and concrete suggestions that can be incorporated into an effective practice.

One of the most important points to keep in mind in when advising on, or preparing, an HHS waiver application is that it is neither an O-1 nor an immigrant visa petition. Eligibility for the O-1 or similar types of immigration petitions (i.e., outstanding researcher, national interest waiver, alien of extraordinary ability) do not necessarily translate into a successful HHS waiver. This is because the O-1 visa petition and the HHS waiver application have a completely different set of standards and are reviewed by very different audiences. Support letters from the O-1 petition should not be included with the HHS application, nor should the plethora of supporting documentation used to corroborate the O-1 eligibility criteria. In stark contrast to U.S. Citizenship and Immigration Services (USCIS) adjudications, HHS accepts as true the accomplishments included in the applicant’s curriculum vitae (CV). Therefore, separate documentation for each and every point raised is neither necessary nor sought by HHS in its review of the waiver application. In fact, ‘less is more’ would be a more apt approach.

If ‘less is more,’ how does the ‘less’ become ‘more’? Basically, by understanding and focusing on the key issues that HHS relies on in making a waiver recommendation. HHS’ “Supplement A”[7] provides the research waiver request requirements, outlining the principal points that should be addressed in the application. In submitting a waiver request application, each of these points should be enumerated and addressed by the research institution as they are listed on Supplement A and signed by the Principal Program Officer.[8]

The following guidance in addressing Supplement A was initially based on suggestions made by HHS’ prior Executive Secretary[9] and was updated based on author’s own experience and discussions with the current Executive Secretary[10]:

  1. Complete Description of Program/Activity Including How It Serves the National Interest

This should be a concise, scientific description of the research program in which the EV is involved. The emphasis is on science and succinct. HHS does not need a detailed description of the institution itself, or platitudes regarding the institution’s standing in the field. Moreover, it is not necessary to assert how important this research is to the National Institutes of Health (NIH), as the application is adjudicated by NIH/HHS, and it will make its own determination of the importance to the relevant agency. However, if the program is supported by a NIH grant, the grant name and number should be included.

  1. Exchange Visitor’s Essentiality to the Program and Unique Capabilities

 The section on essentiality is one of the most misunderstood of HHS’ criteria. This section should not be a detailed description of the applicant’s background and accomplishments that made them ‘essential’ to the program. Rather, HHS wants to understand why the EV needs to continue to be in the U.S.  The focus should thus be on the EV’s day-to-day role in the program, his or her specific job duties relevant to the research program itself. HHS is only interested in the EV’s scientific role in the program, not in any teaching, training, or clinical responsibilities. In discussing EV’s responsibilities, it is helpful to highlight unique or rare technical expertise, combination of disciplines essential to performing the research, or role in the design and initial execution of the program.  If such expertise is essential to the research, even a recent graduate or post-doctoral fellow may be an appropriate waiver candidate. It is also important to include information on grant funding awarded to the EV either individually or as the principal investigator (PI) of a project.

  1. Information Regarding Current Personnel

The application should address this point to reinforce the EV’s essentiality to the program; namely, is there anyone else already within the program who can take over applicant’s role and responsibilities.  If so, applicant is not “essential” to the research.  As such, it is often helpful to briefly explain what distinguishes the EV from the others involved in the program, and the extent to which they rely on the EV’s skills and expertise for their own part in the program.  It is not about the distinguished reputations of these people, but rather how their skill sets interact with, or complement, that of the EV, such that EV is essential to the program not only for her own responsibilities, but also in terms of supporting others.

  1. Recruitment Efforts

As with the “current personnel,” the purpose of the recruitment requirement is to demonstrate that there is no one available who can step in and fill the EV’s shoes.  The ads should therefore address the skill set necessary to perform EV’s responsibilities at the applicant’s level.  This is, after all, about essentiality to a nationally important research program and should not be confused with “minimum requirements.”

HHS requires at least two different forms of recruitment placed within 18 months prior to filing, and at least one form of recruitment should be in a national journal (website of affiliated with a national journal is acceptable). The national journal ad must contain a salary range at fair market value.  The other form of recruitment can also be a journal ad, or it can be placed on Indeed, on the employer’s website, or even a listserve relevant to the field. The summary of recruitment efforts should be kept brief and simple: (a) where and when the ads were placed; and (b) any responses from qualified applicants. Keep in mind that if there were qualified applicants, and they are interested in the job, there may be no waiver application…

  1. Future of Program if Waiver not Granted

If, in fact, the EV is essential to the program, there are going to be repercussions if the waiver is not granted, and the EV is required to fulfill the two-year home residency requirement. One way to document such consequences is to note delays in the research prior to the EV joining the program, or anticipated delays if the EV were no longer available to contribute. Another critical element would be any program funding belonging to EV that would be lost if EV had to leave, potential funding that EV is currently precluded from obtaining because of immigration status, or program funding dependent on EV’s skill, regardless of whether he or she is listed in the actual grant.

  1. Long Range Plans for Exchange Visitor

This section is simply to demonstrate that the employer has a vested interest in the EV.  It does not have to be a detailed discussion, but more simply, noting whether applicant will be considered for a promotion, either tenure-track or advanced research track, or if the institution providing support for the applicant to become a self-funded researcher.  Two to three sentences at most should be sufficient.

As opposed to the first six points on the supplemental sheet, the seventh point is not one that needs to be addressed by the employer support letter. The seventh point requests “Information Concerning the Exchange Visitor’s Qualifications, Including Evidence of Special Accomplishments and External Letters of Recommendation.” These external support letters should come from experts outside the sponsoring institution. The text of these letters should address the EV’s history of excellence in the context of the research program, as well as other research accomplishments for which the EV received recognition.

When advising on the number and type of external support letters, do not include letters that basically reiterate the same point, and do not use the letters from the O-1, particularly if they are still addressed to ‘USCIS.’ Since this is a peer review process, letters should be written from one scientist to another, and should not include platitudes or superlatives in their description. While it is important to use letters from recognized experts in the relevant field, Supplement A specifically requests that only the applicant’s CV be included. One would hope that HHS is already familiar with the letter writer’s reputation and accomplishments. If HHS is not familiar with the letter writer’s reputation, the letter itself may not be given the same level of consideration as a letter from a more established expert.

In addition to the institutional support letter and the external letters of recommendation, Supplement A also requires the EV’s curriculum vitae, bibliography, copies of abstracts from most recent relevant publications, copies of all Forms IAP-66 and/or DS-2019, and current visa status materials. Supplement A specifically notes “Please do not include copies of any presentations.”  As noted above, less is more in an HHS waiver application, and lots of paper does not make a stronger application, quite the opposite.

As with most immigration filings, the appropriate form with the appropriate authorized signatures must also be included. For the HHS waiver, it is HHS Form 426. HHS Form 426 requires two signatures: (1) the principal program officer, defined as the individual who can answer substantive questions regarding the research; and (2) the administrative officer authorized to sign on behalf of the institution, not just the department where the research is being conducted. This is to ensure that the institution itself, and not just the applicant’s department, supports the waiver application.   If outside counsel is representing the institution in the submission, a G-28 should also be included.

The forms, support letters, and other documentation should be compiled and submitted in the following suggested order:

  1. Duly executed HHS Application Form 426 and G-28
  2. DOS Third Party Bar Code and DS-3035
  3. EV’s CV and degrees
  4. EV’s immigration documents (IAP-66s, DS-2019s, I-94, I-797s)
  5. EV’s publications (first page of a few recent and relevant articles)
  6. Employer’s support letter
  7. Recruitment efforts (copy of ad)
  8. External letters of support

The hard copy materials are submitted with an identical scanned copy on a CD to HHS.  For this reason, my office keeps a steady supply of CDs.

In noting what should be included with the application, also note what should not be included, as including it would only impede the waiver review process. This includes the CV of anyone other than the EV, background information about the sponsoring institution or the importance of the research program (HHS will make its own determination of the importance of the program), full copies of grants (simply provide the grant name and number), EV’s honors and awards, applicant’s older publications (HHS suggests submitting only those from the last two years or those that are considered ‘important,’ but generally no more than 7 to 10 publications, and only the first page of each), citations to his or her work, requests for reprints, or anything else included in EV’s CV. As noted above, HHS will review the EV’s CV and trust that it is accurate. Moreover, the cover letter from counsel should simply be a list of what is included, not a summary of the evidence nor a treatise on why a favorable recommendation of the waiver is warranted.

Applications received by HHS are first administratively reviewed by the Waiver Review Board’s Executive Secretary to ensure that the requisite information is included. If the application is missing basic documentation (e.g., institutional support letter, HHS form, recruitment, appropriate signatures), the administrative official of the sponsoring institution or the attorney of record will be contacted and given the opportunity to supply the necessary documents. Once it is determined that the application is complete, a ‘receipt’ letter is sent either to the institution or to the attorney of record. It is at that point that the scientific review, and at present the lengthy wait, commences.

The scientific review is performed by both technical experts and scientist emeritus who may be located anywhere in the U.S.  A copy of both the paper file and the CD travels from one reviewer to another, as such, once the formal review process has begun, no additional information can be added to the file. The need for the file to travel is one of the causes of the delays experienced in the adjudication of the waiver. Another cause of delay is that nearly everyone involved in the review process is a full-time scientist, and their role in the review process is a service they perform on a volunteer basis, in addition to their already busy schedules.

The first part of the scientific review is a ‘Technical Review.’ The technical review is not done by members of the Board; rather the technical review is done by experts within the appropriate HHS institute with the greatest interest in the research program. If there is an NIH grant supporting the research, the technical review will be done by the grant source. The technical review does not evaluate the application to ensure compliance with the waiver requirements, but rather to render an opinion as to the scientific value of the program and the applicant’s essentiality to the program. The technical reviewers do supply an opinion as to whether the waiver should be recommended. Since this opinion is generally based solely on the scientific merit of the program, and not on the HHS waiver policy, it is used only as a guide for the Board.

The comments from the Technical Review are returned to the Waiver Review Board’s Executive Secretary, who then selects members of the Board to review the application. There is no prescribed number of Board members, but the aim is to have twelve (12). [11]  Ultimately, the application will be reviewed by two Board members, with the application going to one Board member, back to the Executive Secretary, and then to the second Board member. While the Board members are scientists, they are not required to be experts in the relevant field.

The role of the Board is to apply the policy and goals of the HHS waiver program as articulated in its regulations. This basically requires weighing the technical evidence against the regulatory criteria; the importance of the program itself and the absolute essentiality of the EV to the continuation of the program, in contrast to policy considerations of enforcing the two-year home residency requirement. The Board considers factors such as the EV’s salary, publication record, technical or multi-disciplinary expertise, and potential (i.e., if EV is on track to become a stand-alone researcher).

The Board does not actually meet. The two Board members provide written comments on the merits of the application. If they agree, their decision is followed. If they disagree, the Executive Secretary may make a recommendation to the Board President,[12] who may act as the tiebreaker. In this regard, the Executive Secretary may request additional information from the applicant institution, check the specific grant to verify the EV’s time commitment, check if the EV’s work is discussed in the grant’s annual report, or decide that a favorable recommendation is not warranted. If an application is not recommended for a waiver, the sponsoring institution is sent a letter outlining the deficiencies of the application.  While there is no appeal process, institutions may provide documentation to address the deficiencies and if satisfactory, the EV may be recommended for the waiver.

According to the Executive Secretary, HHS receives an average of 34 research waivers per year,[13] recommending approximately 95% of waivers.  For those that are not initially recommended but are subsequently able to address the deficiencies, approximately 99% are ultimately approved.  Of course, there are those who do not attempt to address the deficiencies.

While applications that follow the suggestions provided by this article are not guaranteed a favorable recommendation, they may at least enjoy a facilitated adjudications process. More importantly, these suggestions will hopefully assist in advising clients not only as to the preparation of the application, but also in providing a more informed opinion as to the likelihood of success of the waiver application.

 

Suzanne B. Seltzer is the Principal of The Seltzer Firm, PLLC.  Ms. Seltzer recently completed her tenure as Vice Chair of the American Immigration Lawyers Association’s (AILA) USCIS Benefits and Policy Committee.  She was previously Chair of AILA’s Service Center Operations (SCOPS) Liaison Committee and served for many years on AILA’s Annual Conference Committee.  Ms. Seltzer also co-founded the New York Anti-Trafficking Network (NYATN) in 2002 and sat on its Steering Committee from 2002 – 2017. She regularly speaks and publishes on matters relating to immigration law.  Ms. Seltzer is ranked among the nation’s top 20 practitioners in the area of Immigration Law by LawDragon, and is also ranked in Chambers Global, Chambers USA, and included in Best Lawyers in America, New York Super Lawyers, and New York Magazine’s Best Lawyer’s in New York. She obtained her JD from Georgetown University Law Center, and her B.A. from the University of Pennsylvania.

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[1] https://j1visa.state.gov/programs

[2] https://www.americanimmigrationcouncil.org/research/exchange-visitor-program-and-j-1-visas

[3] https://www.nsf.gov/od/oise/visa-waivers.jsp

[4] https://basicresearch.defense.gov/Programs/DoD-J1-Visa-Waiver-Program/

[5] https://www.energy.gov/management/office-management/employee-services/exchange-visitors-program

[6] https://www.hhs.gov/about/agencies/oga/about-oga/what-we-do/exchange-visitor-program/index.html

[7] https://www.hhs.gov/about/agencies/oga/about-oga/what-we-do/visitor-exchange-program/supplementary-a-research.html

[8] For purposes of the HHS waiver, the “applicant” is the sponsoring research institution, not the Exchange Visitor.

[9] The indomitable Joyce Jones during a NAFSA panel in 2002.

[10] The author is grateful to Executive Secretary of HHS’ Exchange Visitor Waiver Review Board, Heber Willis, for his invaluable contributions to the article.

[11] As of writing this article (July 2021) there are eight (8) Board members.  Two members were not able to receive mail during COVID, and therefore were not able to review.  Two other members retired.

[12] The Director of Office of Global Affairs (OGA), or her designee, is the Board President. The designee is traditionally the Deputy Director of OGA.

[13] HHS receives many more clinical waivers, and the Executive Secretary oversees both programs.