MICHAEL BARNES ESQ, of dcbalaw.com________
“DEA agents have no business second-guessing health care providers’ decisions on medical needs and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”
REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, BERES E. MUSCHETT, STRATEGIC ADVISOR
Norman J Clement, Aaron Howard, Rick Fertil demand the return of our DEA pharmacy Control Substance Registrations Immediately.
By Pat Anson, Editor PAIN NEWS NETWORK
November 11, 2020
DEA Expanding Surveillance of Prescription Drug Data
The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy, and patient in the country that shows signs of drug diversion or abusing their medication. (5)
In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter. (1)
Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.
“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. (2)
“DEA agents have no business second-guessing health care providers’ decisions on medical needs and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”
‘Unlimited Access’ to Prescription Data
Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD). Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills, and forms of payment.
The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.
“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work. (3)
Asked how many DEA investigators would have access to the prescription data at any given time, the agency said there could be over a thousand.
“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.
Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.
Bypassing PDMPs
State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data. (4)
The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”
The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”
Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs. For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.
“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN.
‘Appalling for People’s Health’
The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone.
“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment.
“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”
“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”
The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020, and continue for a minimum of one year, with an option for up to four years The potential cost of the program has not been disclosed.
In 2017 Former Utah Senator
This video is the game changer which exposes the nature of DEA/DOJ abuses in targeting BLACK OWN PHARMACIES: Senator Hatch on DEA and Opioid Crisis and Abuse| C-SPAN.org
https://www.c-span.org/video/?435395-3/senator-hatch-dea-opioid-crisis
FOR NOW YOU ARE WITHIN THE NORMS
END NOTES
- https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5fac5d699a1aef48f6f43d39/1605131626625/DEA+RFP+amendment.pdf
- https://dcbalaw.com
- https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5fac5d699a1aef48f6f43d39/1605131626625/DEA+RFP+amendment.pdf
- https://coloradosun.com/2019/11/11/dea-subpoena-opioid-pharmacy-board/
- https://www.painnewsnetwork.org/stories/2020/11/11/dea-planning-expanded-surveillance-of-prescription-data
THE AMERICAN MEDICAL ASSOCIATION
THE CHART BELOW SHOWS AS EARLY AS 2010 THE AMERICAN MEDICAL ASSOCIATION REPORTED THE OPIOID OVERDOSE PROBLEM WAS FROM HEROIN AND ILLICIT FENTANYL HOWEVER BOTH CDC AND DEA-DOJ IGNORED THESE CLEAR FACTS AND CONTINUE PUSHING MME
CONGRESS WAS PUT ON NOTICE EARLY BUT FAILED TO ACT
AS DEA HAS LIED TO CONGRESS ON DECEMBER 18, 2019
THE DRUG ENFORCEMENT ADMINISTRATION (DEA) WROTE:
“As a law enforcement agency, DEA is not in a position to authorize or dictate what a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it comes to the practice of medicine because no sick waiver exists.
As the United States’ competent body charged with the management of controlled substances and chemicals for scientific, medical, research, and industrial applications; DEA regulates the flow of controlled substances, not the practice of medicine.
The changing prescribing practices of practitioners are derived by a shift to prescribe medicine consistent with the guidance issued by the Center of Disease Control and Prevention along with the guidance and recommendations of state boards of medicine.”
These are exact word-for-word quotes from the DEA to a sitting Congresswoman. If the DEA denies they wrote this to a member of Congress they are lying.
MASSIVE GOVERNMENTAL OVERREACH
Helen Borel writes in ” American Agony The Opipiod War Against Patients in Pain,”
” The Overreach of government lawyers, police, and prosecutors into the lives of patients in pain, which has been going on for years and is still happening, has gone from distressing to death-promoting. Too many, almost all, of the autocrats, have been blithely abusing their unrestricted powers.
Which abusers include many State prosecutors who’ve gone overboard in their zeal to bring down an entire industry – Prescription Medicine Manufacturering – vital to 21 Century health and survival. Which include Big Pharma corporations that have developed and manufactured opioid medications commonly used for over a century to treat various levels of pain.”
