July 7, 2020
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8010
Baltimore, Maryland 21244
Re: CMS-5531-IFC. Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program
Submitted electronically: http://www.regulations.gov
Dear Administrator Verma and CMS Colleagues:
The Center for Medicare Advocacy (Center) submits these comments on the Interim Final Rule with Comment, which requires nursing facilities to collect and report to the Centers for Disease Control and Prevention (CDC) detailed information about COVID-19, including information about the number of cases of suspected or confirmed COVID-19 cases among residents and staff, numbers of deaths from COVID-19, and all deaths, as well as information about facilities’ staffing and personal protective equipment. The rule also mandates reporting to residents and families.
The Center endorses comments made by the Consumer Voice for Quality Long-Term Care, as discussed below. We also present additional recommendations to require (1) audits of facility-submitted data, (2) a mandatory per day civil money penalty when a facility reports materially false or inaccurate data to CDC or fails to report information, as required, to residents and families (or both), and (3) continuation of national reporting requirements by facilities, after COVID-19, for all infections. National data reporting and analysis should continue, even when the pandemic ends. Our recommendations are discussed more fully below.
The Center for Medicare Advocacy (Center) is a national, private, non-profit law organization, founded in 1986, that provides education, analysis, advocacy, and legal assistance to assist people nationwide, primarily the elderly and people with disabilities, to obtain necessary health care, therapy, and Medicare. The Center focuses on the needs of Medicare beneficiaries, people with chronic conditions, and those in need of long-term care and provides training regarding Medicare and health care rights throughout the country. It advocates on behalf of beneficiaries in administrative and legislative forums, and serves as legal counsel in litigation of importance to Medicare beneficiaries and others seeking health coverage.
Consumer Voice Recommendations
The Center specifically supports Consumer Voice recommendations
- At §483.80(g)(1)(i)-(ii) to add reporting of recovered COVID-19 cases among residents and staff; hospitalizations of residents and staff; and aggregate data that will enable better understanding of racial and ethnic disparities.
- At §483.80(g)(1)(vi) to define personal protective equipment.
- At §483.80(g)(1)(vi) to require that residents and staff actually be tested for COVID-19, at facility expense, and that facilities report to CDC more detailed information about testing of residents and staff.
- At §483.80(g)(3) to both simplify and make more comprehensive the information that facilities must report to residents, families, and staff.
- At §483.80(g)(5) to require that facilities provide comprehensive information to the public, on request. People who are inquiring about admission of a relative, for example, need, and should receive, meaningful, accurate, and comprehensive information about COVID-19 in the facility.
Center’s Additional Recommendations
The Center makes three additional recommendations.
Audits of Data Submitted by Nursing Facilities to CDC
CDC is transmitting the information it receives from nursing facilities to CMS, which is both relying on the information for public policy purposes and making the information publicly available. CMS, families, facility staff, and the broader public all rely on the accuracy and comprehensiveness of the information that facilities transmit to CDC.
While there was understandably some confusion about new reporting requirements in May 2020 and reporting should improve over time as facilities gain experience with the requirements, there is also reason to question the accuracy of nursing facilities’ self-reported data. For many years, nursing facilities self-reported staffing information and resident assessment information to CMS, which used the self-reported information (unaudited and unedited) to report the two domains of staffing and quality measures on Nursing Home Compare. Self-reported data proved largely inaccurate.
Facilities are now required to report staffing based on payroll. Implementation of the payroll-based data system demonstrated that facilities have fewer staff than they had self-reported under the earlier system.
Quality measures are still largely self-reported and the result is that most facilities report data that result in four and five stars, the highest categories. High ratings in the quality measures domain persist, even in the poorest quality facilities in the country. CMS has implicitly recognized the inaccuracy of the data for some of the most poorly performing facilities in the country with its decision to no longer report on Nursing Home Compare any star rating information for Special Focus Facilities.
Our point is that CMS needs to ensure that the data are as accurate as possible. Perhaps attestations on the data submissions would reinforce the importance of accuracy and comprehensiveness. But there is also a need to conduct audits, starting with facilities whose data are most obviously and clearly flawed, in order to take steps to ensure that data are accurate.
CMS Needs to Impose Meaningful Penalties When Facilities Report Materially Inaccurate Information to the CDC; CMS Needs to Impose Penalties When Facilities Fail to Report Information to Residents, Families, and Staff
Related to the concern about the accuracy of self-reported information is the need to authorize meaningful penalties when facilities report information that is materially false. Small, infrequent errors are inevitable in a complex data system. But when a facility knowingly reports materially false information, there need to be meaningful enforcement consequences. Under the Interim Final Rule with Comment, as previewed by CMS in surveyor guidance, CMS will impose trivial fines ($1000, increased by $500 per week for continued failure to report), but only for a facility’s complete failure to report any data to CDC. Such a limited enforcement system is insufficient to ensure the accuracy of reported data. We recommend that CMS impose a daily fine of $1000 for reporting materially false and inaccurate information to CDC as well as for total failure to report.
CMS fails to authorize any penalty for a facility’s failure to inform residents and families about COVID-19 among residents and staff, as required. Again, small infrequent errors are inevitable in a complex data system. But when a facility refuses to provide any information to residents, families, and staff, or when it intentionally provides false information, or when it provides limited and essentially useless information, there needs to be a meaningful enforcement response. We recommend that CMS impose a daily fine of $500 for any of these facility failures.
Ongoing reporting of all infections needs to continue beyond the COVID-19 pandemic
By the terms of the interim final rule, reporting is required solely for COVID-19. National data reporting and analysis for all infections should continue, even when the pandemic and national emergency end. The fact that infections have been the most frequently cited deficiency in nursing homes for years means that facilities have not adequately addressed problems of infections. The COVID-19 pandemic has brought into clearer public attention this longstanding and serious problem.
CMS has written repeatedly in preambles to Requirements of Participation – both the final rules published in October 2016 and the proposed rules published July 2019 – that infections are a critical issue in nursing facilities. CMS reports that each year, residents experience hundreds of thousands of infections, leading to hundreds of thousands of hospitalizations and deaths.
The Government Accountability Office reported in May 2020 that 82% of facilities received an infection control deficiency at least once in the five-year period 2013-2017 and that 48% received an infection control deficiency in multiple years. Infections are a serious issue that need greater ongoing attention. Nursing facilities do not effectively or consistently prevent or contain infections.
Recent research indicates that higher levels of registered nurse staffing reduce the likelihood of COVID-19 infections. One answer to rampant infections is mandating a registered nurse in all facilities 24 hours per day.
Treating infection control deficiencies and imposing penalties – instead of labeling more than 99% of them as no-harm – could also help improve infection rates and deaths in nursing facilities.
However, even as we move towards better staffing levels and better enforcement of existing infection prevention and control requirements, we also need to continue focusing on all infections in nursing facilities. The second wave of COVID this Fall and Winter may be COVID-20.
It is critical that the interim final rule with comment be extended to all infections, not just COVID-19.
Thank you for the opportunity to comment on the Interim Final Rule with Comment.
Toby S. Edelman
 Abt Associations, “Nursing Home Compare: The First Four Years of the Five-Star Quality Rating System” (PowerPoint at GSA Annual Scientific Meeting, Nov. 2013), slide 16, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/2013-The-First-Four-Years-of-Five-Star.pdf’
Katie Thomas, “Medicare Star Ratings Allow Nursing Homes to Game the System,” The New York Times (Aug. 24, 2014), https://www.nytimes.com/2014/08/25/business/medicare-star-ratings-allow-nursing-homes-to-game-the-system.html?searchResultPosition=3.
 CMS, “Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes,” QSO-20-29-NH (May 6, 2020), https://www.cms.gov/files/document/qso-20-29-nh.pdf.
 81 Fed. Reg. 68688, 68808 (Oct. 4, 2016), https://www.govinfo.gov/content/pkg/FR-2016-10-04/pdf/2016-23503.pdf.
 84 Fed. Reg. 34737, 34746 (Jul. 18, 2019), https://www.govinfo.gov/content/pkg/FR-2019-07-18/pdf/2019-14946.pdf.
 GAO, Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic, GAO-20-576R (May 20, 2020), https://www.gao.gov/assets/710/707069.pdf.,
 Yue Li, Helena Temkin-Greener, Shan Gao, and Xueya Cai, “COVID-19 infections and deaths among Connecticut nursing home residents: facility correlates,” Journal of the American Geriatrics Society (Jun. 18, 2020), https://onlinelibrary.wiley.com/doi/10.1111/jgs.16689.
 The GAO announced plans “to examine CMS guidance and oversight of infection prevention and control in a future GAO report, including the classification of infection prevention and control deficiencies.” GAO, Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic (Highlights), https://www.gao.gov/products/GAO-20-576R.