Restrictions on Prescribing of Hydroxychloroquine and Supply of HCQ

[Updated April 21, 2020]

Supply of Hydroxychloroquine

The Federation of State Medical Boards writes:

Physicians, nurses, pharmacists, pharmacies and hospitals have an ethical duty to put the needs of patients first, and this includes observing strict prescribing guidelines. On March 28, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate. The authorization allows these medications to be prescribed by clinicians for hospitalized adult and adolescent patients “for whom a clinical trial is not available, or participation is not feasible.” Clinicians should avoid prescribing for themselves or their family members and should be aware that deviating from the standard of care could put their license at risk.

What the FSMB states is incorrect!

Although the FDA’s EUA only restricts use of the supply from the national stockpile, the FSMB is making it sound like the EUA applies more broadly and that physicians’ licenses would be at risk for off-label use. That is incorrect.

California Medical Board Statement Regarding Improper Prescribing of Medications Related to Treatment for Novel Coronavirus (COVID-19)

The California Department of Consumer Affairs (DCA) is aware of recent news and social media reports of prescribers wrongfully hoarding and prescribing for themselves and family members certain medications referenced in the media relating to the novel coronavirus (COVID-19).

Several states have recently issued emergency restrictions on how the drugs can be dispensed. Many require that medications be prescribed and dispensed only to patients with a legitimate and current medical condition. Further, the FDA recently issued an Emergency Use Authorization to allow for the use of hydroxychloroquine sulfate and chloroquine phosphate products donated by the Strategic National Stockpile for certain hospitalized patients with COVID-19.

DCA, the Medical Board of California, and the California State Board of Pharmacy remind health care professionals that inappropriately prescribing or dispensing medications constitutes unprofessional conduct in California. Prescribers and pharmacists are obligated to follow the law, standard of care, and professional codes of ethics in serving their patients and public health.

FDA Letter of Authorization: March 28, 2020 stating national stockpile hydroxychloroquine can only be used in hospitalized patients

Dr. Rick Bright, Ph.D.
Director Biomedical Advanced Research and Development Authority (BARDA)
Office of Assistant Secretary for Preparedness and Response (ASPR)
U.S. Department of Health and Human Services (HHS)
330 Independence Ave, S.W. Room 640G
Washington, D.C. 20201

“Dear Dr. Bright: This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine”

Our country MUST have good data on COVID19, and we are not able to gather it given the CDC changes as of March 24, and April 1.

Please read to end to find the perverse incentives for hospitals to “overcode” COVID19. Mind you I am only saying the perverse incentive exists. Would not want anyone to be so tempted.

Two CDC documents that changed the playbook on coding for COVID19 diagnosis and COVID19 death

  1. March 24: how CODERS are to code for COVID19 death: https:// coronavirus/Alert-2-New-ICD- code-introduced-for-COVID-19- deaths.pdf
  2. April 1: How CODERS are to code for COVID19 diagnosis https:// icd/Announcement-New-ICD-code- for-coronavirus-3-18-2020.pdf

Americans lack the following sorely needed data:

1. Survival rates among all demographics including the elderly and those with preexisting conditions.

2. Whether we are increasing in COVID19 death numbers and rate of infection or decreasing. NB: the rate cannot be determined by nasal swab tests alone; these tests test for RNA, may indicate old and recovered infection tend to be negative early in the onset and then positive weeks later (possibly after one has recovered).

3. We cannot have answers to #1 or #2 without antibody (blood) testing, which can show a patient has had and fully recovered from COVID-19. 4. Accurate death statistics must all be gathered the exact same way throughout the pandemic.The 2 CDC docs above prevent this.

Only when we get the above data can the American people be advised specifically as to accurate public health predictions of COVID-19.

The changed mortality coding will create confusion, prevent accurate data collection and obfuscate collection of the most data. Specifically, the two documents referenced above may result in higher death and diagnosis rates being attributed to COVID-19 than is actually accurate worldwide, and even more so in the USA.

Note the discrepancy:

· WHO provides two codes (i) death due to the COVID19 or (ii) death due to suspected COVID19. Both these two codes are being used for the purpose of collecting death statistics all over the world, with the exception of the United States.

· In the United States, the CDC is announced in the March 24, and April 1, documents that they’re only collecting death statistics using one code, which includes death due to COVID19 or death due to suspected COVID19. As a result and In the future, the rest of world will be able to separate assumed and actual coronavirus deaths, but the United States will not.

Potential solutions to resolve the discrepancies:

· Both reimbursement codes — U07.1 and U07.2 – be applied, as appropriate in each case.

· For coding death or diagnosis due to suspected COVID19, this determination should only be made the attending bedside physician (physician of record).

· Reimbursement for both codes should be the same and be transparent.

· Follow-up must take place moving forward on all COVID19 cases already coded to ensure they were coded accurately for the purpose of data.

· A comprehensive audit of COVID-19 cases dating back to the onset of the outbreak must take place to ensure accurate coding.

As an additional financial integrity concern stemming from the announcement is that there is no cost-sharing for COVID-19 related diagnosis, any entity collecting from Medicare, Medicaid or commercial insurance has a potentially perverse incentive to up-code for COVID-19.

Minnesota state Senator Dr. Scott Jensen: Right now Medicare is determining that if you have a COVID-19 admission to the hospital you get $13,000. If that COVID-19 patient goes on a ventilator you get $39,000, three times as much. Nobody can tell me after 35 years in the world of medicine that sometimes those kinds of things impact on what we do.

From: https:// patient-goes-on-ventilator-video/

The American Hospital Association (AHA)  has a whole presentation on codes for COVID19. (screenshots taken. It’s also on websites) and describes how the CDC announcements March 24 and April 1 ( April 1, retroactive) for coding COVID19 change the rules. This info is going to AHA member hospitals (not practicing physicians)