Sens. Casey, Wyden, Warren: Reports Reveal Nursing Homes Gave Residents Hydroxychloroquine to Treat COVID-19 Without Consent
"Recent state inspection reports of nursing homes in
In
"Despite the new scientific evidence and updated guidance from
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Read the letter below:
To: The Honorable
Dear Commissioner Hahn:
Nursing homes continue to be at the epicenter of the spread of the novel coronavirus (COVID-19) in
Between the middle of February and the end of April, the use of hydroxychloroquine increased significantly and patients who regularly used hydroxychloroquine to treat other conditions like lupus experienced shortages./7 Despite the increasing use of hydroxychloroquine, scientific studies soon indicated that the use of hydroxychloroquine to treat individuals with COVID-19 could lead to serious complications./8 On
hydroxychloroquine should not be use outside a hospital or clinical trial due to the possibility that it could lead to heart arrhythmias, which could be fatal./9 On
Although the
Recently, state inspection reports revealed that residents in nursing homes were treated with hydroxychloroquine in
To provide additional clarity regarding the
1) Has
2) What steps has the
3) Has
4) How many adverse event reports has
5) Is
6) Has
7) Has
Given the urgency of this matter we request this information as soon as possible, but in no event later than
Sincerely,
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Footnotes:
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5 https://abcnews.go.com/Health/timeline-tracking-trump-alongside-scientific-developments-hydroxychloroquine/story?id=72170553 6
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Read the letter to CMS below:
To: The Honorable Seema Verma, Administrator,
Dear Administrator Verma:
Nursing homes continue to be at the epicenter of the spread of the novel coronavirus disease 2019 (COVID-19) in
Early in the pandemic, and without significant study or consensus among the scientific community, the
In
Despite these reports and now official state inspection reports indicating the inappropriate use of this drug, CMS has failed to issue guidance to nursing homes on the use of hydroxychloroquine. Furthermore, despite the availability of Medicare data and information provided by some state surveyors through infection control inspections, is not clear whether CMS is adequately monitoring the treatment of COVID-19 patients in nursing homes to determine how widespread the use of hydroxychloroquine is and whether its use has resulted in adverse outcomes for residents.
To help us understand what CMS has done to monitor the use of hydroxychloroquine in nursing homes, and communicate with nursing home operators, residents and states regarding the inappropriate use of this treatment, we request the following information:
1) Please provide any guidance or other documentation issued by CMS on the use of hydroxychloroquine to nursing homes and providers associated with these facilities.
2) Medical experts have raised specific concerns about using hydroxychloroquine to treat elderly patients because of various comorbidities and interactions with commonly used prescription medication. Please provide any guidance or other documentation issued by CMS on the use of hydroxychloroquine to nursing homes to state survey and licensing agencies, including any guidance on monitoring such use.
3) Please provide the number of payments made by Medicare for the use of hydroxychloroquine to treat COVID-19 patients or prevent COVID-19 infections in nursing homes, since
4) Please provide the number of Medicare claims that indicate that the hospitalization was related in whole or in part to hydroxychloroquine being administered.
5) Has CMS taken any steps, or directed state survey agencies to take any steps, to monitor the use of hydroxychloroquine to treat residents for COVID-19 in nursing homes? If so please describe the steps that have been taken and provide any data that has been collected.
6) Has CMS received any complaints related to the use of hydroxychloroquine in nursing homes to treat or prevent COVID-19? If so, please provide de-identified versions of those reports and complaints.
7) Has CMS or its regional offices received any outreach from state agencies on the use of hydroxychloroquine in nursing homes? If so please describe that outreach and provide any correspondence associated with it.
8) Has CMS received any outreach from facilities about the use of hydroxychloroquine? If so, please describe that outreach and provide any correspondence associated with it.
9) What, if any guidance, has CMS given facilities on the use of hydroxychloroquine if it is prescribed by an attending physician not associated with their nursing home?
10) Has CMS reviewed state survey or inspection reports to determine whether nursing homes that were treating residents for COVID-19 received adequate consent for that treatment?
11) Has CMS opened any investigations into the use of hydroxychloroquine by nursing homes or taken any enforcement action against such homes? If so, please provide the number of investigations and enforcement actions, the names of the facilities involved, and any other relevant findings or information.
12) Is CMS aware of any other drugs being used by nursing homes to prevent or treat COVID-19? If so, please identify those treatment regimens and the facilities implementing them.
13) What protocols must nursing homes put in place to ensure that residents or their guardians provide knowing consent in advance of treatment? How are these protocols enforced? How are nursing homes held accountable when these protocols are not in place or are not followed?
Given the urgency of this matter we request this information as soon as possible, but in no event later than
Sincerely,
Ron WydenUnited States Senator
CC:
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Footnotes:
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2 42 CFR Sec.483.10(c).
3 e.g.
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10 42 CFR Sec.483.10(c).
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Read the letter to HHS below:
To: The Honorable
Dear Ms. Grimm:
Recent reports from state inspection officials have revealed that residents in multiple nursing homes were treated for COVID-19 with hydroxychloroquine without their informed consent or without approval from state officials. Such actions may be in violation of
A growing body of scientific evidence is demonstrating that hydroxychloroquine is not an effective treatment for COVID-19, and that it can even have serious side effects for some individuals. However, the
Specifically,
Recent state inspection reports of nursing homes in
In
The use of this experimental treatment on patients without proper approval and without their consent is a violation of patient rights. As such, we request that HHS OIG open an investigation to determine:
1) Whether nursing homes violated the rights of residents by treating them with hydroxychloroquine without their informed consent, or the informed consent of their guardians; and
2) Whether nursing homes properly tracked and reported adverse events associated with the use of hydroxychloroquine; and
3) Whether CMS took actions to ensure that nursing homes have followed all requirements for participation in Medicare and Medicaid regarding the approval and use of hydroxychloroquine; and
4) Whether CMS has properly used its authority to hold providers accountable for known misuse of this treatment, and whether appropriate guidance was given to providers about the use of hydroxychloroquine.
Sincerely,
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Footnotes:
1 42 CFR Sec.483.10(c).
2 Quint Forgey and
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