HHS Waiver Article (00364372;1)

DEMYSTIFYING THE HHS WAIVER PROCESS by Suzanne Seltzer The “J” exchange visitor program permits re- strating why the applicant’s continued presence in the searchers, scholars, professors, medical trainees, and United States is in the interest of that IGA. As a re- others to come to the United States to participate in a sult, it is often difficult for advocates or institutions, sponsored program. According to the U.S. Depart- who are not necessarily scientific experts, to advise ment of State, the J-1 program is designed to promote on these petitions or provide effective guidance and the interchange of persons, knowledge, and skills in assistance. 1 the fields of education, arts, and sciences. Since the The purpose of this article is to evaluate the IGA purpose is the exchange of information, knowledge, waiver process via a review of the Department of and skills, many exchange visitors are required to re- Health and Human Services (HHS) Exchange Visitor turn to their home country at the completion of their Waiver Review Board’s procedure.6 The specifics of program, to share their newly acquired information, this procedure were provided by the administrator of 2 knowledge, or skills. Yet in many instances, those the Exchange Visitor Waiver Review Board (Board) with a two-year home requirement are reluctant to re- at HHS.7 Through this evaluation, it is hoped that turn. and if it can be establish that their continuing much needed insight will be afforded, providing con- presence is in the interest of a U.S. government agen- crete suggestions that can be incorporated into an ef- 3 cy, they may not have to. fective practice. There is only a handful of U.S. Interested Govern- One of the most important points to keep in mind in ment Agencies (IGA) that have a formal application when both advising on, and preparing, an HHS waiver 4 process to initiate a waiver recommendation. These application is that it is not an O-1 nor an immigrant include, inter alia, the National Science Foundation, visa petition. Eligibility for the O-1 or similar types of the Department of Defense, the Department of Ener- immigration petitions (i.e., outstanding researcher, na- gy, and the Department of Health and Human Ser- tional interest waiver, alien of extraordinary ability) do 5 vices. Waivers submitted to these IGAs are given not necessarily translate into a successful HHS waiver. technical review by relevant experts in the field. This is because the O-1 visa petition and the HHS Therefore, such applications require a sophisticated waiver application have a completely different set of level of scientific and technical information demon- standards, and are reviewed by very different audi- ences. Supporting letters from the O-1 petition should 1 www.travel.state.gov/visa/tempvisitors_types_scholars.html. not be included with the HHS application, nor should 2Immigration and Nationality Act of 1952, Pub. L. No. the plethora of supporting documentation used to cor- 82-414, §212(e), 66 Stat. 163 (codified as amended at 8 USC roborate the O-1 eligibility criteria. In stark contrast to §§1101 et seq.) (INA) . U.S. Citizenship and Immigration Services (USCIS) 3 Id. Note, this article is limited to waivers through an IGA. adjudications, HHS accepts as true the accomplish- Other options for waivers may include: state health agency ments included in the applicant’s curriculum vitae recommendation, hardship to a U.S. citizen or permanent resi- dent spouse or child, fear of persecution in the home country, (CV). Therefore, separate documentation for each and or a statement of no objection from the home country. every point raised is neither necessary, nor sought by 4 IGAs do not grant waivers. The authority to grant waivers HHS in its review of the waiver application. In fact, is made by USCIS. The IGAs have the authority to recom- “less is more” would be a more apt approach. mend waivers to the Department of State, which then re- If “less is more,” how does the ‘less’ become views the application and makes its recommendation to US- ‘more’? Basically, by understanding and focusing on CIS. Note that the lack of a formal program does not pre- clude a federal agency from recommending a waiver. the key issues that HHS relies on in making a waiver recommendation. In order to facilitate this under- 5 These are not the only IGAs that may recommend a waiver. Any IGA may recommend a waiver of the two year home 6 residency requirement. For example, the Federal Trade 45 CFR Part 50. Commission and the Department of Commerce have acted as 7 As of the time of writing, Joyce Jones was the administrator an IGA where it was established that doing so was in the in- of the HHS waiver program, and references to “HHS” or terest of their agency. “the administrator” were based on her comments. Demystifying the HHS Waiver Process standing, HHS has issued a supplemental informa- 3. Information Regarding Current Personnel—The tion sheet,8 outlining the principal points that should application should address this point to reinforce the be addressed in the application. In submitting a applicant’s essentiality to the program, and describe waiver request application, each of these points how exactly the applicant fits into the program. HHS should be enumerated and addressed by the employ- is interested in the skill sets of the others involved in er/institution as they are listed on the supplemental the program to the extent that they rely on applican- information sheet, and signed by the Principal Pro- t’s skills for their own work, and to understand why gram Officer.9 The following guidance in addressing such other personnel would not be able to step in these points is based on suggestions made by HHS and pick up applicant’s responsibilities, if the appli- regarding what specific information should be pro- cant were no longer available. HHS is not interested vided: in the distinguished reputations of these people, but rather how their skills sets interact with, or comple- 1. Complete Description of Program or Activity In- ment, that of the applicant for purposes of the re- cluding How It Serves the National Interest—This search. should be a concise, scientific description of the research program in which the exchange visitor is in- 4. Recruitment Efforts—Again, in order to ensure volved. The emphasis is on science and succinct. that the applicant is essential to the program, HHS HHS does not need a detailed description of the in- wants evidence that at least one ad was placed in a stitution itself, or platitudes regarding the institu- national journal in search of a replacement with the tion’s standing in the field. Moreover, it is not nec- appropriate skill set. The salary, or a statement that essary to assert how important this research is to the “salary will be commensurate with experience,” National Institutes of Health (NIH), as the applica- should be included in the ad. The recruitment sum- tion is adjudicated by NIH/HHS, and it will make its mary should be kept brief and simple: (a) where and own determination if it is in fact important to the rel- when the ad was placed; and (b) any responses from evant agency. However, if the program is supported qualified applicants. by a NIH grant, the grant name and number should be included. 5. Future of Program if Waiver not Granted—If, in fact, the applicant is essential to the program, there 2. Exchange Visitor’s Essentiality to the Program and are going to be some repercussions if the waiver is Unique Capabilities—The section on essentiality is not granted and the applicant is required to fulfill the one of the most misunderstood of HHS’ criteria. This two-year home residency requirement. One way to section should not be a detailed description of the ap- document such consequences is to note delays in the plicant’s background and accomplishments, which research prior to applicant joining program, or antic- made them “essential” to the program. Rather, what ipated delays if applicant were no longer available to HHS is looking for in this section is the applicant’s contribute. Another critical element would be any day-to-day role in the program, his or her specific job program funding belonging to applicant that would duties relevant to the program itself. HHS is not inter- be lost if applicant had to leave, potential funding ested in applicant’s teaching or training responsibili- that applicant is currently precluded from obtaining ties, but only in the applicant’s scientific role in the because of immigration status, or program funding program. In discussing applicant’s job duties, it is help- dependent on applicant’s skill, regardless of whether ful to include any unique or rare technical expertise, or he or she is listed in the actual grant. combination of disciplines essential to the work. If such expertise is essential to the research, even a recent 6. Long Range Plans for Exchange Visitor—In three graduate or post-doctoral fellow may be an appropriate sentences or less, describe the institution’s intentions waiver candidate. It is also important to include infor- for the applicant. For example, for what promotions mation on grant funding awarded to applicant either in- may the applicant be considered, either tenure-track dividually or as the principal investigator (PI) of a or advanced research track. project. 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 8 Available at www.globalhealth.gov/supplementA.shtml. seventh point requests “Information Concerning the 9 HHS will only consider waiver applications supported by Exchange Visitor’s Qualifications, Including Evi- an institutional sponsor. Individuals may not self-petition for dence of Special Accomplishments and External the HHS waiver. Klasko, Rulon, Stock & Seltzer, LLP Page 46 of 5 Demystifying the HHS Waiver Process

Letters of Recommendation.” These external sup- The forms, support letters, and other documenta- port letters should come from outside the sponsoring tion should be compiled and submitted in the follow- institution. The text of these letters should address ing suggested order:11 the applicant’s history of excellence in the context of . Cover Letter the research program, as well as other accomplishments for which the applicant has received recogni- . G-28 tion. When advising on the number and type of ex- . HHS Application Form 426 ternal support letters, do not include letters that basi- . Applicant’s CV cally reiterate the same point, and do not use the letters from the O-1—particularly if they are still ad- . Applicant’s immigration documents (IAP-66s, dressed to “USCIS.” Since this is a peer review DS-2019s, I-94, I-797s) process, letters should be written from one scientist . Applicant’s publications (limited to a selection of to another, and should not include platitudes or su- the most recent full manuscripts); perlatives in their description. It is important to use . Employer’s support letter letters from recognized experts in the relevant field, . Recruitment efforts (copy of ad) but HHS’ supplemental information sheet specifical- ly requests that only the applicant’s CV be includ- . External letters of support ed. One would hope that HHS is already familiar In noting what should be included with the appli- with the letter writer’s reputation and accomplish- cation, also note what should not be included, as in- ments. If HHS is not familiar with the letter writer’s cluding it would only impede the waiver review reputation, the letter itself may not be given the process. This includes the CV of anyone other than same level of consideration as a letter from a more the applicant, background information about the established expert. sponsoring institution or the importance of the re- While the institutional support letter and the ex- search program (HHS will make its own determina- ternal letters of recommendation are critical to the tion of the importance of the program), full copies of application, there are other documents that must be grants (simply provide the grant name and number), included as well. Similar to any USCIS submission, applicant’s honors and awards, applicant’s older pub- the appropriate form with the appropriate authorized lications (HHS suggests submitting only those from signatures must also be included. For the HHS waiv- the last two years or those that are considered “impor- er, it is HHS Form 426.10 HHS Form 426 requires tant”—but generally no more than 10 publications), two signatures: (1) the principal program officer, de- citations to his or her work, requests for reprints, or fined as the individual who can answer substantive anything else included in applicant’s CV. As noted questions regarding the research; and (2) administra- above, HHS will review the applicant’s CV and trust tive officer authorized to sign on behalf of the insti- that it is accurate. Moreover, the cover letter from tution as a whole, not just the specific department counsel should simply be a list of what is included, where the research is being conducted. The waiver not a summary of the evidence nor a treatise on why a review board at HHS maintains a list of the appro- favorable recommendation of the waiver is warranted. priate individuals at each institution authorized to Applications received by HHS are first adminis- sign, which is usually someone in the office of inter- tratively reviewed by the Waiver Review Board’s Ex- national scholars or the immigration office at the in- ecutive Secretary to ensure that the requisite informa- stitution. HHS is very concerned that the institution tion is included. If the application is not properly pre- as a whole, and not just the applicant’s department, pared, it may be literally taken apart, as it must fit supports the waiver application and, therefore, en- within a folder that will then travel to each of the indi- suring the appropriate administrative signature on viduals involved in the review process. the form is absolutely critical to the process. If no There are a number of different people within one is designated, the institution’s general counsel HHS that are involved in the review process. These should contact the Waiver Review Board to appoint individuals are housed in different offices in different someone, and submit such authorization to HHS in parts of the city. Therefore, the file literally travels writing. If outside counsel is representing the institution in the submission, a G-28 should also be includ- 11 Note that the Department of State (DOS) Waiver Review ed, signed by the administrative officer. case number does not need to be included at the time of fil- ing, but will need to be submitted prior to HHS issuing a fa- 10 www.globalhealth.gov/exchangevisitor.shtml. vorable recommendation to DOS. Klasko, Rulon, Stock & Seltzer, LLP Page 47 of 5 Demystifying the HHS Waiver Process from one office to another. Because of the limited The role of the Board is to apply the policy and room available in the file, any documentation consid- goals of the HHS waiver program as articulated in ered extraneous may be discarded. Moreover, since its regulations. This basically requires weighing the the file travels, once the formal review process has technical evidence against the regulatory criteria; the begun, no additional information should be added to importance of the program itself and the absolute es- the file. The need for the file to travel is one of the sentiality of the applicant to the continuation of the causes of the delays experienced in the adjudication program, in contrast to policy considerations of en- of the waiver. Another cause of delay is that nearly forcing the two year home residency requirement. everyone involved in the review process is a full-time The Board considers factors such as the applicant’s scientist, and their role in the review process is a ser- salary, publication record, technical or multi-disci- vice they perform on a volunteer basis, in addition to plinary expertise, and potential (i.e., if applicant is their already busy schedules. on track to become a stand-alone researcher). More If the application is missing basic documentation and more, the Board is recognizing the importance necessary for Board review (e.g., institutional support of clinical research, particularly as bench and clini- letter, HHS form, appropriate signatures), the admin- cal research are increasingly overlapping. istrative official of the sponsoring institution or the at- In considering applications from clinical re- torney of record will be contacted. Note that applica- searchers, the Board looks closely at the percentage tions missing basic documentation may incur lengthi- of time spent on research versus purely clinical care, er processing times. Once it is determined that the ap- as well as the applicant’s publication record. In any plication is complete, a “receipt” letter is sent either case, it is important to note that NIH/HHS grants are to the institution or to the attorney of record.12 It is at not decisive; research programs funded by other that point that the scientific review commences. How- agencies, industry, or even internally by the institu- ever, because the application must first be administra- tion may be eligible for a waiver. The key factor is tively reviewed and prepared for the scientific review, whether HHS believes this specific research pro- it may be 3-6 months following submission before a gram is important and what the applicant’s role in formal “receipt” is issued. the program is. The first part of the scientific review is a “Tech- The Board does not actually meet. The two Board nical Review.” The technical review is not done by members provide written comments on the merits of members of the Board, rather the technical review is the application. If they agree, their decision is fol- done by experts within the appropriate HHS institute lowed. If they disagree, the Executive Secretary may most interested in the research program. If there is act as the tie breaker. In this regard, she may request an NIH grant supporting the research, the technical additional information, check the specific grant to review will be done by the grant source. The techni- verify the applicant’s time commitment, check if the cal review does not evaluate the application to en- applicant’s work is discussed in the grant’s annual re- sure compliance with the waiver requirements, but port, or decide that a favorable recommendation is not rather to render an opinion as to the scientific value warranted. If an application is not recommended for a of the program, and of the applicant’s accomplish- waiver, the sponsoring institution is sent a letter in- ments/publications. However, the technical review- forming them simply of that fact. If the institution ers do supply an opinion as to whether the waiver wants more detailed information regarding the defi- should be recommended. Since this opinion is gener- ciencies of the application, it must request it in writ- ally based solely on the scientific merit of the pro- ing. HHS will give institutions one opportunity to gram, and not on the HHS waiver policy, it is used cure any deficiencies. only as a guide for the Board. According to HHS, the Board makes favorable After the technical review is completed, the re- recommendations in about 60 percent of the approx- viewers’ comments are returned with the file to the imately 200 applications they receive each year. Waiver Review Board’s Executive Secretary, who While applications that follow the suggestions pro- then selects two members of the Board (out of a list vided by this article are not guaranteed a favorable of five) to review the application. The list of five recommendation, they may at least enjoy a facilitat- Board members includes scientists emeritus who are ed adjudications process. More importantly, these not necessarily experts in the relevant field. suggestions will hopefully assist in advising clients not only as to the preparation of the application, but 12 Klasko, Rulon, Stock & Seltzer, LLP Page 48 of 5 Demystifying the HHS Waiver Process also in providing a more informed opinion as to the likelihood of success of the waiver application.

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