As we reported last week, the Department of Health and Human Services (HHS) announced that it was developing “performance indicators” for distribution of an additional $2 billion to nursing homes this fall. On September 3, 2020, HHS published the metrics for evaluating performance for these performance-based incentive payments. Qualified nursing homes and skilled nursing facilities that report data through the National Healthcare Safety Network long-term care facility (LTCF) COVID-19 module will be measured against a baseline level of infection in the community where the facility is located. Against this baseline, facilities will have performance measured on: (1) ability to keep new COVID infection rates low among residents; and (2) ability to keep COVID mortality low among residents. There will be four individual performance periods (September, October, November, and December) each with $500 million available. Nursing homes will not have to apply to receive a share of this $2 billion incentive payment allocation, but will need to agree to the applicable Terms and Conditions.
On September 1, 2020, the Department of Health and Human Services (HHS) announced that assisted living facilities may now apply for Provider Relief Fund payments to help address the economic harm and additional expenses caused by the COVID-19 pandemic. Assisted living facilities that may have previously been ineligible for Phase 2 General Funding of the Provider Relief Fund are invited to apply. Assisted living facilities may receive 2% of their annual revenue from patient care under this funding. Eligible facilities can apply at the Provider Relief Fund site here until September 13, 2020.
On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that establishes new requirements for laboratories to submit daily reports on COVID-19 test results to the Secretary of the United States Department of Health and Human Services (HHS). HHS is to issue further guidance on the form and manner of reporting. All laboratories conducting COVID-19 testing and reporting patient-specific results – including hospital labs, nursing homes, and other facilities conducting testing for COVID-19 – will be required to comply. The requirement will apply only to CLIA-certified labs, i.e., labs that are subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The IFR allows CMS to take enforcement action against laboratories that fail to provide the required data. Specifically, if a laboratory does not report the required information, CMS will impose 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. This new requirement supplements existing HHS guidance that had instructed laboratories to report test results and additional information, such as demographic data. CMS states that this reporting is needed by federal, state, and local officials to conduct effective surveillance of the COVID-19 pandemic. As set forth in further detail in the IFR, based on the Public Health Emergency (PHE), CMS is waiving both the notice and comment period and the 30-day delay in the effective date and making the new reporting requirements effective on the date the IFR is published (which is expected any day). The reporting requirement will continue in effect through the COVID-19 PHE.
On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that establishes new requirements for hospitals and critical access hospitals (CAHs) on tracking the incidence and impact of COVID-19. Specifically, CMS has added new Medicare and Medicaid Conditions of Participation (CoPs) mandating hospitals and CAHs to report COVID-19 data to HHS during the COVID-19 Public Health Emergency (PHE).
This information must be reported in the frequency and format to be specified by HHS. On July 29, 2020, HHS issued “COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting” listing the data elements hospitals and CAHs should report daily to HHS. (Please note this does not relieve hospitals and CAHs of the responsibility to also report to local and state health departments.)
Most hospitals already voluntarily report this data to HHS, but now it is mandatory to report this data in the frequency and format specified by HHS, and there are significant penalties for noncompliance. In its announcement, CMS threatens: “Hospitals will face possible termination of Medicare and Medicaid payment if unable to correct reporting deficiencies.” As set forth in further detail in the IFR, based on the PHE, CMS is waiving both the notice and comment period and the 30-day delay in the effective date and making the new reporting requirements effective on the date the IFR is published (which is expected any day). The reporting requirement will continue in effect through the COVID-19 PHE.
On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that updates the previous Extraordinary Circumstances Exceptions (ECE) granted to ESRD facilities, hospitals, and SNFs to reduce the data collection and reporting burden on these facilities and providers so they could direct their full resources to patient care during the early months of the pandemic. CMS is now updating ECEs that granted ECE for the following value-based purchasing programs:
- The End-Stage Renal Disease Quality Incentive Program (ESRD QIP);
- The Hospital-Acquired Condition (HAC) Reduction Program;
- The Hospital Readmissions Reduction Program (HRRP); and
- The Hospital Value-Based Purchasing (HVBP) Program.
Under these updated ECEs, CMS will only score data that was optionally reported for fourth quarter CY 2019. It is also excluding data optionally reported for the first two quarters of CY 2020.
On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that changes existing infection control regulations for nursing homes and mandates weekly reporting of COVID-19 related data.
Testing. CMS states that, in support of national efforts to control the spread of COVID-19, nursing homes will be required to test staff and to offer testing to residents for COVID-19. The testing of “staff” includes employees, individuals providing services under arrangement and volunteers. CMS acknowledges that not all residents and staff will consent or be able to be tested for COVID-19. Regarding these situations, CMS states in the IFR:
“We acknowledge that not all residents and staff will consent to COVID-19 testing. In accordance with the requirements at § 483.10(c)(6),residents have the right to refuse and/or discontinue treatment. In addition, staff retain the right to refuse COVID-19 testing. There may also be instances in which facility residents or staff are not able to be tested, such as the presence of anatomical or other medical contraindications. At § 483.80(h)(5), we are requiring that the facility have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse or are unable to be tested. In these instances, we also expect facilities to take steps to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19 that may include limiting the staff’s access to the facility and cohorting residents [further described in the IFR].”
The frequency of staff testing will be based on the degree of community spread as an indicator that a facility may be at increased risk for COVID-19 transmission. CMS states that additional guidance on the testing frequency is forthcoming. The IFR’s testing requirement will be formally implemented through a revision of the LTC facility infection control regulations at § 483.80.
Reporting. The IFR also requires nursing homes to submit reports of COVID-19 related facility data to the CDC National Healthcare Safety Network (HNSN) not less than weekly. Noncompliance with the reporting requirement will be cited at a scope of “widespread,” and a severity of “no actual harm with potential for more than minimal harm that is not immediate jeopardy,” and will constitute a level “F” deficiency. Civil Monetary Penalties (CMPs) will be imposed for each failure to report with a minimum of $1,000 in CMPs for the first time the facility fails to submit a timely report, and an incremental increase of $500 in the CMPs for each subsequent failure. For example, the first failure to timely report would entail a $1,000 fine and the second failure to timely report would entail a $1,500 fine.
Additional details on the new infection control and reporting regulations are contained in the IFR. CMS is waiving the normal notice-and-comment process for this Interim Final Rule citing the Administrative Procedure Act section related to Public Health Emergencies. The IFR will take effect upon its publication in the Federal Register, which had not occurred as of this writing [August 28, 2020].
On August 27, 2020, the Department of Health and Human Services (HHS) announced it has distributed almost $2.5 billion of an allocated $5 billion from the Provider Relief Fund to nursing homes to support increased testing, staffing, and supply needs to combat COVID-19. HHS plans to distribute another $2 billion to nursing homes later this fall based on “certain performance indicators” that have yet to be published. According to HHS data, 208 Kentucky nursing homes have received a total of roughly $41 million from the $2.5 billion distribution.
During August, CMS released a compilation of creative COVID-19 plans implemented by state governments and other entities in the form of a Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes. CMS states this is an informational document only and does not constitute guidance from CMS and does not replace CMS requirements.
In its August 27, 2020 edition of mlnconnects, CMS announced HCPCS codes to use during the Public Health Emergency (PHE) for Medicare Part B claims that are subject to the cost-sharing waivers (coinsurance and deductible amounts) for COVID-19 testing-related services. Specific HCPCS Cost-Sharing (CS) modifiers must be used on applicable claim lines to identify the service as subject to this cost-sharing waiver by the following provider types: Physicians and Non-Physician Practitioners, Hospital Outpatient Departments paid under the Outpatient Prospective Payment System (OPPS), Rural Health Clinics (RHCs), Federally Qualified Health Centers (FQHCs) and Critical Access Hospitals (CAHs). CMS stated that if a provider uses the CS modifier with HCPCS codes that are not on the list, the claim will be returned. On August 26th, CMS also revised page 11 of MLN Matters Special Edition Article SE20011, Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19), to add information about the HCPCS codes and CS modifiers.
On August 19, 2020, the Department of Health and Human Services (HHS) announced that it had amended the March 17, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) concerning the COVID-19 Public Health Emergency to increase accessibility of lifesaving childhood vaccines in order to control preventable outbreaks and diseases and mitigate additional strains on the healthcare system. The directive authorizes state-licensed pharmacists to administer, without a doctor’s prescription, vaccines to children ages 3 to 18, pursuant to certain conditions and restrictions. Twenty-eight states already allow pharmacists to administer vaccinations to children. On August 20th, HHS also announced it was expanding the PREP Act’s liability immunity provisions to protect pharmacists and pharmacy interns from liability for alleged harm arising from their administration of vaccines to children.
The amended Declaration can be reviewed here. The American Academy of Pediatrics published an announcement opposing the HHS action, calling it “incredibly misguided” and arguing that pediatricians are the best and safest administrators of childhood vaccinations.