Get a firm handle on your COVID-19 case data now that a new interim final rule requires the information to be reported to the Department of Health and Human Services (HHS) as a Medicare Condition of Participation (CoP).
The interim rule, which was pre-published for public inspection late Thursday, says the data must be reported daily as specified by HHS and points to a July FAQ for the current list of information sets that must be reported.
The change means that as soon as the interim rule is posted to the Federal Register—scheduled for September 2, 2020—failures to report the data could result in a condition-level deficiency and impact your ability to bill Medicare.
The rule tacks on the requirement to the CoP at § 482.42 for acute care hospitals and § 485.640 for critical access hospitals requiring, “active facility-wide programs, for the surveillance, prevention, and control of healthcare-associated infections (HAIs) and other infectious diseases and for the optimization of antibiotic use through stewardship.”
Most hospitals are already familiar with the data requirements, but some have been struggling to meet all the elements.
“From what I have read to date, the majority of hospitals (92%) are already reporting some data,” said Jennifer Cowel, RN, MHSA, president and CEO of Patton Healthcare Consulting in Naperville, Illinois, and a former TJC executive.
“However, the daily mandate will be a challenge to many and according to the July 14 CDC data below there is still 8% of facilities that are not reporting at all. The 92% could be misleading also. This number reflects facilities reporting at least one data element—it does not mean they are collecting full datasets from that group,” she said.
“The fact that this is now a CoP will certainly make this a priority for all hospitals,” Cowel noted.
Meanwhile, the American Hospital Association (AHA) called implementing the new CoP without public input “heavy-handed.”
The interim rule “will require hospitals to report daily data including, but not limited to, elements such as the number of confirmed or suspected COVID-19 positive patients, intensive care unit beds occupied, and availability of supplies and equipment, such as ventilators and personal protective equipment,” noted the AHA in a statement.
“In addition to the new CoP requirement, the interim final rule directs surveyors to inspect nursing homes for adherence to new COVID-19 testing requirements, with penalties including sanctions and civil monetary penalties. The rule also implements new laboratory reporting requirements in accordance with the Coronavirus Aid, Relief, and Economic Security Act. Failure to comply with these requirements could result in civil monetary penalties of $1,000 a day for the first day and $500 a day for each subsequent day,” said the AHA.
In a statement, AHA President and CEO Rick Pollack said, “While hospitals and health systems remain focused on patient care, they're also committed to providing our government with the public health data it needs. However, a new heavy-handed regulatory approach put forward by the Administration threatens to expel hospitals from the Medicare program. This disturbing move, announced in final form without consultation, or the opportunity to provide feedback through appropriate administrative procedures prior to it becoming effective, could jeopardize access to care and leave patients and communities without vital health services from their local hospital during a pandemic.”
In the interim rule, CMS acknowledges the strain the requirements may pose for some facilities, but said the data is crucial to pandemic control efforts during the public health emergency (PHE) declared in March:
“We believe that universal reporting by all hospitals and CAHs is and will be an important tool for supporting surveillance of COVID-19 and for future planning to prevent the spread of the virus, especially to those most vulnerable and at risk to its effects, and we thank the thousands of hospitals and CAHs that have voluntarily reported this data in support of our efforts. However, while we recognize the important and immeasurable role that the timely and continued delivery of COVID-19 information plays in protecting both individual patients, as well as the overall health of the general public, we also recognize the crucial need for data reporting options that will help eliminate the duplicative and sometimes competing reporting requests that continue to place a significant burden on hospitals and CAHs whose resources are already stressed during this PHE for COVID-19,” said CMS.
“We expect that the new reporting requirements that will be specified by the [HHS] Secretary, would include reporting channel options to make submission of data as user-friendly as possible to reduce the strain and burden hospitals and CAHs are currently experiencing as they face data requests from a multitude of federal, state, local, and private entities,” according to the rule.
Your hospital, urgent care center, nursing home, laboratory or other healthcare facility has just survived a hurricane. Or a wildfire. Or a tornado. Or any other disaster. Now you need help with recovery.
If you are affiliated with a state, tribal, territorial or local government operation, or are a non-profit providing critical healthcare services in a declared disaster area, the Federal Emergency Management Agency (FEMA) has a public assistance program ready to help.
“Private non-profit (PNP) and state or county-operated healthcare facilities are eligible for reimbursement if they are located in the declared disaster area and provide emergency medical care (diagnosis or treatment) of mental or physical injury or disease,” according to a “Guide to Federal Recovery Programs for Healthcare Organizations” published on the Department of Health and Human Services’ (HHS) Technical Resources, Assistance Center, and Information Exchange (TRACIE).
For-profit organizations may be eligible for assistance through the Small Business Administration, notes the 14-page guide, which also encourages to facilities to review disaster insurance coverage and explore options through the U.S. Department of Housing and Urban Development.
For non-profits, FEMA can provide grants to help with hazard mitigation during recovery. The grants are generally provided to a state or regional agency, that then administers subgrants to eligible facilities.
Those facilities can include:
Clinics
Facilities that provide in-patient care for convalescent or chronic disease patients
Hospices and nursing homes
Hospitals and related facilities such as:
Central service facilities operated in connection with hospitals
Extended-care facilities
Facilities related to home-health services
Laboratories
Self-care units
Storage, administration and record areas
Long-term care facilities
Outpatient facilities
Rehabilitation centers that provide medical care
You can find out more information about available resources and how to apply for help through your local healthcare coalition. Among other things, you will likely be asked to present documentation about disaster-related damage and what emergency work needs to be done.
What’s work is eligible?
FEMA reimbursement is available for eligible work, which can include, according to the TRACIE booklet:
Category A: Debris Removal
Debris removal activities such as clearance, removal, and disposal. These activities will count if they are in the public interest, meaning it:
Eliminates immediate threats to lives, public health, and safety;
Eliminates immediate threats of significant damage to improved public or private property; and/or
Ensures economic recovery of the affected community to the benefit of the community at large.
For a PNP, eligible debris removal is limited to that associated with an eligible facility, including debris on the property of the eligible facility
Category B: Emergency Protective Measures
Emergency evacuations
Labor costs for emergency mass care or shelter operations
Overtime pay for permanent, reassigned or
temporary employees doing emergency work
Regular and overtime pay for contractors
doing emergency work
Temporary repairs to the facility or equipment,
keeping it functional until permanent repairs
can be made
Emergency protective measures (e.g., provision of shelters/emergency care, sandbagging, bracing/shoring structures, emergency repairs or emergency demolition,
and removal of safety hazards)
Temporary generators
Category E: Buildings and Equipment
FEMA reimbursement will only cover eligible repair costs for items that were damaged by the event. Proving so is a comprehensive process dependent on thorough documentation, assessments, and inspection by FEMA representatives to examine repairs. Reimbursement for damaged or destroyed equipment and supplies is permitted if the equivalent items are similar in age, condition, and capacity.
Repairs could include:
Facility repairs and any required increased code compliance
Facility repair costs if they exceed 50% of the replacement cost
Overtime labor costs, specific to construction
Permanent work to bring the facility back to pre-disaster condition
If equipment is not repairable, FEMA uses “blue book” values or similar price guides to estimate eligible costs.
Category Z: Management Costs
Management costs are indirect costs, administrative expenses, and other expenses incurred through the administration and management of public assistance awards that are not directly chargeable to a specific project.
You must have prepared prior to event
The booklet summarizes other aid that may be available but notes in several places that healthcare facilities are expected to have participated in emergency management.
Hospitals deemed eligible for Medicare through The Joint Commission have long been required to show emergency preparedness activities, and since 2016 other healthcare facilities have also been required to do the same under CMS Conditions of Participation (CoP) and Conditions of Coverage.
Such preparations will help facilities put together requests for disaster assistance, notes the TRACIE booklet:
“Prior to any event, it is imperative that healthcare facilities develop policies and procedures for capturing disaster-related expenses such a staff labor costs, supplemental materials, volunteer hours (such as NGOs) and assessing, documenting and photographing (where appropriate) damages.
“Having a process in place to quickly set up disaster-specific cost centers or having pre-printed or electronic disaster purchase orders will assist greatly in tracking and documenting expenses and improve the chance of reimbursement.
“Facilities should also document ‘normal’ daily expenditures and usage to ensure there is adequate justification for ‘disaster-related’ costs when seeking reimbursement. An estimated scope of work and timelines for completion of proposed projects can also help prepare for reimbursement.”
CMS is gearing up to resume surveys, starting with closing out cases suspended by the March declaration of a national public health emergency (PHE) because of the 2019 coronavirus pandemic.
A nine-page Quality & Safety Oversight (QSO) group letter to state and regional CMS survey offices issued late Monday outlines the priorities for state surveyors to begin culling through the backlog of cases at long-term care or nursing facilities as well as all other providers.
Throughout the memo, CMS notes that surveys should resume primarily in areas that have entered the White House’s Phase 3 of reopening—which can vary from region to region—and that individual facilities can ask for delays if they are experiencing a surge in COVID-19 cases. Many surveys may still focus primarily on infection control and conditions that pose an immediate jeopardy to patients or staff, as they have throughout the PHE.
The bulk of the guidance in QSO-20-35-ALL, “Enforcement Cases Held during the Prioritization Period and Revised Survey Prioritization,” focuses on nursing homes and how and when the clock starts on charging those facilities any civil monetary penalties allowed by law. It also discussed the resumption of cases that could not meet the conditions of a “desk review,” meaning that an in-person site visit was not necessary to determine compliance.
The last three pages of the QSO guidance focus on non-long-term care facilities as well as laboratories that must meet CLIA regulations.
Once a state has entered Phase 3 or reopening “or earlier at the state’s discretion,” the memo says state survey offices are instructed to resume normal survey activities, prioritizing the survey backlog in this order:
“1. Revisit surveys for past non-compliance that do not otherwise qualify for a desk review;
2. Complaint surveys triaged as non-IJ level or higher that have not been completed;
3. Special Purpose Renal Dialysis Facilities (SPRDF);
4. Initial surveys of new providers;
5. Past-due recertification surveys with a statutorily required survey interval; and
6. Past-due recertification surveys without a statutorily required survey interval.”
The memo also advises surveyors to continue to focus their efforts on “the COVID-19 Focused Infection Control Survey: Acute and Continuing Care specified in QSO-20-20-All as part of any survey that is conducted.”
Validation surveys in which CMS officials check behind accrediting organizations are still in limbo.
“While CMS recognizes that resumption of surveys will depend on State reopening plans, staffing, and resources, CMS is requesting that states work with their respective CMS locations to discuss plans and proposed timeframes for completion of required surveys postponed due to the COVID-19 PHE,” notes the August 17 memo.
“Accrediting organizations with Medicare-approved programs may resume normal activity based on State reopening criteria. Any variations from the approved reaccreditation survey process must receive CMS approval prior to implementation.”
That last bit of guidance may explain why late last week The Joint Commission (TJC) removed from its Coronavirus Resources page a position statement on “Preventing Nosocomial COVID-19 Infections as Organizations Resume Regular Care Delivery.”
In a two-paragraph replacement document, TJC said it was removing the position statement.
“This guidance document was originally written in May 2020 when COVID-19 cases in the U.S. were declining, healthcare organizations were rapidly working to resume elective procedures and ambulatory care, and The Joint Commission was receiving many questions regarding reopening. Unfortunately, COVID-19 cases surged across many parts of the country that had been relatively unaffected, and we are now in a very different situation; healthcare organizations are trying to balance providing safe, routine care while combatting the continuing epidemic amidst persistent shortages of personal protective equipment (PPE).”
“The situation in the U.S. continues to evolve, and we have heard from a number of professional societies and healthcare organizations that sections of the position statement were problematic because of the changes in the COVID-19 epidemic and our understanding of the science around COVID-19 transmission. The CDC has updated their guidance to address some of the issues discussed in the position statement, including definitions of contingency strategies and crisis standards of care for conservation of PPE and when these should be applied. For these reasons, we believe the position statement is no longer useful, so we are removing it from the website,” according to TJC.
The number of sentinel events reviewed by The Joint Commission (TJC) in the first half of this pandemic-dominated year are well under the pace for last year. But that’s probably not unexpected given the lockdown of the nation’s hospitals as they focused on preparing for the 2019 coronavirus patient surge.
In announcing the statistics for the review period of January 1 through June 30 of this year, TJC noted that while the focus on COVID-19 patients presented significant and unique challenges for all healthcare organizations, "future studies will be required to fully quantify its true impact as a causative factor in sentinel events," said Raji Thomas, DNP, MBA, CPHQ, CPPS, director of TJC’s Office of Quality and Patient Safety in the statement released online.
As in 2019, care management problems led the list of sentinel events. That same year, TJC grouped different categories together. The care management category, including falls, delays in treatment and medication management errors.
Next on the sentinel list was surgical or invasive procedures, which includes foreign objects left accidentally in patients, operating on the wrong site of the body, plus operative and postoperative complications.
In the first half of the year, TJC reviewed only 41 suicide events, compared to 96 for all of 2019 — that includes suicides in inpatient and emergency department settings as well as within 72 hours after discharge.
Despite the challenges of the year, TJC will continue to review and work with healthcare organizations to reduce sentinel events. Thomas promised the commission will be sensitive to the challenges facing hospitals and other healthcare organizations.
“Our patient safety specialists have been sensitive to the unprecedented stressors that healthcare organizations face because of the pandemic,” Thomas stated.
“Our department strives to be nimble and accommodating to meet the individualized needs of organizations as they manage competing priorities. We appreciate that health care organizations continue to find value in working with The Joint Commission to evaluate harm events and implement sustainable mitigation plans to prevent recurrences while managing these unfamiliar crisis situations.”
The statistics, as released by TJC for the first half of 2020, followed by all of 2019, by category were:
The Facilities Guidelines Institute (FGI) is asking for public comment through September on the 2020 update to the FGI Guidelines for Design and Construction, which “provide minimum standards for design and construction of hospitals, outpatient facilities, and residential health, care, and support facilities,” according to an FGI announcement.
Used by many state and local authorities having jurisdiction to “regulate design and construction of these facilities,” The Joint Commission (TJC) also cites the guidelines under Environment of Care standard EC.02.06.05.
The standard requires hospitals to manage risks to the environment of care during demolition, renovation and new construction and cites the guidelines as one of the acceptable references for design criteria during that process.
Among the overall proposed changes, according to FGI, are:
Use of ANSI/ASHRAE/IES Standard 90.1, STANDARD 90.1-2019, Energy Standard for Buildings except Low-rise Residential Buildings, in the absence of a state- or locally adopted energy code
Requirements and considerations for palliative care design in the Hospital and Residential documents
Requirements and considerations for use of color and light that accentuate contrast for low-vision populations in the Hospital and Residential documents
Recommendations for noise risk assessments in the Hospital and Outpatient documents
Provision of new emergency department (ED) clinical spaces in the Hospital and Outpatient documents
Requirements for facilities for an intensive outpatient and partial hospitalization program for behavioral and mental health patients in the Hospital and Outpatient documents
Clarifications on clean and sterile supply storage in operating suites in the Hospital and Outpatient documents
In addition, specifically under the Hospital Guidelines, the proposed changes include:
Updated appendices for the behavioral and mental health risk portion of the safety risk assessment
Minimum requirements and recommended best practices for burn units and hospice units
Provision of an anteroom for an airborne infection isolation room predicated on an infection control risk assessment (ICRA); design considerations for anterooms added to the appendix
New guidance on ED design to improve flexibility, accessibility, and safety
New information to encourage small and specialty hospitals, where appropriate, to use the critical access hospital chapter; new guidance to increase flexibility of room use in critical access hospitals
The guidelines got their start more than 70 years ago as a federal-private venture to set building standards for the nation’s hospitals being built across the continent under the post-World War II Hill-Burton program. Publishing of the guidelines is now administered under the American Society for Healthcare Engineering (ASHE).
Now that Health and Human Services (HHS) Secretary Alex Azar has again renewed the official declaration of a public health emergency (PHE) related to the 2019 novel coronavirus, hospitals and other providers can continue to take advantage of CMS blanket 1135 waivers.
Hospitals, for instance, have used the blanket waivers to expand the use of telehealth, delay some testing and maintenance of non-critical systems, and use temporary facilities as ways to ease the financial and daily burden of meeting the surge of COVID-19 patients.
First issued in March, the PHE must be revisited every 90 days. The July 24 order came just one day shy of the deadline, prompting healthcare leaders to push the administration for the promised renewal.
Rick Pollack, president and CEO, American Hospital Association, offered appreciation for the support. “With our nation’s hospitals, physicians, nurses and other front-line health care workers intently focused on fighting this battle against the virus, now is not the time to pull back, especially as COVID-19 cases and hospitalizations have risen in many parts of the country in recent weeks. This action will allow us to continue our efforts to ensure that hospitals and health systems are using every tool available to respond to COVID-19.”
The Joint Commission also has said that it will consider whether a facility was actively in the middle of PHE activities when determining when to conduct a survey to renew accreditation.
The Joint Commission (TJC) again has earned CMS approval as a national accrediting organization (AO) for hospitals, but only for two years.
The last time TJC was renewed as a hospital AO was in 2014, for a six-year period. That ran out as of July 15, 2020.
In a special filing in the July 15, 2020, Federal Register, CMS published a notice that TJC had been approved as a hospital AO through July 15, 2022.
The federal announcement made note that the approval was only two years, instead of the six years maximum allowed by regulation.
“This shorter term of approval is based on our concerns related to the comparability of TJC’s survey processes to those of CMS, as well as what CMS has observed of TJC’s performance on the survey observation. Some of these concerns stem from the level of detail TJC provides in the daily briefings it provides to facilities, as well as TJC’s processes surrounding its staff interview practices. Additionally, we are concerned about TJC’s review of medical records and surveying off-site locations, in particular for the Physical Environment Condition of Participation (CoP),” said CMS.
In the last few months, TJC has revised or expanded standards to meet CMS demands. Among other things, according to the notice, TJC also revised surveyor training and required the AO to provide more information to hospitals during the survey’s daily briefing.
CMS said it remains “concerned about the thoroughness of review conducted within the facilities.” The agency acknowledged all the changes TJC has made, but “we will continue ongoing review of TJC’s survey processes across all their approved accrediting programs to ensure that all our recommended changes have been implemented. In keeping with CMS’s initiative to increase AO oversight, and ensure that our requested revisions by TJC are complied with, CMS expects more frequent review of TJC’s activities to avoid any continued inconsistencies.”
In a statement, Mark R. Chassin, MD, FACP, MPP, MPH, TJC's president and chief executive officer, promised his organization would work with CMS on continuing to improve patient safety.
“The Joint Commission is pleased that the Centers for Medicare & Medicaid Services (CMS) recognizes the value of continuing to grant hospital deeming authority to The Joint Commission. The deeming authority designation allows The Joint Commission to evaluate our nation’s hospitals for compliance with CMS health and safety requirements, while also surveying for adherence to our own rigorous quality performance standards. All issues raised by CMS about comparability of our respective processes were adjudicated during the deeming authority application process, as noted in CMS’ public notice granting approval of our application," said the statement.
“The Joint Commission appreciates that CMS began an initiative last year to increase its oversight of all hospital accrediting organizations. We will continue to demonstrate that Joint Commission accreditation provides the nation’s most state-of-the art and effective evaluation of hospitals. We look forward to our ongoing work with CMS to improve patient safety and quality of care.”
For several years, CMS has cracked down on TJC and all the AOs, even separating out a performance report on AOs to Congress that had previously been part of the agency’s annual financial report.
Then in December 2018, CMS issued a request for comment on possible conflicts of interest by AOs that also offered consulting services for a fee.
In February of this year, CMS sent the Office of Management and Budget a proposed rule to review on “Strengthening Oversight of Accrediting Organizations (AO) and Related Provisions.” While that proposal was expected to be published in the spring, it still is before the OMB, presumably backlogged because of the coronavirus pandemic.
The CDC’s National Institute for Occupational Safety and Health (NIOSH) is seeking comment through the end of June on a long-awaited update to its list of drugs used in healthcare that pose potential hazards to those who administer and otherwise handle them.
The proposal includes a name change and reorganization of drug lists so that not all antineoplastic drugs, most often associated with cancer treatments, are grouped together. Formerly the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings,” the list will be called more simply the “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.”
The list, which is a basic reference document for OSHA, USP and other standard-setting organizations, has not been updated since 2016.
Nurses, pharmacists, and physicians should pay particular attention to a companion document published along with the updated list in the May 1 Federal Register outlining how to manage hazardous drugs in healthcare settings, says Kurt Patton, MS, RPh, pharmacist, founder of Patton Healthcare Consulting, and former director of accreditation services for The Joint Commission (TJC).
The companion document, “Managing Hazardous Drug Exposures: Information for Healthcare Settings,” takes information that in the 2016 list was under “Table 5: Personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings” to create a “new, comprehensive document on risk management strategies,” according to the NIOSH proposal.
Table 5 was taken out of the main list “in order to clarify that the list is a hazard identification tool,” according to NIOSH. The new document is 87 pages, but still includes a revised version of the table on PPE and engineering controls.
The Federal Docket folder of supporting information behind the NIOSH proposal includes not only a draft of the actual 2020 list and the document on managing drug exposures, but also a draft of the procedures NIOSH used to develop the 2020 list.
While overall comments are welcome on all the documents, NIOSH is soliciting answers to specific questions on each document, according to the proposal.
Under the section discussing the new document on handling hazardous drugs, healthcare workers—pharmacists, physicians and nurses particularly—should pay special attention to questions 5, 6, 7, and 8, advises Patton.
Those questions seek thoughts on the usefulness of the table on approaches to handling hazardous drugs, including what format changes could be made to improve the table’s usefulness, what information is redundant, suggestions for more useful risk management information, and recommendations on other studies or scientific information “related to the use of a medical surveillance program as an additional approach to protect workers in healthcare settings. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants,” according to NIOSH.
While the list of drugs continues to grow, the proposal does note that some drugs have been removed and that other drugs proposed for addition two years ago were not actually added.
“One highlight is that botulinum toxin (Botox), which had been added to the proposed hazardous drug list in 2018, has now been removed,” notes Patton. “Hospitals that struggle to be compliant with this medication in many outpatient settings will find that removal not adding to their existing regulatory burdens.”
Patton recommends that all the documents in the docket be downloaded and read by potential stakeholders who may want to comment.
The new document on managing drug exposures may be the most significant for healthcare organizations, especially as they ramp to compliance with USP <800> Hazardous Drugs—Handling in Healthcare Settings, says Patton. That USP general chapter became official December 1, 2019, but remains only informational unless adopted by local authorities having jurisdiction.
The update to the 2016 NIOSH list “has been a long time in coming, and it is not finished yet,” pending the newest round of comments, notes Patton.
To add your comments to the process, you must do so by June 30, online, or by mail to NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998. Comments must be identified by docket numbers CDC-2020-0046 and NIOSH-233-C. Remember that comments will be made public, unless you request anonymity.
