Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development, 1353-1356 [2016-32003]
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Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
located in HPSAs must submit an NHSC
Site Application and Site Recertification
Application to determine the eligibility
of sites to participate in the NHSC as an
approved service site. The NHSC LRP
participant application asks for
personal, professional, and financial
information needed to determine the
applicant’s eligibility to participate in
the NHSC LRP. In addition, applicants
must provide information regarding the
loans for which repayment is being
requested. NHSC policy requires
behavioral health providers to practice
in community-based settings that
provide access to comprehensive
behavioral health services. Accordingly,
for those sites seeking to be assigned
behavioral health NHSC participants,
additional site information collected
from an NHSC Comprehensive
Behavioral Health Services Checklist is
used. NHSC sites that do not directly
offer all required behavioral health
services must demonstrate a formal
affiliation with a comprehensive,
community-based primary behavioral
health setting or facility to provide these
services.
Likely Respondents: Likely
respondents include: Licensed primary
care medical, dental, and behavioral
health providers who are employed or
seeking employment, and are interested
in serving underserved populations;
health care facilities interested in
participating in the NHSC and becoming
an NHSC-approved service site; and
NHSC sites providing behavioral health
care services directly or through a
formal affiliation with a comprehensive
community-based primary behavioral
health setting or facility providing
comprehensive behavioral health
services.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and be able to respond to a
collection of information; to search data
sources; to complete and review the
collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NHSC LRP Application ........................................................
Authorization for Disclosure of Loan Information Form .......
Privacy Act Release Authorization Form .............................
Verification of Disadvantaged Background Form ................
Private Practice Option Form ..............................................
NHSC Comprehensive Behavioral Health Services Checklist .....................................................................................
NHSC Site Application (including recertification) ................
8,200
6,500
275
600
300
1
1
1
1
1
8,200
6,500
275
600
300
1
.10
.10
.50
.10
8,200
650
27.5
300
30
* 4,000
* 3,700
1
1
4,000
3,700
.13
.5
520
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
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Amy McNulty,
Deputy Director, Division of the Executive
Secretariat.
[FR Doc. 2016–31723 Filed 1–4–17; 8:45 am]
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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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Response to comments.
AGENCY:
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
SUMMARY:
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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 https://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, blacklung@hrsa.gov.
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
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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
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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
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‘‘Black Lung Clinics Program
Expectations and Principles of
Practice.’’ Others indicated that funding
should prioritize services that are nonreimbursable, 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.
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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
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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-topeer 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.
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Data Collection
Summary of Comments
Commenters were in near-universal
agreement about the benefits of patientlevel 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
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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
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1355
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 nontraditional 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 costeffective for the clinic to try to meet this
standard for additional grant funding.
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 Blacklung@hrsa.gov.
Diana Espinosa,
Deputy Administrator.
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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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authority Under Title III,
Part D, Section 340B(d)(1)(B)(vi) of the
Public Health Service Act (PHSA)
Notice is hereby given that I have
delegated to the Inspector General,
Office of Inspector General, the
authority vested in the Secretary of
Health and Human Services under Title
III, Part D, Section 340B(d)(1)(B)(vi) of
the Public Health Service Act (PHSA),
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as amended, to impose sanctions in the
form of civil monetary penalties against
manufacturers that knowingly and
intentionally charge a 340B covered
entity a price for purchase of a drug that
exceeds the maximum applicable
ceiling price as defined by section
340B(a)(1) of the PHSA. In accordance
with section 340B(d)(1)(B)(vi)(II) of the
PHSA, such sanctions shall not exceed
$5,000 for each instance of overcharging
a 340B covered entity that may have
occurred. This authority may be
redelegated. This delegation excludes
the authority to issue regulations.
I have affirmed and ratified any
actions taken by the Inspector General,
or subordinates, that involved the
exercise of the authority delegated
herein prior to the effective date of the
delegation.
This delegation became effective upon
date of signature.
Authority: 42 U.S.C. 256b(d)(1)(B)(vi)
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–31944 Filed 1–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Risk and Disease Prevention
Study Section.
Date: January 23–24, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Stacey FitzSimmons,
Ph.D., MPH, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
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[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]
-----------------------------------------------------------------------
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 https://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,
blacklung@hrsa.gov.
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 Blacklung@hrsa.gov.
Diana Espinosa,
Deputy Administrator.
[FR Doc. 2016-32003 Filed 1-4-17; 8:45 am]
BILLING CODE 4165-15-P
