Quality Oversight

Quality Oversight / en Mon, 28 Apr 2025 03:04:32 -0500 Wed, 19 Feb 25 14:57:21 -0600 CMS suspends Hospice Special Focus Program /news/headline/2025-02-19-cms-suspends-hospice-special-focus-program The Centers for Medicare &amp; Medicaid Services Feb. 14 <a href="https://www.cms.gov/medicare/health-safety-standards/certification-compliance/hospice-special-focus-program" title="special focus">announced</a> it ceased implementation of the Hospice Special Focus Program so the agency can further evaluate it. The program, established from the 2024 home health prospective payment system <a href="https://www.govinfo.gov/content/pkg/FR-2023-11-13/pdf/2023-24455.pdf" title="final rule">final rule</a>, was created to identify poor-performing hospices for increased oversight to ensure they met Medicare requirements. Wed, 19 Feb 2025 14:57:21 -0600 Quality Oversight FDA evaluating certain plastic syringes made in China /news/headline/2023-12-04-fda-evaluating-certain-plastic-syringes-made-china The Food and Drug Administration is <a href="https://www.fda.gov/medical-devices/safety-communications/evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication">evaluating</a>&nbsp;Chinese-made plastic syringes used to inject or withdraw fluids from the body, citing concern that they may not provide adequate quality and performance, including their ability to deliver the correct dose of medication when used alone or with other medical devices, such as infusion pumps. Meanwhile, health care facilities should use other plastic syringes or closely monitor their use, the agency said. The concern does not currently apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. Mon, 04 Dec 2023 14:38:48 -0600 Quality Oversight AHA blog: QAPI changes highlight board’s role in advancing quality improvement /news/headline/2023-11-10-aha-blog-qapi-changes-highlight-boards-role-advancing-quality-improvement The latest revisions to the Centers for Medicare &amp; Medicaid Services’ Quality Assurance and Performance Improvement program underscore the integral role of board members in advancing quality improvement initiatives, writes Sue Ellen Wagner, AHA’s vice president of trustee engagement and strategy. <a href="/news/blog/2023-11-08-boards-role-quality-oversight-and-patient-safety" target="_blank">READ MORE</a> Fri, 10 Nov 2023 14:01:35 -0600 Quality Oversight AHA Letter in Support of the Value in Health Care Act of 2023 /lettercomment/2023-07-27-aha-letter-support-value-health-care-act-2023 <div class="container"><div class="row"><div class="col-md-8">July 27, 2023<div class="row"><div class="col-md-6">The Honorable Darin LaHood 1424 Longworth House Office Building Washington, DC 20515The Honorable Brad Wenstrup, D.P.M. 2335 Rayburn House Office Building Washington, DC 20515The Honorable Larry Bucshon, M.D. 2313 Rayburn House Office Bulding Washington, DC 20515</div><div class="col-md-6">The Honorable Suzan DelBene 2330 Rayburn House Office Building Washington, DC 20515The Honorable Earl Blumenauer 1111 Longworth House Office Building Washington, DC 20515The Honorable Kim Schrier, M.D. 1110 Longworth House Office Building Washington, DC 20515</div></div></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2023/07/AHA-Letter-in-Support-of-Value-in-Health-Care-Act-0f-2023-20230727.pdf" target="_blank" title="Click here to download the AHA Letter in Support of the Value in Health Care Act of 2023 PDF download.">Download the Letter PDF</a></div></div></div><div class="row"><div class="col-md-8">Dear Representatives LaHood, DelBene, Wenstrup, Blumenauer, Bucshon and Schrier:On behalf of the undersigned organizations, we thank you for your leadership in supporting value-based health care. We write to endorse the Value in Health Care Act of 2023. This bipartisan legislation makes several important reforms to ensure that alternative payment models (APMs) continue to produce high quality care for the Medicare program and its beneficiaries.In the last decade, some APMs have generated billions of dollars in savings for taxpayers all while maintaining quality of care for patients. The growth of APMs may have also produced a “spill-over” effect on care delivery across the nation, potentially slowing the overall rate of growth of health care spending. The Congressional Budget Office (CBO) reported earlier this year that actual Medicare and Medicaid spending between 2010–2020 was 9 percent lower than original projections, with improvements to care management and more efficient use of technology playing a role in slowing spending on federal health programs.<a href="#fn1">1</a>A key aim of the bipartisan Medicare Access and CHIP Reauthorization Act (MACRA) was to speed the transition to patient-centered, value-based care by encouraging physicians and other clinicians to transition into APMs. While MACRA was a step in the right direction, the transition has been slower than anticipated and more needs to be done to drive long-term system transformations. The Value in Health Care Act helps maintain and further strengthen the movement towards high-quality care in which financial performance is linked to the quality of patient care rather than the number of services delivered.We are pleased that the bill provides a multi-year commitment to reforming care delivery by extending MACRA’s 5 percent advanced APM incentives that are scheduled to expire at the end of the year. It also gives the Centers for Medicare &amp; Medicaid Services (CMS) authority to adjust APM qualifying thresholds so that the current one-size-fits-all approach does not serve as a disincentive to including rural, underserved, primary care or specialty practices in APMs.We are also encouraged that the bill removes revenue-based distinctions that disadvantage rural and safety net providers, which is critical to improving access to care and improving health equity. The bill also improves financial benchmarks so that APM participants are not penalized for their own success. To allow more clinicians to continue the transition to value, the bill establishes a voluntary track for accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on higher levels of risk and provides technical assistance for clinicians new to APMs. Lastly, the bill seeks to explore the potential of providing parity between APMs and the Medicare Advantage (MA) program by studying ways to increase alignment that will ease burdens on physicians and ensure that both APMs and MA are atractive and sustainable options.Thank you for your leadership on these important issues. This bill is a comprehensive approach that will strengthen the Medicare program and ensure high quality, lower cost care for our nation’s seniors. We look forward to working with you.Sincerely,Accountable for Health American Academy of Family Physicians American Academy of Orthopaedic Surgeons American College of Physicians �� Association American Medical Association America’s Essential Hospitals America’s Physician Groups AMGA Association of American Medical Colleges Federation of ��s Healthcare Leadership Council Health Care Transformation Task Force Medical Group Management Association National Association of ACOs National Rural Health Association Premier, Inc.<hr><ol><li id="fn1">Congressional Budget Office (2023, March 17). CBO’s Projections of Federal Health Care Spending. <a href="https://www.cbo.gov/system/files/2023-03/58997-Whitehouse.pdf" target="_blank">https://www.cbo.gov/system/files/2023-03/58997-Whitehouse.pdf</a></li></ol></div><div class="col-md-4"><a href="/system/files/media/file/2023/07/AHA-Letter-in-Support-of-Value-in-Health-Care-Act-0f-2023-20230727.pdf" target="_blank" title="Click here to download the AHA Letter in Support of the Value in Health Care Act of 2023 PDF download."><img src="/sites/default/files/inline-images/Page-1-AHA-Letter-in-Support-of-Value-in-Health-Care-Act-0f-2023-20230727.png" data-entity-uuid="df454439-5929-48c1-b110-e9271d278014" data-entity-type="file" alt="AHA Letter in Support of the Value in Health Care Act of 2023 page 1." width="695" height="900"></a></div></div></div> Thu, 27 Jul 2023 11:15:19 -0500 Quality Oversight CMS updates guidance for assessing hospital compliance with Medicare quality requirement /news/headline/2023-03-10-cms-updates-guidance-assessing-hospital-compliance-medicare-quality-requirement The Centers for Medicare &amp; Medicaid Services yesterday released updated interpretive <a href="https://www.cms.gov/files/document/qso-23-09-hospital.pdf" target="_blank">guidance</a>&nbsp;for surveyors assessing whether a hospital’s Quality Assessment &amp; Performance Improvement Program complies with Medicare requirements, emphasizing the integral role hospital leadership and governance play in advancing quality improvement throughout the hospital. Medicare-certified hospitals are required to have a QAPI program, and surveyors will now be looking for evidence of hospital leadership involvement and governance involvement in the prioritization and oversight of the program.&nbsp; “CMS does not prescribe a particular QAPI program that all hospitals must use,” the guidance notes. “Rather, each hospital is provided with the flexibility to develop its own program based on its unique needs, priorities, clinical programs, as well as its own considerations for the health equity needs of its patient population.” Fri, 10 Mar 2023 14:59:41 -0600 Quality Oversight FDA finalizes updates to mammography facility requirements /news/headline/2023-03-09-fda-finalizes-updates-mammography-facility-requirements The Food and Drug Administration today <a href="http://public-inspection.federalregister.gov/2023-04550.pdf" target="_blank">finalized</a> a 2019 proposed rule updating requirements under the Mammography Quality Standards Act of 1992, which authorized FDA oversight of mammography facilities. Effective Sept. 10, 2024, the rule expands the information that mammography facilities must provide to patients and health care professionals, incorporates current best practices and enhances facility oversight, the&nbsp;<a href="https://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance" target="_blank">FDA said</a>. For example, the rule requires facilities to include information on breast density in the report to the clinician and the patient’s summary letter to enable patients and their doctors to have a more informed discussion about the enhanced risks associated with dense breasts if appropriate. Thu, 09 Mar 2023 15:51:18 -0600 Quality Oversight AHA Letter to the Senate on VALID Act /lettercomment/2022-06-03-aha-letter-senate-valid-act June 3, 2022 <table border="0" cellpadding="1" cellspacing="1"> <tbody> <tr> <td>The Honorable Patty Murray Chair Committee on Health, Education, Labor, and Pensions United States Senate Washington, DC 20510</td> <td>The Honorable Richard Burr Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate Washington, DC 20510</td> </tr> </tbody> </table> Dear Chairwoman Murray and Ranking Member Burr: On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinical partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the �� Association (AHA) appreciates the opportunity to provide feedback on the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S.4348). Specifically, we appreciate the opportunity to share our thoughts about the Verifying Accurate Leading- Edge IVCT Development (VALID) Act of 2022, which significantly modifies the regulatory framework for laboratory developed tests (LDTs). Many hospitals and health systems create LDTs, particularly larger hospitals and academic medical centers. LDTs are diagnostic tests that are not commercially distributed to other laboratories but, instead, are developed, validated and performed inhouse by individual laboratories. These range from routine tests to more complex molecular and genetic tests in cancer, heart disease, and rare and infectious diseases. LDTs provide timely patient access to accurate and high quality testing for many conditions for which no commercial test exists or where an existing test does not meet current clinical needs. They provide physicians with important clinical information to diagnose and treat patients and are critical in the practice of all areas of medicine. These tests are typically developed at the request of, and in close collaboration with, clinical caregivers. The AHA is concerned that, if enacted in its current form, the VALID Act could lead to a loss of patient access to many critical tests and could dramatically slow down advances in hospital and health system laboratory medicine. Given the value of these tests to caregivers and patients, any framework for regulatory oversight of LDTs must ensure that the technological and clinical innovation that is essential to their development remains unrestricted; that quality and reliability are maintained at the highest levels possible; and that they continue to be widely accessible to patients. In contrast, we believe the provisions in the VALID Act could cause confusion and delays that could hinder the achievement of these goals and possibly prevent hospital and health system laboratories from continuing to develop cutting-edge LDTs in response to immediate clinical care needs. Since the VALID Act would modify the existing regulatory framework for these critical medical services, it is essential that any changes protect patient access to innovative diagnostic testing. We appreciate some of the changes in the updated version of the bill, particularly those related to modifications, the request for information for grandfathered LDTs, technology certification, and the preemption provisions. However, we urge the Committee to resolve the issues surrounding the following provisions described below prior to advancing this legislation. <h2>ISSUES FOR CONSIDERATION WITH THE VALID ACT</h2> <h3>Scope</h3> We believe that the scope of this legislation is too far-reaching and could hamper patient access to timely and appropriate care and will harm health care emergency readiness. The AHA recommends that the Committee tailor the VALID Act’s risk-based framework to place the greatest oversight on those tests that pose the greatest risk of harm to patients and lack demonstrated validity. Specifically, the Committee should consider targeted changes, including: <ul> <li>Initially focusing its oversight on manufacturers and commercial laboratories selling and distributing test kits, rather than academic and clinical laboratories, which are integrated in hospitals and health systems providing direct medical care to patients. &nbsp;</li> <li>Prioritizing the oversight of direct-to-consumer tests and tests used outside of the physician-patient context, as these tests may impose higher risk. &nbsp;</li> <li>Expanding and clarifying the criteria for low-risk tests to include most of the non-grandfathered LDTs developed and performed by CLIA-regulated laboratories that are integrated as part of hospitals and health systems providing direct medical care to patients.</li> </ul> <h3>Registration and Listing</h3> While we appreciate that the VALID Act grandfathers LDTs that were offered prior to enactment and generally exempts these tests from premarket review and several other FDA requirements, we are concerned that hospitals and health system laboratories will still be subject to overly burdensome requirements for registration and listing for grandfathered LDTs. The updated legislation would reduce the amount of listing information required for grandfathered tests, however these requirements remain incredibly onerous, particularly for academic medical centers with very large esoteric test menus and limited resources. Proactive requirements for registration and listing have limited value as the FDA will already have the authority, through the “request for information” provisions, to take action to address LDTs with insufficient evidence of clinical or analytic validity, those that are false or misleading claims, and those with probable serious adverse health consequences. We recommend that the listing information proactively required should be aligned with risk and based on FDA’s least burdensome principles. <h3>Preemption of State Requirements</h3> Many hospital and health system laboratories participate in validity and quality review programs, such as those directed by the well-regarded New York State Department of Health’s Wadsworth Center. The AHA encourages the Committee to recognize the value of such programs and prevent duplication with state efforts. We appreciate that the Committee has revised the preemption provisions to take into consideration these special cases by allowing state laws enacted prior to January 1, 2022 to remain in effect as long as they do not differ from any requirement of the VALID Act and by stating that the Secretary may exempt such laboratories in that state from compliance. We encourage the Committee to strengthen and provide additional certainty in the preemption provisions by including additional language that would require the Secretary to exempt authorized laboratories in an excepted state from compliance with the VALID Act. <h3>Transition</h3> While we acknowledge the significant transition period included in the VALID Act, we are concerned that it will create a large backlog of “transitional” LDTs developed by hospital and health system laboratories that the FDA will need to review prior to the effective date of the Act. Further, these transitional LDTs will be developed without access to FDA guidance or regulation explaining what information will eventually be required in a submission. As a result, hospital and health system laboratories wanting to provide novel testing for their patients during the transition period will not have a comprehensive understanding of the documentation that will eventually be required. The AHA recommends extending the grandfathering deadline for hospital and health system LDTs to the effective date of the legislation, or at least post issuance of relevant FDA guidance and regulations. <h3>Conclusion</h3> Thank you again for the opportunity to provide additional feedback on the FDASLA. We look forward to continue working with you on this important issue. Sincerely, /s/ Stacey Hughes Executive Vice President Fri, 03 Jun 2022 13:02:16 -0500 Quality Oversight CMS grants certain quality reporting exceptions for Texas winter storms /news/headline/2021-04-21-cms-grants-certain-quality-reporting-exceptions-texas-winter-storms The Centers for Medicare &amp; Medicaid Services Friday granted certain <a href="https://qualitynet.cms.gov/news/6079a8ababa8620022335d08">quality reporting exceptions</a>&nbsp;to Texas acute-care hospitals, ambulatory surgical centers, prospective payment system-exempt cancer hospitals, inpatient psychiatric facilities, inpatient rehabilitation facilities, long-term care hospitals and skilled nursing facilities in counties affected this year by severe winter storms. &nbsp; The cited exceptions only apply to providers in the federally designated disaster areas, but other providers may request extraordinary circumstances exceptions. Providers in the disaster areas also may request additional exceptions through the ECE process, which CMS will decide on a case-by-case basis. &nbsp; Wed, 21 Apr 2021 14:27:44 -0500 Quality Oversight COVID-19 blanket exceptions for Medicare quality reporting programs end /news/headline/2020-07-02-covid-19-blanket-exceptions-medicare-quality-reporting-programs-end The blanket data reporting <a href="https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf">exceptions and extensions</a> implemented in March across Medicare quality reporting and value-based payment programs for hospitals<s> </s>expired July 1. Specifically, the Centers for Medicare &amp; Medicaid Services made it optional to submit data from the fourth quarter of 2019 (October through December) and the first two quarters of 2020 (January through March, and April through June); and will not use claims data from Jan. 1 through June 30, 2020 to calculate performance in its quality reporting and value-based purchasing programs. CMS expects hospitals to collect and report data for the third and fourth quarters of 2020 in accordance with regular program requirements. “We are currently considering options to address providers’ concerns that we’ve heard from directly and through the COVID-19 inbox that the data may be impacted by the flexibilities and public health emergency,” CMS said in an update yesterday. “These options could include a change to the way voluntarily reported Q1 and Q2 2020 data are used in some of these programs.&nbsp;CMS intends to address this issue further in a future rule. Even though flexibilities were provided for reporting Q4 2019 data to meet spring 2020 reporting deadlines, we note that we still received very robust data reporting (&gt;95% for most measures) for that quarter.” While CMS’s blanket reporting exception has ended, hospitals unable to meet third and/or fourth quarter 2020 data collection and reporting requirements under the hospital quality reporting and value-based purchasing programs due to COVID-19 or another event beyond their control may use the programs’ existing policies to <a href="https://www.qualityreportingcenter.com/globalassets/2020/01/iqr/cms-quality-program-ece-request-form-april-2019508c.pdf">request</a> an exception within 90 calendar days of the extraordinary circumstance. Thu, 02 Jul 2020 15:10:15 -0500 Quality Oversight CMS to streamline survey process for psychiatric hospitals /news/headline/2020-01-13-cms-streamline-survey-process-psychiatric-hospitals Beginning in March, the Centers for Medicare &amp; Medicaid Services will implement a streamlined survey and certification process for psychiatric hospitals, the agency <a href="https://www.cms.gov/newsroom/fact-sheets/cms-reduces-psychiatric-hospital-burden-new-survey-process">announced</a>&nbsp;today. Under the new process, state survey agencies will perform one comprehensive survey to review compliance with both hospital and psychiatric hospital participation requirements instead of two, allowing inspectors to take a broader view of a psychiatric hospital’s operations and better identify systemic quality issues, the agency said. “The policy of multiple inspections for psychiatric hospitals is emblematic of the absurd status quo in health care,” said CMS Administrator Seema Verma. “For too long, fragmented and misaligned processes have increased burden and administrative costs.” For more on the announcement, see the <a href="https://www.cms.gov/httpswwwcmsgovmedicareprovider-enrollment-and-certificationsurveycertificationgeninfoadministrative/informational-notice-forthcoming-integration-psychiatric-hospital-program-hospital-program-and-state">CMS memorandum</a>. Mon, 13 Jan 2020 14:43:06 -0600 Quality Oversight