[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1353-1356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Proposed Changes to the Black Lung Clinics Program for 
Consideration for the FY 2017 Funding Opportunity Announcement 
Development

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Response to comments.

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SUMMARY: The Federal Office of Rural Health Policy (FORHP) in HRSA 
published a 30-day public notice in the Federal Register on August 22, 
2016 soliciting feedback on a range of issues pertaining to the Black 
Lung Clinics Program (BLCP). In particular, FORHP requested 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. This notice responds to the comments received 
during this 30-day public notice.

ADDRESSES: Further information on the Black Lung clinics program is 
available at http://www.hrsa.gov/gethealthcare/conditions/blacklung/.

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: The Federal Office of Rural Health Policy 
(FORHP) in HRSA published a 30-day public notice in the Federal 
Register on August 22, 2016 (Federal Register volume 81, number 162, 
pp. 56660-56662) soliciting feedback on a range of issues pertaining to 
the Black Lung Clinics Program (BLCP). In particular, FORHP requested 
feedback on how to best determine the needs of coal miners and their 
families, given the available

[[Page 1354]]

data, and how to better equip future BLCP grantees to meet those needs.

Background

    The 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.
    Following the release of the Fiscal Year (FY) 2014 BLCP funding 
opportunity announcement (FOA), HRSA received feedback on the funding 
approach used and other elements of the program. On August 22, 2016, 
through a Federal Register Notice (FRN), HRSA announced a 30-day public 
comment period to solicit input on BLCP and better understand the needs 
of coal miners and the clinics that serve them. In particular, HRSA 
received feedback on the following program components in response to 
the FRN:
     Funding Approach;
     Determining Need;
     Data Collection;
     Black Lung Center of Excellence (BLCE);
     Timeliness and Quality of U.S. Department of Labor (DOL) 
Exams;
     Grantee Collaboration;
     Pulmonary Rehabilitation; and
     Geographic Boundaries.
    HRSA carefully reviewed and considered the comments it received and 
used them to both guide the development of the FY 2017 BLCP FOA and to 
inform the broader landscape in which the program operates.

Comments on the Proposed Changes to the Black Lung Clinics Program

    HRSA received 17 comments to the FRN, representing 15 black lung 
clinics; the National Coalition of Black Lung and Respiratory Disease 
Clinics, Inc.; and attorneys from a law firm that represents claimants 
in black lung claims. HRSA has synthesized and summarized the comments 
below.

Funding Approach

Summary of Comments

    Commenters provided a variety of input on funding allocations. Some 
commenters suggested that funding should be prioritized based on the 
level and quality of services offered at the site. For example, some 
commenters recommended that funding should be weighted toward sites 
that can offer all required testing at one location or whose service 
offerings are more comprehensive, with one commenter stating that 
funding levels should be based on providing all the services 
recommended in HRSA's 2002-08 Policy Information Notice entitled 
``Black Lung Clinics Program Expectations and Principles of Practice.'' 
Others indicated that funding should prioritize services that are non-
reimbursable, like benefits counseling. Several commenters said the 
funding tier system instituted in FY 2014 should be eliminated because 
it limited the clinics' ability to tailor services to meet their 
patients' needs and imposed standards that were difficult for rural 
clinics to meet, given workforce shortages and other challenges. 
Another commenter expressed concerns about the funding cap HRSA 
instituted on individual applicants. Most of the commenters agreed that 
funding should be allocated based on several factors, including the 
number of miners (active and inactive) served, the geographic service 
area, and/or historical funding amounts. Some commenters thought taking 
BLCP awardees' historical funding amounts into account was reasonable, 
while others thought historical funding amounts were irrelevant in a 
competitive cycle. Still another commenter suggested that HRSA give all 
BLCP awardees an equal base award amount and then add incremental award 
amounts based on the number of active and retired coal miners in a 
service area and the breadth and quality of services that require grant 
funding.

Response

    In developing the new funding approach outlined in the FY 2017 BLCP 
FOA, HRSA sought to address respondents' concerns regarding the 
previous three-tiered funding structure and per-applicant cap, while 
also minimizing service disruption and adhering to statutory 
requirements.
    The FY 2017 BLCP FOA does not include the previous per-applicant 
cap. Funding amounts are allocated to service areas based on the amount 
each area received in FY 2016, assuming the same level of appropriation 
as in the previous year. Each service area represents an area currently 
covered by a BLCP awardee. Any individual applicant can apply for the 
full amount awarded to an area, but they can only apply to serve one 
service area.
    HRSA also removed the three-tiered funding structure. Instead, a 
set of minimum service and staffing requirements for all applicants was 
instituted. In addition, applicants applying to serve areas in which 
BLCP awardees are currently providing more advanced levels of service 
are encouraged to maintain those levels (referred to in the FY 2017 
BLCP FOA as ``recommended guidelines'') in order to minimize service 
disruptions.
    However, recognizing that BLCP awardees have developed different 
approaches to delivering care to coal miners in response to their 
patients' needs and organizational capacity, applicants may request to 
be excepted from up to two of the recommended guidelines. The 
exceptions give BLCP awardees flexibility to tailor their programs 
according to their patients' needs and organizational capacity.
    The FY 2017 BLCP FOA assumes no increases in funding for the BLCP, 
so each service area is expected to receive the same ratio of funding 
it received in FY 2016 in order to minimize service disruptions. 
However, commenters' suggestions for how to allocate funding across 
applicants will be considered in future grant cycles.

Determining Need

Summary of Comments

    Nearly all of the commenters agreed that there are limitations in 
the data for determining miners' needs for services and some said that 
the availability of patient-level data would strengthen their ability 
to determine need. One commenter stated that relying on data from areas 
with only active mines does not present an accurate picture of need 
since these data overlook miners with needs in service areas with non-
active mines. Another commenter noted that they lack data on the number 
of disabled or retired miners in their service areas and that a 
possible solution to this would be to rely on claims data filed with 
DOL to determine the needs of that specific miner population. Still 
others recommended that HRSA take into account information available 
through data sources, research publications, academic medical centers 
and other government entities; the location of black lung clinics in 
relation to the populations they serve; miners' employment status; and 
the existence of coal-fired power plant workers to determine need. 
Finally, one commenter suggested using a weighted disability index 
system using age and level of impairment to determine need.

Response

    HRSA recognizes that there are many different factors that should 
to be taken into account when assessing coal miners' needs, as well as 
challenges given the limited and fragmented data available on U.S. coal 
miners. As in previous FOAs, HRSA included ``Need'' as a review 
criterion in the FY 2017 BLCP FOA and applicants are encouraged to 
utilize a range of local, state, and national resources to describe

[[Page 1355]]

the number of coal miners in their service area as well as their health 
status and unmet health needs. While HRSA cannot implement all of the 
commenters' suggestions for how to determine need in this grant cycle, 
it will consider them in future cycles.

Grantee Collaboration

Summary of Comments

    Nearly all of the commenters agreed that networking and peer-to-
peer training and sharing of best practices are important components of 
successful program implementation. Most commenters supported a yearly 
peer-to-peer workshop and also stated that collaboration should 
continue through existing forums, such as the annual HRSA, Pipestem, 
and National Coalition of Black Lung and Respiratory Disease Clinics 
meetings. Commenters noted that it was ``essential'' that HRSA continue 
to support these trainings and collaboration forums and one stated that 
BLCP grant funds should be allowed for travel to the National Coalition 
of Black Lung and Respiratory Disease Clinic's annual educational 
conference.

Response

    HRSA recognizes the important role that educational conferences 
play in strengthening the quality and breadth of services provided to 
coal miners. In the FY 2014 BLCP FOA, HRSA placed a restriction on 
using BLCP grant funds to subsidize attendance to the annual National 
Coalition of Black Lung and Respiratory Disease Clinics' annual 
educational conference. The FY 2017 BLCP FOA lifts this restriction, 
although applicants must justify the reasonableness of their proposed 
conference attendance and travel budgets and assure compliance with 
grant guidance related to advocacy activities. However, HRSA retained 
the restriction on using BLCP grant funds to subsidize membership dues 
and fees associated with the National Coalition of Black Lung and 
Respiratory Disease Clinics. Subject to the availability of travel 
funds and other factors, HRSA will continue to attend and participate 
in the existing education and collaboration forums.

Data Collection

Summary of Comments

    Commenters were in near-universal agreement about the benefits of 
patient-level data collection and the inadequacies of the current 
performance measurement system, but some expressed concerns about the 
burden patient-level data collection would impose on clinics. 
Commenters noted that data collection methods and databases vary across 
the grantees, and that some grantees may need more IT support and 
funding than others to carry out new data collection activities. Others 
noted the administrative burden of reporting data into more than one 
database. Some commenters stated that the REDCap database, a patient-
level database that has been piloted with a few grantees by the BLCE, 
was a promising start, and at least one commenter recommended that it 
be expanded to all grantees as one possible common platform. Other 
commenters said a patient-level database should be housed in and 
maintained by HRSA and not by the BLCE.

Response

    Patient-level data collection and reporting will benefit the coal 
miners, clinics, and the broader medical and public health communities 
by enabling HRSA and BLCP awardees to better assess miners' needs and 
program impact. Therefore, for the purposes of the FY 2017-2020 grant 
cycle, HRSA will explore the development of a patient-level database 
and will work with its federal partners, the BLCE, and BLCP awardees to 
develop a new set of data measures for the program. By the third year 
of the grant (July 1, 2019-June 30, 2020), it is anticipated that all 
BLCP awardees will be expected to collect and report patient-level data 
to HRSA. In developing these requirements, efforts will be made to 
minimize administrative and financial burden on BLCP awardees.

BLCE

Summary of Comments

    Commenters expressed mixed support for BLCE in its current form. In 
general, the training modules developed by the BLCE were well received 
and one commenter stated that they appreciated having training come 
from the BLCE as opposed to other grantees who may be in direct 
competition with them for patients. One commenter stated BLCE has not 
achieved its stated goals and that BLCE funding would be more effective 
if allocated to the clinics, while others questioned whether BLCE's 
services were being used or if they were relevant to non-hospital-based 
clinics. Still others suggested that the BLCE be restructured to 
encourage contributions from other grantees and that technical 
assistance around benefits counseling would be beneficial.

Response

    HRSA established the BLCE in FY 2014 to provide technical 
assistance and training to BLCP awardees and to identify and 
disseminate best practices. HRSA agrees that the role and expectations 
of the BLCE should be better defined in order to maximize its impact. 
For the FY 2017-2020 grant cycle, HRSA refined the scope of the BLCE to 
focus on strengthening the operation of BLCP awardees and their ability 
to examine and treat respiratory and pulmonary impairments in active 
and inactive coal miners through improved data collection and analysis 
and contributing to the body of knowledge on the health status and 
needs of U.S. coal miners nationally. At the same time, the FY 2017 
BLCE FOA allowed applicants to propose additional technical assistance 
and/or training activities in recognition of the ongoing and evolving 
need for these initiatives.

Timeliness and Quality of DOL Exams

Summary of Comments

    Two commenters agreed with HRSA's proposal to hold 413(b) providers 
affiliated with FORHP-funded black lung clinics accountable to DOL's 
standards for medical exam timeliness. Another suggested that DOL issue 
``report cards'' to 413(b) providers on timeliness so they can correct 
course if necessary before HRSA holds them accountable. A few 
commenters expressed concern that the timeliness requirement could 
affect the quality of the exam or have other unintended consequences. 
Regarding the proposal to require clinical personnel to take the DOL-
sponsored training modules, some commenters agreed that the proposal 
was reasonable, while others expressed concern that the few providers 
performing DOL exams would shy away from participating if they were 
required to take the modules. One commenter stated that the requirement 
for BLCP staff to complete the DOL training modules should come from 
DOL and not HRSA, and another commenter disagreed entirely with the 
training requirement proposal.

Response

    HRSA recognizes the importance of working closely with DOL's Office 
of Workers' Compensation Programs to ensure that providers performing 
DOL medical exams adhere to DOL's timeliness and quality standards and 
goals, while also understanding some of the limitations these providers 
face. Therefore, the FY 2017 BLCP FOA strongly encourages BLCP awardees 
performing DOL medical exams onsite to (1) adhere to the performance 
measures as outlined in DOL-Office of

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Workers' Compensation Programs Performance Measures as it relates to 
the Black Lung Program, (2) to submit documents relevant to active 
Black Lung benefits claims electronically into Claimant Online Access 
Link (C.O.A.L.) and (3) to follow other procedures and training related 
to diagnostic and medical providers. This last point encompasses the 
learning modules entitled ``Black Lung Disability Evaluation and Claims 
Training for Medical Examiners'' and available at https://www.publichealthlearning.com/course/category.php?id=35. HRSA will 
continue to work with DOL and BLCP awardees to strengthen this 
component of the BLCP.

Pulmonary Rehabilitation

Summary of Comments

    All of the commenters agreed that onsite pulmonary rehabilitation 
is a vital service. However, most commenters expressed concerns that 
this service is not widely available to miners who need it because it 
is costly to operate, there are low rates of reimbursement, and miners 
often aren't able to travel to clinics that do offer treatment. Some 
commenters said that consideration should be given for non-traditional 
pulmonary treatment programs, such as in-home treatments, and that HRSA 
should further research the effectiveness of these programs. A few 
commenters argued that BLCP clinics should collaborate more with 
hospital-based pulmonary rehabilitation programs in multiple 
communities to make it more feasible for miners to receive treatment. 
Nearly all of the commenters expressed concerns that American 
Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) 
certification is difficult to obtain and financially burdensome to the 
clinics, and that it is not cost-effective for the clinic to try to 
meet this standard for additional grant funding.

Response

    In the FY 2014 BLCP FOA, BLCP awardees receiving the highest level 
of funding were required to provide AACVPR-certified pulmonary 
rehabilitation programs onsite. The FY 2017 BLCP FOA removes this 
requirement and instead requires all applicants to propose, at a 
minimum, onsite, contracted, or referral to accredited Phase II or 
Phase III pulmonary rehab services. BLCP awardees providing AACVPR-
certified programs to coal miners may maintain their certification if 
they choose, but this is no longer a requirement.

Geographic Boundaries

Summary of Comments

    A few commenters expressed concern over how HRSA defines the 
service areas of each clinic. At least two noted that in some cases, 
coal miners work or reside in closer proximity to clinics in 
neighboring states than to those within the same state, but that HRSA 
limits clinics' ability to conduct outreach in other states. Another 
commenter stated that some clinics provide complementary services in 
close proximity to one another.

Response

    In certain cases, the FY 2017 BLCP FOA allows more than one BLCP 
awardee to provide services to coal miners in a given county, provided 
those awardees detail how they will avoid duplicating efforts of other 
black lung clinics. Applicants may also propose to provide services 
(including outreach) to coal miners in counties other than the ones 
listed in the FY 2017 BLCP FOA, including counties in neighboring 
states, provided that they demonstrate how their services will 
complement--rather than duplicate--existing efforts in those counties. 
A coal miner may receive services at a black lung clinic of his or her 
choosing, regardless of that clinic's location or service area 
designation.

Conclusion

    HRSA considers many of the comments received to be useful and 
informative to future discussions on how to strengthen the BLCP in 
future years and appreciates the interest and dedication of the 
commenters who are committed to serving U.S. coal miners. Any questions 
or concerns should be directed to [email protected].

Diana Espinosa,
Deputy Administrator.
[FR Doc. 2016-32003 Filed 1-4-17; 8:45 am]
 BILLING CODE 4165-15-P