[This month’s ABCs of Immigration issue is adapted from Greg Siskind’s book, co-authored by Elissa Taub, The Physician Immigration Handbook.]

Under §212(e) of the Immigration and Nationality Act (INA), theoretically any one of the federal government agencies is capable of sponsoring a J-1 visa holder for a waiver of the home residency requirement if the agency believes that such a waiver would be in the best interest of the public. Practically speaking, there are only a handful of federal agencies which grant all of the public interest waiver recommendations for J-1 physicians. The majority of these waivers are predicated upon the physician committing to work in underserved communities or facilities, or in Veterans Administration (VA) hospitals. These waivers are governed by an additional set of rules.

What are the common rules governing federal interested agency (IGA) waivers?

Pursuant to Title 22 of the Code of Federal Regulations §41.63(c), the U.S. Department of State (DOS) grants any U.S. government agency the ability to request a waiver of the two-year home residency requirement and physical-presence requirement for a J-1 exchange visitor as long as the person is, “actively and substantially involved in a program or activity sponsored by or of interest to such agency.” Numerous agencies take advantage of this provision and have programs to sponsor doctors to work in locations they deem to be in their interest.

Currently, there are five programs run by four agencies which regularly sponsor J-1 waivers for physicians. These four agencies are:

  • The Appalachian Regional Commission (ARC),
  • The Delta Regional Authority (DRA),
  • The Department of Veterans Affairs (VA), and
  • The Department of Health and Human Services (HHS).

The Department of State established a specific set of rules for programs placing doctors in shortage areas. The three programs which are subject to these rules are those run by ARC, DRA, and HHS’ clinical physician program. The VA program and the HHS researcher program are not subject to this special rule set.

What are the differences between the rules governing federal IGA waivers and Conrad 30 state health agency waivers?

  • It is required that Conrad 30 waivers have a “no objection” letter from the home country when the international medical graduate (IMG) is contractually obligated to return.
  • Federal shortage-area waiver applications may not include noncompetition provisions within their employment contracts.
  • Federal law does not impose a recruitment requirement on Conrad 30 waivers, though states almost always require evidence of unsuccessful recruitment of an American physician.
  • Employers seeking a federal waiver for a physician must accept Medicare/Medicaid.
  • Federal programs do not have the option to approve flex applications in non-shortage areas.

What items must be included in all federal IGA waiver applications?

  1. A written request from head of agency or designee.
  2. Forms IAP=66 and DS-2019, Certificate of Eligibility for Exchange Visitor (J-1) Status.
  3. A copy of the employment contract between the IMG and the facility at which the physician will be employed adhering to the following criterion:
    • A term of employment of a minimum of three years;
    • Employment of no less than 40 hours per week of primary care or specialty medicine;
    • The physician’s services will be performed in a Health Professional Shortage Area (HPSA) or Medically Underserved Area (MUA), unless it is a VA waiver based upon other factors than working in underserved areas; and
    • The contract will contain no noncomplete clauses.
  4. Statement signed by the head of the facility attesting to:
    • The facility’s location in an HHS-shortage area;
    • The facility providing care to both Medicaid- and Medicare-eligible patients and indigent uninsured patients; and
    • The facility serving HHS-designated underserved areas (with a listing of the Federal Information Processing Standards (FIPS) country code and census tract or block number or nine-digit zip code along with the identification numbers of the shortage area.
  5. Statement from the physician stating the following:

[NAME OF EXCHANGE VISITOR] HEREBY DECLARE AND CERTIFY, UNDER PENALTY OF THE PROVISIONS OF 18 U.S.C. 1001, THAT I DO NOT NOW HAVE PENDING NOR AM I SUBMITTING DURING THE PENDENCY OF THIS REQUEST, ANOTHER REQUEST TO ANY UNITED STATES GOVERNMENT DEPARTMENT OR AGENCY OR ANY STATE DEPARTMENT OF PUBLIC HEALTH, OR EQUIVALENT, OTHER THAN [NAME OF UNITED STATES GOVERNMENT AGENCY REQUESTING WAIVER] TO ACT ON MY BEHALF TO ACT ON MY BEHALF IN ANY MATTER RELATING TO A WAIVEFR OF MY TOW-YEAR HOME-COUNTRY PHYSICAL PRESENCE REQUIREMENT.

  1. Documentation of unsuccessful efforts to recruit a U.S. citizen physician for the position to be filled.

HHS Clinical Waivers

Before the creation of the Conrad program for health departments in 1994, a handful of agencies provided J-1 waivers for physicians. The United States Department of Agriculture provided waivers for physicians who agreed to work in rural communities. The Department of Housing and Urban Development issued waivers for physicians who agreed to work in underserved areas in cities. The Veterans Administration maintained its program for staffing physicians in VA hospitals. The Department of Health and Human Services had a program for providing waivers for physicians engaged in research. Finally, the Appalachian Regional Commission had a program for physicians who agreed to work in the counties in 12 states covered by that regional development agency.

Between then and now, the federal agency waiver landscape has changed. The Department of Agriculture and the Department of Housing and Urban Development have closed their programs. A new regional agency, the Delta Regional Authority, modelled after the Appalachian Regional Commission, created a popular J-1 program. Additionally, the Department of Health and Human Services created a second waiver program in 2002, narrowly tailored to certain federally qualified health centers, rural clinics, and Native American tribal health facilities.

Shortly after the ending of the Department of Agriculture’s program in 2002, HHS initiated a new waiver program which provided a path to a J-1 waiver for a narrow subset of the community previously served by the Department of Agriculture program. The 2002 regulation was remarkably broad, stating the HHS would issue J-1 waivers to primary-care physicians, required recruiting, and mandated that employers accept Medicare, Medicaid, and indigent patients. In June 2003, HHS issued guidelines that were relatively broad with regard to the types of applications that would be accepted, but those guidelines were quickly withdrawn. December 2003 saw the release of the new guidelines, and they have only been modified slightly in the years since.

What types of facilities can file HHS clinical waivers for J-1 physicians?

  1. Federally qualified health centers, defined under Section 330 of the Public Health Service Act, which are receiving grants under Section 330;
  2. Rural health clinics defined under Section 1102 and 1871 of the Social Security Act; or
  3. A Native American/Alaskan Native tribal facility as defined by the Indian Self-Determination and Education Assistance Act.

What physician specialties will be considered for HHS clinical waivers?

HHS will exclusively sponsor primary-care doctors. These are defined as doctors who practice family medicine, general internal medicine, general pediatrics, obstetrics and gynecology, and general psychiatry. HHS will exclusively support physicians who have no fellowship training.

Does a facility need to be in a shortage area?

It does. HHS has a requirement that applicants be in facilities in Health Professional Shortage Areas (HPSA) with a minimum score of 7. Medically Underserved Areas (MUA) and Medically Underserved Populations (MUP) are not considered.

Can an employer use HHS’ National Health Service Corps (NHSC) program and pursue an HHS J-1 waiver simultaneously?

It is possible, but the NHSC position must remain unfilled at after the NHSC placement cycle has ended.

What items must a physician provide HHS as part of the waiver application?

The physician must provide the following:

  • 2 copies of a U.S. Department of State J-1 Waiver Data Sheet;
  • Copies of Form DS 2019 for each year in J-1 status;
  • A physician statement, using specific language provided by HHS, that the doctor does not have other pending waiver applications;
  • Current curriculum vitae with Social Security number;
  • Three letters of recommendations from U.S. residents familiar with the doctor’s qualifications; and
  • Documents of credentials, such as diplomas, licenses, license applications, etc.

What recruiting documentation must an employer provide HHS?

An employer needs to provide evidence of both regional and national recruiting efforts. Additionally, the employer must provide names of non-foreign doctors who are either applying for the job or who were interviewed and the reason why they were not hired.

What are the HHS requirements for the physician’s employment contract?

The J-1 application must include a signed contract which contains the following elements:

  • A duration of three years;
  • A requirement that the doctor work 40 hours per week providing outpatient primary care;
  • Specifics of the worksite(s), including the HPSA identifier number, and all listed sites must be in HPSA locations with a score of at least 7.
  • No noncompetition clause or restrictive covenant;
  • Signatures from the head of the medical facility and the physician; and
  • Date and notarization.

What items are included in an HHS clinical application?

Employers are also required to submit the following items:

  • Form HHS 426, Application for Waiver of the Two-Year Foreign Resident Requirement of the Exchange Visitor Program;
  • A cover letter;
  • Form G-28, Notice of Entry of Appearance as Attorney or Accredited Representative;
  • Letter of need from the medical facility, signed by the head of the facility, dated and on letterhead, including the identifier number of the federally designated underserved area in which the facility is located. In the even the physician is seeking employment at more than one site, all of the sites’ identifier numbers must be included. Included in the letter must be a statement that the facility treats al patients regardless of ability to pay, accepts Medicare, Medicaid, and State Children’s Health Insurance Program (S-CHIP) assignment, and uses a sliding-fee scale for persons at or below 200 percent of the poverty income level;
  • Three letters of community support for the hiring of the doctor, including contact information;
  • Letter from state health department supporting or acknowledging the waiver application or documentation that the letter has requested;
  • Prevailing wage documentation;
  • Proof of the facility’s existence;
  • Rural health clinics must provide a copy of the Letter of Certification issued by Centers for Medicare and Medicaid Services;
  • An attestation from the employer that it is in a shortage area, including listing ID number, and treats Medicare/Medicaid/indigent patients;

Applications must be submitted both in an unbound hard copy and in Adobe PDF format on a CD, with the Department of State case number listed on each page.

How does HHS make decisions on its clinical waiver cases?

HHS initiated the Exchange Visitor Waiver Review Board (EVWRB) for J-1 waiver recommendation applications. The EVWRB has a minimum of three members in addition to two alternates. The director of the Office of Global Health Affairs, Office of the Secretary, acts as the chairman. In the event the director is absent, the he or she may appoint a staff member to serve. The assistant secretary of health of HHS is responsible for appointing the other two members and two alternates. The EVWRB may establish a workgroup from the operating divisions of HHS to consider applications for waivers based on the health care needs of underserved populations. An HHS administrator handles the review of applications on a day-to-day basis.

HHS Researcher Waivers

What are the main requirements to qualify for an HHS researcher waiver?

In order to qualify for an HHS researcher waiver, an applicant organization must demonstrate the following:

  1. The program or activity at the applicant’s institution or organization is of “high priority” and of “national or international significance” in an area of interest to HHS.
  2. The J-1 exchange visitor is playing an imperative role in the program or activity and that the loss of the individual’s services would significantly restrain the initiation, continuation, completion, or success of the program or activity, or a major part thereof; and
  3. The J-1 exchange visitor has outstanding qualifications which exceed accomplishments at graduate, postgraduate, and residency levels, and the applicant must be capable of making original and significant contributions to the program.

As a whole, the agency is interested in supporting waivers for researchers who are essential to their ongoing program of research and have a significant level of recognition in their field.

How does one demonstrate that being denied a waiver would significantly impact a research program?

Applicant organizations are required to provide evidence on how the loss or unavailability of the J-1 exchange visitor’s services would negatively impact the initiation, continuance, completion, or success,” of the program or activity. For example, the applicant should describe as detailed as possible how the exchange visitor departing would affect the ongoing research. Additionally, if the institution took a significant amount of time to hire the researcher due to his or her unique skill set, or if the physician has acted in a leading role in the research, the institution could make the argument the physician’s departure would make the program’s continuation impossible without a major disruption.

Furthermore, it is required the applicant organization demonstrate that finding a suitable replacement through recruitment or other means is not possible. The HHS program rules explicitly note that the principle problem may not be one of administrative, budgetary, or program inconvenience to the applicant organization.

Does qualifying for an O-1 visa mean the J-1 waiver applicant is likely to qualify for an HHS waiver?

While possible, this is not necessarily the case. Demonstrating that one has outstanding qualifications is an imperative aspect of an HHS researcher waiver, but heavy consideration is also given to the overall importance of the research and the role of the researcher therein.

Also, dissimilar to an O-1 visa which is reviewed by a USCIS examiner who has no expertise in the researcher’s field, HHS has experts reviewing the application and will generally place greater importance on the researcher’s curriculum vitae as opposed to support letters from experts in the field. It is still a good idea, however, to submit letters of support.

What documentation must be included to support an HHS researcher waiver application?

In addition to Form HHS 426, Application for Waiver of the Two-Year Foreign Residence Requirement of the Exchange Visitor Program, HHS requests the following:

  1. A detailed description of the program or activity in which the exchange visitor is engaged, including factual evidence of the way in which the program or activity serves in the national or international public interest.
  2. Evidence of the visitor’s essentiality to the program, and specific information describing the exchange visitor’s role and unique capabilities to contribute to the program over an extended period of time.
  3. Information pertaining to the personnel engaged in the program and how the visitor’s expertise relates to those individuals.
  4. Evidence of a minimum of two means of recruitment dated no longer than 18 months from the waiver application’s date of submission, indicating the applying institution made genuine efforts to recruit for the exchange visitor’s position without finding a suitable candidate.
    • Clearly demonstrate a suitable replacement for the exchange visitor is unable to be found via recruitment or any other means, and the position cannot be filled by any individual not subject to the foreign residence requirement.
    • Provide copies of recruitment advertisements, placed in nationally circulated journals, or online career/job boards associated with a nationally circulated journal, or on USAJOBS, with specific information provided as to the results, including why candidates were unqualified. Salary level should be advertised showing a range at a fair market rate.
    • Include additional information including placement on an organization’s website, internet recruitment, and letters to colleagues in the field.
  5. A description of the probable future of the program if the waiver were to be denied, including specific evidence demonstrating how the loss of the exchange visitor’s services would significantly restrain the initiation, continuation, completion, or success of the program or activity, or a major part thereof.
  6. An explanation of the long-term plans of the applicant institution for the exchange visitor, and ways in which the visitor will contribute in the future to the activities in which he or she is employed.
  7. Information concerning the qualifications of the exchange visitor, including evidence of special accomplishments and external letters of recommendation.
  8. The exchange visitor’s curriculum vitae, bibliography and copies of abstracts for the J-1’s most recent relevant publications, copies of all Forms IAP=66 and/or DS-2019, current visa status materials. Copies of any presentations need not be included.
  9. Any other pertinent facts.

What should not be included in the application?

The applicant should leave out copies of grants, honors, awards, any publications more that a few years old, citations, curriculum vitae of anyone other than the applicant, and background information on the sponsoring institution.

Who needs to write the letters of recommendation and what should be included therein?

Dissimilar to O-1 and EB-1 petitions which include letters form a wide variety of sources both inside and outside the institution, HHS has a strong preference for letters coming from individuals outside an applicant institution. Letters should highlight the accomplishments of the applicant as they pertain to the area of research that is the basis for the application, in addition to any other indicators that the J-1 is outstanding in the field. While there is no minimum or maximum number of applications, HHS prefers diverse letters that do not contain largely the same material.

Letters are to be specifically addressed to HHS and not simply be copies of other letters sent to USCIS supporting another application. It is best if the letter is authored by an individual who is well known in the field and likely to be recognized by the expert reviewing the position. Note that the curriculum vitae of external letter writers is not to be included.

Who needs to sign the HHS Form 426?

The Form HHS-426 needs to be signed by two individuals at the applicant institution, specifically the principle program officer and the responsible administrative officer. The former is an individual who will be familiar with the research and can provide additional information to HHS regarding the application. The latter should be a senior person at the institution, authorized to sign on the behalf of the entire institution.

HHS keeps a list of authorized signatories and the responsible administrative officer should match the name on the list. Otherwise, the institution’s general counsel should notify the EVWRB of the name of the authorized singer.

What happens after the application is submitted?

Upon the application’s submission, it receives an initial review from the EVWRB executive secretary. That review focuses on ensuring the application contains all of the necessary information and documentation. The application is then sent to a volunteer expert, a full-time scientist who is an expert in the particular field of research, for technical review. If the National Institutes of Health (NIH) has provided grant funding supporting the research which is the subject of the application, NIH will be part of this technical review process. After the technical review is complete and comments have been sent back to the EVWRB, the executive secretary sends the application to two of the five members of the EVWRB. While the EVWRB members are emeritus scientists, they are not necessarily experts in the particular field of research.

The EVWRB reviewers are making sure the application adheres to the overall criteria for the program. After each EVWRB finishes reviewing, he or she individually sends comments back to the executive secretary. IF the two reviewers come to a different recommendation, the executive secretary makes the decision. The executive secretary then informs the institution of the positive or negative decision.

If the decision is favorable, the executive secretary sends the recommendation to the Department of State’s Waiver Review Board for the later stage of J-1 waiver processing.

Is clinical research eligible for an HHS researcher waiver?

Yes, clinical research may be considered. The EVWRB will look at the amount of time spent on research compared to patient care alone and will also look at the J-1’s publication history to gauge the importance of the clinical research.

What if NIH or HHS grant-funding does not support the research?

NIH or HHS grant-funding can be important, but funding from other sources, such as other government agencies, private sector funding, or internal funding from the institution, is considered in determining whether the research is of interest to HHS and if the J-1’s role in that research is critical.

Can a researcher waiver application be appealed?

If a case is denied and an institution believes the decision to be unjustified, the institution can submit a written request for more information on the application’s deficiencies. HHS will then grant an informal re-adjudication of the request on a one-time basis to those institutions that request the opportunity to cure any deficiencies in the initial application.

What is the expected processing time for an HHS research waiver?

Currently, HHS takes over a year to adjudicate waiver applications. Not included in this timeframe is the processing by the U.S. Department of State or USCIS, or the amount of time taken to prepare the waiver application for filing, which can take several months. HHS would like to shorten its application processing time, but for the time being, those seeking HHS research waivers should plan for a lengthy process.

For further reading, including information on the Appalachian Regional Commission (ARC) and the Delta Regional Authority (DRA), view Chapter 7 in The Physician Immigration Handbook.

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Disclaimer: This newsletter is provided as a public service and not intended to establish an attorney client relationship. Any reliance on information contained herein is taken at your own risk.

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