DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 50

RIN: 0991-AB21

HHS Exchange Visitor Program; Request for Waiver of the Two-Year
Foreign Residence Requirement

AGENCY: Office of the Secretary, HHS.

ACTION: Interim final rule with opportunity for public comment.

SUMMARY: This interim final rule with comment period amends the regulations governing requests for the waiver of the two-year foreign residence requirement of the Health and Human Services (HHS) Exchange Visitor Program. These revisions permit institutions and health care facilities to submit to HHS requests for waiver of the two-year home-country physical presence requirement for physician Exchange Visitors to deliver health care services in underserved areas.

DATES: These interim final regulations are effective December 19, 2002.
As discussed below, comments on the regulations are invited but must be received by February 3, 2003.

ADDRESSES: Written comments should be addressed to Dr. William R.
Steiger, Office of Global Health Affairs, 200 Independence Ave., SW.,
Room 639-H, Washington, DC 20201. All comments received will be available for public inspection and copying at the above address, weekdays (Federal holidays excepted) between the hours of 9:00 a.m. and
5:30 p.m.

FOR FURTHER INFORMATION CONTACT: Dr. William R. Steiger, Office of
Global

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Health Affairs, 200 Independence Ave., SW., Room 639-H, Washington, DC
20201. Telephone: 202-690-6174; Fax: 202-690-7127.

SUPPLEMENTARY INFORMATION: The U.S. Exchange Visitor Program, administered by the Department of State, seeks to promote peaceful relations and mutual understanding with other countries through educational and cultural exchange programs. Under one facet of this program, foreign national physicians may come to the United States to participate in graduate medical education programs under J-1 visas.

Upon completion of the graduate medical education program and expiration of the visa and prior to pursuing permanent residency, the Exchange Visitor physician must return to his or her country of nationality or last country of legal permanent residence for a minimum of two years to share the benefit of the knowledge and experience gained in the United States. Under limited and exceptional circumstances, an Exchange Visitor may obtain a waiver of the requirement to return home. An avenue through which a waiver may be obtained is by a request made, on the Exchange Visitor's behalf, by an interested United States Government Agency (IGA). Numerous Federal agencies have sought waivers as IGA’s.

The vast majority of IGA requests for waivers involve international medical graduates who entered the United States to pursue graduate medical education or training. Historically, HHS has restricted its activity as an IGA to requesting waivers for researchers whose research could have national or international significance. In contrast, the Department of Agriculture and the Appalachian Regional Commission have been the most active IGAs seeking waivers for physicians to provide services in Health Professional Shortage Areas (HPSAs) or Medically
Underserved Areas and Populations (MUA/Ps). On April 16, 2002, the Department of Agriculture announced it would process its pending waiver requests and then cease participation as an IGA.

Pursuant to section 332 of the Public Health Service Act, HHS designates areas, facilities or population groups as HPSAs if they meet the criteria specified in 42 CFR part 5. HPSA designations are separated into three categories: those for shortages of primary medical care, dental, and mental health professionals. HHS publishes lists of the designated areas annually in the Federal Register, and publishes updates to the list on the HHS web site periodically. Pursuant to Sec. 330(b)(3)-(6), HHS also designates areas and population groups as MUA/
Ps based on established criteria that indicate a shortage of personal health services.

HHS is committed to increasing access to care for the nation's most medically underserved individuals. In accordance with this mission, HHS has decided to request waivers for physicians to provide primary care services in HPSAs and MUA/Ps and for psychiatrists to provide care in Mental Health HPSAs. In determining whether to request a waiver for an Exchange Visitor to deliver primary health care services, HHS will consider information from and coordinate with State Departments of Public Health (or the equivalent), other IGAs that request waivers, HHS programs such as the National Health Service Corps, and other relevant government agencies. This change in HHS's role requires amendment of the HHS regulations governing J-1 visa waiver requests.
The Secretary recognizes that the determination of need for health care services in specific geographic areas is affected by services provided by physicians holding nonimmigrant visas, as well as physicians assigned to these areas under HHS programs, such as the National Health Service Corps. On a related issue, during the first quarter of calendar year 2003, the Secretary intends to propose revisions to the regulations governing the designation of HPSAs and
MUA/Ps.

HHS continues to endorse the philosophy that Exchange Visitors are committed to return to their country of nationality or last legal permanent residence home for at least two years after completing their program. Consistent with this philosophy, the regulations provide that the HHS Exchange Visitor Waiver Review Board may determine the appropriate numbers and geographic areas for waivers for the delivery of health care service. These determinations would be made based on data relating to the health care needs of the relevant areas.

The HHS eligibility criteria established under this rule are solely for the purpose of requesting HHS to act as an IGA and are consistent with the Department of State regulations governing such waiver requests. HHS eligibility requirement criteria for waiver requests are in addition to and independent of the existing waiver and visa criteria established by the Immigration and Naturalization Service (INS), the Department of State, and the Department of Labor. HHS stresses that its waiver regulations do not relieve alien physicians from their responsibility to comply with visa requirements on a timely basis to maintain lawful status. Nor should these HHS regulations be confused with criteria applicable to the waiver program implemented by state
departments of health (the Conrad program). Alien physicians are strongly encouraged to begin the waiver process as early as they possibly can while still in the residency training program. Early filing of the waiver request by the alien physician, coupled with timely processing of the request by the relevant government agencies, will facilitate the timely completion of the waiver process before the authorized J-1 admission expires, and the physician's subsequent application for change of nonimmigrant status from J-1 to H-1B.

HHS also notes that during the 12-month period following completion of the residency training program, an alien physician who has departed from the United States is still eligible to apply for an IGA waiver. He or she may pursue the waiver from abroad. If the waiver is granted, the alien physician may then procure an H-1B visa and seek admission to the
United States to begin working in the location specified in the employment contract and approved by HHS. The HHS criteria for waiver requests incorporate the requirements currently imposed by the Department of State regulations that govern
waiver requests from IGAs based on the need for the delivery of health care services. In brief, the criteria for a waiver recommendation by HHS acting as an IGA are as follows:

1. Eligibility to apply for HHS waiver requests is limited to primary care physicians, and general psychiatrists who have completed their primary care or psychiatric residency training programs no more than 12 months before the date of commencement of employment under the contract described in the paragraph below. This 12-month eligibility
limitation is to ensure that the physicians' primary care training is current and they are not engaged in subspecialty training. This HHS eligibility requirement relates only to eligibility for an HHS waiver recommendation and does not relieve physicians of the responsibility to maintain their lawful status. Primary care physicians are defined as:
physicians practicing general internal medicine, pediatrics, family practice or obstetrics/gynecology and who are willing to work in a primary care HPSA or MUA/P; and general psychiatrists willing to work in a Mental Health HPSA.

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2. The petitioning health care facility must establish that it has recruited actively and in good faith for U.S. physicians in the recent past, but has been unable to recruit a qualified United States physician.

3. The head of a petitioning health care facility must execute a statement to confirm that the facility is located in a specific,
designated HPSA or MUA/P, and that it provides medical care to Medicaid and Medicare eligible patients and the uninsured indigent.

4. The Exchange Visitor must execute a statement that he or she does not have pending, and will not submit, other IGA waiver requests while HHS processes the waiver request.

5. The employment contract must require the Exchange Visitor to practice a specific primary care discipline for a minimum of three years, 40 hours per week in a specified HPSA or MUA/P. It may not include a non-compete clause that limits the Exchange Visitor's ability to continue to practice in any HHS-designated primary care or mental health HPSA or MUA/P after the period of obligation. The contract must be terminable only for cause and not terminable by mutual agreement
until completion of the three-year commitment, except that the contract may be assigned to another eligible employer, subject to approval by HHS and consistent with all applicable INS and Department of Labor
requirements.

6. Both the employer and the alien physician must submit information to HHS as the Secretary may reasonably require.

7. Both the employer and the alien physician must comply with all applicable Department of State, Department of Labor, INS, and HHS statutes, regulations and policies. HHS notes that if an alien physician acquires H-1B nonimmigrant
status following approval by the INS of a request for waiver, then he or she becomes subject not only to the terms and conditions of the waiver, but also the terms and conditions of the H-1B nonimmigrant status. Failure to comply with those conditions will make that physician subject to removal from the United States by the INS. This rule also amends the HHS regulations by replacing references to the United States Information Agency (USIA) with the Department of State, following the consolidation of USIA and the Department of State as mandated by the Foreign Affairs Agencies Consolidation Act of 1998.

The amendments to 45 CFR Part 50 are as follows:
(1) Revise Sec. 50.1 to replace the reference to ``the United States Information Agency'' with ``the Department of State'' to reflect the reorganization of the two agencies.

(2) In Sec. 50.2 revise paragraph (b) to delete the ``s'' in ``Exchanges Visitor Program''; revise paragraph (c) to replace the
reference to ``Office of International Affairs'' with the ``Office of Global Health Affairs''; remove the parenthetical examples in sentence three and add a new sentence at the end to authorize the Exchange Visitor Waiver Review Board to establish a workgroup to review requests for waivers for the delivery of health care services; and redesignate and move former paragraph (d) to new Sec. 50.6(a) entitled ``Procedures for submission of application to HHS.''

(3) In Sec. 50.3 redesignate and move former paragraphs (a)(1) through (3) to new Sec. 50.4 entitled ``Waivers for research,'' and revise former Sec. 50.3 to include policy for waivers for the delivery of health care services.

(4) Revise Sec. 50.4 to redesignate, remove former paragraph (b) as unnecessary and move former paragraph (a) to make it paragraph (b) of new Sec. 50.6. Retitle Sec. 50.4 as ``Waivers for research'' and insert former paragraphs Sec. 50.3 (a)(1) through (3) as new paragraphs (a) through (c). Revise new paragraph (a) to remove the sentence which reads ``The Board will not request a waiver when the application demonstrates that the exchange visitor is needed merely to provide services for a limited geographical area and/or to alleviate a local community or institutional manpower shortage, however serious.''

(5) Add a new Sec. 50.5 entitled ``Waivers for the delivery of health care service'' to provide criteria for requests for waivers
based on a need for the provision of health care service.

(6) Add new Sec. 50.6 entitled ``Procedures for Submission of application to HHS'' and insert former paragraph Sec. 50.2(d) as paragraph (a), and former paragraphs Sec. 50.4(a) and (b) as paragraphs (b) and (c).

(7) Redesignate former Sec. 50.5 as new Sec. 50.7.

(8) Remove former Sec. 50.6 as unnecessary.

(9) Add new Sec. 50.8 entitled ``Compliance'' to note the enforcement authority of INS and the responsibility of the alien
physician for compliance with the terms and conditions of both the applicable visa status and of the waiver.

Justification for Omitting Notice of Proposed Rulemaking

Notice and public comment and delayed effective date have been waived for these amendments because it has been found for good cause in accordance with 5 U.S.C. 553 that notice and comment are ``impracticable, unnecessary or contrary to the public interest.'' Since the mid-1990's, the Department of Agriculture placed more than 3,098 physicians in underserved areas in 48 states through its J-1 visa waiver program.

While the Department of Agriculture will no longer
be doing so, there remains a critical need for physicians in many parts of the United States that HHS is prepared to help meet by expanding its role in the J-1 visa waiver program and improving coordination of the placement of physicians in these areas. Any delay in implementation of these regulations would harm the medical needs of these vulnerable populations. Health care entities which will apply for exchange-visitor waivers have been unable to recruit adequate numbers of physicians to
provide health services within their geographic areas.

While the health care needs of underserved areas have decreased through the success of programs such as the National Health Service Corps and waivers requested by state public health departments, chronic shortages of physicians continue in certain geographic areas. Without Exchange Visitor physicians to help fill this gap, the health care needs of the populations in these areas remain unmet. Accordingly, the Secretary has determined, in accordance with 5 U.S.C. 553 and HHS policy, that it would be unnecessary and contrary to
the public interest to follow proposed rulemaking procedures in the issuance of these regulations or to delay their effective date. However, comments will be accepted at the above listed address for a period of 45 days following the publication of these regulations.

Economic and Regulatory Impact

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety distributive and equity effects). In addition, under the Regulatory Flexibility Act (RFA of 1980), if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

Executive Order 12866 requires that all regulations reflect consideration of alternatives of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations which are ``significant'' because of cost, adverse effects on the economy, inconsistency with
other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

The Department has determined that the resources required to implement the requirement in these regulations are minimal. Therefore, according to the RFA and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies this action will not impose a significant burden on a substantial number of small entities. The Secretary has also determined that this action does not meet criteria for a major rule as defined by Executive Order 12866 and
would have no major effect on the economy of Federal expenditures.

We have determined that the rule is not a ``major rule'' within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, the rule will not have effects on State, local and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. Further, Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed the action herein under the threshold criteria of Executive Order 13132, Federalism, and have determined that this action would not have substantial direct effects on the rights, roles and responsibilities of States.

Paperwork Reduction Act of 1995

This rule at 45 CFR Part 50 contains collection of information requirements subject to Office of Management and Budget (OMB) Review under the Paperwork Reduction Act (PRA) of 1995. These collection of information requirements are necessary to carry out the provisions of the Exchange Visitor program. In order to fairly evaluate whether an
information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: [sbull] Whether the information collection is necessary and useful to carry out the proper functions of the agency;[sbull] The accuracy of the agency's estimate of the information collection burden; [sbull] The quality, utility, and clarity of the information to be collected; and [sbull] Recommendations to minimize the information collection
burden on the affected public, including automated collection techniques.

Section 50.4 of the rule contains information collection requirements currently approved under OMB Control Number 0990-0001. Sections 50.5(e)(4) and (5) of the rule contain disclosure requirements. Section 50.5(e)(4) requires facilities or practices sponsoring an Exchange Visitor waiver request for the delivery of health care to post a notice of the charges for services. On an annual basis it is estimated that it will take 300 practices one hour each to prepare and post such notices. The total annual burden associated with this requirement is 300 hours. Section 50.5(e)(5) of the rules contains the requirements for the submission of evidence that the applicant made unsuccessful efforts to recruit a U.S. physician. The burden associated with these requirements is the time and effort necessary for an applicant to submit the documentation. On an annual basis it is estimated that it will take 300 applicants two hours each to and submit this documentation. The total annual burden associated with this requirement is 600 hours.

The Department will submit a copy of this Rule to the Office of Management and Budget (OMB) for its review of the information collection requirements described above. These requirements are not effective until OMB has approved them.
If you comment on any of these information collection requirements, please mail copies directly to the following:

Cynthia Agens Bauer, OS Reports Clearance Officer, Room 503H,
Humphrey Building, 200 Independence Avenue SW., Washington DC, 20201;
and Office of Information and Regulatory Affairs, Office of Management
and Budget, Room 10235, New Executive Office Building, Washington, DC
20503, ATTN: Allison Eydt, HHS Desk Officer.

National Health Objectives for the Year 2010