82_FR_1356 82 FR 1353 - Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development

82 FR 1353 - Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range1353-1356
FR Document2016-32003

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.

Federal Register, Volume 82 Issue 3 (Thursday, January 5, 2017)
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1353-1356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-32003]


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

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.

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

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

[[Page 1356]]

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



                                                                                            Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices                                                                         1353

                                                  located in HPSAs must submit an NHSC                                         used. NHSC sites that do not directly                           Burden Statement: Burden in this
                                                  Site Application and Site Recertification                                    offer all required behavioral health                         context means the time expended by
                                                  Application to determine the eligibility                                     services must demonstrate a formal                           persons to generate, maintain, retain,
                                                  of sites to participate in the NHSC as an                                    affiliation with a comprehensive,                            disclose, or provide the information
                                                  approved service site. The NHSC LRP                                          community-based primary behavioral                           requested. This includes the time
                                                  participant application asks for                                             health setting or facility to provide these                  needed to review instructions; to
                                                  personal, professional, and financial                                        services.                                                    develop, acquire, install, and utilize
                                                  information needed to determine the                                             Likely Respondents: Likely                                technology and systems for the purpose
                                                                                                                               respondents include: Licensed primary
                                                  applicant’s eligibility to participate in                                                                                                 of collecting, validating and verifying
                                                                                                                               care medical, dental, and behavioral
                                                  the NHSC LRP. In addition, applicants                                                                                                     information, processing and
                                                                                                                               health providers who are employed or
                                                  must provide information regarding the                                       seeking employment, and are interested                       maintaining information, and disclosing
                                                  loans for which repayment is being                                           in serving underserved populations;                          and providing information; to train
                                                  requested. NHSC policy requires                                              health care facilities interested in                         personnel and be able to respond to a
                                                  behavioral health providers to practice                                      participating in the NHSC and becoming                       collection of information; to search data
                                                  in community-based settings that                                             an NHSC-approved service site; and                           sources; to complete and review the
                                                  provide access to comprehensive                                              NHSC sites providing behavioral health                       collection of information; and to
                                                  behavioral health services. Accordingly,                                     care services directly or through a                          transmit or otherwise disclose the
                                                  for those sites seeking to be assigned                                       formal affiliation with a comprehensive                      information. The total annual burden
                                                  behavioral health NHSC participants,                                         community-based primary behavioral                           hours estimated for this Information
                                                  additional site information collected                                        health setting or facility providing                         Collection Request are summarized in
                                                  from an NHSC Comprehensive                                                   comprehensive behavioral health                              the table below.
                                                  Behavioral Health Services Checklist is                                      services.
                                                                                                                       TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                Average
                                                                                                                                                                    Number of
                                                                                                                                                  Number of                                    Total          burden per              Total burden
                                                                                      Form name                                                                   responses per
                                                                                                                                                 respondents                                responses          response                  hours
                                                                                                                                                                    respondent                                 (in hours)

                                                  NHSC LRP Application ........................................................                         8,200                         1           8,200                         1            8,200
                                                  Authorization for Disclosure of Loan Information Form .......                                         6,500                         1           6,500                       .10              650
                                                  Privacy Act Release Authorization Form .............................                                    275                         1             275                       .10             27.5
                                                  Verification of Disadvantaged Background Form ................                                          600                         1             600                       .50              300
                                                  Private Practice Option Form ..............................................                             300                         1             300                       .10               30
                                                  NHSC Comprehensive Behavioral Health Services Check-
                                                    list .....................................................................................         * 4,000                        1           4,000                       .13              520
                                                  NHSC Site Application (including recertification) ................                                   * 3,700                        1           3,700                         .5           1,850

                                                        Total ..............................................................................           19,875    ........................        19,875    ........................      11,577.50
                                                     * The same respondents are completing the NHSC Comprehensive Behavioral Services Checklist and the NHSC Site Application.


                                                    HRSA specifically requests comments                                        DEPARTMENT OF HEALTH AND                                     grantees to meet those needs. This
                                                  on (1) the necessity and utility of the                                      HUMAN SERVICES                                               notice responds to the comments
                                                  proposed information collection for the                                                                                                   received during this 30-day public
                                                  proper performance of the agency’s                                           Health Resources and Services                                notice.
                                                  functions, (2) the accuracy of the                                           Administration                                               ADDRESSES: Further information on the
                                                  estimated burden, (3) ways to enhance                                                                                                     Black Lung clinics program is available
                                                                                                                               Proposed Changes to the Black Lung
                                                  the quality, utility, and clarity of the                                                                                                  at http://www.hrsa.gov/gethealthcare/
                                                                                                                               Clinics Program for Consideration for
                                                  information to be collected, and (4) the                                     the FY 2017 Funding Opportunity                              conditions/blacklung/.
                                                  use of automated collection techniques                                       Announcement Development                                     FOR FURTHER INFORMATION CONTACT:
                                                  or other forms of information                                                                                                             Allison Hutchings, Program
                                                  technology to minimize the information                                       AGENCY:  Health Resources and Services                       Coordinator, Black Lung Clinics
                                                  collection burden.                                                           Administration (HRSA), Department of                         Program, Federal Office of Rural Health
                                                                                                                               Health and Human Services.                                   Policy, Health Resources and Services
                                                  Amy McNulty,                                                                                                                              Administration, blacklung@hrsa.gov.
                                                                                                                               ACTION: Response to comments.
                                                  Deputy Director, Division of the Executive                                                                                                SUPPLEMENTARY INFORMATION: The
                                                  Secretariat.                                                                 SUMMARY:    The Federal Office of Rural                      Federal Office of Rural Health Policy
                                                  [FR Doc. 2016–31723 Filed 1–4–17; 8:45 am]                                   Health Policy (FORHP) in HRSA                                (FORHP) in HRSA published a 30-day
                                                  BILLING CODE 4165–15–P                                                       published a 30-day public notice in the                      public notice in the Federal Register on
                                                                                                                               Federal Register on August 22, 2016                          August 22, 2016 (Federal Register
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                               soliciting feedback on a range of issues                     volume 81, number 162, pp. 56660–
                                                                                                                               pertaining to the Black Lung Clinics                         56662) soliciting feedback on a range of
                                                                                                                               Program (BLCP). In particular, FORHP                         issues pertaining to the Black Lung
                                                                                                                               requested feedback on how to best                            Clinics Program (BLCP). In particular,
                                                                                                                               determine the needs of coal miners and                       FORHP requested feedback on how to
                                                                                                                               their families, given the available data,                    best determine the needs of coal miners
                                                                                                                               and how to better equip future BLCP                          and their families, given the available


                                             VerDate Sep<11>2014         21:06 Jan 04, 2017          Jkt 241001       PO 00000        Frm 00044   Fmt 4703   Sfmt 4703    E:\FR\FM\05JAN1.SGM     05JAN1


                                                  1354                          Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices

                                                  data, and how to better equip future                    ‘‘Black Lung Clinics Program                              However, recognizing that BLCP
                                                  BLCP grantees to meet those needs.                      Expectations and Principles of                         awardees have developed different
                                                                                                          Practice.’’ Others indicated that funding              approaches to delivering care to coal
                                                  Background
                                                                                                          should prioritize services that are non-               miners in response to their patients’
                                                    The BLCP is authorized by Section                     reimbursable, like benefits counseling.                needs and organizational capacity,
                                                  427(a) of the Federal Mine Safety and                   Several commenters said the funding                    applicants may request to be excepted
                                                  Health Act of 1977 (30 U.S.C. 937(a)), as               tier system instituted in FY 2014 should               from up to two of the recommended
                                                  amended, and accompanying                               be eliminated because it limited the                   guidelines. The exceptions give BLCP
                                                  regulations found at 42 CFR part 55a.                   clinics’ ability to tailor services to meet            awardees flexibility to tailor their
                                                    Following the release of the Fiscal                   their patients’ needs and imposed                      programs according to their patients’
                                                  Year (FY) 2014 BLCP funding                             standards that were difficult for rural                needs and organizational capacity.
                                                  opportunity announcement (FOA),                         clinics to meet, given workforce                          The FY 2017 BLCP FOA assumes no
                                                  HRSA received feedback on the funding                   shortages and other challenges. Another                increases in funding for the BLCP, so
                                                  approach used and other elements of the                 commenter expressed concerns about                     each service area is expected to receive
                                                  program. On August 22, 2016, through                    the funding cap HRSA instituted on                     the same ratio of funding it received in
                                                  a Federal Register Notice (FRN), HRSA                   individual applicants. Most of the                     FY 2016 in order to minimize service
                                                  announced a 30-day public comment                       commenters agreed that funding should                  disruptions. However, commenters’
                                                  period to solicit input on BLCP and                     be allocated based on several factors,                 suggestions for how to allocate funding
                                                  better understand the needs of coal                     including the number of miners (active                 across applicants will be considered in
                                                  miners and the clinics that serve them.                 and inactive) served, the geographic                   future grant cycles.
                                                  In particular, HRSA received feedback                   service area, and/or historical funding
                                                  on the following program components                     amounts. Some commenters thought                       Determining Need
                                                  in response to the FRN:                                 taking BLCP awardees’ historical                       Summary of Comments
                                                    • Funding Approach;                                   funding amounts into account was
                                                                                                                                                                    Nearly all of the commenters agreed
                                                    • Determining Need;                                   reasonable, while others thought
                                                                                                                                                                 that there are limitations in the data for
                                                    • Data Collection;                                    historical funding amounts were
                                                                                                                                                                 determining miners’ needs for services
                                                    • Black Lung Center of Excellence                     irrelevant in a competitive cycle. Still
                                                                                                                                                                 and some said that the availability of
                                                  (BLCE);                                                 another commenter suggested that
                                                                                                                                                                 patient-level data would strengthen
                                                    • Timeliness and Quality of U.S.                      HRSA give all BLCP awardees an equal
                                                                                                                                                                 their ability to determine need. One
                                                  Department of Labor (DOL) Exams;                        base award amount and then add
                                                                                                                                                                 commenter stated that relying on data
                                                    • Grantee Collaboration;                              incremental award amounts based on
                                                                                                                                                                 from areas with only active mines does
                                                    • Pulmonary Rehabilitation; and                       the number of active and retired coal
                                                                                                                                                                 not present an accurate picture of need
                                                    • Geographic Boundaries.                              miners in a service area and the breadth
                                                                                                                                                                 since these data overlook miners with
                                                    HRSA carefully reviewed and                           and quality of services that require grant
                                                                                                          funding.                                               needs in service areas with non-active
                                                  considered the comments it received                                                                            mines. Another commenter noted that
                                                  and used them to both guide the                         Response                                               they lack data on the number of
                                                  development of the FY 2017 BLCP FOA                                                                            disabled or retired miners in their
                                                  and to inform the broader landscape in                     In developing the new funding
                                                                                                          approach outlined in the FY 2017 BLCP                  service areas and that a possible
                                                  which the program operates.                                                                                    solution to this would be to rely on
                                                                                                          FOA, HRSA sought to address
                                                  Comments on the Proposed Changes to                     respondents’ concerns regarding the                    claims data filed with DOL to determine
                                                  the Black Lung Clinics Program                          previous three-tiered funding structure                the needs of that specific miner
                                                                                                          and per-applicant cap, while also                      population. Still others recommended
                                                    HRSA received 17 comments to the
                                                                                                          minimizing service disruption and                      that HRSA take into account
                                                  FRN, representing 15 black lung clinics;
                                                                                                          adhering to statutory requirements.                    information available through data
                                                  the National Coalition of Black Lung
                                                                                                             The FY 2017 BLCP FOA does not                       sources, research publications,
                                                  and Respiratory Disease Clinics, Inc.;
                                                                                                          include the previous per-applicant cap.                academic medical centers and other
                                                  and attorneys from a law firm that
                                                                                                          Funding amounts are allocated to                       government entities; the location of
                                                  represents claimants in black lung
                                                                                                          service areas based on the amount each                 black lung clinics in relation to the
                                                  claims. HRSA has synthesized and
                                                                                                          area received in FY 2016, assuming the                 populations they serve; miners’
                                                  summarized the comments below.
                                                                                                          same level of appropriation as in the                  employment status; and the existence of
                                                  Funding Approach                                        previous year. Each service area                       coal-fired power plant workers to
                                                                                                          represents an area currently covered by                determine need. Finally, one commenter
                                                  Summary of Comments
                                                                                                          a BLCP awardee. Any individual                         suggested using a weighted disability
                                                     Commenters provided a variety of                     applicant can apply for the full amount                index system using age and level of
                                                  input on funding allocations. Some                      awarded to an area, but they can only                  impairment to determine need.
                                                  commenters suggested that funding                       apply to serve one service area.
                                                  should be prioritized based on the level                   HRSA also removed the three-tiered                  Response
                                                  and quality of services offered at the                  funding structure. Instead, a set of                     HRSA recognizes that there are many
                                                  site. For example, some commenters                      minimum service and staffing                           different factors that should to be taken
                                                  recommended that funding should be                      requirements for all applicants was                    into account when assessing coal
                                                  weighted toward sites that can offer all                instituted. In addition, applicants                    miners’ needs, as well as challenges
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                                                  required testing at one location or                     applying to serve areas in which BLCP                  given the limited and fragmented data
                                                  whose service offerings are more                        awardees are currently providing more                  available on U.S. coal miners. As in
                                                  comprehensive, with one commenter                       advanced levels of service are                         previous FOAs, HRSA included ‘‘Need’’
                                                  stating that funding levels should be                   encouraged to maintain those levels                    as a review criterion in the FY 2017
                                                  based on providing all the services                     (referred to in the FY 2017 BLCP FOA                   BLCP FOA and applicants are
                                                  recommended in HRSA’s 2002–08                           as ‘‘recommended guidelines’’) in order                encouraged to utilize a range of local,
                                                  Policy Information Notice entitled                      to minimize service disruptions.                       state, and national resources to describe


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                                                                                Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices                                             1355

                                                  the number of coal miners in their                      that data collection methods and                       training to BLCP awardees and to
                                                  service area as well as their health status             databases vary across the grantees, and                identify and disseminate best practices.
                                                  and unmet health needs. While HRSA                      that some grantees may need more IT                    HRSA agrees that the role and
                                                  cannot implement all of the                             support and funding than others to carry               expectations of the BLCE should be
                                                  commenters’ suggestions for how to                      out new data collection activities.                    better defined in order to maximize its
                                                  determine need in this grant cycle, it                  Others noted the administrative burden                 impact. For the FY 2017–2020 grant
                                                  will consider them in future cycles.                    of reporting data into more than one                   cycle, HRSA refined the scope of the
                                                  Grantee Collaboration                                   database. Some commenters stated that                  BLCE to focus on strengthening the
                                                                                                          the REDCap database, a patient-level                   operation of BLCP awardees and their
                                                  Summary of Comments                                     database that has been piloted with a                  ability to examine and treat respiratory
                                                     Nearly all of the commenters agreed                  few grantees by the BLCE, was a                        and pulmonary impairments in active
                                                  that networking and peer-to-peer                        promising start, and at least one                      and inactive coal miners through
                                                  training and sharing of best practices are              commenter recommended that it be                       improved data collection and analysis
                                                  important components of successful                      expanded to all grantees as one possible               and contributing to the body of
                                                  program implementation. Most                            common platform. Other commenters                      knowledge on the health status and
                                                  commenters supported a yearly peer-to-                  said a patient-level database should be                needs of U.S. coal miners nationally. At
                                                  peer workshop and also stated that                      housed in and maintained by HRSA and                   the same time, the FY 2017 BLCE FOA
                                                  collaboration should continue through                   not by the BLCE.                                       allowed applicants to propose
                                                  existing forums, such as the annual                                                                            additional technical assistance and/or
                                                                                                          Response
                                                  HRSA, Pipestem, and National Coalition                                                                         training activities in recognition of the
                                                  of Black Lung and Respiratory Disease                      Patient-level data collection and                   ongoing and evolving need for these
                                                  Clinics meetings. Commenters noted                      reporting will benefit the coal miners,                initiatives.
                                                  that it was ‘‘essential’’ that HRSA                     clinics, and the broader medical and
                                                                                                          public health communities by enabling                  Timeliness and Quality of DOL Exams
                                                  continue to support these trainings and
                                                  collaboration forums and one stated that                HRSA and BLCP awardees to better                       Summary of Comments
                                                  BLCP grant funds should be allowed for                  assess miners’ needs and program                          Two commenters agreed with HRSA’s
                                                  travel to the National Coalition of Black               impact. Therefore, for the purposes of                 proposal to hold 413(b) providers
                                                  Lung and Respiratory Disease Clinic’s                   the FY 2017–2020 grant cycle, HRSA                     affiliated with FORHP-funded black
                                                  annual educational conference.                          will explore the development of a                      lung clinics accountable to DOL’s
                                                                                                          patient-level database and will work                   standards for medical exam timeliness.
                                                  Response                                                with its federal partners, the BLCE, and               Another suggested that DOL issue
                                                     HRSA recognizes the important role                   BLCP awardees to develop a new set of                  ‘‘report cards’’ to 413(b) providers on
                                                  that educational conferences play in                    data measures for the program. By the                  timeliness so they can correct course if
                                                  strengthening the quality and breadth of                third year of the grant (July 1, 2019–June             necessary before HRSA holds them
                                                  services provided to coal miners. In the                30, 2020), it is anticipated that all BLCP             accountable. A few commenters
                                                  FY 2014 BLCP FOA, HRSA placed a                         awardees will be expected to collect and               expressed concern that the timeliness
                                                  restriction on using BLCP grant funds to                report patient-level data to HRSA. In                  requirement could affect the quality of
                                                  subsidize attendance to the annual                      developing these requirements, efforts                 the exam or have other unintended
                                                  National Coalition of Black Lung and                    will be made to minimize                               consequences. Regarding the proposal to
                                                  Respiratory Disease Clinics’ annual                     administrative and financial burden on                 require clinical personnel to take the
                                                  educational conference. The FY 2017                     BLCP awardees.                                         DOL-sponsored training modules, some
                                                  BLCP FOA lifts this restriction, although                                                                      commenters agreed that the proposal
                                                                                                          BLCE
                                                  applicants must justify the                                                                                    was reasonable, while others expressed
                                                  reasonableness of their proposed                        Summary of Comments                                    concern that the few providers
                                                  conference attendance and travel                           Commenters expressed mixed support                  performing DOL exams would shy away
                                                  budgets and assure compliance with                      for BLCE in its current form. In general,              from participating if they were required
                                                  grant guidance related to advocacy                      the training modules developed by the                  to take the modules. One commenter
                                                  activities. However, HRSA retained the                  BLCE were well received and one                        stated that the requirement for BLCP
                                                  restriction on using BLCP grant funds to                commenter stated that they appreciated                 staff to complete the DOL training
                                                  subsidize membership dues and fees                      having training come from the BLCE as                  modules should come from DOL and
                                                  associated with the National Coalition                  opposed to other grantees who may be                   not HRSA, and another commenter
                                                  of Black Lung and Respiratory Disease                   in direct competition with them for                    disagreed entirely with the training
                                                  Clinics. Subject to the availability of                 patients. One commenter stated BLCE                    requirement proposal.
                                                  travel funds and other factors, HRSA                    has not achieved its stated goals and
                                                  will continue to attend and participate                                                                        Response
                                                                                                          that BLCE funding would be more
                                                  in the existing education and                           effective if allocated to the clinics, while              HRSA recognizes the importance of
                                                  collaboration forums.                                   others questioned whether BLCE’s                       working closely with DOL’s Office of
                                                  Data Collection                                         services were being used or if they were               Workers’ Compensation Programs to
                                                                                                          relevant to non-hospital-based clinics.                ensure that providers performing DOL
                                                  Summary of Comments                                     Still others suggested that the BLCE be                medical exams adhere to DOL’s
                                                    Commenters were in near-universal                                                                            timeliness and quality standards and
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                                                                                                          restructured to encourage contributions
                                                  agreement about the benefits of patient-                from other grantees and that technical                 goals, while also understanding some of
                                                  level data collection and the                           assistance around benefits counseling                  the limitations these providers face.
                                                  inadequacies of the current performance                 would be beneficial.                                   Therefore, the FY 2017 BLCP FOA
                                                  measurement system, but some                                                                                   strongly encourages BLCP awardees
                                                  expressed concerns about the burden                     Response                                               performing DOL medical exams onsite
                                                  patient-level data collection would                       HRSA established the BLCE in FY                      to (1) adhere to the performance
                                                  impose on clinics. Commenters noted                     2014 to provide technical assistance and               measures as outlined in DOL-Office of


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                                                  1356                          Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices

                                                  Workers’ Compensation Programs                          Geographic Boundaries                                  as amended, to impose sanctions in the
                                                  Performance Measures as it relates to                                                                          form of civil monetary penalties against
                                                                                                          Summary of Comments
                                                  the Black Lung Program, (2) to submit                                                                          manufacturers that knowingly and
                                                  documents relevant to active Black Lung                    A few commenters expressed concern                  intentionally charge a 340B covered
                                                  benefits claims electronically into                     over how HRSA defines the service                      entity a price for purchase of a drug that
                                                  Claimant Online Access Link (C.O.A.L.)                  areas of each clinic. At least two noted               exceeds the maximum applicable
                                                  and (3) to follow other procedures and                  that in some cases, coal miners work or                ceiling price as defined by section
                                                  training related to diagnostic and                      reside in closer proximity to clinics in               340B(a)(1) of the PHSA. In accordance
                                                  medical providers. This last point                      neighboring states than to those within                with section 340B(d)(1)(B)(vi)(II) of the
                                                  encompasses the learning modules                        the same state, but that HRSA limits                   PHSA, such sanctions shall not exceed
                                                  entitled ‘‘Black Lung Disability                        clinics’ ability to conduct outreach in                $5,000 for each instance of overcharging
                                                  Evaluation and Claims Training for                      other states. Another commenter stated                 a 340B covered entity that may have
                                                  Medical Examiners’’ and available at                    that some clinics provide                              occurred. This authority may be
                                                  https://www.publichealthlearning.com/                   complementary services in close                        redelegated. This delegation excludes
                                                  course/category.php?id=35. HRSA will                    proximity to one another.                              the authority to issue regulations.
                                                  continue to work with DOL and BLCP                                                                               I have affirmed and ratified any
                                                                                                          Response
                                                  awardees to strengthen this component                                                                          actions taken by the Inspector General,
                                                  of the BLCP.                                              In certain cases, the FY 2017 BLCP                   or subordinates, that involved the
                                                                                                          FOA allows more than one BLCP                          exercise of the authority delegated
                                                  Pulmonary Rehabilitation                                awardee to provide services to coal                    herein prior to the effective date of the
                                                                                                          miners in a given county, provided                     delegation.
                                                  Summary of Comments                                     those awardees detail how they will                      This delegation became effective upon
                                                     All of the commenters agreed that                    avoid duplicating efforts of other black               date of signature.
                                                  onsite pulmonary rehabilitation is a                    lung clinics. Applicants may also                        Authority: 42 U.S.C. 256b(d)(1)(B)(vi)
                                                  vital service. However, most                            propose to provide services (including
                                                  commenters expressed concerns that                      outreach) to coal miners in counties                   Sylvia M. Burwell,
                                                  this service is not widely available to                 other than the ones listed in the FY                   Secretary, Department of Health and Human
                                                                                                          2017 BLCP FOA, including counties in                   Services.
                                                  miners who need it because it is costly
                                                  to operate, there are low rates of                      neighboring states, provided that they                 [FR Doc. 2016–31944 Filed 1–4–17; 8:45 am]
                                                  reimbursement, and miners often aren’t                  demonstrate how their services will                    BILLING CODE 4165–15–P

                                                  able to travel to clinics that do offer                 complement—rather than duplicate—
                                                  treatment. Some commenters said that                    existing efforts in those counties. A coal
                                                  consideration should be given for non-                  miner may receive services at a black                  DEPARTMENT OF HEALTH AND
                                                  traditional pulmonary treatment                         lung clinic of his or her choosing,                    HUMAN SERVICES
                                                  programs, such as in-home treatments,                   regardless of that clinic’s location or
                                                                                                          service area designation.                              National Institutes of Health
                                                  and that HRSA should further research
                                                  the effectiveness of these programs. A                  Conclusion                                             Center for Scientific Review; Notice of
                                                  few commenters argued that BLCP                                                                                Closed Meetings
                                                                                                            HRSA considers many of the
                                                  clinics should collaborate more with
                                                                                                          comments received to be useful and                       Pursuant to section 10(d) of the
                                                  hospital-based pulmonary rehabilitation
                                                                                                          informative to future discussions on                   Federal Advisory Committee Act, as
                                                  programs in multiple communities to
                                                                                                          how to strengthen the BLCP in future                   amended (5 U.S.C. App.), notice is
                                                  make it more feasible for miners to
                                                                                                          years and appreciates the interest and                 hereby given of the following meetings.
                                                  receive treatment. Nearly all of the
                                                                                                          dedication of the commenters who are                     The meetings will be closed to the
                                                  commenters expressed concerns that
                                                                                                          committed to serving U.S. coal miners.                 public in accordance with the
                                                  American Association of Cardiovascular
                                                                                                          Any questions or concerns should be                    provisions set forth in sections
                                                  and Pulmonary Rehabilitation
                                                                                                          directed to Blacklung@hrsa.gov.                        552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  (AACVPR) certification is difficult to
                                                  obtain and financially burdensome to                                                                           as amended. The grant applications and
                                                                                                          Diana Espinosa,
                                                  the clinics, and that it is not cost-                                                                          the discussions could disclose
                                                                                                          Deputy Administrator.
                                                  effective for the clinic to try to meet this                                                                   confidential trade secrets or commercial
                                                                                                          [FR Doc. 2016–32003 Filed 1–4–17; 8:45 am]             property such as patentable material,
                                                  standard for additional grant funding.                  BILLING CODE 4165–15–P                                 and personal information concerning
                                                  Response                                                                                                       individuals associated with the grant
                                                                                                                                                                 applications, the disclosure of which
                                                    In the FY 2014 BLCP FOA, BLCP                         DEPARTMENT OF HEALTH AND                               would constitute a clearly unwarranted
                                                  awardees receiving the highest level of                 HUMAN SERVICES                                         invasion of personal privacy.
                                                  funding were required to provide
                                                                                                          Office of the Secretary                                  Name of Committee: Risk, Prevention and
                                                  AACVPR-certified pulmonary                                                                                     Health Behavior Integrated Review Group;
                                                  rehabilitation programs onsite. The FY                                                                         Psychosocial Risk and Disease Prevention
                                                                                                          Delegation of Authority Under Title III,
                                                  2017 BLCP FOA removes this                                                                                     Study Section.
                                                                                                          Part D, Section 340B(d)(1)(B)(vi) of the
                                                  requirement and instead requires all                                                                             Date: January 23–24, 2017.
                                                                                                          Public Health Service Act (PHSA)
                                                  applicants to propose, at a minimum,                                                                             Time: 8:00 a.m. to 5:00 p.m.
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                                                  onsite, contracted, or referral to                         Notice is hereby given that I have                    Agenda: To review and evaluate grant
                                                  accredited Phase II or Phase III                        delegated to the Inspector General,                    applications.
                                                  pulmonary rehab services. BLCP                          Office of Inspector General, the                         Place: The Westgate Hotel, 1055 Second
                                                                                                                                                                 Avenue, San Diego, CA 92101.
                                                  awardees providing AACVPR-certified                     authority vested in the Secretary of                     Contact Person: Stacey FitzSimmons,
                                                  programs to coal miners may maintain                    Health and Human Services under Title                  Ph.D., MPH, Scientific Review Officer, Center
                                                  their certification if they choose, but                 III, Part D, Section 340B(d)(1)(B)(vi) of              for Scientific Review, National Institutes of
                                                  this is no longer a requirement.                        the Public Health Service Act (PHSA),                  Health, 6701 Rockledge Drive, Room 3114,



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Document Created: 2018-02-01 14:51:29
Document Modified: 2018-02-01 14:51:29
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
ActionResponse to comments.
ContactAllison Hutchings, Program Coordinator, Black Lung Clinics Program, Federal Office of Rural Health Policy, Health Resources and Services Administration, [email protected]
FR Citation82 FR 1353 

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