WAGS: corporate greed: overcharging insurance and pts – profits at any cost ?

Posted on March 17, 2022 by Pharmaciststeve

Walgreens sued by BCBS payers, health systems for alleged drug overcharging fraud scheme

https://www.beckerspayer.com/payer/walgreens-sued-by-bcbs-payers-health-systems-for-alleged-drug-overcharging-fraud-scheme.html

Blue Cross Blue Shield affiliates and other payers are suing Walgreens for allegedly overcharging payers and customers for prescription drugs.

Court documents filed March 15 in the U.S. District Court for the Northern District of Illinois Eastern Division claim that Walgreens “knowingly and intentionally engaged in an ongoing fraudulent scheme” to overcharge payers by submitting claims with artificially inflated drug prices.

The lawsuit alleges that Walgreens concealed the fraud scheme by making false statements and leaving out facts related to its true usual and customary prices for prescriptions given to the individuals enrolled in the plaintiff’s health plans. The suit alleges that Walgreens overcharged payers and health systems by hundreds of millions of dollars for more than a decade by submitting falsely inflated usual and customary prices on millions of reimbursed claims.

The plaintiffs named in the suit are CareFirst of Maryland, Group Hospitalization and Medical Services, CareFirst BlueChoice, Blue Cross Blue Shield of South Carolina, BlueChoice HealthPlan of South Carolina, Louisiana Health Service and Indemnity Co., Blue Cross and Blue Shield of Louisiana, and HMO Louisiana.

The court documents say that plaintiffs are owed at least the amount of money they were overcharged on reimbursement claims.

The suit also says that Walgreens’ alleged scheme affected consumers directly. By purchasing prescription drugs from Walgreens’ pharmacies with falsely inflated prices, payers increased copays, coinsurance, deductibles and premiums.

The lawsuit claims that Walgreens’ alleged fraudulent actions are still happening and that the company continues to report falsely inflated prices for payer claims. Because of this, the plaintiffs believe they are still threatened with future harm from Walgreens.

Walgreens declined to provide a comment to Becker’s Hospital Review.

Here is another blog post from today… https://www.pharmaciststeve.com/colorado-wags-pharmacy-techs-shine-light-on-shortages-delays-mistakes/

suggests that WAGS is under paying their Rx dept employees, while at the same time under staffing and over working the same employees. It is almost like WAGS is “pocket-picking” just about everyone’s pockets that deals with them – at least in the Rx dept.

Filed under: General Problems | Leave a Comment »

Colorado WAGS pharmacy techs shine light on shortages, delays, MISTAKES

Posted on March 17, 2022 by Pharmaciststeve

Colorado pharmacy techs shine light on shortages, delays

https://www.thedenverchannel.com/news/contact-denver7/colorado-pharmacy-techs-shine-light-on-shortages-delays

After almost seven years as a pharmacy technician at a Centennial Walgreens, Melanie- who asked Denver7 to not use her last name to protect her privacy- quit right before her shift last summer.

“I just sent a message to my store manager, and I said, ‘I’m really sorry. I know that multiple people have done this now, but I am to the point where I can’t do it anymore,'” said Melanie. “I couldn’t even get out of bed that day. I physically couldn’t handle the stress anymore.”

She still has a copy of her six-day-a-week Walgreens work schedule from last year, as well as text after text begging her for help.

“I told my managers, ‘We need help. We need to find people. We need bodies that can count by five,'” Melanie said, recalling how pharmacy workers had to juggle prescriptions, COVID-19 shots, vaccinations and even stocking the store, all with no breaks.

“Mistakes happened all the time,” she said. “It was a matter of if we were able to get the patient to come back and correct it, make sure that they left happy so their report didn’t have to get filed. My pharmacists on a daily basis were scared they were going to be losing their license. To get all of that stuff done on top of vaccines on top of testing, it’s not possible. It’s physically not possible.”

Ali DiLorenzo has been a pharmacy tech at Wheat Ridge Professional Pharmacy for more than a decade and says Walgreens has a reputation in the industry.

“They are overworked, underpaid, and understaffed. They’re closing. You can’t get a hold of anybody. I mean, it’s just a nightmare,” said DiLorenzo. “You’re in a field where you make a mistake, you could kill somebody.”

The Colorado Pharmacists Society tells Contact Denver7 that the issue is much larger than Walgreens, stemming back to insurance companies not reimbursing pharmacies for the full cost of drugs.

“The margins have continued to be less and less and less and less. Sometimes we’re getting paid 10 cents to dispense a prescription. That used to be $10,” said Emily Zadvorny, executive director of the Colorado Pharmacists Society. “So when you have a situation where, whether that’s a chain or an independent, where they can barely scrape by to make enough money to keep the doors open, they’re certainly not going to be able to hire four more pharmacists.”

Zadvorny says pharmacies have no choice but to sign contracts with the three big health plans, which then reimburse pharmacies for less than the cost of the drug.

“I see it as them forcing you basically to go to mail order where they don’t have to staff in-house pharmacy,” said DiLorenzo. “Obviously, the insurance companies and the drug companies are making a ton of money. But the pharmacies themselves are not most of them are operating at a loss.”

While Wheat Ridge Professional Pharmacy has been taking on more patients, they say they can only take on so many if they are not being reimbursed.

Contact Denver7 reached out to Walgreens, and a spokesman released this statement:

While we are grateful for the hard work and dedication of our pharmacy staff, we also recognize some of the challenges facing our team members — and healthcare workers in general – in the current environment.   We continue to take steps to help mitigate current staffing pressures, including hiring thousands of new pharmacy team members, adjusting vaccine appointment availability and store hours as needed and expanding remote pharmacy capabilities to help reduce workload. 

Melanie says she is now much happier working for a different company in a more clinical setting and is making twice as much. She wants patients who are waiting in long lines for delayed prescriptions to understand that there is more to the story.

“I feel like a lot of patients would come through and be so upset because they’re like, ‘You don’t care. You don’t even care.’ We do! I mean, I had techs leaving in tears on a daily basis because they just couldn’t handle the stress,” she said. “It’s not a matter of Walgreens not being able to find people to work. It’s that people don’t want to work for minimum wage in unworkable conditions.”

Editor’s note: Denver7 seeks out audience tips and feedback to help people in need, resolve problems and hold the powerful accountable. If you know of a community need our call center could address, or have a story idea for our investigative team to pursue, please email us at contact7@thedenverchannel.com or call (720) 462-7777. Find more Contact Denver7 stories here.

You only have ONE LIFE…. ONE HEALTH…. don’t let corporate greed cause you to loose either one

Filed under: General Problems | 1 Comment »

Clock is ticking on making a comment on the proposed 2022 CDC opiate dosing guidelines

Posted on March 17, 2022 by Pharmaciststeve

Did anyone notice that seemingly innocuous link to the left top of on this page  https://www.regulations.gov/commenton/CDC-2022-0024-0001  When you click on it… the rest of this post is what shows up …

  • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters  
  • this line could be the most important line in the entire text…  “well supported comment” could very well me a comment with references to clinical studies to support the statement… the 211 page 2022 proposed dosing guidelines contained 20 pages of footnotes and references.  And in looking at those 20 pages… one whole page had references with one of the author of each reference being one of the 5 who wrote/supervised the creation of this proposed guidelines.
  • Historically, pt’s personal observation of health/pain issues are discounted as being anecdotal and of no clinical value, since they are considered as potentially biases and did not follow some sort of approved protocol and thus your submission may not be considered “well supported”
  • There is about three weeks left to make comments. Right now there is abt 2600 comments have been accepted and posted. Just how many of comments from pts will have any influence on the final 2022 guidelines when they are published. We may never know, you can use the link above to go to the page to make a comment.

Write a Comment

Commenter’s Checklist

https://www.regulations.gov/commenton/CDC-2022-0024-0001

Commenter’s Checklist

Tips for Submitting Effective Comments*

Overview

A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.

These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.

Summary

  • Read and understand the regulatory document you are commenting on
  • Feel free to reach out to the agency with questions
  • Be concise but support your claims
  • Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
  • Address trade-offs and opposing views in your comment
  • There is no minimum or maximum length for an effective comment
  • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters

Detailed Recommendations

  1. Comment periods close at 11:59 eastern time on the date comments are due – begin work well before the deadline.
  2. Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document. Note: Although the agency contact can answer your questions about the document’s meaning, official comments must be submitted through the comment form.
  3. Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.
  4. If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best.
  5. Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
  6. Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
  7. If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
  8. The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
  9. Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
  10. Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
  11. Consider including examples of how the proposed rule would impact you negatively or positively.
  12. Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
  13. Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning.
  14. If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles:
    • Attachment1_<insert title of document>
    • Attachment2_<insert title of document>
    • Attachment3_<insert title of document>

    This standardized file naming convention will help agency reviewers distinguish your submitted attachments and aid in the comment review process.

  15. Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.

Posted Comments

After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:

  • The comment is part of a mass submission campaign or is a duplicate.
  • The comment is incomplete.
  • The comment is not related to the regulation.
  • The comment has been identified as spam.
  • The comment contains Personally Identifiable Information (PII) data.
  • The comment contains profanity or other inappropriate language.
  • The submitter requested the comment not be posted.

Form Letters

Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a “vote” regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.

* Throughout this document, the term “Comment” is used in place of the more technically accurate term “Public Submission” in order to make the recommendations easier to read and understand.

Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns.

Filed under: General Problems | 3 Comments »

Independent Pharmacy: if there is a problem, make sure you are talking to THE BOSS/OWNER

Posted on March 17, 2022 by Pharmaciststeve

A intractable chronic pain reached out to me … concerning a new pharmacist at a pharmacy she had been patronizing for years, and this pharmacist decided that the medication that this pt had been taking for years – by the book – had some potential interactions that the pharmacist “had concerns about”.  Was hassling the pt about filling them. The next day the pt talk to the pharmacist at the pharmacy who had filled her Rxs before and that pharmacist declined to fill her Rxs.  Maybe the first pharmacist was more of a “bully” and the second pharmacist was more of a “wimp”.
If this had been the first time that the pt was coming to have these medications filled, I could understand the pharmacist’s concern and may there would have been a need to have a conversation with the prescriber over the pharmacist’s concerns of POTENTIAL INTERACTIONS… but because the pt had been taking these meds for several years. The concerns of POTENTIAL INTERACTIONS should have been quickly viewed as a non-concern.

I was surprised of this sort of attitude from a independent pharmacy, I had own my own pharmacy for 20 yrs and pretty familiar with the typical mindset of a independent pharmacy owner.  This independent pharmacy was one of  a “multi-store” independent and the owner of the stores did not work in this store. The pt was ready to discontinue the use of one or more of her medications.  I suggest to the pt that she reach out to the OWNER of this store, that he/she may not be aware of  how this new employee was dealing with the store’s pts’ medication needs.

The pt took my recommendation, and reached out to the owner… but had to leave a message… HOWEVER.. the owner did contacted the pt by the end of the that same day.  Apologized PROFUSELY for how she was treated…. and the pharmacy DELIVERED her medications the very next day at NO CHARGE.

This is excellent example why I suggest that pts that are having trouble/issues with chain pharmacies filling their Rxs, that they find a local independent pharmacy and I regularly share this link to find a independent pharmacy by zip code https://ncpa.org/pharmacy-locator

The typical chain pharmacist and the Rx dept is GROSSLY UNDERSTAFFED and GROSSLY OVERWORKED.  I have seen some chain pharmacist making statements on some private/closed pharmacist FB pages that they are upwards of TEN DAYS BEHIND IN FILLING PRESCRIPTIONS.   Here is a PUBLIC FACE BOOK PAGE https://www.facebook.com/PizzaIsNotWorking that one particular pharmacist has started creating a rebellion of chain pharmacists … I believe that the “final straw” genesis of that revolt was triggered by what I shared on this blog post https://www.pharmaciststeve.com/cvs-pharmacist-dies-on-the-job-from-cardiac-mi-forced-to-wait-for-relief-pharmacist-to-show-up/

Why are independent pharmacies better staffed ?  Most independents are normally not sitting on “high price real estate”…  they don’t have to financially support layers of upper management and a large corporate headquarter bldg, their stores are much smaller and few-if any – have 24 hr operations and they depend more on word of mouth advertisement than large multi media advertising campaigns.  They commit all those financial resources to better staffing and better pt services.

 

 

 

Filed under: General Problems | Leave a Comment »

What’s your story: pt leaving our country to find better pain management

Posted on March 16, 2022 by Pharmaciststeve


Hi I’m Sam I’ve have RSD, chronic migraines pcos, TD, neuralgia.
After everything I’ve tried in my 21 years of chronic pain I decided to leave my country because of the cdc guidelines. My pharmacy of 16 years got raided for doing the right thing and continued to help us chronic pain patients out. My PM doctor was forced tapering me to nothing as I was withdrawaling with my toddler near me, they didn’t care that I had a little one to take care of.
So I made the toughest decision to move out of the country for better pain care and for my husband’s family’s help to watch our child. Unfortunately my husband couldn’t come with me and I probably won’t see him for a very long time because he needs to make the money to keep care of me in Guatemala because let’s face it, I’ll never get better but atleast I’ll have the quality of life since before the opioid crisis began. And I was able to get my anxiety medication back over here after 7 years because it was a benzodiazepine and im taking a pain medication on top of it and I’m not dying or in danger like the cdc states. I took that combination for years before the cdc stuck their noses where it didn’t belong.
This is the craziness we must face now, chronic pain patients moving out of our country for better pain care and leaving your loved ones behind?

Filed under: General Problems | 5 Comments »

what’s your story ?

Posted on March 16, 2022 by Pharmaciststeve

A chronic pain pt asked if I would share their story…

So I am not only going to share this pt’ story,  I have created a NEW TAB on the first page of my blog and will put links to pt’s stories who share in the future

If you have a story you want shared sent it to steve@steveariens.com

Filed under: General Problems | 1 Comment »

Dr WALMART will be with you shortly… feel free to walk around the store.. we will text you.. we are a little behind

Posted on March 15, 2022 by Pharmaciststeve

Spine group launches franchise following Walmart pilot

https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/53851-spine-group-launches-franchise-following-walmart-pilot.html

Brentwood, Tenn.-based IMAC Holdings plans to launch a franchise of spinal health and wellness centers called The Back Company on April 1.

The franchise follows the July launch of The Back Space, a chain of retail spine clinics piloted in Walmart stores. 

The Back Company will provide chiropractic adjustments, corrective instrument adjusting and percussion therapies for soft tissue recovery, muscle relaxation and spinal wellness, the company said in a March 15 news release. Services are priced at $25 per treatment, with memberships available for $65 per month, in addition to family and wellness plans.

The franchises will be positioned in retail centers, large retail stores and medical facilities.

“We have the ability to leverage a competitive advantage in a $20 billion industry that will efficiently utilize capital to increase storefronts quickly through franchising,” said Jeff Ervin, CEO of IMAC. “Our pilot allowed us to develop our technical infrastructure, refine the services and messaging and implement the infrastructure needed to launch the franchise program. With the majority of the pilot program expenses behind us, this initiative will reverse the course from cash outlay into cash receipts for the intellectual property we have developed.”

Filed under: General Problems | Leave a Comment »

The CDC: a excellent example of BUREAUCRATIC CREEP

Posted on March 15, 2022 by Pharmaciststeve

I was looking around Indiana’s PDMP ( INSPECT ), which automatically links a Narxcare report…

Here is a copy of a “generic warning”  about a pt taking both a opiate & benzo –  and LOOK who the warn is from  CDC – I thought that the FDA was in charge of medications ?

Also on the Narxcare report they apparently have “developed ” a  LME ( Lorazepam mgs Equivalents)

this is just a guess on my part, but… suspect that there was similar amount of clinical studies/science behind developing that “equivalence system” as was put behind the MME system and according to this information … that would be NONE !

As this recent post on my blog explains    Was/is the CDC 2016 guidelines built on a “false foundation ” and created a covert genocide on a protect class of people ?

 

After a little more research … it would appear that the CDC in late 2020 added the word “PREVENTION” to the name of their agency – but did not stop using the initials CDC .d Amazing how large the scope of the agency could be changed with just the addition of a single word ?

National Center for Injury Prevention and Control (NCIPC)

NCIPC Organization Chart pdf icon[PDF – 67 KB]

NCIPC Mission Statement pdf icon[PDF – 177 KB]

Website

Department of Health and Human Services
Centers for Disease Control and Prevention (CDC)

Deputy Director for Non-Infectious Diseases, (C,U)
National Center for Injury Prevention and Control, (C,U,H)

Filed under: General Problems | Leave a Comment »

30 Days Left of Public Comment on CDC’s Draft Clinical Practice Guideline for Prescribing Opioids

Posted on March 14, 2022 by Pharmaciststeve
30 Days Left of Public Comment on CDC’s Draft Clinical Practice Guideline for Prescribing Opioids
The CDC draft Clinical Practice Guideline for Prescribing Opioids (update to the 2016 Guideline for Prescribing Opioids for Chronic Pain) has posted in the Federal Register and 30 days remain in the 60-day public comment period. Public comment provides valuable insight from the populations that we serve. Please note that the 60-day public comment period will end on April 11, 2022.
CDC is committed to supporting safe and effective pain care options for patients. CDC’s National Center for Injury Prevention and Control (NCIPC) is in the process of updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. Both healthcare professionals and members of the public who experience acute or chronic pain have expressed interest in understanding the recommendations outlined in the draft updated Guideline, and CDC highly values public and partner engagement and feedback in this process.
Please see our webpage detailing the process of updating the Guideline. Encourage people you know who have direct experience with the role of opioids in pain care and the importance of the patient-clinician relationship to visit the Federal Register, review the draft update to the Guideline, and add their perspectives to the Federal Register Notice.
Submit and Comment
See below for instructions to submit a comment during the public comment period. More detailed instructions can also be found on the Federal Register Notice (FRN) webpage and in the FRN for this document.
To locate the FRN and view the draft of the updated Guideline, you can either:

To submit a comment to CDC, please view the methods outlined in the FRN under the “Addresses” heading and select which option you prefer:
  • Go to https://www.regulations.gov and search for “CDC Guideline for Prescribing Opioids”
  • A comment button on the top left of the page will allow you to submit your comments via a webpage with step-by-step instructions
  • Mail
  • Directions for how to submit a comment through the mail are provided in the “Addresses” section of the FRN on FederalRegister.gov
To ask a question, click on the “For Further Information Contact” heading in the FRN for the agency official contact information.
General information about the process to provide a public comment can be found at the following links:
Help us spread the word about this opportunity for input through social media.
Tweet or social media post: Everyone deserves safe, effective pain care. CDC’s draft updated Clinical Practice Guideline for Prescribing Opioids is open for public comment now through April 11, 2022. Please add your feedback on this important update: https://go.usa.gov/xtAW5 
Tweet or social media post: Your voice matters. CDC is accepting public comment on the draft updated Guideline for Prescribing Opioids through April 11, 2022. Please share your perspectives and experiences with pain care today: http://go.usa.gov/xznWH

Shareable Graphic:
Visit the new Process for Updating the Opioid Prescribing Guideline webpage 

Are You or Others Interested in Future Information?

Anyone who would like to receive information related to the work of the National Center for Injury Prevention and Control (NCIPC), specific to drug overdose prevention (including the response to the opioid overdose epidemic) as well as other drug overdose updates (e.g., pertaining to resources and tools), may sign up at www.cdc.gov/emailupdates and select topics of interest.

 

  • Subscription Topics: Injury, Violence, and Safety
  • Subtopic: Drug Overdose News
Thank you again for your interest in the Injury Center’s work. CDC values your continued partnership.
CDC Facebook CDC Twitter CDC Streaming Health CDC Instagram

Centers for Disease Control and Prevention

1600 Clifton Rd   Atlanta, GA 30329   1-800-CDC-INFO (800-232-4636)   TTY: 888-232-6348
Questions or Problems  |  Unsubscribe

Filed under: General Problems | Leave a Comment »

Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD

Posted on March 14, 2022 by Pharmaciststeve

Supreme Court Hearing Room

Ron Chapman II wrote a succinct explanation of the Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD in his blog. He has given me permission to share his blog post. But also, please go to his original blog as that will help his search engine ratings as well. Thank you, Ron, for allowing us to share.
Ron Chapman II’s Post:

The Supreme Court heard oral argument today in the most important healthcare case since 1975, Ruan v. United States . While we were hoping for a glimmer of justice, what we got was a dizzying lesson on grammar, parsing of words, and speed limit analogies. But Justice Gorsuch in his gentle, fatherly cross examination style attempted to bring the argument for petitioners back on track by showing the nonsensical and circular nature of the Government’s argument.

This issue before the Supreme Court is thoroughly addressed here and if you aren’t familiar go back and read that article first.

Before we get into the oral argument its important to understand the changes in the case prior to the parties taking the podium. The issue before the 11th Circuit was the failure to give a “good faith” instruction which essentially permitted the Government to convict Ruan under a strict liability standard. The 11th Circuit believed that if his conduct failed to comport with the objective requirements of the practice of medicine then he should be convicted. Petitioners argued that if he subjectively believed he was following objective standards then he should be acquitted. The Government, straying from the 11th Circuit’s opinion pivoted in their opening brief and said that the physician must make an “honest effort to comply” with the objective standard of practice. This is where the train left the tracks. As Ruan’s counsel pointedly argued – the Government’s argument is a malpractice standard gussied up as an objective standard. The Government pivoted so hard that their argument appeared to turn in the direction of the petitioner, arguing that a subjective “honest effort” is enough. But instead of seizing on that juicy opportunity the justices questions sped past the issues at the heart of the case and turned into a confusing digression into the statutory elements of the offense.

I’ll explain.
THE INTENT COMPONENT

21 U.S.C. 841(a) is a drug trafficking statute. It basically says that its unlawful to knowingly and intentionally distribute controlled substances. But an exception exists in the statute for licensed practitioners. Doctors, pharmacists, and other prescribers and dispensers are exempt from the statute as long as their conduct is “for a legitimate medical purpose in the course of professional practice”. In order to address whether the “good faith” of a physician is relevant the court needed to answer a threshold question and that is whether the intent requirement of the statute applies to the distribution or the exception. Thus, the question is: Does the government need to prove that the doctor knowingly and intentionally distributed drugs or does the government have to prove that the doctor knowingly and intentionally prescribed “outside the course of professional practice and for other than a legitimate medical purpose”. If the government needs to prove only that a physician intended to prescribe drugs then the only doctor who escapes this element is one who prescribes in a coma – as Ruan’s counsel pointed out.

And so the court debated, for some time, whether the intent of the statute was to incorporate the prescriber’s exception as an element of the offense or an affirmative defense to the crime. If its an element, the the intent component must apply to the exception if its not then the intent component only applies to the distribution. Justice Alito seemed to think that the intent element is only related to the distribution and Gorsuch seemed to think that its related to the prescriber’s exception. The other justices didn’t offer much of a position but it seems that Breyer and Alito favor applying it to the distribution because failure to do so creates a statute with two separate intent requirements – one for prescribers and a separate for the general public. Breyer and Alito likely believe that such a reading frustrates the intent of congress in creating the statute.
ONE GLARING OMISSION

But in all of the heated debate surrounding the statutory text of the Controlled Substances Act, the Court and the parties missed the most important issue in the case, and all physician prosecutions. Both the Government and Petitioners conceded in their briefs that the standard applied in such cases is an objective standard of practice- which is incorrect. Both United States v. Moore and Gonzalez v. Oregon clearly state that the Federal Government lacks authority to regulate the practice of medicine. The Government only has authority to punish physicians who act so flagrantly that their conduct can be seen as “drug pushing”. And so, the Government’s proof that a physician’s conduct departed from some sort of “objective standard of care” amounts to mere malpractice and something for State Boards to consider – an issue hinted at in Justice Thomas’s final question. Petitioners should have taken the position that the standard of care is relevant in physician prosecutions only to show the jury the reasonableness of the physician’s conduct but in order for the government to fully satisfy the elements of 841(a) they must prove that a physician’s conduct departed so far from the practice of medicine that they ceased practicing medicine at all.

For more on that point read my article “7 Dirty Words”.

Instead of arguing this federalist argument, the parties were landlocked by the fact that the court granted Cert on the “good faith” issue which necessarily requires an argument regarding the intent elements instead of elevating above this crucial digression and discussing the authority of the Controlled Substance Act to regulate the practice of medicine generally.

Tying an objective standard of care to the elements of an 841(a) violation is dangerous because (1) there is no consensus on what that standard actually is in the medical community, (2) it requires juries to grapple with complex and ever changing medical topics, (3) it allows the government and DEA to drive the standards of practice through CDC guidelines, “red flags”, DEA administrative decisions, and other unpromulgated guidance documents. This is dangerous because either subjectively or objectively the parties have permitted the government to take the position that violation of an invisible and ad hoc standard is sufficient for conviction in the first place.
PREDICTION OF THE COURT’S DECISION IN RUAN V. UNITED STATES

Predicting the outcome of a pending supreme court case is a bit like predicting the weather 30 days out – it ignores the dynamic interplay of the politics of the court. But I’ll take a stab. The Government abandoned the 11th Circuit’s rationale and the Court has no choice but to reverse the 11th Circuit and permit a good faith instruction or at the very minimum a proper instruction on the intent component of an 841(a) violation. It seems that at least five justices agreed with the fact that the intent requirement relates to the prescribers exception: Barrett, Gorsuch, Kavanaugh, Thomas, and Roberts. I think there are enough votes for reversal. But the tougher question is what relief, if any, can be afforded to doctors in the future given that both sides seemed to agree that an objective standard of practice is the standard in interpreting the phrase “legitimate medical purpose”. Kavanaugh seems to take the position that the statute is vague in the first place and may offer a concurring opinion and discuss vagueness unless he can pull the other four in his direction. But I don’t think he will be successful because of the politics of the Court. Determining that 841(a) is vague as applied to physicians will disrupt the balance of justice and require reversal of a lot, actually a ton, of convictions. And one thing we know about the Supreme Court is that it doesn’t favor such sweeping changes. Now this problem was set up by the Court in the first place in failing to address the statutory text since it was first enacted. Since 1975 we have been left without the voice of the court on this statute allowing the circuits to take differing interpretations and circuit splits as they grapple with the statutory text that was most likely written by a congressional staffer in 1970. But I do expect at least some comment on vagueness.

In sum, I expect Ruan and Khan to get some sort of relief from this decision because the jury instructions in their case mis-applied the intent requirement of the statute and made drug trafficking a strict liability offense (like speeding) as applied to physicians. But I don’t expect a sweeping change here, I expect a tailored attack on the 11th Circuit’s reasoning and I expect that the Circuit Courts will pigeonhole the Supreme Court’s decision to prevent its broad application to all physicians convicted under the statute.

There is some good news, potentially, on the horizon though. The Court has held the case of Naum v. United States pending the outcome in Ruan. This is a case where the federalism argument is very much alive. Its a case I have personally handled and if Cert is granted I will be arguing before the Supreme Court. We don’t know why Naum was held by the court but its likely because the Court didn’t want to address the federalism argument until it first decided the more minor issue of good faith and its application to the statutory text.

Filed under: General Problems | 4 Comments »

« Previous Page — Next Page »