[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]
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