HAP Comments about Establishment of Patient Safety Standards for Qualified Health Plan Issuers
December 21, 2015
Medicare & Medicaid Services
Health and Human Services
P.O. Box 8016
CMS-9937-P, Patient Protection and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for 2017 Proposed Rule. Comments specific to
§156.1110 Establishment of Patient Safety Standards for Qualified Health Plan
On behalf of
The Hospital & Healthsystem Association of Pennsylvania (HAP), which
represents approximately 240 member institutions, we appreciate the opportunity
to comment about the proposed standards for health insurers regarding quality
that the proposed rule provides reasonable exceptions to the patient safety
standards for qualified health plans (QHP) under the Affordable Care Act (ACA).
Allowing flexibility and promoting alignment of the standards to support
hospitals already engaged in effective national or state, public or private
safety programs, such as the Hospital Engagement Network (HEN) and Quality
Improvement Networks, is important.
recognition of hospital involvement in evidence-based initiatives, such as a
HEN, as a means of demonstrating compliance with the regulations. There
are 118 Pennsylvania hospitals participating in the Pennsylvania Hospital
Engagement Network (PA-HEN), which HAP manages. During the past three years,
hospitals participating in PA-HEN have shown significant reductions in all-cause
harm and preventable readmissions. Additional Pennsylvania hospitals
participate in a number of national HENs.
requests that Centers for Medicare and Medicaid Service (CMS) confirm that the
flexibility envisioned in the proposed rule would permit QHPs to comply with
federal patient safety standards if hospitals participate in Pennsylvania’s
mandatory Patient Safety Reporting System (PSRS) under Pennsylvania Act 13 of
2002 (The Medical Care Availability and Reduction of Error Act).
hospitals—regardless of size—as a condition of state licensure, are required to
report serious events and incidents or near misses to the Pennsylvania Patient
Safety Authority (PSA). For Pennsylvania hospitals, PSA is, in essence, a
patient safety organization (PSO). PSA analyzes the events and incidents to
identify patterns and systemic issues that enable Pennsylvania hospitals and
health systems to improve health care and reduce harm to patients through the
use of evidence-based practices. This,
along with HEN activities, has helped Pennsylvania health care
facilities to reduce events with greater harm by 45 percent.
inception, PSA has collaborated with health care facilities, physician
organizations, government agencies, and others to address patient safety. This
has included standardizing color-coded wristbands, reducing events of
mislabeled blood specimens, reducing falls with harm, reducing wrong-site
surgeries, and addressing adverse drug events, with a focus on opioids.
Improvements in patient safety in Pennsylvania reflect the commitment that
hospitals and health systems have to improving care, coupled with the
significant work of the PSA.
issues the Pennsylvania Patient
Safety Advisory that has extensive readership throughout the health
nearly 50 toolkits regarding a variety of patient safety topics
a patient safety liaison program that provides a regional liaison to every
hospital to help the hospital in analyzing events, providing education,
and linking the hospital to collaborative resources for patient care
Pennsylvania law, HAP does not believe it would be appropriate for Pennsylvania
hospitals to be separately required to contract with a federally-approved PSO.
HAP strongly urges CMS to support PSA’s request for an exception to verify that
QHP issuers would be in compliance with patient safety standards (§ 156.1110),
if the applicable QHP contracts with Pennsylvania hospitals participating in
the commonwealth’s mandatory reporting system (PSRS) as required under
Pennsylvania Act 13 of 2002. HAP would not support requirements for QHPs that
create redundant reporting by Pennsylvania hospitals for purposes of complying
with §156.1110. Given the scope and
proven effectiveness of the required reporting under Pennsylvania law, we
believe the §156.1110 standards are already being met.
In the proposed
regulations, CMS also announced it was seeking comment regarding mandatory use
of the Agency for Healthcare Research and Quality (AHRQ) common formats. HAP
believes that CMS should allow alternate standardized reporting formats that
are equivalent to the common format. The Pennsylvania PSRS includes a database
of 2.4 million safety reports, which has allowed PSA to capture information for
analysis to improve patient care. The data collected through PSRS is comparable
to the common format. Requiring all hospitals to collect data through use of
the common format would cause undue burdens to Pennsylvania hospitals that are already
reporting data in a standardized manner through PSRS. HAP’s member hospitals
and health systems believe the reporting format used by PSRS meets or exceeds
the requirements of the Patient Safety and Quality Improvement Act.
to believe that Pennsylvania hospitals’ and health systems’ experience with PSA
serves as a model for the nation in how a mandatory reporting system can
support creation of cultures of safety that reduce harm and preventable
readmissions. We appreciate the proposed regulations inclusion of alternative
approaches that would enable states, such as Pennsylvania, to continue
advancing patient safety and quality in a manner that clearly reflects the
intent of the Patient Safety and Quality Improvement Act. To do anything less
than recognizing PSA under the exception provision would fall short of the
overall goals of this act.
Thank you for
the opportunity to comment. If you have questions, you may contact me at (717) 561-5344.