81_FR_56822 81 FR 56660 - Proposed Changes to the Black Lung Clinics Program

81 FR 56660 - Proposed Changes to the Black Lung Clinics Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 162 (August 22, 2016)

Page Range56660-56662
FR Document2016-19938

This notice seeks comments on a range of issues pertaining to the Black Lung Clinics Program (BLCP), which will be competitive in Fiscal Year (FY) 2017. HRSA's Federal Office of Rural Health Policy allocates funds for state, public, or private entities that provide medical, educational, and outreach services to active, inactive, and retired coal miners with disabilities. Funding allocations take into account the number of miners to be served; their medical, outreach, and educational needs; and the quality and breadth of services that are provided. HRSA requests feedback on how to best determine the needs of coal miners and their families, given the available data, and how to better equip future BLCP grantees to meet those needs.

Federal Register, Volume 81 Issue 162 (Monday, August 22, 2016)
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56660-56662]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Proposed Changes to the Black Lung Clinics Program

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Request for Public Comment on Proposed Changes to the Black 
Lung Clinics Program for Consideration for the FY 2017 Funding 
Opportunity Announcement Development.

-----------------------------------------------------------------------

SUMMARY: This notice seeks comments on a range of issues pertaining to 
the Black Lung Clinics Program (BLCP), which will be competitive in 
Fiscal Year (FY) 2017. HRSA's Federal Office of Rural Health Policy 
allocates funds for state, public, or private entities that provide 
medical, educational, and outreach services to active, inactive, and 
retired coal miners with disabilities. Funding allocations take into 
account the number of miners to be served; their medical, outreach, and 
educational needs; and the quality and breadth of services that are 
provided. HRSA requests feedback on how to best determine the needs of 
coal miners and their families, given the available data, and how to 
better equip future BLCP grantees to meet those needs.

DATES: Submit written comments no later than September 21, 2016.

ADDRESSES: Written comments should be submitted to [email protected].

FOR FURTHER INFORMATION CONTACT: Allison Hutchings, Program 
Coordinator, Black Lung Clinics Program, Federal Office of Rural Health 
Policy, Health Resources and Services Administration, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

a. Authorizing Legislation and Program Regulations

    BLCP is authorized by Section 427(a) of the Federal Mine Safety and 
Health Act of 1977 (30 U.S.C. 937(a)), as amended, and accompanying 
regulations found at 42 CFR part 55a (``BLCP regulations''). HRSA began 
administering the program in FY 1979, when $7.5 million was 
appropriated. HRSA awarded approximately $6.5 million to clinics in FY 
2015.
    The primary goal of the BLCP is to reduce the morbidity and 
mortality associated with occupationally-related coal mine dust lung 
disease. The BLCP regulations (42 CFR part 55a) state that BLCP 
grantees must provide for the following services to active and inactive 
miners, in consultation with a physician with special training or 
experience in the diagnosis and treatment of respiratory diseases: 
primary care; patient and family education and counseling; outreach; 
patient care coordination; antismoking advice; and other symptomatic 
treatments. Additionally, BLCP grantees must serve as payers of last 
resort and be able to administer, or provide referrals for, U.S. 
Department of Labor (DOL) disability examinations.

b. Eligibility and Funding Criteria

    The BLCP funding opportunity is open to any state or public or 
private entity that meets the requirements of the BLCP as described 
above. These entities include faith-based and community-based 
organizations, as well as federally recognized Tribes and Tribal 
organizations.
    The BLCP regulations state that the funding criteria for applicants 
should take into account: (1) The number of miners to be served and 
their needs; and (2) the quality and breadth of services to be 
provided. The regulations also state that ``the Secretary will give 
preference to a State, which meets the requirement of this part and 
applies for a grant under this part, over other applications in that 
State''.

c. Application Cycle

    HRSA administers the BLCP over 3-year grant cycles. The program was 
last competitive in FY 2014, and current BLCP grantees finished their 
second year of the cycle on June 30, 2016. The program will be 
competitive again in FY 2017.

II. Current Challenges

a. Growing Need for Black Lung Services

    In FY 2000, surveillance data from the Centers for Disease Control 
and Prevention's National Institute of Occupational Safety and Health 
(NIOSH) showed an unexpected increase in the national prevalence of 
coal workers' pneumoconiosis (CWP), also known as black lung disease, 
after nearly three decades of steady decline following the enactment of 
the Federal Coal Mine Health and Safety Act of 1969. The overall CWP 
prevalence among U.S. coal workers declined from 11 percent in 1970 to 
2 percent in 1999. However, since 2000, the prevalence of CWP has 
increased to 3 percent and continues to rise. According to NIOSH 
surveillance data, the rise in CWP has been the most severe among coal 
miners

[[Page 56661]]

in Kentucky, Virginia, and West Virginia. Compared with coal miners in 
other states, these miners tend to be younger, with fewer years of work 
experience in underground mines. Investigators from NIOSH reported that 
the prevalence of progressive massive fibrosis (PMF), the most severe 
form of black lung disease, increased 900 percent between 2000 and 
2012, affecting over 3 percent of miners with over 25 years of work. 
This level of prevalence of PMF has not been seen since the 1970s. 
Additionally, NIOSH has reported that coal miners are developing severe 
CWP at relatively young ages.
    Finally, the U.S. coal industry is currently experiencing a 
downturn. Industry analysts estimate that nearly 50 coal companies have 
sought bankruptcy court protection since 2012, resulting in layoffs 
and, in some cases, lost retirement benefits for coal miners. According 
to a 2016 report by the Appalachian Regional Commission, Appalachian 
Kentucky experienced a coal mining job decline of 56 percent between 
2011 and 2015, while Tennessee and Virginia both experienced declines 
of approximately 40 percent during the same time period. The West 
Virginia Office of Miners Health Safety and Training has estimated that 
there are currently 12,000 coal miners employed in the state, down from 
22,000 in 2011. Widespread coal mining job losses have also been 
reported in other states such as Pennsylvania, Ohio, and Alabama. These 
trends have the potential to affect coal miners' economic welfare and, 
by extension, their ability to access or afford health care. Indeed, 
some current BLCP grantees have noted in their annual progress reports 
to HRSA, submitted April 2016, and in written email communication ahead 
of the March 2016 HRSA BLCP Grantee Workshop, that they have witnessed 
a recent uptick in the number of coal miners visiting their clinics, 
which some attribute to industry layoffs.

b. Ongoing Challenges in Meeting Those Needs

    Current BLCP grantees reported facing several challenges in meeting 
the needs of coal miners in their service areas during a March 2016 
BLCP Grantee Workshop hosted by HRSA. First, recruitment, training, and 
retention of qualified clinical and benefits counseling staff remain 
difficult, particularly in rural areas. Second, coal miners often face 
transportation and other barriers to accessing health services, which 
is problematic given that many suffer from chronic conditions that 
require regular management and treatment. Third, BLCP grantees have 
indicated that some miners, including those who have been laid off or 
are not part of a union, are difficult to locate, which can complicate 
outreach and service delivery efforts. Finally, there continues to be a 
shortage of clinicians willing and able to perform exams related to the 
emerging DOL standards for x-rays, pulmonary testing, and medical 
documentation, particularly in rural areas.

c. Limited Available Data

    Overarching these challenges is the lack of a single, 
comprehensive, national dataset that contains information on active, 
inactive and retired, and disabled U.S. coal miners who have worked in 
surface and underground mines. DOL's Office of Workers' Compensation 
Programs and Mine Safety and Health Administration, along with NIOSH's 
Coal Workers' Health Surveillance Program, each regularly collect 
health and safety data on coal miners, but these data address specific 
and separate aspects of this population. HRSA also collects yearly 
performance data from BLCP grantees, but these data are in aggregate 
form making it problematic to analyze patient-level data or link to DOL 
or NIOSH's datasets. As a result, it is difficult to ascertain both the 
total number of active, inactive and retired, and coal miners with 
disabilities in a given service area, as well as the complete health 
and wellness profile of U.S. coal miners. This makes it difficult for 
HRSA to assess where U.S. coal miners reside and what their needs are. 
Per statute, HRSA is required to allocate BLCP grant funds based in 
part on ``the number of miners to be served and their needs.'' 
Additionally, the lack of comprehensive data on coal miners is a 
challenge to current BLCP grantees that use BLCP funds to target and 
deliver services to miners.

III. FY 2014 Funding Approach and Current BLCP Cohort

a. Overview of FY 2014 Funding Approach

    In FY 2014, HRSA tested a new funding approach that aimed to 
respond to the growing national need for BLCP services, as well as the 
BLCP regulations' requirement to allocate BLCP grant funds according 
to: (1) The number of miners to be served and their needs; and (2) the 
quality and breadth of services to be provided. The new funding 
approach enabled individual applicants to apply for a specific tier of 
funding, depending on the level of services they intended to provide 
(see pp. 6-9 of the FY 2014 Funding Opportunity Announcement). 
Historically, the mix of BLCP grantees and applicants has been broad in 
terms of those who are very clinically focused and those who are more 
geared towards outreach, education, and counseling. The tiered-based 
funding approach was designed, in part, to account for these 
differences. Additionally, the funding methodology took into account 
available data on the number of coal miners and coal mines in a service 
area, as reported by the U.S. Department of Energy's Energy Information 
Administration (EIA) and other national, state, and local resources.

b. Current BLCP Cohort

    Following a competitive application process, HRSA allocated 
approximately $6.5 million among 15 BLCP grantees. These grantees 
provided medical, outreach, educational, and counseling services to 
11,843 miners across 14 states in FY 2014.

c. Black Lung Center of Excellence

    HRSA also funded one Black Lung Center of Excellence (BLCE) through 
a cooperative agreement in FY 2014 to strengthen the quality of the 
BLCP and respond to some of the challenges faced by BLCP grantees and 
the program as a whole, including around the emerging clinical 
requirements related to DOL's black lung claims process.

IV. Request for Public Comment on Next Funding Opportunity Announcement 
(FOA)

a. Background

    The BLCP will be competitive again in FY 2017, and HRSA is seeking 
public comment on issues pertaining to the program, including:

b. Funding Approach

    Following the release of the new funding approach in FY 2014, some 
stakeholders expressed concern that the funding tiers increased the 
administrative burden on applicants and, in some cases, reduced funding 
for applicants that experienced a high demand for black lung services 
in their service areas. With this request, HRSA invites public comment 
on the FY 2014 funding approach and suggestions for other funding 
methodologies that will allocate BLCP grant funds based on the 
healthcare needs of coal miners and the ability of applicants to meet 
those needs, while minimizing service disruption, aligning with the 
program's statutory and regulatory requirements, and taking into 
account the amount of available funding.

[[Page 56662]]

    One approach HRSA would like to seek feedback on includes a service 
area competition whereby HRSA allocates funds to states based on the 
need for services (which includes the number of miners in the state) 
and the implications of taking into account historical funding amounts 
in administering the program.

c. Determining Need

    HRSA's FY 2014 funding methodology aimed to better align the BLCP 
with the regulations, which require HRSA to allocate funds based on: 
(1) The number of miners to be served and their needs; and (2) the 
quality and breadth of services to be provided. To that end, the FY 
2014 funding methodology took into account the number of coal miners 
and coal mines in a service area, as reported by EIA and other 
national, state, and local resources, as well as the level of services 
an applicant intended to provide. HRSA recognizes that these data do 
not necessarily encapsulate important factors like disease severity and 
comorbidity, disability, and employment status, all of which could 
affect the time and resources grantees must devote to delivering health 
and social services to coal miners. With the recent downturn of the 
U.S. coal industry, and the corresponding layoffs of coal miners, the 
numbers of active coal miners and coal mines in a service area may not 
be the most accurate indicators of need for services. Therefore, HRSA 
invites public comment on how to better define and measure the diverse 
needs of coal miners based on publicly available data to ensure that 
HRSA allocates BLCP grant funds to areas of the country where they are 
most needed.

d. Data Collection

    Currently, BLCP grantees report performance data on the number of 
coal miners they serve and the number and type of services they provide 
to HRSA. These aggregated data provide little insight into the quality 
of services clinics provide, nor relevant factors such as comorbid 
conditions, smoking history, and insurance coverage. Requiring BLCP 
grantees to collect and report on patient-level data would strengthen 
the quality of the BLCP by enabling HRSA to better understand coal 
miners' needs, the ability of BLCP grantees to meet those needs, and, 
importantly, how to better allocate BLCP grant funds. Additionally, 
given that the majority of coal miners served by BLCP grantees are 
retired, collecting patient-level data would enable HRSA to add to the 
limited body of knowledge on this population.
    However, despite the benefits of patient-level data collection, 
HRSA recognizes that this process may be administratively and 
financially burdensome for BLCP grantees. Therefore, HRSA invites 
public comment on whether it should require grantees to collect and 
report patient-level data, either through the current performance 
measurement system or a separate black lung clinical database.

e. The Black Lung Center of Excellence (BLCE)

    In FY 2014, HRSA funded one BLCE through a cooperative agreement to 
focus on the quality aspect of the BLCP. The current BLCE grantee, with 
assistance from HRSA, has implemented a number of activities aimed at 
achieving HRSA's goals around quality, including:
     Developing and launching the BLCE Web site to provide BLCP 
grantees, miners, and others who provide services to miners with 
educational expertise and resources on coal mine dust lung disease;
     Creating four training modules in collaboration with the 
DOL, Division of Coal Mine Workers Compensation, for medical providers 
and Black Lung examiners that provide in-depth information on 
screening, diagnosis, and treatment of coal mine lung dust disease;
     Providing technical assistance to BLCP grantees; and
     Developing and piloting the Black Lung Clinical Research 
Database (REDCap) to standardize clinical data collection and 
performance data submission by HRSA BLCP grantees.

HRSA invites public comment on how HRSA can better leverage the BLCE's 
expertise and quantify the BLCE's impact on BLCP grantees and the coal 
miners they serve through performance measures.

f. Timeliness and Quality of DOL Exams

    One of the goals of the BLCP, as outlined in the FY 2014 funding 
opportunity announcement, is to ``provide well-reasoned medical 
opinions and timely scheduling/completion of DOL medical exams to 
facilitate the filing of Federal Black Lung Benefits claims.'' HRSA 
proposes to work with DOL's Office of Workers' Compensation Programs 
(OWCP) to hold BLCP grantees to standards for medical exam timeliness. 
In particular, these standards would require clinicians performing 
413(b) examinations, who are affiliated with BLCP clinics, to complete 
initial 413(b) requests within 90 days and 413(b) supplemental medical 
evidence development within 60 days. Additionally, to strengthen the 
quality of services provided by BLCP grantees, HRSA proposes requiring 
medical and non-medical personnel from all BLCP clinics to complete the 
OWCP-sponsored training modules entitled ``Black Lung Disability 
Evaluation and Claims Training for Medical Examiners'' prior to 
applying for BLCP grant funds. HRSA invites public comment on whether 
these requirements are reasonable and attentive approaches to 
strengthening the quality of medical services provided by BLCP 
grantees.

g. Grantee Collaboration

    The current BLCP grantees and applicants are mixed in terms of 
those who are clinically focused and those who are service focused. 
Encouraging grantees to share best practices and provide technical 
assistance to one another could help strengthen the quality of the 
BLCP. Proposed mechanisms for achieving greater collaboration include 
allowing grantees to allocate a portion of their award towards 
providing on-site or remote technical assistance to other clinics and/
or encouraging grantees to participate in a yearly peer learning 
workshop hosted by HRSA. HRSA invites public comment on these 
strategies as well as how the BLCE can play a role in facilitating 
grantee collaboration.

h. Pulmonary Rehabilitation

    The current BLCP grant guidance requires grantees to provide for 
accredited pulmonary rehabilitation services. The first two funding 
tiers require BLCP grantees to provide ``on-site or contracted 
accredited Phase II or Phase III rehabilitation services,'' while the 
third and highest funding tier requires BLCP grantees to provide an 
``on-site'' and ``American Association of Cardiovascular and Pulmonary 
Rehabilitation (AACVPR)-certified'' pulmonary rehabilitation program. 
Current BLCP grantees have expressed concerns that these standards are 
difficult to meet, particularly in rural areas where miners have to 
travel long distances to attend multiple sessions a week. Thus, HRSA 
invites public comment on how to revise the BLCP requirements around 
pulmonary rehabilitation such that they are feasible but still ensure 
that miners receive a variation of this beneficial service.

    Dated: August 15, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-19938 Filed 8-19-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                    56660                                 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices

                                                                                                                 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                             Number of                                                Average
                                                                                                                                                  Number of                   responses                Total annual
                                                                                   21 CFR section                                                                                                                                   burden per              Total hours
                                                                                                                                                 respondents                     per                    responses                    response
                                                                                                                                                                             respondent

                                                    516.20;   content and format of MUMS request ....................                                               15                          5                         75                         16            1200
                                                    516.26;   requirements for amending MUMS designation .....                                                       3                          1                          3                          2               6
                                                    516.27;   change in sponsorship ............................................                                     1                          1                          1                          1               1
                                                    516.29;   termination of MUMS designation ..........................                                             2                          1                          2                          1               2
                                                    516.30;   requirements of annual reports ..............................                                         15                          5                         75                          2             150
                                                    516.36;   insufficient quantities ..............................................                                 1                          1                          1                          3               3

                                                         Total ..............................................................................   ........................   ........................   ........................   ........................          1,362
                                                       1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                      The burden estimate for this reporting                                  their families, given the available data,                                   b. Eligibility and Funding Criteria
                                                    requirement was derived in our Office                                     and how to better equip future BLCP                                           The BLCP funding opportunity is
                                                    of Minor Use and Minor Species Animal                                     grantees to meet those needs.                                               open to any state or public or private
                                                    Drug Development by extrapolating the                                                                                                                 entity that meets the requirements of the
                                                                                                                              DATES:  Submit written comments no
                                                    investigational new animal drug/new                                                                                                                   BLCP as described above. These entities
                                                    animal drug application reporting                                         later than September 21, 2016.
                                                                                                                                                                                                          include faith-based and community-
                                                    requirements for similar actions by this                                  ADDRESSES: Written comments should                                          based organizations, as well as federally
                                                    same segment of the regulated industry                                    be submitted to Blacklung@hrsa.gov.                                         recognized Tribes and Tribal
                                                    and from previous interactions with the                                                                                                               organizations.
                                                                                                                              FOR FURTHER INFORMATION CONTACT:
                                                    minor use/minor species community.                                                                                                                      The BLCP regulations state that the
                                                                                                                              Allison Hutchings, Program
                                                      Dated: August 16, 2016.                                                 Coordinator, Black Lung Clinics                                             funding criteria for applicants should
                                                    Jeremy Sharp,                                                             Program, Federal Office of Rural Health                                     take into account: (1) The number of
                                                    Deputy Commissioner for Policy, Planning,                                 Policy, Health Resources and Services                                       miners to be served and their needs; and
                                                    Legislation, and Analysis.                                                Administration, Blacklung@hrsa.gov.                                         (2) the quality and breadth of services to
                                                    [FR Doc. 2016–19919 Filed 8–19–16; 8:45 am]                                                                                                           be provided. The regulations also state
                                                                                                                              SUPPLEMENTARY INFORMATION:                                                  that ‘‘the Secretary will give preference
                                                    BILLING CODE 4164–01–P
                                                                                                                              I. Background                                                               to a State, which meets the requirement
                                                                                                                                                                                                          of this part and applies for a grant under
                                                    DEPARTMENT OF HEALTH AND                                                  a. Authorizing Legislation and Program                                      this part, over other applications in that
                                                    HUMAN SERVICES                                                            Regulations                                                                 State’’.

                                                    Health Resources and Services                                                BLCP is authorized by Section 427(a)                                     c. Application Cycle
                                                    Administration                                                            of the Federal Mine Safety and Health                                         HRSA administers the BLCP over 3-
                                                                                                                              Act of 1977 (30 U.S.C. 937(a)), as                                          year grant cycles. The program was last
                                                    Proposed Changes to the Black Lung                                        amended, and accompanying                                                   competitive in FY 2014, and current
                                                    Clinics Program                                                           regulations found at 42 CFR part 55a                                        BLCP grantees finished their second
                                                                                                                              (‘‘BLCP regulations’’). HRSA began                                          year of the cycle on June 30, 2016. The
                                                    AGENCY:  Health Resources and Services
                                                                                                                              administering the program in FY 1979,                                       program will be competitive again in FY
                                                    Administration (HRSA), HHS.
                                                                                                                              when $7.5 million was appropriated.                                         2017.
                                                    ACTION: Request for Public Comment on                                     HRSA awarded approximately $6.5
                                                    Proposed Changes to the Black Lung                                        million to clinics in FY 2015.                                              II. Current Challenges
                                                    Clinics Program for Consideration for                                                                                                                 a. Growing Need for Black Lung Services
                                                    the FY 2017 Funding Opportunity                                              The primary goal of the BLCP is to
                                                    Announcement Development.                                                 reduce the morbidity and mortality                                            In FY 2000, surveillance data from the
                                                                                                                              associated with occupationally-related                                      Centers for Disease Control and
                                                    SUMMARY:   This notice seeks comments                                     coal mine dust lung disease. The BLCP                                       Prevention’s National Institute of
                                                    on a range of issues pertaining to the                                    regulations (42 CFR part 55a) state that                                    Occupational Safety and Health
                                                    Black Lung Clinics Program (BLCP),                                        BLCP grantees must provide for the                                          (NIOSH) showed an unexpected
                                                    which will be competitive in Fiscal Year                                  following services to active and inactive                                   increase in the national prevalence of
                                                    (FY) 2017. HRSA’s Federal Office of                                       miners, in consultation with a physician                                    coal workers’ pneumoconiosis (CWP),
                                                    Rural Health Policy allocates funds for                                   with special training or experience in                                      also known as black lung disease, after
                                                    state, public, or private entities that                                   the diagnosis and treatment of                                              nearly three decades of steady decline
                                                    provide medical, educational, and                                         respiratory diseases: primary care;                                         following the enactment of the Federal
                                                    outreach services to active, inactive, and                                patient and family education and                                            Coal Mine Health and Safety Act of
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                                                    retired coal miners with disabilities.                                    counseling; outreach; patient care                                          1969. The overall CWP prevalence
                                                    Funding allocations take into account                                     coordination; antismoking advice; and                                       among U.S. coal workers declined from
                                                    the number of miners to be served; their                                  other symptomatic treatments.                                               11 percent in 1970 to 2 percent in 1999.
                                                    medical, outreach, and educational                                        Additionally, BLCP grantees must serve                                      However, since 2000, the prevalence of
                                                    needs; and the quality and breadth of                                     as payers of last resort and be able to                                     CWP has increased to 3 percent and
                                                    services that are provided. HRSA                                          administer, or provide referrals for, U.S.                                  continues to rise. According to NIOSH
                                                    requests feedback on how to best                                          Department of Labor (DOL) disability                                        surveillance data, the rise in CWP has
                                                    determine the needs of coal miners and                                    examinations.                                                               been the most severe among coal miners


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                                                                                 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices                                           56661

                                                    in Kentucky, Virginia, and West                         conditions that require regular                       services they intended to provide (see
                                                    Virginia. Compared with coal miners in                  management and treatment. Third,                      pp. 6–9 of the FY 2014 Funding
                                                    other states, these miners tend to be                   BLCP grantees have indicated that some                Opportunity Announcement).
                                                    younger, with fewer years of work                       miners, including those who have been                 Historically, the mix of BLCP grantees
                                                    experience in underground mines.                        laid off or are not part of a union, are              and applicants has been broad in terms
                                                    Investigators from NIOSH reported that                  difficult to locate, which can complicate             of those who are very clinically focused
                                                    the prevalence of progressive massive                   outreach and service delivery efforts.                and those who are more geared towards
                                                    fibrosis (PMF), the most severe form of                 Finally, there continues to be a shortage             outreach, education, and counseling.
                                                    black lung disease, increased 900                       of clinicians willing and able to perform             The tiered-based funding approach was
                                                    percent between 2000 and 2012,                          exams related to the emerging DOL                     designed, in part, to account for these
                                                    affecting over 3 percent of miners with                 standards for x-rays, pulmonary testing,              differences. Additionally, the funding
                                                    over 25 years of work. This level of                    and medical documentation,                            methodology took into account available
                                                    prevalence of PMF has not been seen                     particularly in rural areas.                          data on the number of coal miners and
                                                    since the 1970s. Additionally, NIOSH                                                                          coal mines in a service area, as reported
                                                    has reported that coal miners are                       c. Limited Available Data                             by the U.S. Department of Energy’s
                                                    developing severe CWP at relatively                        Overarching these challenges is the                Energy Information Administration
                                                    young ages.                                             lack of a single, comprehensive,                      (EIA) and other national, state, and
                                                       Finally, the U.S. coal industry is                   national dataset that contains                        local resources.
                                                    currently experiencing a downturn.                      information on active, inactive and
                                                    Industry analysts estimate that nearly 50                                                                     b. Current BLCP Cohort
                                                                                                            retired, and disabled U.S. coal miners
                                                    coal companies have sought bankruptcy                   who have worked in surface and                           Following a competitive application
                                                    court protection since 2012, resulting in               underground mines. DOL’s Office of                    process, HRSA allocated approximately
                                                    layoffs and, in some cases, lost                        Workers’ Compensation Programs and                    $6.5 million among 15 BLCP grantees.
                                                    retirement benefits for coal miners.                    Mine Safety and Health Administration,                These grantees provided medical,
                                                    According to a 2016 report by the                       along with NIOSH’s Coal Workers’                      outreach, educational, and counseling
                                                    Appalachian Regional Commission,                        Health Surveillance Program, each                     services to 11,843 miners across 14
                                                    Appalachian Kentucky experienced a                      regularly collect health and safety data              states in FY 2014.
                                                    coal mining job decline of 56 percent                   on coal miners, but these data address                c. Black Lung Center of Excellence
                                                    between 2011 and 2015, while                            specific and separate aspects of this
                                                    Tennessee and Virginia both                                                                                      HRSA also funded one Black Lung
                                                                                                            population. HRSA also collects yearly
                                                    experienced declines of approximately                                                                         Center of Excellence (BLCE) through a
                                                                                                            performance data from BLCP grantees,
                                                    40 percent during the same time period.                                                                       cooperative agreement in FY 2014 to
                                                                                                            but these data are in aggregate form
                                                    The West Virginia Office of Miners                                                                            strengthen the quality of the BLCP and
                                                                                                            making it problematic to analyze
                                                    Health Safety and Training has                                                                                respond to some of the challenges faced
                                                                                                            patient-level data or link to DOL or
                                                    estimated that there are currently 12,000                                                                     by BLCP grantees and the program as a
                                                                                                            NIOSH’s datasets. As a result, it is
                                                    coal miners employed in the state, down                                                                       whole, including around the emerging
                                                                                                            difficult to ascertain both the total                 clinical requirements related to DOL’s
                                                    from 22,000 in 2011. Widespread coal                    number of active, inactive and retired,
                                                    mining job losses have also been                                                                              black lung claims process.
                                                                                                            and coal miners with disabilities in a
                                                    reported in other states such as                        given service area, as well as the                    IV. Request for Public Comment on
                                                    Pennsylvania, Ohio, and Alabama.                        complete health and wellness profile of               Next Funding Opportunity
                                                    These trends have the potential to affect               U.S. coal miners. This makes it difficult             Announcement (FOA)
                                                    coal miners’ economic welfare and, by                   for HRSA to assess where U.S. coal
                                                    extension, their ability to access or                                                                         a. Background
                                                                                                            miners reside and what their needs are.
                                                    afford health care. Indeed, some current                Per statute, HRSA is required to allocate                The BLCP will be competitive again
                                                    BLCP grantees have noted in their                       BLCP grant funds based in part on ‘‘the               in FY 2017, and HRSA is seeking public
                                                    annual progress reports to HRSA,                        number of miners to be served and their               comment on issues pertaining to the
                                                    submitted April 2016, and in written                    needs.’’ Additionally, the lack of                    program, including:
                                                    email communication ahead of the                        comprehensive data on coal miners is a                b. Funding Approach
                                                    March 2016 HRSA BLCP Grantee                            challenge to current BLCP grantees that
                                                    Workshop, that they have witnessed a                                                                             Following the release of the new
                                                                                                            use BLCP funds to target and deliver
                                                    recent uptick in the number of coal                                                                           funding approach in FY 2014, some
                                                                                                            services to miners.                                   stakeholders expressed concern that the
                                                    miners visiting their clinics, which
                                                    some attribute to industry layoffs.                     III. FY 2014 Funding Approach and                     funding tiers increased the
                                                                                                            Current BLCP Cohort                                   administrative burden on applicants
                                                    b. Ongoing Challenges in Meeting Those                                                                        and, in some cases, reduced funding for
                                                    Needs                                                   a. Overview of FY 2014 Funding                        applicants that experienced a high
                                                       Current BLCP grantees reported facing                Approach                                              demand for black lung services in their
                                                    several challenges in meeting the needs                    In FY 2014, HRSA tested a new                      service areas. With this request, HRSA
                                                    of coal miners in their service areas                   funding approach that aimed to respond                invites public comment on the FY 2014
                                                    during a March 2016 BLCP Grantee                        to the growing national need for BLCP                 funding approach and suggestions for
                                                    Workshop hosted by HRSA. First,                         services, as well as the BLCP                         other funding methodologies that will
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                                                    recruitment, training, and retention of                 regulations’ requirement to allocate                  allocate BLCP grant funds based on the
                                                    qualified clinical and benefits                         BLCP grant funds according to: (1) The                healthcare needs of coal miners and the
                                                    counseling staff remain difficult,                      number of miners to be served and their               ability of applicants to meet those
                                                    particularly in rural areas. Second, coal               needs; and (2) the quality and breadth                needs, while minimizing service
                                                    miners often face transportation and                    of services to be provided. The new                   disruption, aligning with the program’s
                                                    other barriers to accessing health                      funding approach enabled individual                   statutory and regulatory requirements,
                                                    services, which is problematic given                    applicants to apply for a specific tier of            and taking into account the amount of
                                                    that many suffer from chronic                           funding, depending on the level of                    available funding.


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                                                    56662                        Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices

                                                      One approach HRSA would like to                         However, despite the benefits of                    60 days. Additionally, to strengthen the
                                                    seek feedback on includes a service area                patient-level data collection, HRSA                   quality of services provided by BLCP
                                                    competition whereby HRSA allocates                      recognizes that this process may be                   grantees, HRSA proposes requiring
                                                    funds to states based on the need for                   administratively and financially                      medical and non-medical personnel
                                                    services (which includes the number of                  burdensome for BLCP grantees.                         from all BLCP clinics to complete the
                                                    miners in the state) and the implications               Therefore, HRSA invites public                        OWCP-sponsored training modules
                                                    of taking into account historical funding               comment on whether it should require                  entitled ‘‘Black Lung Disability
                                                    amounts in administering the program.                   grantees to collect and report patient-               Evaluation and Claims Training for
                                                                                                            level data, either through the current                Medical Examiners’’ prior to applying
                                                    c. Determining Need
                                                                                                            performance measurement system or a                   for BLCP grant funds. HRSA invites
                                                       HRSA’s FY 2014 funding                               separate black lung clinical database.                public comment on whether these
                                                    methodology aimed to better align the                                                                         requirements are reasonable and
                                                    BLCP with the regulations, which                        e. The Black Lung Center of Excellence
                                                                                                            (BLCE)                                                attentive approaches to strengthening
                                                    require HRSA to allocate funds based                                                                          the quality of medical services provided
                                                    on: (1) The number of miners to be                         In FY 2014, HRSA funded one BLCE                   by BLCP grantees.
                                                    served and their needs; and (2) the                     through a cooperative agreement to
                                                    quality and breadth of services to be                   focus on the quality aspect of the BLCP.              g. Grantee Collaboration
                                                    provided. To that end, the FY 2014                      The current BLCE grantee, with
                                                    funding methodology took into account                   assistance from HRSA, has implemented                   The current BLCP grantees and
                                                    the number of coal miners and coal                      a number of activities aimed at                       applicants are mixed in terms of those
                                                    mines in a service area, as reported by                 achieving HRSA’s goals around quality,                who are clinically focused and those
                                                    EIA and other national, state, and local                including:                                            who are service focused. Encouraging
                                                    resources, as well as the level of services                • Developing and launching the BLCE                grantees to share best practices and
                                                    an applicant intended to provide. HRSA                  Web site to provide BLCP grantees,                    provide technical assistance to one
                                                    recognizes that these data do not                       miners, and others who provide services               another could help strengthen the
                                                    necessarily encapsulate important                       to miners with educational expertise                  quality of the BLCP. Proposed
                                                    factors like disease severity and                       and resources on coal mine dust lung                  mechanisms for achieving greater
                                                    comorbidity, disability, and                            disease;                                              collaboration include allowing grantees
                                                    employment status, all of which could                      • Creating four training modules in                to allocate a portion of their award
                                                    affect the time and resources grantees                  collaboration with the DOL, Division of               towards providing on-site or remote
                                                    must devote to delivering health and                    Coal Mine Workers Compensation, for                   technical assistance to other clinics and/
                                                    social services to coal miners. With the                medical providers and Black Lung                      or encouraging grantees to participate in
                                                    recent downturn of the U.S. coal                        examiners that provide in-depth                       a yearly peer learning workshop hosted
                                                    industry, and the corresponding layoffs                 information on screening, diagnosis,                  by HRSA. HRSA invites public
                                                    of coal miners, the numbers of active                   and treatment of coal mine lung dust                  comment on these strategies as well as
                                                    coal miners and coal mines in a service                 disease;                                              how the BLCE can play a role in
                                                    area may not be the most accurate                          • Providing technical assistance to                facilitating grantee collaboration.
                                                    indicators of need for services.                        BLCP grantees; and                                    h. Pulmonary Rehabilitation
                                                    Therefore, HRSA invites public                             • Developing and piloting the Black
                                                    comment on how to better define and                     Lung Clinical Research Database                          The current BLCP grant guidance
                                                    measure the diverse needs of coal                       (REDCap) to standardize clinical data                 requires grantees to provide for
                                                    miners based on publicly available data                 collection and performance data                       accredited pulmonary rehabilitation
                                                    to ensure that HRSA allocates BLCP                      submission by HRSA BLCP grantees.                     services. The first two funding tiers
                                                    grant funds to areas of the country                     HRSA invites public comment on how                    require BLCP grantees to provide ‘‘on-
                                                    where they are most needed.                             HRSA can better leverage the BLCE’s                   site or contracted accredited Phase II or
                                                                                                            expertise and quantify the BLCE’s                     Phase III rehabilitation services,’’ while
                                                    d. Data Collection
                                                                                                            impact on BLCP grantees and the coal                  the third and highest funding tier
                                                       Currently, BLCP grantees report                      miners they serve through performance                 requires BLCP grantees to provide an
                                                    performance data on the number of coal                  measures.                                             ‘‘on-site’’ and ‘‘American Association of
                                                    miners they serve and the number and                                                                          Cardiovascular and Pulmonary
                                                    type of services they provide to HRSA.                  f. Timeliness and Quality of DOL Exams
                                                                                                                                                                  Rehabilitation (AACVPR)-certified’’
                                                    These aggregated data provide little                       One of the goals of the BLCP, as                   pulmonary rehabilitation program.
                                                    insight into the quality of services                    outlined in the FY 2014 funding                       Current BLCP grantees have expressed
                                                    clinics provide, nor relevant factors                   opportunity announcement, is to                       concerns that these standards are
                                                    such as comorbid conditions, smoking                    ‘‘provide well-reasoned medical                       difficult to meet, particularly in rural
                                                    history, and insurance coverage.                        opinions and timely scheduling/                       areas where miners have to travel long
                                                    Requiring BLCP grantees to collect and                  completion of DOL medical exams to                    distances to attend multiple sessions a
                                                    report on patient-level data would                      facilitate the filing of Federal Black                week. Thus, HRSA invites public
                                                    strengthen the quality of the BLCP by                   Lung Benefits claims.’’ HRSA proposes                 comment on how to revise the BLCP
                                                    enabling HRSA to better understand                      to work with DOL’s Office of Workers’                 requirements around pulmonary
                                                    coal miners’ needs, the ability of BLCP                 Compensation Programs (OWCP) to
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                                                                                                                                                                  rehabilitation such that they are feasible
                                                    grantees to meet those needs, and,                      hold BLCP grantees to standards for                   but still ensure that miners receive a
                                                    importantly, how to better allocate                     medical exam timeliness. In particular,               variation of this beneficial service.
                                                    BLCP grant funds. Additionally, given                   these standards would require clinicians
                                                                                                                                                                    Dated: August 15, 2016.
                                                    that the majority of coal miners served                 performing 413(b) examinations, who
                                                    by BLCP grantees are retired, collecting                are affiliated with BLCP clinics, to                  James Macrae,
                                                    patient-level data would enable HRSA                    complete initial 413(b) requests within               Acting Administrator.
                                                    to add to the limited body of knowledge                 90 days and 413(b) supplemental                       [FR Doc. 2016–19938 Filed 8–19–16; 8:45 am]
                                                    on this population.                                     medical evidence development within                   BILLING CODE 4165–15–P




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Document Created: 2018-02-09 11:37:46
Document Modified: 2018-02-09 11:37:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for Public Comment on Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development.
DatesSubmit written comments no later than September 21, 2016.
ContactAllison Hutchings, Program Coordinator, Black Lung Clinics Program, Federal Office of Rural Health Policy, Health Resources and Services Administration, [email protected]
FR Citation81 FR 56660 

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