In This Month’s E-News: March 2024

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Report on Research Compliance 21, no. 3 (March, 2024)

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American innovation system and discourage partnerships between nonprofit research universities and the private sector that help bring cutting-edge technologies to the public,” according to AAU’s Feb. 12 weekly update. The 1980 Bayh-Dole Act “encourages universities and researchers holding patents developed through federally funded research to partner with the private sector to bring new discoveries to market,” AAU explained. The law also “grants federal agencies a limited right to ‘march in’ and to require patent owners to grant additional patent licenses to others.” The National Institute of Standards and Technology in December issued a draft framework that AAU said “reinterprets the Bayh-Dole Act to allow federal agencies to seize patents for drugs or individual products that they deem too expensive.”

AAU commented separately on the framework, writing that, “Without rescission, the existence of this framework as potential agency policy will continue to create uncertainty and confusion for our member institutions and their private sector partners and weaken the powerful engine of innovation and research that is public-private collaboration in the United States.” AAU also joined the American Council on Education, the Association of American Medical Colleges, the Association of Public and Land-grant Universities, AUTM and COGR in a second comment letter. The groups “recommended that the administration immediately withdraw the framework because it violates the spirit and intent of the Bayh-Dole Act and because it would disincentivize private sector partners from licensing advancements made through federally funded research initiatives at nonprofit universities.” (2/15/24)

Auditors for the NSF OIG are recommending that the agency require Dartmouth College repay NSF $104,270 in costs questioned among 209 NSF awards expended from Oct. 1, 2019, to Sept. 30, 2022. Auditors reviewed $1.1 million among more than $51.6 million of costs. “Specifically, the auditors found $104,120 of unallowable expenses and $150 of inadequately supported expenses,” according to the Feb. 2 audit. The largest portion of the questioned expenses consists of $82,595 charged for a subaward from March to September 2022 that auditors said “was not approved by NSF.” Dartmouth agreed with the audit findings and has already repaid most of the questioned costs. Auditors offered no information as to the nature of the subaward nor any explanation as to why it lacked approval. Dartmouth’s response to the draft audit findings also provided no insights. Acknowledging the subaward was unallowable, the college said it “implemented an additional internal control to verify that NSF approval is in place prior to issuing any subaward.”

Auditors said Dartmouth charged “$21,525 in travel expenses that were either not reasonable or did not benefit the awards charged.” This amount was for two trips that were later cancelled, but Dartmouth failed to “process credits” to return the full amount charged. Auditors also questioned $891 for what they called a “premium class airfare,” which was unallowable because “Dartmouth did not document the existence of any circumstances,” justifying the cost. Also questioned was a $150 “cash incentive payment” to a research participant that was improperly documented and a $100 difference between a hotel receipt and a booking confirmation. Additional findings with no financial repayment requests relate to a missing justification for a sole-source expenditure and incorrect application of an indirect cost rate that was two percentage points lower than negotiated. Auditors found a violation of Dartmouth’s research participant payment policies that involved paying back an employee via a gift card who paid participants with cash and personal checks. They made several recommendations for changes to improve Dartmouth’s policies. (2/15/24)

A 10-year-old breach of patients’ protected health information by a then-employee has cost Montefiore Medical Center a $4.75 million settlement with the HHS Office for Civil Rights (OCR), which alleged HIPAA violations occurred when “one of their employees stole the electronic protected health information of 12,517 patients and sold the information to an identity theft ring. Montefiore’s website describes it as the “University Hospital and Academic Medical Center for Albert Einstein College of Medicine.”

According to OCR’s Feb. 6 announcement, in “May 2015, the New York Police Department informed Montefiore Medical Center that there was evidence of theft of a specific patient’s medical information. The incident prompted Montefiore Medical Center to conduct an internal investigation.” Montefiore found the theft occurred from Jan. 1 through June 30, 2013. It notified OCR of the breach on July 22, 2015. The employee “inappropriately accessed patient account information, including the patient’s name, address, [Social Security number], next of kin, and health insurance information” from Montefiore’s electronic medical records system, OCR said in settlement documents. Requirements under the two-year corrective action plan include conducting a security risk assessment, revising policies and procedures and retraining workers. The payment is the largest since a $5.1 million settlement with Lifetime Healthcare Companies, including its affiliate Excellus Health Plan, in 2021, which resulted from a breach of 9.3 million individuals’ records. However, since 2019, when the University of Texas MD Anderson Cancer Center successfully fought OCR’s $4.3 million fine, the agency has routinely reached settlements that rarely exceed several hundred thousand dollars. (2/8/24)

Auditors for the Office of Inspector General (OIG) of the National Science Foundation (NSF) are recommending that the agency require Montana State University (MSU) to repay $119,241 in costs questioned among 50 transactions totaling $1,168,638 that were tested. Overall, the audit encompassed $37.7 million in expenses claimed on 176 NSF awards from Nov. 1. 2019 to Oct. 31, 2022. However, MSU agreed to reimburse NSF only $36,961 of the questioned costs. Unallowable expenses comprise the largest category of questioned costs. “MSU charged six NSF awards a total of $86,881 in indirect costs, airfare expenses, participant support costs, and Graduate Research Fellowship Program (GRFP) expenses that were unallowable per federal regulations” and the agency’s policies, according to the audit. MSU said it “respectfully disagrees” with auditors’ conclusion that $72,578 for what OIG termed equipment was unallowable. Auditors said MSU “did not appropriately capitalize equipment costs invoiced for the construction of a plastic gutter system. Specifically, because the cost to construct the gutter system exceeded $5,000 and the gutter system has a useful life in excess of 1 year, MSU should have classified the gutter system as equipment.”

In its response to draft audit findings, MSU countered that the expense was for a “plastic sheeting system simulating drought at high conditions” that was “accurately proposed, approved by NSF and expensed as a contracted service agreement. It does not represent a capital equipment purchase that would be excluded from the allowability.” Officials added that the investigator, “when pressed, provided only a rough estimate of its potential useful life.” Auditors also questioned $22,015, which they termed “inadequately supported expenses. $6,439 of inappropriately allocated expenses and $3,906 of ACM$ drawdowns that exceeded expenses.” MSU also disputed the auditors’ disallowance of $9,702 in lodging expenses for a principal investigator and a graduate student who were forced to remain in what MSU called “travel status” and were unable to obtain a lease (although one was not required) due to a fire at their lodging. In addition to reimbursement, the auditors made more than a dozen recommendations. Of note, the audit was completed by Sikich CPA LLC, previously known as Cotton & Company. (2/8/24)

Following a year in which it issued only two determination letters, in the month of January, the HHS Office for Human Research Protections (OHRP) posted two such letters—one of which closes a not-for-cause evaluation of Vanderbilt University Medical Center (VUMC) begun nearly five years ago. Both letters are dated Jan. 11. Acknowledging that agency officials “regret the amount of time it has taken us to complete this assessment,” OHRP said it conducted a two-day, onsite, not-for-cause evaluation of Vanderbilt in June 2019. “On January 28, 2022, OHRP requested current copies of the VUMC HRPP’s [human research protections program] organizational chart along with their written procedures, templates, and tools. On February 8, 2022, VUMC sent OHRP the requested information. OHRP requested additional documents and scheduled a meeting with VUMC to clarify certain points. During the March 6, 2023 meeting, VUMC satisfactorily addressed the concerns raised by OHRP,” according to the letter—which makes no mention of these “concerns.” Vanderbilt “agreed to make certain changes,” OHRP said, such as revising definitions. “Based on information obtained during the 2019 site visit, and review of additional documents, OHRP found no evidence of systemic noncompliance with HHS regulations. When changes referenced in your March 28, 2023, letter are finalized, please send us a copy of those revised written procedures,” OHRP wrote.

According to the letter to Stockton University, based in Galloway, N.J., OHRP received a complaint that the university had not updated its policies and procedures to comply with requirements related to institutional review board (IRB) actions, including how meetings are recorded; that consent forms were inadequate; and that it was not using appropriate procedures for expedited research, in violation of the 2018 revised Common Rule, which went into effect in January 2019. OHRP confirmed that all the allegations had merit. The agency wrote to Stockton about five specific allegations on Oct. 18, 2022, and received replies on Dec. 13, 2022, and April 27, 2023. Consent forms OHRP received, for example, violated the regulations because, in at least one study to “learn about health, nutrition, and physical activities in individuals with intellectual and developmental disabilities through interviews,” the documents did not address how identifiable or private information would be safeguarded. Despite all of the issues, it does not appear that OHRP took any actions to halt research at Stockton. According to the new letter, Stockton is still out of compliance with the various requirements; the agency gave the university a deadline of March 7 to submit new policies and procedures that address the deficiencies. “OHRP acknowledges that Stockton University is working diligently to support and stabilize its [HRPP] and IRB,” the agency’s letter said. It listed eight changes Stockton had made, including new staff hires and the use of a consulting firm to help structure its HRPP and develop required policies. (2/1/24)

The Environmental Protection Agency (EPA) is proposing to revise its definition of “scientific integrity and meaningfully strengthen several policy elements that will help ensure a culture of scientific integrity” within the agency, according to a Jan. 24 notice in the Federal Register. The changes reflect “the model scientific integrity policy from the National Science and Technology Council’s A Framework for Federal Scientific Integrity Policy and Practice (2023), lessons learned over the years, and the results of previous surveys of EPA staff on scientific integrity,” it said. The 29-page draft policy is not part of the notice but is posted separately on Changes are proposed in compliance with a White House directive issued in 2021 requiring agencies to update their policies and would replace EPA’s 2012 policy. As proposed, EPA would appoint a scientific integrity officer; it also adds research security, defined as “safeguarding the research enterprise against the misappropriation of research and development to the detriment of national or economic security, related violations of research integrity, and foreign government interference.”

The document states that, among others, it is EPA’s policy to “enhance the security and integrity of the research enterprise and protect against foreign government interference and misappropriation, while maintaining an open environment to foster research discoveries and innovation.” Another change relates to training. “EPA will also provide biennial training for those who propose, review, conduct, manage, and use the results of and communicate about science and scientific activities,” the draft states. As in the 2012 policy, research misconduct is defined as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results; or ordering, advising, or suggesting that subordinates engage in research misconduct.” The deadline for comments is Feb. 23. (2/1/24)

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Health Care Compliance Association (HCCA)

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