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Hospital and clinical lab groups are pushing back on an interim final rule that makes reporting COVID-19 data a condition for participating in Medicare, claiming it would place undue financial burdens on their members. “These requirements are a heavy-handed regulatory approach that threatens to expel hospitals from the Medicare program if they fail to comply with frequently changing and confusing COVID-19 data collection efforts,” Thomas P. Nickels, executive vice president of the American Hospital Association (AHA) wrote in a comment letter to Seema Verma, administrator of the Centers for Medicare and Medicaid Services (CMS).

For labs, the interim rule’s penalties add another layer of confusion in light of Coronavirus Aid, Relief and Economic Security (CARES) Act requirements, Nickels wrote in his comment letter. “Under the CARES Act, laboratories are required to report to their states not only positive and negative results, but also other much more detailed demographic data on every COVID-19 test performed,” he noted. However, the Department of Health and Human Services (HHS) has yet to clarify how it would enforce the reporting of these data elements.

Some groups believe CMS intends to narrowly enforce its conditions of participation (CoP) for labs. At the time of inspection surveys, CMS would ask labs to provide evidence of reporting positive or negative test results to their state labs—but not ask for the more detailed data elements the CARES Act calls for. Labs would still receive civil monetary penalties (CMPs) if they don’t meet this requirement.

“Unfortunately, this approach leaves laboratories no better off than they were before—they still do not know exactly how the reporting of the more detailed CARES Act reporting requirements will be enforced, and now face potential penalties from CMS for non-reporting,” wrote Nickels.

AACC addressed concerns with federal guidance issued on the CARES Act earlier this summer. Labs might not be able to meet these requirements, wrote Carmen L. Wiley, PhD, DABCC, FADLM, AACC’s past president, to HHS Secretary Alex Azar. “Implementing and reporting this information is going to be costly and time-consuming and will require more staff to accomplish. Most if not all clinical laboratories will not be able to modify their electronic health records systems before the August 1st implementation,” added Wiley.

The CMS interim rule delineates additional testing requirements for long-term care facilities, which impacts labs, Andrea Pitkus, PhD, MLS(ASCP)CM , clinical terminology domain expert at the University of Wisconsin School of Medicine and Public Health, told CLN Stat. In an August memorandum, CMS stated that facilities could use rapid point-of-care (POC) diagnostic testing devices or an off-site laboratory to meet testing requirements. While labs will continue to report what’s required of them under CARES and to public health jurisdictions, “long-term care facilities either performing results onsite via POC testing or via contracted off-site laboratories will need to report through their National Healthcare Safety Network connection,” said Pitkus.

AHA is calling on CMS to withdraw the interim rule’s new CoP requirements and eliminate CMP provisions that would apply to labs that fail to report certain data. According to the College of American Pathologists (CAP), CMS would impose penalties of $1,000 for the first day of noncompliance and $500 for each additional day, with a maximum of up to $10,000 per day of noncompliance.

The agency’s decision to impose these penalties for laboratory noncompliance “raises red flags,” wrote Nickels. “At a time when our nation needs as much testing capacity as possible to rapidly detect COVID-19, imposing penalties on laboratories on a narrow part of what they do (i.e. data reporting) seems profoundly misguided,” contended Nickels.

To provide additional clarity on CoP, CMS issued a guidance document on 38 reporting requirements and enforcement provisions. Most hospitals must report daily on 25 of these items. These include: total hospitalized adults and children suspected or confirmed positive for COVID-19; mechanical ventilators in use; ICU bed occupancy, the previous day’s adult and pediatric COVID-19 admissions, and the previous day’s total COVID-19-related ED visits. Items 33 through 38 relate to daily influenza reporting and start off as optional but will eventually become mandatory.

“These reporting requirements support our responsibility to protect the health and safety of hospital and [critical access hospital] CAH patients. This data allows CMS to monitor whether individual hospitals and CAHs are appropriately tracking, responding to, and mitigating the spread and impact of COVID-19 on patients, the staff who care for them, and the general public,” the agency explained in its guidance.

Daily reporting requirements apply to the following hospitals:

  • Short term
  • Long term
  • Critical Access Hospital
  • Children’s
  • Distinct part psychiatric hospital
  • Medicaid only short term
  • Medicaid only children’s
  • Medicaid only long-term hospitals

CMS noted that psychiatric and rehabilitation hospitals will report on these data items weekly.

A facility risks termination in Medicare if it fails to report this data. CMS gives the facility 30 days to comply. Providers will receive several warning notification letters before issuance of a final notice of termination from Medicare.

Hospital groups claim the reporting rules could weaken the pandemic response. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation. Caregivers will comply with reasonable data requests, but this sledgehammer enforcement may well weaken the response of frontline hospitals by diverting time and money from battling the pandemic and serving patients,” said Chip Kahn, president and CEO of the Federation of American Hospitals, in a statement.

While the grace period for reporting is appreciated, “the new rules reflect more questionable piling on” in an industry already burdened with reporting mandates, Kahn added.

AHA expressed similar concerns with the interim rule’s enforcement approach. “This heavy-handed regulatory approach furthermore sends the wrong message to struggling hospitals and health systems,” AHA President and CEO Richard J. Pollack wrote in a September letter to Verma. Instead of penalties, the federal government should be taking steps to provide resources to hospitals to ensure data reporting, he added. AHA has stressed that the hospital industry already has a 94% compliance rate of reporting federal data.

The guidance did answer some questions about compliance, Pollack continued. Hospitals, for instance, would get notified about the status of their data, which would give them enough time to adjust things and come into compliance, he indicated in a special bulletin to members.

Nevertheless, AHA wants the CoP provisions done away with. CAP, in recent comments to the Clinical Laboratory Improvement Advisory Committee, also called for the removal, delay, or reduction of the CMP monetary penalties.

“Clinical laboratories have expended great time and energy as required to meet SARS- CoV-2/COVID-19 testing needs amid shortages of swabs, reagents, and testing platforms, and have done so during this period of significant financial pressures,” the organization asserted, adding that such penalties would place additional financial burdens on labs whose resources are already strained.