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August 31, 2020

Health Headlines – August 31, 2020


CMS Announces New Nursing Home Testing, Reporting, and Training Requirements in Light of COVID-19 Pandemic – On August 25, 2020, CMS announced two new changes pertaining to nursing homes during the COVID-19 public health emergency.  First, CMS published an interim final rule with comment period (IFC), which requires nursing home facilities to test all residents and staff for COVID-19 and report patient-specific results to HHS.  Second, CMS implemented a national nursing home training program for frontline nursing home staff and nursing home management.

New Testing and Reporting Requirements for Nursing Homes

The IFC, titled “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency,” requires nursing homes to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the Secretary of HHS.  These parameters include, but are not limited to:

  • Testing frequency;
  • The identification of certain individuals diagnosed with COVID-19 in the facility;
  • The identification of certain individuals with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19;
  • The criteria for conducting testing of asymptomatic individuals, such as the positivity rate of COVID-19 in a county;
  • The response time for test results; and
  • Other factors specified by the Secretary that help identify and prevent the transmission

of COVID-19.

These parameters are set forth at new 42 C.F.R. § 483.80(h).  Facilities that do not comply with this testing requirement will be cited for non-compliance and may face enforcement sanctions, such as civil monetary penalties in excess of $400 per day or over $8,000 for an instance of non-compliance.

The IFC also requires all laboratories and other facilities conducting testing for COVID-19 (including nursing homes) to report COVID-19 test results daily to the HHS Secretary.  Non-compliance will result in a civil monetary penalty in the amount of $1,000 a day for the first day and $500 for each subsequent day.  Labs will have a one-time, three-week grace period to begin reporting the required test data.  On August 26, 2020, CMS issued additional guidance, outlining the steps that nursing homes must take under the new testing and reporting requirements.

The IFC is available here, and the CMS nursing home guidance is available here.

National Nursing Home Training Program

CMS’s Targeted COVID-19 Training for Frontline Nursing Home Staff and Management incorporates recent lessons learned from nursing homes, and teaches frontline staff best practices they can implement to address issues related to COVID-19.  The training includes five modules designed for frontline clinical staff, which include:

  • Module 1: Hand Hygiene and PPE
  • Module 2: Screening and Surveillance
  • Module 3: Cleaning the Nursing Home
  • Module 4: Cohorting
  • Module 5: Caring for Residents with Dementia in a Pandemic

The training also includes ten modules designed for nursing home management, which include:

  • Module 1: Hand Hygiene and PPE
  • Module 2: Screening and Surveillance
  • Module 3: Cleaning the Nursing Home
  • Module 4: Cohorting
  • Module 5: Caring for Residents with Dementia in a Pandemic
  • Module 6: Basic Infection Control
  • Module 7: Emergency Preparedness and Surge Capacity
  • Module 8: Addressing Emotional Health of Residents and Staff
  • Module 9: Telehealth for Nursing Homes
  • Module 10: Getting Your Vaccine Delivery System Ready

In addition to these training modules, CMS and CDC also have subject matter experts available on bi-weekly webinars from August 27, 2020, through January 7, 2021, from 4:00–5:00 P.M. ET, to answer questions. 

The CMS announcement is available here, and the training is available here.

Reporter, Ahsin Azim, Washington, D.C., +1 202 626 9262, aazim@kslaw.com.

HHS Awards $117 Million to Safety Net ClinicsHHS announced on August 25, 2020 that, through the Health Resources and Services Administration (HRSA), HHS has awarded over $117 million in quality improvement awards to 1,318 health centers.  HRSA-funded health centers provide comprehensive care for uninsured and low-income patients.  The awards are intended to improve access to primary care services and promote quality improvement projects. 

The quality improvement awards recognize both those health centers that demonstrated significant quality improvements over the past year and those that are the highest-performing overall.  Health centers were recognized for achievements in areas including cost efficiency, quality of care, reduction in health disparities, access to comprehensive care, increased volume of people served, improved use of health information technology, and achievement of patient-center medical home recognition.

HRSA-funded health centers serve approximately one in eleven people nationally, according to HHS.  They not only serve as a safety net for the medically underserved but have also been on the front lines of the COVID-19 response.  Health centers have provided over 3 million COVID-19 tests and have continued to provide care throughout the pandemic.

The HHS press release is available here.  The list of award recipients is available here.

Reporter, Rebecca Gittelson, Atlanta, +1 404 572 4679, rgittelson@kslaw.com.  

CMS Extends Timeline to Finalize Proposed Stark ChangesOn August 24, 2020, CMS released a notice extending its timeline to publish its final rule with significant changes to the Stark regulations that was proposed in October 2019.  Previously, CMS had indicated that it intended to finalize the rule in August 2020.  However, the agency notice explains that CMS is “still working through the complexity of the issues raised by comments received on the proposed rule,” and therefore is not able to meet the target publication date.  Now CMS’s timeline for finalizing the rule is extended for an additional year to August 31, 2021, although the agency could publish the rule earlier. 

As previously reported CMS’s proposed rule included significant and highly anticipated changes to the regulations implementing the Stark Law, including changes to address value-based arrangements and major changes to other key Stark Law concepts and definitions.  On the same day, OIG also released its own proposed rule as part of the Regulatory Sprint to Coordinated Care initiative that included changes to the safe harbors under the Anti-Kickback Statute and the beneficiary inducements provision in the civil monetary penalties law. 

The Office of Management and Budget (OMB) website indicates that both OIG and CMS’s final rules were received by OMB for review on July 21, 2020 and that both have final action dates scheduled for August 2020.  OIG has not issued a public statement about the status of publication of modifications to the Anti-Kickback Statute safe harbors and the beneficiary inducements rules.

CMS’s notice that was published in the Federal Register on August 27, 2020 is available here.

Reporter, Isabella E. Wood, Atlanta, + 1 404 572 3527, iwood@kslaw.com.

ALSO IN THE NEWS

OIG Releases Report Identifying Problems with Extrapolated Overpayments in Medicare Appeals – On August 25, 2020, OIG released a report indicating that Medicare contractors were not consistent in how they reviewed extrapolated overpayments in the provider appeals process.  Specifically, the report found that CMS did not always provide sufficient guidance and oversight to ensure that these reviews were performed in a consistent manner. When an overpayment is identified in Medicare Part A or Part B, providers have the right to contest the overpayment amount using the Medicare administrative appeals process.  If an extrapolated estimate of an overpayment is overturned during the administrative appeals process, then the provider is liable only for the overpayment identified in the sample but not the extrapolated amount.  The most significant inconsistency identified in the report involved the use of a type of simulation testing that was performed only by a subset of contractors.  The test was associated with at least $42 million in extrapolated overpayments that were overturned in fiscal years 2017 and 2018.  The report is available here.