CMS published a warning to states today that if they are contracted with the federal agency to carry out health and safety surveys that failure to carry out their responsibilities will result in a reduction of federal funds to the state’s survey offices.

Editor's note: This article was originally published by the HCPro Accreditation & Quality Compliance Center.

One way or another, CMS is promising states that it will enforce its recent interim final rule requiring hospital and other healthcare staff caring for COVID-19 patients to be fully vaccinated.

CMS published a warning to states today that if they are contracted with the federal agency to carry out health and safety surveys that failure to carry out their responsibilities, including enforcing the new vaccine requirement, will result in a reduction of federal funds to the state’s survey offices.

Federal funds will be used then to “address any gaps” in implementing requirements under the Medicare Conditions of Participation, said CMS. Funds will be used, says CMS, to enforce the requirement through other means.

To that end, CMS is reducing the state of Florida’s survey and certification funding by more than $1.2 million, according to a statement issued by CMS in reply to a query from the Accreditation & Quality Compliance Center. Florida’s governor said last month he will not allow the vaccine mandate to be enforced.

In a Quality, Safety & Oversight Group memo, QSO-22-12-ALL, published February 9, CMS reminded its state survey agencies that funding for their offices was a result of an agreement between the Department of Health and Human Services and each state under Section 1864 of the Social Security Act.

The agreement “stipulates the functions of the State to, among other things, certify whether or not providers and suppliers within the state comply with all applicable definitions and requirements under the Act and implementing regulations,” which the memo said included “surveying for the purpose of certifying to the Secretary the compliance or non-compliance of providers and suppliers of services and resurveying such entities, at such times and manner as the Secretary may direct.”

That includes enforcing the interim final rule set out late last year and earlier this year that mandated all healthcare personnel who might be exposed to COVID-19 be full vaccinated.

In answering a query about the QSO, CMS stated:

“The prevalence of COVID-19 and its variants in health care settings continues to increase the risk of staff contracting and transmitting COVID-19, putting patients, families, and broader communities at risk. The Centers for Medicare & Medicaid Services (CMS) used its authority—confirmed by the U.S. Supreme Court—to protect the health and safety of patients and staff by requiring health care facilities and suppliers that participate in Medicare and Medicaid to vaccinate their staff.”

“As CMS implements the rule, states are responsible under their federal agreements for certifying that facilities are in compliance with the rule. If states refuse to carry out all their responsibilities under the law, CMS can exercise its discretionary authority under the terms of agreements between the agency and the state to revise budget allocations to account for the survey work the state is not performing. This would allow CMS to engage other federal resources to establish a means of evaluating compliance with the requirements of the CMS health care worker vaccine rule that the state survey agency refuses to survey.”

The statement went on to address Florida specifically.

“In keeping with the longstanding agreements CMS has with states under the Social Security Act, CMS is exercising its discretionary authority under the terms of agreements between the agency and the state to reduce Florida’s survey and certification budget allocation by $1,245,400 to adjust for the limited scope of survey work,” said the statement.

“CMS will continue to provide Florida with more than $11 million to support the state’s other surveying responsibilities. CMS remains committed to protecting people from the devastating effects of COVID-19 while also ensuring programs operate according to the law.”

The memo informs “states of potential funding risks that may result from their failure to carry out their responsibilities under these agreements” with CMS. “Federal resources will be engaged to address any gaps.”

That may include hiring other contractors to carry out surveys for the vaccine requirements, said the QSO memo.

“These state allocations would be reduced for the current fiscal year and each successive year until the state resumes full oversight of the entirety of Medicare and Medicaid regulations. These funds would be used by CMS to support federal oversight alternatives in the state (including contractor support) to safeguard the health and safety of those receiving care from Medicare and Medicaid certified providers and suppliers. The scope of the allocation reduction will be commensurate with the impact of the State actions and the federal resources needed to provide appropriate oversight of providers and suppliers.”

Regardless of what is going on within a state, hospitals and other providers are still expected to comply with the CoPs, said CMS.

And accrediting organizations will continue to enforce the vaccine regardless of the state, CMS said.

“Despite a decision by a State Survey Agency to restrict their compliance reviews, Accrediting Organizations with deeming authority are required to continue surveying for compliance with all Medicare and Medicaid regulations. Medicare and Medicaid certified providers and suppliers within every State continue to be responsible for compliance with the federal requirements for all Conditions of Participation, Conditions for Coverage, and Requirements for Participation.”

The interim final rule published late last year establishing new CoPs outlining the vaccine requirements was challenged in several state courts. After a request for an injunction against enforcement went before the Supreme Court, the justices lifted the injunction and CMS has gone forward with enforcement.

In just more than a decade, the number of complaint surveys CMS has investigated in hospitals has gone from 1,294 in 2008 to 3,491 complaint surveys in 2019.

Editor's note: This article was originally published by the HCPro Accreditation & Quality Compliance Center.

Missed deficiencies within the physical environment, fire safety, infection control and patients’ rights continues to dominate CMS’ annual report card on the annual performance of accrediting organizations (AOs).

In a report to Congress released late Wednesday, CMS said it will continue putting pressure on AOs to do a better job of enforcing Medicare’s Conditions of Participation but is also fine-tuning the process of how it validates their performance.

Concerns remained concentrated on AOs failures to find problems within the physical environment that were spotted by CMS’s state survey agencies (SAs) during surveys to validate the AOs findings. Validations surveys are supposed to be conducted within 60 days of an AO’s triennial visit.

“Examining the specific condition-level deficiencies cited by the SAs across all 60-day validation surveys provides an indication of the types of quality problems that exist in these facility types as well as the relationship between SA and AO citations for specific conditions,” wrote CMS in the report.

“CMS uses two approaches for this analysis: (1) a review of the types of condition-level citations identified by SAs and the comparable AO deficiency findings; and (2) a comparison of the number of surveys with PE condition-level deficiencies and the number of surveys with other types of condition-level deficiencies. Both approaches highlight the same conclusion: SAs identify more PE condition-level deficiencies than any other type of deficiency on validation surveys; and AOs miss a significant number of these PE deficiencies.”

While the report is dated fiscal 2020, the AOs were evaluated during federal fiscal year 2019, which would have gone from October 1, 2018, through September 30, 2019 — before the COVID-19 pandemic upended both CMS and AO surveys.

CMS has increased pressure on AOs as well as hospitals for a few years, including creating a website to highlight the CMS surveys that revealed the most serious patient safety deficiencies and separating them by the AO responsible for oversight.

In just more than a decade, the number of complaint surveys CMS has investigated in hospitals has gone from 1,294 in 2008 to 3,491 complaint surveys in 2019.

The Joint Commission continues to be the largest of the AOs, with responsibility for 2,891 hospital surveys in fiscal 2019, compared to the next largest AO, DNV Healthcare, at 286, according to the report.

The oldest CMS-approved hospital accreditation program in the nation, the Healthcare Facilities Accreditation Program (HFAP) surveyed 89 hospitals in fiscal 2019, while the Center for Improvement in Healthcare Quality (CIHQ) did just 68 surveys.

The pressure to improve performance was largely behind CMS’ move in July 2020 to limit The Joint Commission to just a two-year approval, and to HFAP’s merger with the Accreditation Commission for Health Care (ACHC) that October. HFAP is now transitioning its new brand name as ACHC.

TJC has already submitted its application for renewal as an AO. CMS published a request for comment on the application on December 10 in the Federal Register. Comments will be accepted through January 9. See the Federal Register announcement for details on how to submit comment.

OSHA has extended the public comment period until January 19, 2022.

Editor's note: This article was originally published by the HCPro Accreditation & Quality Compliance Center.

Didn’t have time to gather your thoughts yet on OSHA’s emergency temporary standard (ETS) requiring vaccination and testing for employers with 100 or more employees? You can still offer up your two cents!

OSHA has extended the public comment period until January 19, 2022. (The original comment deadline was January 4.)

The ETS is on the Federal Register as Docket No. OSHA-2021-0007. You can file electronically at https://www.regulations.gov, which is the Federal e-Rulemaking Portal and the only way to submit comments on this rule, according to OSHA.

OSHA also asks that you follow the online instructions for making electronic submissions. You can read the Nov. 5, 2021 Federal Register notice on the ETS for details.

The ETS, according to OSHA, is designed to “protect workers from the spread of coronavirus on the job.” Employers with 100 or more employees “must develop, implement and enforce a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to either get vaccinated or undergo regular COVID-19 testing and wear a face covering at work.”

The rule originally had an effective date of 30 days after publication for implementation of testing and 60 days after publication for the vaccine requirement.

However, after court challenges, OSHA suspended enforcement until the legal issues were resolved.

You can find more information, including a rule summary and fact sheets, at OSHA’s COVID-19 Vaccination and Testing ETS webpage.

"They took out a lot of unnecessary complexity," observed Kurt Patton, MS, RPh, pharmacist, founder of Patton Healthcare Consulting, and former director of accreditation services for The Joint Commission.

Editor's note: This article was originally published by the HCPro Accreditation & Quality Compliance Center.

If your hospital or its satellite buildings are co-located with other healthcare facilities, you now face slightly fewer requirements than first proposed for ensuring compliance with acute care Medicare Conditions of Participation (CoP) when sharing services with other entities not bound to the hospital requirements.

For instance, there is no more discussion on when floating nurses or other personnel meet the CoP for nursing services and there’s no need for a floor plan to show surveyors evaluating whether patient rights are protected as they are transferred from one area to another between co-located healthcare entities.

Those discussions were part of a 10-page memo to CMS state surveyors in May 2019— before COVID-19 —with proposed guidance from the Quality, Safety & Oversight Group in QSO-19-13-Hospital.

After accepting comments on that proposal, that memo is now six pages and is effective immediately for surveyors to use to evaluate compliance as hospitals seek to share services to save money will also delivering quality care, according to CMS.

“Hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services,” according to the memo.

While the memo has many of the same sections on contracted staff, emergency services and identification of shared spaces, much of the more prescriptive sections are either shortened or deleted. That includes guidance for surveyors to ask for floor plans to evaluate how patients are transported from one space to another and examples of when the use of floating nurses are in violation of CoP requirements.

“They took out a lot of unnecessary complexity,” observed Kurt Patton, MS, RPh, pharmacist, founder of Patton Healthcare Consulting, and former director of accreditation services for The Joint Commission (TJC). 

There was pushback on the proposed guidance from the American Hospital Association and other organizations, although The Joint Commission (TJC), HFAP (now ACHC) and other accrediting organizations made preparations to enforce the requirements.

The revised memo does reinforce CMS’ expectation to maintain patient safety and privacy as patients are cared for in shared spaces.

“All co-located hospitals must demonstrate independent compliance with the hospital CoPs,” says the memo. “This guidance clarifies how hospitals may organize shared spaces, services, personnel, and emergency services to meet regulatory requirements. When hospitals choose to co-locate, they should consider the risk to compliance through any shared space or shared service arrangements.”

And within the guidance, surveyors are told that regardless of why a hospital may be sharing space with other healthcare entities, “when a hospital is in the same location (campus or building) as another hospital or healthcare entity, each entity is responsible for demonstrating its compliance with all applicable Medicare and Medicaid program participation requirements.”

CMS promises it will be updating the State Operations Manual (SOM), Appendix A, with the revised guidance. Eventually. The last time the SOM was updated was in 2020, and much of that was just placeholder language for guidance to come later.