Fwd: Re: [EXTERNAL] Questions regarding previous statement Subject: Fwd: Re: [EXTERNAL] Questions regarding previous statement From: Brad Racino Date: 6/19/20, 4O04 PM To: "Butler, Cynthia C." CC: "Menzie, Christopher J." , "Haas, David R. (VHASDC)" Cynthia, Thank for for providing answers to some of my questions. However I still haven't received a response to my question Monday about the VA's statement regarding the investigations. Could you please let me know whether the VA will be responding to that question or any of the questions that remain from my last email, such as: Can you please provide or point to documentation outlining the “industry standards of care” the VA relies on for using ketamine for treatment resistant depression? When and how did the VA learn that Kadima was providing vets with IM ketamine, and when did the VA decide to terminate its relationship with Kadima for doing so? Did the VA address its concerns with Kadima about administering IM ketamine? If so when, and what was Kadima’s response? Were the VA psychiatrists who referred the vets to Kadima not aware that Kadima was administering IM ketamine? If they were aware, please explain why this is just now becoming a problem. If the claim is they were not aware, please reconcile this with the fact that numerous veteran authorization forms show psychiatrists such as Dr. Printz and Dr. Ramanathan made note of the IM route and signed off on it. Also, please reconcile this with the fact that Dr. Feifel specializes in IM and the VA has sent him veterans for at least five years. If the VA is concerned that IM ketamine is not FDA approved for depression, shouldn't the VA likewise be concerned that IV ketamine is also not FDA approved for depression, and the VA statement provided Monday said vets will be put on IV ketamine if Spravato doesn’t work? Could you explain how treatment is individualized? Isn’t IV ketamine treatment at the VA capped at 1.0mg/kg, no matter the treatment history, body mass or other factors of each veteran? Could you also explain how treatment is individualized when there has been no consultation with Dr. Feifel regarding treatment history with these veterans, or how he individualizes his treatment? Did the VA confer with the veterans’ VA psychiatrists such as Dr. Printz or Dr. Ramanathan before deciding to discontinue their ketamine treatments at Kadima? Did those psychiatrists support the decision to remove vets from Kadima? Please explain why the VA provided me with a different statement on May 21 regarding the reasons vets were being discontinued at Kadima. Thank you. From: Brad Racino Date: June 18, 2020 at 3:50 PM To: "Butler, Cynthia C." CC: "Menzie, Christopher J." , "Haas, David R. (VHASDC)" , "Smith, Robert J." , "Abair, Cynthia E." , "Printz, David" Subject: [EXTERNAL] Questions regarding previous statement Good afternoon Cynthia, Is there any update to this request? I would appreciate an ETA on the response. Thank you in advance, -Brad From: Butler, Cynthia C. Date: June 17, 2020 at 10:09 AM To: Brad Racino CC: "Menzie, Christopher J." , "Haas, David R. (VHASDC)" , "Smith, Robert J." , "Abair, Cynthia E." , "Printz, David" Subject: [EXTERNAL] Questions regarding previous statement Hello – I will get response. thanks, From: Brad Racino Sent: Wednesday, June 17, 2020 9:07 AM To: Butler, Cynthia C. Cc: Menzie, Christopher J. ; Haas, David R. (VHASDC) ; Smith, Robert J. ; Abair, Cynthia E. ; Printz, David Subject: [EXTERNAL] Questions regarding previous statement Good morning, I’m writing to follow up on two things: The first is the VA statement regarding the House and OIG investigations. Could you please let me know if you’ll be providing that response? The second is the statement provided June 15 regarding the VA's reasoning for removing veterans from Kadima. There were several parts of that statement that I have questions about. I would appreciate a response by the close of business today: 1. The VA responded that, “This particular provider repeatedly deviated from industry standards of care ... by administering intramuscular ketamine.” Can you please provide or point to documentation outlining the “industry standards of care” the VA relies on for using ketamine for treatment resistant depression? When and how did the VA learn that Kadima was providing vets with IM ketamine, and when did the VA decide to terminate its relationship with Kadima for doing so? Did the VA address its concerns with Kadima about administering IM ketamine? If so when, and what was Kadima’s response? 2. The VA responded that, “This particular provider repeatedly deviated … from what VA had authorized by administering intramuscular ketamine.” Do VA ketamine authorization documents provided to Kadima specify a non-IM route of administration, such as IV or oral? Were the VA psychiatrists who referred the vets to Kadima not aware that Kadima was administering IM ketamine? If they were aware, please explain why this is just now becoming a problem. If the claim is they were not aware, please reconcile this with the fact that numerous veteran authorization forms show psychiatrists such as Dr. Printz and Dr. Ramanathan made note of the IM route and signed off on it. Also, please reconcile this with the fact that Dr. Feifel specializes in IM and the VA has sent him veterans for at least five years. If the VA is concerned about the safety of veterans at Kadima, why is it allowing vets to continue getting treatment at the clinic through September? 3. The VA responded that intramuscular ketamine injection “is not FDA approved.” The VA is aware that both IM and IV ketamine are FDA approved as an anesthetic, correct? If the VA is concerned that IM ketamine is not FDA approved for depression, shouldn't the VA likewise be concerned that IV ketamine is also not FDA approved for depression, and the VA statement provided Monday said vets will be put on IV ketamine if Spravato doesn’t work? 4. The VA responded that intramuscular ketamine injection “is not supported by any peer reviewed research to support its long-term use for Treatment Resistant Depression.” Intramuscular ketamine injection is supported by peer reviewed research, though not for long term use — however no research that I could find supports long-term ketamine treatments in any form. Is the VA under the impression that long-term IV ketamine treatment is supported by peer-reviewed research? If so, can you please point me to that research? If the VA cannot point to that research, please explain why IV ketamine — which lacks both FDA approval for treatment resistant depression and peer-reviewed research supporting long-term use — is considered safer or superior to IM ketamine at Kadima? 5. The VA responded that it is administering ketamine in three ways and that “treatment is individualized to patient needs.” Could you explain how treatment is individualized? Isn’t IV ketamine treatment at the VA capped at 1.0mg/kg, no matter the treatment history, body mass or other factors of each veteran? Could you also explain how treatment is individualized when there has been no consultation with Dr. Feifel regarding treatment history with these veterans, or how he individualizes his treatment? Did the VA confer with the veterans’ VA psychiatrists such as Dr. Printz or Dr. Ramanathan before deciding to discontinue their ketamine treatments at Kadima? Did those psychiatrists support the decision to remove vets from Kadima? 1 of 2 6. Please explain why the VA provided me with a different statement on May 21 regarding the reasons vets were being discontinued at Kadima. 7. Most important: Please explain why the VA is treating suicidal veterans with Spravato when the VA formulary specifically states the exclusionary criteria for the drug includes patients with “Active suicidal ideation.” 6/24/20, 8:38 PM Fwd: Re: [EXTERNAL] Questions regarding previous statement -- BRAD RACINO Senior Reporter & Assistant Director inewsource.org c. (845) 553-4170 t. @bradracino P.S. We want to hear from you! Take a brief survey to help us get to know you and the topics you want us to look into. From: Brad Racino Date: June 17, 2020 at 9:06 AM To: "Butler, Cynthia C." CC: "Menzie, Christopher J." , "Haas, David R. (VHASDC)" , Robert.Smith@va.gov, cynthia.abair@va.gov, david.printz@va.gov Subject: Questions regarding previous statement Good morning, I’m writing to follow up on two things: The first is the VA statement regarding the House and OIG investigations. Could you please let me know if you’ll be providing that response? The second is the statement provided June 15 regarding the VA's reasoning for removing veterans from Kadima. There were several parts of that statement that I have questions about. I would appreciate a response by the close of business today: 1. The VA responded that, “This particular provider repeatedly deviated from industry standards of care ... by administering intramuscular ketamine.” Can you please provide or point to documentation outlining the “industry standards of care” the VA relies on for using ketamine for treatment resistant depression? When and how did the VA learn that Kadima was providing vets with IM ketamine, and when did the VA decide to terminate its relationship with Kadima for doing so? Did the VA address its concerns with Kadima about administering IM ketamine? If so when, and what was Kadima’s response? 2. The VA responded that, “This particular provider repeatedly deviated … from what VA had authorized by administering intramuscular ketamine.” Do VA ketamine authorization documents provided to Kadima specify a non-IM route of administration, such as IV or oral? Were the VA psychiatrists who referred the vets to Kadima not aware that Kadima was administering IM ketamine? If they were aware, please explain why this is just now becoming a problem. If the claim is they were not aware, please reconcile this with the fact that numerous veteran authorization forms show psychiatrists such as Dr. Printz and Dr. Ramanathan made note of the IM route and signed off on it. Also, please reconcile this with the fact that Dr. Feifel specializes in IM and the VA has sent him veterans for at least five years. If the VA is concerned about the safety of veterans at Kadima, why is it allowing vets to continue getting treatment at the clinic through September? 3. The VA responded that intramuscular ketamine injection “is not FDA approved.” The VA is aware that both IM and IV ketamine are FDA approved as an anesthetic, correct? If the VA is concerned that IM ketamine is not FDA approved for depression, shouldn't the VA likewise be concerned that IV ketamine is also not FDA approved for depression, and the VA statement provided Monday said vets will be put on IV ketamine if Spravato doesn’t work? 4. The VA responded that intramuscular ketamine injection “is not supported by any peer reviewed research to support its long-term use for Treatment Resistant Depression.” Intramuscular ketamine injection is supported by peer reviewed research, though not for long term use — however no research that I could find supports long-term ketamine treatments in any form. Is the VA under the impression that long-term IV ketamine treatment is supported by peer-reviewed research? If so, can you please point me to that research? If the VA cannot point to that research, please explain why IV ketamine — which lacks both FDA approval for treatment resistant depression and peer-reviewed research supporting long-term use — is considered safer or superior to IM ketamine at Kadima? 5. The VA responded that it is administering ketamine in three ways and that “treatment is individualized to patient needs.” Could you explain how treatment is individualized? Isn’t IV ketamine treatment at the VA capped at 1.0mg/kg, no matter the treatment history, body mass or other factors of each veteran? Could you also explain how treatment is individualized when there has been no consultation with Dr. Feifel regarding treatment history with these veterans, or how he individualizes his treatment? Did the VA confer with the veterans’ VA psychiatrists such as Dr. Printz or Dr. Ramanathan before deciding to discontinue their ketamine treatments at Kadima? Did those psychiatrists support the decision to remove vets from Kadima? 6. Please explain why the VA provided me with a different statement on May 21 regarding the reasons vets were being discontinued at Kadima. 7. Most important: Please explain why the VA is treating suicidal veterans with Spravato when the VA formulary specifically states the exclusionary criteria for the drug includes patients with “Active suicidal ideation.” -BRAD RACINO Senior Reporter & Assistant Director inewsource.org c. (845) 553-4170 t. @bradracino P.S. We want to hear from you! Take a brief survey to help us get to know you and the topics you want us to look into. 2 of 2 6/24/20, 8:38 PM