Hospital Association of Pennsylvania > Advocacy > Federal Advocacy > Patient-Safety-Standards-Comment-Letter


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HAP Comments about Establishment of Patient Safety Standards for Qualified Health Plan Issuers

December 21, 2015

Andrew Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-9937-P
P.O. Box 8016 Baltimore, MD 21244-8016

RE:  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 Issuers

Dear Mr. Slavitt:

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 (§156.1110).

HAP appreciates 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.

HAP supports 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.

HAP also 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).

All Pennsylvania 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.

Since its 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.

PSA also:

  • Regularly issues the Pennsylvania Patient Safety Advisory that has extensive readership throughout the health care community
  • Provides nearly 50 toolkits regarding a variety of patient safety topics
  • Established 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 improvement

Given 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.

HAP continues 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.



Paula A. Bussard
Chief Strategy Officer   

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