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[Federal Register Volume 75, Number 90 (Tuesday, May 11, 2010)]
[Proposed Rules]
[Pages 26167-26171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 5

Designation of Medically Underserved Populations and Health 
Professions Shortage Areas; Intent To Form Negotiated Rulemaking 
Committee

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of Intent To Form Negotiated Rulemaking Committee.

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SUMMARY: As required by Section 5602 of Public Law 111-148, the Patient 
Protection and Affordable Care Act of 2010, HRSA plans to establish a 
comprehensive methodology and criteria for Designation of Medically 
Underserved Populations (MUPs) and Primary Care Health Professions 
Shortage Areas (HPSAs) [under sections 330(b)(3) and 332 of the Public 
Health Service (PHS) Act, respectively], using a Negotiated Rulemaking 
process. To do this, HRSA intends to establish a Negotiated Rulemaking 
Committee under the Federal Advisory Committee Act (FACA).
    Use of this Negotiated Rulemaking (NR) process follows two previous 
publications of Proposed Rules on MUP/HPSA designation for public 
comment, one in 1998 and one in 2008. In both cases, many public 
comments were received, and the concerns expressed resulted in a HRSA 
decision to reconsider and develop a new proposal to be published at a 
later date; no final revised rule has yet been adopted. It is hoped 
that use of the NR process will yield a consensus among technical 
experts and stakeholders on a new rule, which will then be published as 
an Interim Final Rule in accordance with Section 5602.
    HRSA plans that the NR Committee on designations will include 
technical experts on indicators of underservice/shortage, data 
analysis, and on methodologies for combining multiple indicators, 
representing the public's interest in assuring that the areas, 
populations and entities to be designated under these rules, which 
become eligible for various Federal programs/resources, are truly 
underserved and/or have workforce shortages and representatives of 
programs and other stakeholders that are involved in the designation 
process and/or likely to be significantly affected by the designation 
rules; and (c) a HRSA representative. The Committee will also be 
assisted by a neutral facilitator.

[[Page 26168]]

    Topics on which Public Comments are solicited are:
    (1) Whether HRSA has properly identified the key issues in this 
designation rulemaking effort;
    (2) Whether HRSA has adequately identified key sources of subject 
matter technical expertise relevant to defining underservice and 
shortage and designating underserved areas and populations; and
    (3) Whether we have identified appropriate representatives of the 
various stakeholders/interests that will be affected by the final 
designation rules.

DATES: Comments, including requests to participate on the committee, 
will be considered if we receive them at the address provided below no 
later than 5 p.m. June 10, 2010.
    Address and Mode of Transmission for Comments: You may submit 
comments in one of three ways, as listed below. The first is the 
preferred method. Please submit your comments in only one of these 
ways, so that no duplicates are received.
    1. Federal eRulemaking Portal. You may submit comments 
electronically to http://www.regulations.gov. Click on the link 
``Submit electronic comments on HRSA regulations with an open comment 
period.'' Submit your actual comments as an attachment to your message 
or cover letter. (Attachments should be in Microsoft Word or 
WordPerfect; however, we prefer Microsoft Word.)
    2. By regular, express or overnight mail. You may mail written 
comments to the following address only: Health Resources and Services 
Administration, Department of Health and Human Services, Attention: 
HRSA Regulations Officer, Parklawn Building Rm. 14A-11, 5600 Fishers 
Lane, Rockville, MD 20857. Please allow sufficient time for mailed 
comments to be received before the close of the comment period.
    3. Delivery by hand (in person or by courier). If you prefer, you 
may deliver your written comments before the close of the comment 
period to the same address: Parklawn Building Room 14A-11, 5600 Fishers 
Lane, Rockville, MD 20857. Please call in advance to schedule your 
arrival with one of our HRSA Regulations Office staff members at 
telephone number (301) 443-1785.
    Because of staffing and resource limitations, and to ensure that no 
comments are misplaced, we cannot accept comments by facsimile (FAX) 
transmission.
    In commenting, please refer to file code  HRSA-1. Comments 
received on a timely basis will be available for public inspection as 
they are received, beginning approximately 3 weeks after publication of 
this Notice, in Room 14-05 of the Health Resources and Services 
Administration's offices at 5600 Fishers Lane, Rockville, MD., on 
Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: 
301-443-1785).

FOR FURTHER INFORMATION CONTACT: Director, HRSA Division of Policy 
Review and Coordination, at 301-443-1785.

SUPPLEMENTARY INFORMATION:

I. Negotiated Rulemaking Act

    The Negotiated Rulemaking Act (Pub. L. 101-648, 5 U.S.C. 561-570) 
establishes a seven-point framework for agency determinations to 
conduct negotiated rulemaking to enhance the rulemaking process. 
However, Congress in Public 111-148 has mandated the use of this 
process for developing a new MUP-HPSA designation methodology.
    In Negotiated Rulemaking (NR), negotiations are conducted by a 
committee, chartered under the Federal Advisory Committee Act (FACA) (5 
U.S.C. App. 2), with members chosen to represent the various interests 
that will be significantly affected by the rule. Each NR committee 
includes an agency representative and is assisted by a neutral 
facilitator. The goal of the committee is to reach consensus on the 
treatment of the major issues involved in the rule, including key 
issues of language. If consensus is reached, it is to be used as the 
basis of the agency's proposed rule. The NR process does not affect 
otherwise applicable procedural requirements of FACA, the 
Administrative Procedures Act or other statutes.

II. Subject and Scope of the Rule

A. Need for the Rule

    The current Health Professional Shortage Area (HPSA) criteria date 
back to 1978, when they were issued under Section 332 of the PHS Act, 
as amended in 1976; their predecessor, the Critical Health Manpower 
Shortage Area (CHMSA) criteria, date back to the 1971 legislation 
creating the National Health Service Corps. By statute, an area, 
population or facility must have a HPSA designation to be eligible to 
apply for placement of National Health Service Corps (NHSC) personnel.
    The original CHMSA criteria simply required that a population-to-
primary care physician ratio threshold be exceeded within a rational 
geographic service area to demonstrate shortage; the HPSA criteria kept 
this basic approach but expanded it to allow a lower threshold ratio 
for areas with unusually high needs, as indicated by high poverty, 
infant mortality or fertility rates, overutilization, or excessive 
waiting times, and to consider population groups with access barriers 
within areas where the general population has sufficient resources. 
Facility HPSA criteria were also included for prisons/correctional 
institutions and for other facilities serving designated areas or 
population groups.
    The current Medically Underserved Population (MUP) criteria date 
back to 1975, when they were issued to implement legislation enacted in 
1973 and 1974 establishing grants to support Health Maintenance 
Organizations (HMOs) and Community Health Centers (CHCs) serving 
medically underserved populations.
    The original MUP criteria, still in effect, employ a four-variable 
Index of Medical Underservice (IMU), with those variables being: 
percent of the population with incomes below the poverty level; primary 
care physician-to-population ratio; infant mortality rate; and percent 
of the population aged 65 or over. Data on these four variables within 
a geographic service area can be used to compute an IMU score for the 
area; areas whose score is below an established threshold are 
identified as medically underserved areas (MUAs). There are also 
guidelines for applying the IMU to identify certain underserved 
population groups within adequately served areas, and additional 
provisions for designation of other underserved populations, including 
special provisions for migrant and homeless populations, and for 
designation in unique circumstances upon recommendation of a State 
Governor and local officials. The term MUP is defined to include both 
residents of geographic MUAs and population groups designated as MUPs 
through various means.
    Since the time that designations of MUPs and HPSAs were first 
required by statute in connection with the NHSC and Community Health 
Center programs, additional programs have also been required by statute 
to use these designations. These include certification by the Centers 
for Medicare and Medicaid Services (CMS) of Rural Health Clinics (RHCs) 
located within rural areas that are HPSAs or MUPs, and the CMS Medicare 
Incentive Program, which provides higher reimbursement for physician 
services delivered in HPSAs. CMS also certifies as Federally Qualified 
Health Centers (FQHCs), organizations that do not receive HRSA grants 
but serve an MUP and otherwise

[[Page 26169]]

meet the definition of a Health Center under Section 330 of the PHS 
Act.
    Over the years there has been an evolution, both in the types of 
requests for HPSA or MUP designation received, and in the methods for 
application of the established criteria. Beyond the relatively simple 
geographic area requests, such as for whole counties and rural 
subcounty areas, increasingly more requests have been made for urban 
neighborhood and population group designations. The availability of 
census data on poverty, race, and ethnicity at the census tract level 
has enabled the delineation of urban service areas based on their 
economic and race/ethnicity characteristics. Areas with concentrations 
of poor, minority and/or linguistically isolated populations have 
achieved area or population group HPSA designations based on their 
limited access to physicians adequately serving other parts of their 
metropolitan areas. As a result, the conceptual distinction between 
HPSA and MUP designations has become less apparent.
    However, while the HPSAs are required by statute to be updated on a 
regular basis, no such statutory requirement exists for MUPs, with the 
result that many MUP designations are now significantly outdated. It is 
important that the list of designated MUPs, which is used by a variety 
of Federal programs, be reasonably current, and that the criteria used 
for these designations reflect underservice indicators currently 
relevant and available (and the currently prevailing range of values of 
those indicators), rather than being limited to those indicators that 
were available in the 1970s (and the range of indicator values then 
prevailing).
    For these reasons, consideration has been given to the development 
of a revised, more coordinated MUP and HPSA designation methodology and 
procedure that would, at a minimum, define consistently the indicators 
used for both designation types; clarify the distinctions between MUPs 
and HPSAs; and update both types of designation on a regular, 
simultaneous basis. Given the extensive numbers of comments received 
during the previous two attempts to do this using standard rulemaking 
procedures, Congress has now mandated the use of negotiated rulemaking.

B. Issues and Questions To Be Resolved

    Issues that HRSA anticipates will require resolution through the NR 
process are outlined below. HRSA also invites public comment on whether 
there are other issues important to this rulemaking and within the 
scope of the rule.
    1. Are the objectives of the MUP designations and the HPSA 
designations clearly different, therefore justifying two separate 
processes? Or are the objectives so closely related that a single 
designation approach should be used both for MUPs and for HPSAs?
    2. The MUP and HPSA statutes (PHS Act Sec. 330(b) and 332 
respectively) require the inclusion of factors indicative of health 
status, ability to pay for services, the accessibility of services, and 
the availability of health professionals, as well as other indicators 
of a need for health services (including infant mortality rates). What 
specific underservice/shortage indicators should be included, for 
either or both designation types, and how should they be defined/
measured? To what extent should national data sources be used, versus 
State and local sources? What existing data sources are accurate and 
reliable enough to use, at the appropriate level?
    (a) What provider availability measures should be used?
    (b) What economic factors may influence access and how can they be 
measured?
    (c) What health status indicators should be included?
    (d) What measures of utilization should be included?
    (e) What demographic indicators should be included, if any?
    3. What methodology or methodologies should be used to incorporate/
combine the impact of these various underservice indicators on access? 
Should indicators be combined in the same way or in different ways for 
use in MUP and HPSA designations?
    4. Within provider availability measures (such as population-to-
clinician ratios), which clinicians/providers should be included? How 
do we define full-time-equivalents (FTEs), as opposed to ``head 
counts''?
    5. In counting the clinicians available within an area (or to a 
population group) for designation update purposes, should those 
clinicians placed in the designated area under a Federal program be 
included?
    6. How should ``Rational Service Areas'' or RSAs be defined for 
designation purposes?
    7. What types of Population Groups should be considered for 
designation?
    8. What is the role of Facility designations, which are included 
under the HPSA authority (in Sec. 332 of the PHS Act)?
    9. How should appropriate threshold levels of various underservice/
shortage indicators incorporated in the method be identified to 
separate those areas, population groups and facilities found to qualify 
for designation from all others?
    10. How can the revised methodology and procedures be designed so 
as to reduce the burden of the designation application and update 
process on States and local entities?
    11. How should the Committee assess the potential impact of revised 
MUP/HPSA methodologies, versus continued use of the current methods? 
How can the impact of various options and methodologies best be 
summarized and displayed?
    12. How can the new methodology be implemented in a manner that 
minimizes disruption and assures equity to the various areas affected?

III. Affected Interests and Potential Participants

    We are proposing to include representatives of the following 
interest groups and/or organizations as negotiation participants.
    (1) Up to 3 State Primary Care Offices (PCOs) representing a range 
of States in terms of size, rural/urban, and different regions of the 
country, including at least one which is also a State Office of Rural 
Health (SORH). These PCO representatives would be requested to consult 
with their fellow PCOs between meetings.
    (2) National Organization of State Offices of Rural Health 
(NOSOHR).
    (3) Association of State and Territorial Health Officers (ASTHO) or 
National Academy for State Health Policy (NASHP).
    (4) Up to 3 State Primary Care Associations (PCAs) from different 
types of States.
    (5) National Association of Community Health Centers (NACHC).
    (6) National Association of Rural Health Clinics (NARHC).
    (7) National Rural Health Association.
    (8) Representatives of the Native American community, such as the 
National Indian Health Board (NIHB), or the National Council of Urban 
Indian Health (NCUIH).
    (9) Dartmouth Institute. It has expertise in rational service areas 
for primary care and hospital services, and the use of Medicare data 
for health systems analysis.
    (10) American Academy of Family Physicians, Robert Graham Center. 
It has expertise in health center service areas analysis and maintains 
``Health Landscape'' on-line data base of health care data for 
geographical analysis.
    (11) Representatives of primary care providers and training 
programs with expertise on supply and demand

[[Page 26170]]

analysis and issues of underservice. Representatives from some of these 
groups would be asked to represent a larger group's interests, 
including coordinating with sister organizations between NR meetings.
    (12) Representative(s) of organizations and institutions with 
expertise in complex data analysis, as well as expertise in measuring 
access to care and underservice.
    (13) Representatives of organizations representing State, 
territorial and local government elected officials to ensure their 
views are reflected in the process. Representatives from some of these 
groups would be asked to represent a larger group's interests, 
including coordinating with sister organizations between NR meetings.
    We invite comment on this list of negotiation participants. The 
intent in establishing the negotiating committee is that all relevant 
types of interests are represented, not necessarily all parties with 
similar interests. We believe this proposed list of participants 
represents all types of interests likely to be affected by the rule to 
be negotiated. If comments suggest that other interests should perhaps 
be included, the procedure described in section V.C below will be 
followed.

IV. Schedule for the Negotiation

    Public Law 111-148, the Patient Protection and Affordable Health 
Care Act of 2010, requires that this Notice be published within 45 days 
of enactment (i.e., by May 7, 2010), followed by a 30-day comment 
period (i.e., comments due approximately June 7, 2010). The Committee 
is to be appointed by the Secretary of Health and Human Services (HHS) 
within 30 days after the expiration of the comment period, or by 
approximately July 7, 2010. Within 10 days thereafter, the Secretary of 
HHS will nominate her choice of a facilitator. The facilitator will be 
subject to consensus approval by the NR Committee.
    Once the Committee membership is selected, a Notice regarding the 
meeting schedule will be published; it is anticipated that the meetings 
will begin in August or September. The first day's meeting will include 
discussion in detail on how the negotiations will proceed and how the 
Committee will function. The Committee will agree to ground rules for 
committee operation, will approve a facilitator, and discuss how best 
to address the principal issues (i.e., which issues to address first, 
and a tentative schedule for consideration of the rest of the issues). 
The Committee will then begin to address those issues.
    Subsequent meetings of the Committee will be held approximately 
monthly until all issues are resolved, allowing for members to report 
to and confer with their respective interest groups between meetings. 
We anticipate approximately six meetings, with each meeting lasting for 
2 to 3 days. If more meetings are required in order to resolve 
fractious issues, or to avoid slipping the target date, additional 
face-to-face meetings may be scheduled (up to a total of two per 
month), or detailed discussions on specific issues may be handled with 
conference telephone calls among identified subgroups of the Committee. 
The next key action is the submission of a preliminary committee report 
on the Committee's progress towards achieving consensus and the 
likelihood of achieving such a consensus by July 2011.
    If the preliminary report indicates that consensus is likely by 
July 1, 2011, HRSA would then help the Committee develop appropriate 
regulatory wording to implement the Committee's decisions. The 
Committee would submit a final report to the Secretary, including the 
draft version of the interim final rule (as required by the 
legislation). The target date for the final report would be July 1, 
2011. Actual publication would follow Departmental and Office of 
Management and Budget (OMB) review.
    If the preliminary committee report indicates a need for some 
additional time to achieve consensus, with corresponding postponement 
of the target date, the Secretary may grant a reasonable amount of 
additional time (such as 60 days). If the preliminary report indicates 
that the Committee has failed to make significant progress toward 
consensus and is unlikely to do so by the target date, the Secretary 
may terminate the activities of the Committee, and the Committee may 
submit to the Secretary a report specifying any areas of consensus and 
including any other information, recommendations or materials that the 
Committee considers appropriate. The Secretary will pursue publication 
of an interim-final rule by the target date, taking into account any 
areas of consensus, recommendations, and materials provided by the 
Committee.

V. Formation of the Negotiated Committee

A. Procedure for Establishing an Advisory Committee

    An agency of the Federal government is required to comply with the 
requirements of FACA when it establishes or uses a group that includes 
non-federal members as a source of advice. Under FACA, an advisory 
committee becomes established only after approval of an agreed-upon 
charter. We have prepared a draft charter and initiated the requisite 
consultation process. Following review of public comments on this 
Notice and upon successful completion of the approved charter, we will 
form the Committee and begin negotiations.

B. Participants

    The total number of individuals who will be asked to participate in 
this effort as NR Committee members is estimated to be about 20, and 
should not exceed 25. (A number larger than this would make it 
extremely difficult to conduct effective negotiations.) Each member 
will be asked to designate an Alternate in case the member is unable to 
attend one or more meetings, or wishes to share the responsibility with 
a close associate. (Alternates may attend any meeting with the Lead 
member, but in general the Lead member will be expected to do most of 
the talking when both are present.)
    One purpose of this Notice is to determine whether the proposed 
rule might significantly affect additional interests not adequately 
represented by the list of proposed participants included above. Each 
potentially affected organization or group of individuals does not 
necessarily need its own representative, since groups of organizations 
can work together to see that their collective interests are adequately 
represented. (See groupings of interest groups suggested above.) 
However, each identifiably separate interest must be adequately 
represented. Moreover, HRSA must be satisfied that the group as a whole 
reflects a proper balance and mix of the various interests.

C. Requests for Additional Representation

    Persons who wish to apply for membership on the Committee may 
submit an application or nomination, which shall include the following:
    (1) The name of the applicant or nominee and a description of the 
interests such person shall represent;
    (2) Evidence that the applicant or nominee is authorized to 
represent parties related to the interests the person proposes to 
represent;
    (3) A written commitment that the applicant or nominee shall 
actively participate in good faith in the development of the rule under 
consideration; and
    (4) The reasons that the persons specified in the notice under 
Section III do not adequately represent the interests

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of the person submitting the application or nomination.
    If, in response to this notice, representatives of additional 
interest groups request membership or representation in the negotiating 
group, HRSA will determine whether that representative should be added 
to the NR Committee or simply asked to submit its comments and concerns 
to us and to another Committee member. HRSA will make that decision 
based on whether the interest group:
     Would be significantly affected by the rule; and
     Is or is not already adequately represented on the 
proposed NR Committee.

D. Establishing the Committee

    After reviewing any public comments on this Notice and any requests 
for additional representation, HRSA will take the final steps required 
to form the Committee.

VI. Negotiation Procedures

    If and when this NR Committee is formed, the following procedures 
and guidelines will apply, unless they are modified as a result of 
comments received on this notice or during the negotiating process.

A. Facilitator

    HRSA will use a neutral facilitator. The facilitator will not be 
involved with advocating for substantive aspects of the regulation. The 
facilitator's role is to:
     Chair negotiating sessions, assuring equal opportunity 
among the various members to present their points of view;
     Help the negotiation process to run smoothly; and
     Help participants define and reach consensus.

B. Good Faith Negotiations

    Participants must be willing to negotiate in good faith, and must 
be authorized to so negotiate by the leaders of the organizations/
groups/interests they represent. This may best be accomplished by the 
selection of senior officials of the affected organizations or groups 
as participants, and/or by the selection of experienced individuals in 
such organizations/groups who have expertise in the issues subsumed by 
this rule and who have access to such senior officials, allowing them 
to obtain concurrence at each stage of the NR process. This applies to 
HRSA as well, and HRSA will appoint an appropriate representative, to 
represent HRSA/HHS when the committee is appointed. (Representatives of 
components of HRSA and CMS which use the MUP and HPSA designations will 
also be invited to attend the NR meetings as resources on how their 
programs relate to the designations, but the HRSA/HHS representative 
will be the spokesperson for HRSA and HHS interests in this NR effort 
and will meet with other HHS component representatives between NR 
Committee meetings to maximize coordination.)

C. Administrative Support

    HRSA will supply logistical, administrative and management support. 
HRSA will also provide technical support to the Committee in gathering 
and analyzing appropriate indicator data, methodologies and other 
information relevant to the Committee's work, and conduct appropriate 
impact analyses, with contractual support from John Snow, Inc. (JSI).

D. Meetings

    Meetings will typically be held in the DC metropolitan area or, if 
necessary, in another location, at the convenience of the Committee. 
HRSA will announce scheduled Committee meetings and agendas either in 
the Federal Register or on a committee Web site, yet to be established, 
whose location will be published in the Federal Register. Unless 
announced otherwise, meetings are open to the public.

E. Committee Procedures

    Under the general guidance and direction of the facilitator, and 
subject to any applicable legal requirements, the members will 
establish at the first meeting the detailed procedures for committee 
meetings which they consider most appropriate.

F. Defining Consensus

    The goal of the negotiating process is consensus. Under the 
Negotiated Rulemaking Act, consensus generally means that each interest 
group represented concurs in the result, unless the term is defined 
otherwise by the Committee. HRSA expects the participants to agree upon 
their working definition of this term at the first meeting.

G. Failure of Advisory Committee to Reach Consensus

    Parties to the NR effort may withdraw at any time. If this happens, 
the remaining Committee members and HRSA will evaluate whether the 
Committee should continue.
    If the Committee is unable to reach consensus, HRSA will proceed to 
develop a proposed/interim final rule on its own, as described above.

H. Record of Meetings

    In accordance with FACA's requirements, minutes of all Committee 
meetings will be kept. The minutes will be placed on the Committee's 
Web site and a copy kept in the public rulemaking record.

    Dated: May 6, 2010.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Dated: May 6, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-11214 Filed 5-7-10; 11:15 am]
BILLING CODE 4165-15-P
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