The Centers of Medicare and Medicaid Services has removed MD Anderson Cancer Center’s Medicare “deemed” status, which means that, until the Houston hospital demonstrates compliance with federal regulations, the institution is at risk of having its Medicare provider agreement terminated.
On June 3, CMS sent a letter to MD Anderson President Peter Pisters, declaring that the agency has found “substantial noncompliance,” based on “significant deficiencies” at the hospital.
“These deficiencies have been determined to be of such a serious nature as to substantially limit your hospital’s capacity to render adequate care and prevent it from being in compliance with all the applicable Medicare Conditions of Participation,” wrote Karen Hillman, a manager at the CMS Enforcement Branch.
The CMS letter is available here.
Usually, a hospital that loses its Medicare deemed status may continue to accept Medicare patients and receive federal funding in all previous payment models, experts say. However, the hospital’s status will not be reinstated until a corrective action plan has been accepted by federal regulators.
Acceptance is based on the hospital’s ability to demonstrate its compliance with all federal standards during a follow-up survey.
As Pister’s administration works to regain deemed status for full compliance with CMS regulations, MD Anderson’s participation in all existing payment models—including Medicare and prospective payment rates based on Diagnosis Related Groups—remains intact.
This means that MD Anderson was given a fair warning and an opportunity to set things right. If the institution fails to demonstrate compliance, it would lose Medicare privileges.
CMS’s decision to take punitive action appears to stem from a blood transfusion-related adverse event that MD Anderson reported to FDA, as per federal requirements for reporting of harm or injury to patients:
“In December 2018, The University of MD Anderson Cancer Center self-reported a blood transfusion-related adverse event to the Food and Drug Administration,” MD Anderson officials said in a statement to The Cancer Letter. “Based on the self-reported information, the FDA conducted a full investigation and no citations were provided. Per policy, the FDA referred the case to the Centers for Medicare and Medicaid Services.
“CMS, in conjunction with the Texas Department of State Health Services, conducted surveys of MD Anderson from March 29 to April 5 and from May 13 to May 17. MD Anderson cooperated fully with CMS to address surveyor questions, and our resulting focus is on resolution, learning and improvement.”
Several observers said they were shocked by the CMS action—findings of broad noncompliance and subsequent removal of a hospital’s “deemed” status are usually associated with small, lesser-known institutions, not an academic powerhouse. The U.S. News & World Report has ranked MD Anderson as the top cancer center in the U.S. for the past 10 of 11 years.
Medicare-certified providers and suppliers of health care services must be substantially compliant with federal health and safety requirements, according to two CMS rules:
Final rule, January 2017: “Facilities not meeting requirements would either correct the inappropriate practice(s) or would be terminated from participation in the Medicare or Medicaid programs.”
Proposed rule, May 2019: “A Medicare-certified provider or supplier that does not substantially comply with the applicable health and safety requirements risks having its Medicare provider agreement terminated.”
Because MD Anderson’s deemed status is suspended, the hospital is on an “enforcement track” with CMS, experts say. While on this track, the cancer center retains its accreditation and ability to bill CMS for services provided to Medicare beneficiaries.
MD Anderson officials said that the cancer center is “not on a pathway” to losing its Medicare contract.
“CMS has the right and responsibility to survey any hospital participating in Medicare and Medicaid programs,” officials said in a statement. “CMS has avenues of escalating serious events that pose an immediate threat to patient care. MD Anderson did not receive that level of rating and is not on a pathway to termination from CMS programs.”
In February, CMS issued a similar letter to Baylor St. Luke’s Medical Center, after an emergency room patient died as a result of receiving the wrong blood type in a transfusion—six months after CMS cut off Medicare funding for heart transplants at St. Luke’s, according to a Feb. 7 report in the Houston Chronicle.
MD Anderson officials said the cancer center’s blood transfusion adverse event did not involve mislabeling, according to the Houston Chronicle.
When a health care provider is accredited by a national accrediting organization—for instance, The Joint Commission—the provider is “deemed” by CMS to have met or exceeded all applicable Medicare and Medicaid requirements.
According to The Joint Commission, “in order to participate in and receive federal payment from Medicare or Medicaid programs, a health care organization must meet the government requirements for program participation, including a certification of compliance with the health and safety requirements called Conditions of Participation (CoPs) or Conditions for Coverage (CfCs), which are set forth in federal regulations.”
CMS may temporarily remove deemed status—and therefore the accrediting organization’s jurisdiction—when a survey team identifies noncompliance at the condition level. This is a serious deficiency that is not in substantial compliance with one or more of the CoPs in the Medicare program, experts say.
Nationally, about 300 accredited hospitals are found “out of compliance” at the condition level, which means these facilities had their deemed status suspended, until they came back into compliance—or were terminated from participating in CMS programs.
CMS found MD Anderson to be “out of compliance” with five Medicare Conditions of Participation:
42 CFR 482.12 Governing Body: “The hospital must have an effective governing body legally responsible for the conduct of the hospital as an institution.”
42 CFR 482.13 Patient Rights: “A hospital must protect and promote each patients’ rights.”
42 CFR 482.21 QAPI: “The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.”
42 CFR 482.23 Nursing Services: “The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse.”
42 CFR 482.27 Laboratory Services: “The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients.”
The full text of Conditions of Participation for Hospitals, Part 482, Subchapter G on Standards and Certification, Code of Federal Regulations, is available here.
“A plan of corrective action is not required at this time,” CMS’s Hillman wrote in the June 3 letter to MD Anderson’s Pisters. “However, it is to your advantage to initiate corrective action on the identified deficient practices in order to bring your hospital in compliance with the regulations.”
Though accreditation is voluntary, and seeking deemed status is an option, not a requirement, many providers choose the accreditation process—to demonstrate compliance with CoPs—instead of certification based on a survey conducted by a state agency on behalf of the federal government.
When a hospital is found to be noncompliant, CMS advises the accredited hospital its deemed status has been removed, and its compliance monitoring is being placed under the state survey agency’s jurisdiction. MD Anderson is now under the jurisdiction of the Texas Health and Human Services Commission, the agency that surveys Texas providers on behalf of CMS.
“The deemed status of your hospital was removed on June 3, 2019, as a result of the findings of substantial noncompliance from the May 17, 2019, survey, and survey jurisdiction has been transferred to the HHSC,” Hillman wrote in the June 3 letter to Pisters.
Earlier this year, the HHSC conducted a survey of MD Anderson based on “substantial allegations of a significant deficiency or deficiencies which would adversely affect health and safety of patients if found to be present.”
CMS will not accept any accreditation decisions or recommendations made by an accrediting organization—The Joint Commission, in MD Anderson’s case—when deemed status is removed, and while a provider or supplier is under state survey agency jurisdiction,” according to a 2018 memorandum issued by the CMS Center for Clinical Standards and Quality/Quality, Safety & Oversight Group to state survey agency directors.
MD Anderson’s Accreditation and Regulatory Readiness Executive Steering Committee, led by Rosanna Morris, chief operating officer, and Stephen Hahn, chief medical executive, will be taking prompt corrective action, officials said.
“In response to specific items identified by CMS during its recent surveys, multidisciplinary teams are developing plans of action, which will be submitted next week,” MD Anderson officials said in a statement. “This Executive Steering Committee is working to streamline decision-making and to ensure MD Anderson’s policies and procedures align with the care and services we provide.”
MD Anderson has been accredited by The Joint Commission since 1951.
“An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 20,000 health care organizations and programs in the United States,” MD Anderson’s website states. “Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.
“Every three years, The Joint Commission surveys The University of Texas MD Anderson for one week closely observing a range of quality, safety, patient care and support practices.”
MD Anderson received its most recent accreditation from The Joint Commission beginning Sept. 24, 2016. The commission summarized its survey findings in a 50-page report, posted here.
Of the 50 pages, the commission dedicated at least 35 pages to describing “Insufficient Compliance” and “Partial Compliance” by MD Anderson to standards required for accreditation. The determination, “This Standard is NOT MET” appears 25 times throughout the report.
For instance, on page 33 of the report, the commission wrote: “Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is NOT MET.”
The commission directed the hospital to provide evidence of compliance for 11 standards within 45 days, and evidence of compliance for the other 14 standards within 60 days. MD Anderson did not receive a Preliminary Denial of Accreditation status, which would have required the hospital to respond to all noncompliance findings within 45 days.
A section of the report, “Summary of CMS Findings,” lists five areas of noncompliance: patient rights, nursing services, physical environment, infection control, and respiratory care services.
A letter of accreditation was issued by the commission to MD Anderson on Dec. 22, 2016.
MD Anderson officials say they welcome the review and feedback received from the CMS survey process.
“It affords us the opportunity to further strengthen and supplement our efforts, which includes our continued and expanded approach toward quality patient care through a culture of performance improvement,” officials said in a statement.
“MD Anderson constantly strives to ensure the highest standards of patient care, resulting in the best clinical quality outcomes. We are unwavering in our commitment to provide the highest standard of care to our patients.”