Proposed DEA restrictions on telehealth will accelerate America’s opioid crisis

https://rollcall.com/2023/04/04/proposed-dea-restrictions-on-telehealth-will-accelerate-americas-opioid-crisis/

Former Democratic congressman calls for ‘Cabinet-level leadership’ on opioids

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Here is the SMOKING GUN to prove civil rights violations – could support a class action lawsuit – but the community needs to stand up

Above is a post that I made just a couple of days ago and below is a quote I saw on the web, don’t know what city this is happening in, but this would appear to be the actions/reactions of one or more chain pharmacies to the recent HUGE FINES that these chains agreed to because without admitting to any guilt – agreed to pay BILLION OF DOLLARS because of being part of the contribution to the fabricated opioid crisis. It would appear that chronic pain pts are going to be the collateral damage of this “social” war on drugs/pts.  This could be the FIRST SHOE of many shoes that will drop.  Use this phrase in a search engine to find the law firms “law firms and class actions civil right Americans with Disability Act”  If you are waiting for GEORGE TO DO IT –   George is NOT COMING TO HELP YOU !

If you don’t believe that healthcare is nothing more – nothing less than a PROFIT DRIVEN INDUSTRY.  Pay attention to the graph below,  look at the average GROWTH of these major healthcare entities REVENUE. Remember that United Health is endorsed by AARP and what article I have read in AARP publications, they are mostly in lock step with the DEA and others believing that prescription opiates are the genesis of the fabricated opioid crisis.

Every preferred pharmacy has let my pain management practice know that they are no longer accepting prescriptions from their practice. I originally thought this was just my pain management practice but after speaking to other pain patients in our area who see other pain management doctors or practices they have run into this same issue. All the work spent in open enrollment to figure out where best to get medications was all for naught since I am no longer receiving discounts for a preferred pharmacy and worse trying to find pharmacies that will accept and fill your prescriptions are few and far between and most requiring that all your medications be filled by them no matter the cost that you as a patient have to pay. Someone said it was due to the suits discussed here and these bigger pharmacies and chain pharmacies just are not accepting or filling prescriptions that can set them up for additional settlements or suits in the future.

From 2021 to 2022, the big 5 payers got even bigger.

In order, here’s their 2022 revenue:
– UnitedHealth Group: $435B
– CVS: $367B
– Cigna: $181B
– Elevance Health: $180B
– Humana: $93B

Whether you like it or not, these plans (along with the large BCBS plans and Kaiser) dominate health insurance.

The fundamental problem with health insurance as a pure business is that it is low margin (due to MLR and ALR requirements), hard to scale, and has high capital costs (i.e., risk-based capital requirements).

Since 80-85% of the cost is guaranteed to go into medical spend (although some reclassification of expenses exists), it only makes business sense for payers to launch provider services.

To some degree, they are able to double dip profits, first from the plan perspective and then from the provider side.

Now the question remains, will doctors use services rendered by payer entities? I know many doctors who prefer not to refer to these subsidiaries, because they often battle with the payer over prior auth and rate negotiations.

Regardless, bigger ideas are coming. Who is next and what will they buy?

Credit: Gist Healthcare

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The link below is to the nearly 600 page agreement between the three major drug wholesalers and 50 state AG’s, Native American Reservations and others. There is supposedly a similar settlement for 13+ billion with Walgreen, CVS, Walmart. SURPRISE !! the settlement money is suppose to be used in a “don’t do drugs” patterned after the Tobacco Lawsuit.  Most of the state annuity that the Tobacco lawsuit created will mostly DRY UP in another couple of years, and many of the state involved in that lawsuit, promised a “do not smoke education campaign” with the money they got from the lawsuit, but many states have just put that money into the STATE’S GENERAL FUND.

What was agreed  upon in this agreement could be the basis for chronic pain pts to approached law firms that deal with civil rights violations under ADA, especially class actions.  This could be the “SMOKING GUN ” for the chronic pain community to seek some level the playing field

The 3 major drug wholesalers agreed to funding educating prescriber to be consistent with the 2016 CDC opioid dosing guidelines, even hospital pts. Which heavily references the MME SYSTEM which has been proven to have no science nor double blind clinical studies to support its conclusions.

This article makes the point that the DEA/DOJ are targeting the limiting of Adderalls and Xanax being sold to pharmacies by these drug wholesalers  Xanax and Adderall Access Is Being Blocked by Secret Drug Limits   

It is claimed that there is 25-35  million intractable chronic pain pts… each requiring pain management 24/7, these are high acuity pts – the sickest of the sick.  What would happen if all these pts were limited to the fabricated 90 MME/day or  have their necessary pain medication reduced and/or totally stopped ?

If you are reading this – SHARE IT… feel free to contact a civil rights law firm… this is not a single state issue, this is happening in most/all states.  Use this to do a web search “law firms class action civil rights violation ” It typically only needs 1 or 2 lead plaintiff to get a class action started… if those in the community do NOTHING… that is where your controlled meds being prescribed will get down to – NOTHING !!

Click to access Final-Distributor-Settlement-Agreement-3.25.22-Final.pdf

PREVENTION PROGRAMS

1. Funding for media campaigns to prevent opioid use (similar to the FDA’s “Real Cost” campaign to prevent youth from misusing tobacco);
2. Funding for evidence-based prevention programs in schools;
3. Funding for medical provider education and outreach regarding best prescribing practices for opioids consistent with the 2016 CDC guidelines, including providers at hospitals (academic detailing);
4. Funding for community drug disposal programs; and
5. Funding and training for first responders to participate in pre-arrest diversion programs, post-overdose response teams, or similar strategies that connect at-risk individuals to behavioral health services and supports.

F. PREVENT OVER-PRESCRIBING AND ENSURE APPROPRIATE PRESCRIBING AND DISPENSING OF OPIOIDS

Support efforts to prevent over-prescribing and ensure appropriate prescribing and dispensing of opioids through evidence-based or evidence-informed programs or strategies that may include, but are not limited to, the following:
1. Funding medical provider education and outreach regarding best prescribing practices for opioids consistent with the Guidelines for Prescribing Opioids for Chronic Pain from the U.S. Centers for Disease Control and Prevention, including providers at hospitals (academic detailing).
2. Training for health care providers regarding safe and responsible opioid prescribing, dosing, and tapering patients off opioids.
3. Continuing Medical Education (CME) on appropriate prescribing of opioids.
4. Providing Support for non-opioid pain treatment alternatives, including training providers to offer or refer to multi-modal, evidence-informed treatment of pain.
5. Supporting enhancements or improvements to Prescription Drug Monitoring Programs (“PDMPs”), including, but not limited to, improvements that:  FINAL AGREEMENT 3.25.22 E-11
1. Increase the number of prescribers using PDMPs;
2. Improve point-of-care decision-making by increasing the quantity, quality, or format of data available to prescribers using PDMPs, by improving the interface that prescribers use to access PDMP data, or both; or 
3. Enable states to use PDMP data in support of surveillance or intervention strategies, including MAT referrals and follow-up for individuals identified within PDMP data as likely to experience OUD in a manner that complies with all relevant privacy and security laws and rules.
6. Ensuring PDMPs incorporate available overdose/naloxone deployment data, including the United States Department of Transportation’s Emergency Medical Technician overdose database in a manner that complies with all relevant privacy and security laws and rules.
7. Increasing electronic prescribing to prevent diversion or forgery.
8. Educating dispensers on appropriate opioid dispensing.

G. PREVENT MISUSE OF OPIOIDS

Support efforts to discourage or prevent misuse of opioids through evidence-based or evidence-informed programs or strategies that may include, but are not limited to, the following:
1. Funding media campaigns to prevent opioid misuse.
2. Corrective advertising or affirmative public education campaigns based on evidence.
3. Public education relating to drug disposal.
4. Drug take-back disposal or destruction programs.
5. Funding community anti-drug coalitions that engage in drug prevention efforts.
6. Supporting community coalitions in implementing evidence-informed prevention, such as reduced social access and physical access, stigma reduction—including staffing, educational campaigns, support for people in treatment or recovery, or training of coalitions in evidence-informed implementation, including the Strategic Prevention Framework developed by the U.S. Substance Abuse and Mental Health Services Administration (“SAMHSA”).
7. Engaging non-profits and faith-based communities as systems to support prevention.

FINAL AGREEMENT 3.25.22E-12

8. Funding evidence-based prevention programs in schools or evidence-informed  school and community education programs and campaigns for students, families, school employees, school athletic programs, parent-teacher and student associations, and others.
9. School-based or youth-focused programs or strategies that have demonstrated effectiveness in preventing drug misuse and seem likely to be effective in preventing the uptake and use of opioids.
10. Create or support community-based education or intervention services for families, youth, and adolescents at risk for OUD and any co-occurring SUD/MH conditions.
11. Support evidence-informed programs or curricula to address mental health needs of young people who may be at risk of misusing opioids or other drugs, including emotional modulation and resilience skills.
12. Support greater access to mental health services and supports for young people, including services and supports provided by school nurses, behavioral health workers or other school staff, to address mental health needs in young people that (when not properly addressed) increase the risk of opioid or another drug misuse.

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I wonder how many prescribers will not be able to get these 8 hrs of certification finished by the end of June ?  I am not aware of this has to be accomplished in person or can be done on line via recorded sessions or some other approved methodology ?  Wouldn’t it be just like the DEA to require this training/certification to be IN PERSON… knowing that there is not enough presenters nor available training space to accommodate all the number of prescribers that need to complete this certification ?  I looked on line but could not find anything about renewing a expired DEA license, knowing the bureaucracy… there is probably a lot of road blocks and/or monetary fines to get it done.

Xanax and Adderall Access Is Being Blocked by Secret Drug Limits

New DEA License Requirement Starts in June

 The X waiver is gone, but clinicians may need new training to renew their DEA license

https://www.medpagetoday.com/special-reports/exclusives/103870

When the Biden administration killed the X waiveropens in a new tab or window late last year, all clinicians registered with the Drug Enforcement Administration (DEA) learned they would need 8 hours of training on substance use disorder (SUD) management in order to renew their licenses.

The DEA has now issued a deadline for that requirement, and it’s less than 3 months away.

Starting on June 27, all clinicians will have to check a box on their online DEA registration form — whether they’re renewing or initiating a license — affirming they’ve completed that training, according to the DEA’s announcement from last weekopens in a new tab or window.

It’s a one-time requirement that won’t be part of future registration renewals, the DEA said.

Some clinicians will be exempt from completing the 8-hour training, including those who are board-certified in addiction medicine or addiction psychiatry via the American Board of Medical Specialties, the American Board of Addiction Medicine, or the American Osteopathic Association.

Clinicians who have completed a “comprehensive curriculum” that included at least 8 hours of training on treating and managing patients with opioid use disorders or other SUDs, including the appropriate clinical use of all drugs approved by the FDA to treat these conditions, will also be exempt.

Clinicians can satisfy the 8-hour training requirement on treating and managing SUDs by completing courses from a list of approved organizations, including the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, and the American Osteopathic Association.

The training doesn’t have to occur in one session, and can be cumulative across multiple sessions, totaling 8 hours, the DEA said. Past trainings can also count toward meeting requirements. For instance, relevant training from one of the qualified groups prior to the enactment of the policy would count toward the 8-hour requirement.

And, of course, previous trainings completed as part of obtaining an X waiver count as well, the agency noted.

Several groups, including the American Society of Addiction Medicine and the Substance Abuse and Mental Health Services Administration, declined to comment on the new policy. The American Medical Association issued a press releaseopens in a new tab or window announcing the availability of its free courses that would satisfy the new DEA requirement.

The X waiver was a special DEA certification that allowed clinicians to prescribe buprenorphine (Suboxone) to treat SUDs, and it had long been considered a bureaucratic hurdle to improving access to treatment for these patients.

The Biden administration had been chipping away at barriers to care for patients with SUDs, and in April 2021 it scrapped the X waiver’s training requirements for doctors and other healthcare providers. Those wanting to prescribe buprenorphine only had to register for the waiver in order to do so.

Late last year, the administration’s omnibus spending bill carried language eliminating the X waiver requirement completely. Subsequently, the Medication Access and Training Expansion Act bolstered training requirements by requiring all clinicians with a DEA license to have completed a one-time, 8-hour training on managing patients with opioid use disorder and other SUDs.

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$21B opioid settlement is ‘disrupting patient care,’ APhA CEO says

https://www.beckershospitalreview.com/pharmacy/21b-opioid-settlement-is-disrupting-patient-care-apha-ceo-says.html

A $21 billion settlement between 46 attorneys general and three pharmaceutical distributors — AmerisourceBergen, Cardinal Health and McKesson — may be leading to more drug supply issues, The New York Times reported March 13. 

The settlement was intended to tweak former allowances and diminish the nation’s pile of unnecessary prescription painkillers, which helped fuel the opioid epidemic. This tighter leash didn’t just corral opioids, though: Some anxiety, attention-deficit/hyperactivity disorder and addiction medications are now harder to access, according to the Times. 

Because the agreement included multiple controlled substances that could become addictive, including muscle relaxants and Xanax, tens of thousands of drug orders have been canceled. 

As part of the settlement, these distributors have to set monthly caps to some controlled substances, meaning pharmacies cannot order more of these drugs if their supplier already reached its limit — even if patients come in needing a refill. 

Ilisa Bernstein, PharmD, interim CEO of the American Pharmacists Association, told the Times that the new rules, which took effect in July, have led to “havoc” in some pharmacies.

“They have patients coming in to get medication, and they can’t have it,” Dr. Bernstein said. “It’s disrupting patient care.”

Cardinal Health and McKesson did not respond to the outlet’s requests for comment, but AmerisourceBergen told the Times it is waiting on guidance from the government to block misuse of “these drugs without interfering with good-faith clinical decisions made by doctors.”

Why this Pennsylvania city called the proposed $21B opioid settlement ‘unacceptable’

How many times can the bureaucrats “take” profits from companies that are selling legal products ?  Remember the Tobacco settlement in 1999 +/- ?  that only involved the manufacturers of tobacco products… with this settlement 46 states are “confiscating” the profits of the three major USA wholesalers.

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FOR IMMEDIATE RELEASE
April 5, 2023

Contact: CMS Media Relations
CMS Media Inquiries

HHS Finalizes Rule to Strengthen Medicare, Improve Access to Affordable Prescription Drug Coverage, and Hold Private Insurance Companies Accountable to Delivering Quality Health Care for America’s Seniors and People with Disabilities

Thanks to President Biden’s new law to lower prescription drug costs, the final rule will also improve access to affordable prescription drug coverage for an estimated 300,000 low-income individuals

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing a rule to put people with Medicare first and put strong protections in place so that Medicare Advantage (MA) works for them. This final rule will strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care. The new rule will also promote health equity, and implement a key provision of the Inflation Reduction Act—President Biden’s new law to lower prescription drug costs—that will improve access to affordable prescription drug coverage for an estimated 300,000 low-income individuals.

The Biden-Harris Administration is committed to protecting and strengthening Medicare for the 65 million people with Medicare today and for future generations. In the past few months, the Department has taken a series of actions to ensure the Medicare Advantage program works for people with Medicare and that private insurance companies are held accountable for providing quality coverage and care:

In February, CMS finalized a rule to start recovering improper payments made to Medicare Advantage plans through audits for the first time since 2007. Recovering these improper payments and returning this money to the Medicare Trust Funds will protect the fiscal sustainability of Medicare and allow the program to better serve seniors and people with disabilities, today and in the future.
Last week, CMS finalized policies in the 2024 Medicare Advantage and Part D Rate Announcement to improve payment accuracy and ensure taxpayer dollars are appropriately safeguarded and well-spent.

“At HHS, we put seniors and people with disabilities first,” said HHS Secretary Xavier Becerra. “That is exactly what we are doing today. In our latest effort to strengthen Medicare and hold insurance companies accountable, we are putting protections in place so that Medicare Advantage works for beneficiaries and they get the quality care they deserve. We will continue our efforts to deliver on the President’s vision to strengthen this program for the millions of people with Medicare and for future generations to come.”

“The Biden-Harris Administration has made exceptionally clear that one of its top priorities is protecting and strengthening Medicare,” said CMS Administrator Chiquita Brooks-LaSure. “With this final rule, CMS is putting in place new safeguards that make it easier for people with Medicare to access the benefits and services they are entitled to, while also strengthening the Medicare Advantage and Part D programs.”

“People with Medicare deserve to have access to accurate information when making coverage choices, and to be able to get the care they need without excessive burden or delays,” said Dr. Meena Seshamani, CMS Deputy Administrator and Director of the Center for Medicare. “The commonsense policies in this rule further our goals to advance health equity, improve access to care, and drive high-quality, whole-person care.”

Cracking Down on Misleading Marketing Schemes

The final rule includes changes to protect people exploring Medicare Advantage and Part D coverage from confusing and potentially misleading marketing practices. Ads will be prohibited if they do not mention a specific plan name, or if they use the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card, in a misleading way. Further, the final rule strengthens accountability for plans to monitor agent and broker activity.

Removing Barriers to Care Created by Complex Prior Authorization and Utilization Management

CMS is also providing important protections regarding utilization management policies and coverage criteria that ensure that Medicare Advantage enrollees receive the same access to medically necessary care that they would receive in Traditional Medicare. The rule streamlines prior authorization requirements and reduces disruption for enrollees by requiring that a granted prior authorization approval remains valid for as long as medically necessary to avoid disruptions in care, requiring Medicare Advantage plans to annually review utilization management policies, and requiring denials of coverage based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued. These policies complement proposals in CMS’ Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (CMS-0057-P).

Expanding Access to Behavioral Health Care

CMS remains committed to emphasizing the critical role that access to behavioral health plays in whole person care. In line with CMS’ Behavioral Health Strategy and the Administration’s strategy to address the national mental health crisis, CMS is strengthening behavioral health network adequacy in Medicare Advantage by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties. CMS is also finalizing wait time standards for behavioral health and primary care services and more specific notice requirements from plans to patients when these providers are dropped from their networks. In addition, CMS is requiring most types of Medicare Advantage plans to include behavioral health services in care coordination programs, ensuring that behavioral health care is a core part of person-centered care planning.

Promoting More Equitable Care

Additionally, CMS is advancing health equity and driving quality in health coverage by establishing a health equity index in the Star Ratings program that will reward Medicare Advantage and Medicare Part D plans that provide excellent care for underserved populations. Plans will also be required to provide culturally competent care to an expanded list of populations and to improve equitable access to care for those with limited English proficiency, through newly expanded requirements for providing materials in alternate formats and languages. The final rule balances patient experience/complaints measures, access measures, and health outcomes measures in the Star Ratings program to more effectively focus both on patient-centric care and on improving clinical outcomes.

Implementing President Biden’s New Prescription Drug Law

The final rule also implements a key provision of the Inflation Reduction Act that improves access to affordable prescription drug coverage for approximately 300,000 low-income individuals. As outlined in President Biden’s new prescription drug law, CMS is expanding eligibility for the full low-income subsidy benefit (also known as “Extra Help”) to individuals with incomes up to 150% of the federal poverty level who meet eligibility criteria. Beginning January 1, 2024, this change will provide the full low-income subsidy to those who would currently qualify for the partial low-income subsidy. As a result of this change, eligible enrollees will have no deductible, no premiums (if enrolled in a “benchmark” plan), and fixed, lowered copayments for certain medications under Medicare Part D.

View a fact sheet on the final rule.

The final rule can be accessed from the Federal Register at: https://www.federalregister.gov/public-inspection/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program.

Medicare Advantage Value-Based Insurance Design Model Extension

Additionally, today CMS is also releasing more information about the extension of the Center for Medicare and Medicaid Innovation’s Medicare Advantage Value-Based Insurance Design (VBID) Model from 2025 through 2030. This extension will introduce changes intended to more fully address the health-related social needs of patients, advance health equity, and improve care coordination for patients with serious illness. View the fact sheet, and more information, on the model webpage.

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Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSGov

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Dr. Ruan Requests Support For Another Writ

https://www.daily-remedy.com/dr-ruan-requests-support-for-another-writ/

Xiulu Ruan, MD; 66857019

F.C.I. Oakdale 1, Eva 2

P.O. Box 5000, Oakdale, LA 71463

Re: Request for Amicus Brief for Our Upcoming Petition for Writ of Certiorari (Case Number: to be assigned soon)

March 18, 2023

Jane M. Orient, MD, Executive Director Association of American Physicians and Surgeons

1601 N. Tucson Blvd. Suite 9, Tucson AZ 85716-3450

Dear Dr. Orient:

Dr. Couch and I need your help! Pain physicians need your help! Millions of people living in pain need your help!

On June 27, 2022, in a 9:0 decision, the Supreme Court handed down Xiulu Ruan v. U.S., 142 S. Ct. 2730 (“Ruan II”). Ruling in my favor the Court vacated and remanded my case back to the Eleventh Circuit. The Court, however, did not expressly invalidate its earlier precedent, U.S. v. Moore, 423 U.S. 122 (1975). This is problematic.

For close to five decades, Moore (1975) has been the Court’s seminal case law in prosecuting clinicians as drug traffickers under the Controlled Substances Act (CSA) Section 841. The Moore Court, unfortunately, erred when it ruled: “Registered physicians can be prosecuted under the Section 841, when, as here, their activities fell ‘outside the usual course of professional practice’ [‘OUCPP’].”  Based on today’s standard in Ruan II, the above OUCPP Ruling was plain error because it failed to consider the guilty intention or “mens rea” respecting OUCPP (discussed in detail in the attached essay).

Moore (1975) is also self-contradictory: While the Court implicitly authorized the Moore’s Jury Instruction, which contained the phrase “other than in good faith” that served as the requisite “mens rea” at Dr. Moore’s trial, the Court’s OUCPP Ruling, however, mentioned no “mens rea,” thus negating the “mens rea” it had endorsed in Moore’s Jury Instruction. Consequently, Moore (1975) violated the Law of Non-Contradiction, which dictates that the two opposing propositions cannot be both true at the same time in the same sense. (The two premises, “A is B” and “A is not B,” are mutually exclusive and collectively exhaustive and therefore cannot be both true at the same time.)

On my direct appeal, I cited Moore to support my “good faith” or the lack of “mens rea.” The Eleventh Circuit rejected it, citing Moore’s OUCPP Ruling:”This rule reflects the Supreme Court’s decision in U.S. v. Moore, 423 U.S.122 (1975), the first case by the Supreme Court establishing that physicians can be prosecuted for violating the Controlled Substances Act ‘when their activities fall outside the usual course of professional practice.’ Id. at 124″ (U.S. v. Ruan, 966 F.3d 1101, 1166-67) (11th Cir. 2020). This predicament is caused by the Moore Court’s simultaneously embracing two opposing propositions.

In addition, Moore (1975) erroneously acquiesced to a novel prosecution model, the prototype of prosecuting physicians as drug traffickers under Section 841, namely by combining the CSA 841(a) statute with 21 C.F.R. Section 1306.04(a), together with Moore (1975). Today, this compound criminal liability standard has the following appearance:

“It is generally ‘unlawful for any person knowingly or intentionally … to manufacture, distribute, or dispense, or posses with intent to manufacture, distribute, or dispense, a controlled substance.’ 21 U.S.C. Section 841(a). A medical professional’s prescription of a controlled substance is lawful only if ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.’ 21 C.F.R. Section 1306.04; See also United States v. Moore, 423 U.S. 122,

124” (U.S. v. Lague, 971 F.3d 1093 (9th Cir. 2020)).

This compound criminal standard contains multiple fatal flaws . I will briefly mention one here: The violation of Section 1306.04 is akin to a civil infringement, not a felony offense. There is no rational connection between violating Section 1306.04 and violating Section 841 (discussed in detail in the attached essay).

Indeed in U.S. v. Howen, 2022 U.S. Dist. LEXIS 236721 (E.D. Ca. 2022), the Government filed a civil suit against defendant pharmacist Howen and defendant pharmacies for knowingly violating Section 1306.04. The court opined: “Section 1306.04(a) explicitly subjects pharmacists to CIVIL PENALTIES if they ‘knowingly’ fill an invalid prescription [.]’ See 21 C.F.R. Section 1306.04(a)” (2022 U.S. Dist. LEXIS 14) (emphasis added).

Further, the term “OUCPP” in the context of Section 1306.04 differs in meaning from “OUCPP” in the context of Moore (1975). The former contemplates a civil infringement such as in Howen, while the latter represents a felonious offense per Moore’s OUCPP Ruling. Through the equivocal usage of the term “OUCPP” introduced by Moore (1975), a false causal connection between the two was established even though there was no rational connection between them. Thus innocuous conduct such as OUCPP in violation of Section 1306.04 became notorious felonious offense under Section 841.

For close to five decades innumerable clinicians including physicians, surgeons, licensed nurse practitioners and physician assistants, podiatrists, dentists, pharmacists, etc., have been prosecuted under this erroneous criminal standard as well as under Moore’s OUCPP Ruling. (Moore’s other serious errors were discussed in detail in the attached essay.)

Congress designed separate CSA provisions (Section 841, 842, and 843) for different purposes. Indeed the District of Columbia Circuit reasoned that the “broad outline strongly suggests that Congress intended to deal with registrants primarily through a system of administrative controls … and reserving the severe penalties provided in Section 841 for those seeking to avoid regulation entirely by not registering.” (U.S. v. Moore, 505 F.2d 426, 430 (D.C. Cir. 1974))

Following Moore (1975), almost all clinicians charged with “overprescribing” were prosecuted under Section 841, as though Section 842 and 843 had never existed. This practice violated the basic interpretive canon admonished by the Court in Rubin (138 S. Ct. 816) for it rendered 842 and 843 provisions nonsensical and superfluous, thus at odds with Congress’s intention.

Although the Howen Court in California treated the violation of Section 1306.04 as a civil infringement, the Eleventh Circuit, however, pushed it all the way to the other end, treating it like an act of “drug dealing.” For example, in U.S. v. Mencia, 2021 U.S. App. LEXIS 17160 (11th Cir. 2021), the Eleventh Circuit elaborated: “When does a physician stop acting as a doctor and start acting as a “drug pusher[?]” The answer under the Act is when he prescribes controlled substances outside the course of his professional practice or without a legitimate medical purpose.” (2021 U.S. App. LEXIS 40-41)

Shocking, isn’t it? That’s how pliable and insidious 21 C.F.R. Section 1306.04 could be. Its interpretation depends entirely on the caprice of the courts. A violation of it, a civil infringement per a federal court in California, can become a felonious offense of drug trafficking per the Court of Appeals for the Eleventh Circuit in Atlanta. Does this make any sense at all?

In the past two years, tons of illicitly manufactured fentanyl have been smuggled in across the open southern border with minimal government intervention. By contrast, Dr. Couch and I, in our capacity as fellowship-trained, multi-board certified interventional pain specialists, received sentencing enhancement for collectively prescribing FORTY GRAMS of fentanyl -­ during four and half years in treating our patients at Physicians’ Pain Specialists of Alabama, a tertiary interventional pain clinic that had been in practice for 17 years with more than 8,000 active patients (when the Government shut it down in 2015).

In a recent article, “The Misinformed & Misguided Prescription Abuse Prevention Act: A Response to Delfino,” by Robert Capodilupo and Jacob James Rich, published in “Yale Law and Policy Review” — Inter Alia (Spring 2023), the authors pointed out that, while opioid prescribing has declined over the past decade, total opioid deaths have skyrocketed because of a spike in illicit opioid overdoses. They cautioned that the proposed Prescription Abuse Prevention Act by Delfino may create a harmful “chilling effect,” further deterring physicians from prescribing needed pain medicines to treat patients.

Capodilupo and Rich also explained that the drastically increased opioid mortality over the past a few years was mostly due to illicitly manufactured fentanyl, not prescription fentanyl, noting that, by August 2017, the CDC had formally removed fentanyl from the definition of prescription opioid mortality. They predicted that further reduction in opioid prescribing may exacerbate opioid overdoses by orienting pain patients and recreational users to illicit alternatives such as heroin and illicit fentanyl.

The Court should use this petition to re-examine the fatally flawed criminal standard presented, which, for decades, has resulted in enormous harm to clinicians, patients, and our society — a tragedy and disgrace never intended by Congress .

Thank you wholeheartedly in advance for your attention and kind help. We look forward to seeing your Brief of Amicus Curiae in connection with our certiorari.

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How Reliable Are Your Generic Drugs From India?

https://www.peoplespharmacy.com/articles/how-reliable-are-your-generic-drugs-from-india

FDA warning letters to Indian drug companies have increased dramatically in recent years.

Are you taking generic drugs from one of these manufacturers?

For decades the FDA has told Americans that generic drugs are absolutely identical to brand name medicines. Physicians, pharmacists and insurance companies reassure patients that a $4 generic prescription is the same as a brand name medicine that costs over $150 for the same number of pills.

The only problem is that some generic drugs are now skyrocketing in price for lack of competition.

It is puzzling why so many generic drug manufacturers have stopped making certain products. It is almost as if the industry has divvied up the market.

The results are appalling. This is how we ended up with Martin Shkreli at Turing Pharmaceutical jacking up the price of one drug 5,000%. But he isn’t the only one. Other companies are also abusing the American public by raising generic drug prices into the stratosphere. Read more about this scandal at this link.

Give Us More Generic Drugs!

Congress is anxious to see the FDA approve more generic drugs faster. Our legislators want to save money on medicines. After all, federal programs like Medicare, Medicaid and the Veterans Administration spend a lot on prescription drugs.

Private and nonprofit hospitals also want to spend less on medicine. And of course insurance companies are desperate to get people taking cheaper generic medicine.

No one seems to be concerned about quality.

Heck, we didn’t worry about quality either. Starting with our first book, The People’s Pharmacy (published in 1976), we told people that very same thing. For over 25 years we believed that the FDA was totally on top of both the approval and monitoring of generic drugs. We never even stopped to think about manufacturing problems. Of course in those days most generic drugs were made in the U.S.A That all has changed.

Where Your Generic Drugs Come From:

Now that 88 percent of all prescriptions are dispensed as generic medications, the quality of such drugs is more important than ever.

But the vast majority of them now come from abroad, where FDA oversight has historically been dismal.

The active pharmaceutical ingredients (APIs) and the so-called inactive ingredients now come primarily from all over the world: Brazil, China, India, Mexico, Slovakia, Thailand, Turkey and goodness knows where else.

Historically, the FDA hasn’t even known where all the chemicals in your medicine originated. There is no requirement to put country of origin on the drug label.

What the FDA has Found in India:

In the last few years, though, FDA inspectors have been active in India, where so many inexpensive generic drugs are manufactured for the American market. What they have found is frightening.

In just the last few weeks, the FDA reprimanded the Indian drug manufacturer Wockhardt for hiding unwelcome test results and deleting data. This is not the first time Wockhardt has run into trouble. Since April of last year the company has recalled hundreds of millions of tablets and capsules. They included popular blood pressure medicines such as amlodipine and lisinopril as well as the antibiotic azithromycin and the sleeping pill zolpidem.

Wockhardt is not the only Indian pharmaceutical firm to run afoul of the FDA. Other Indian companies that have received warning letters over the last several months include Aurobindo, Dr. Reddy’s Laboratories, IPCA and Sun Pharmaceutical Industries.

Ranbaxy Laboratories, one of the largest of the Indian generic pharmaceutical firms, has had multiple run-ins with the U.S. Food and Drug Administration. A few years ago this company pleaded guilty to felony charges after being accused of falsifying data. The company paid $500 million in fines.

An interesting note on the Ranbaxy mess: Sun Pharmaceuticals of India acquired Ranbaxy for $3.2 billion last year, making Sun Pharma India’s biggest drug company. Sun has itself come under FDA scrutiny. A Bloomberg report noted that Sun Pharma employees had faked test results.

How Many Companies Have Run Into Trouble?

Over the last five years the FDA has banned products from 44 different Indian drug-making facilities.

That should give insurance companies some cause for alarm when they insist that their customers must use generic rather than brand name drugs.

What About China?

India is not the only place that is coming under increased scrutiny by the FDA. For years, the agency only had a few inspectors on the ground in China. Now that there are more, they are discovering shortcomings in Chinese plants too.

Warning letters have been sent to a number of companies in recent months. Even brand name companies have been tainted. Pfizer’s Chinese partner, Zhejiang Hisun, was accused of systemic problems associated with “data manipulation.”

That is a sanitized way of saying employees were cooking the books and violating the rules of good manufacturing practices. Customers had been complaining about drugs not measuring up to standards between 2012 and 2014.

What Should You Do?

Patients are the ultimate customers of foreign-made pharmaceuticals.

We have been receiving complaints about generic drugs that do not work as well as their brand name counterparts for more than a decade:

Problems with Generic Prilosec for Reflux:

We have been hearing about this particular problem for years:

Kathi in Milwaukee:

“I became so ill after my pharmacy plan switched me to generic omeprazole that my MD ordered an endoscopy to make sure I did not have esophageal cancer. I was sick for almost 3 months, and am still having issues almost a year later.”

Linda in Los Angeles:

“I have been taking Prilosec by AstraZenca for 20 years and have had no GERD problems at all. As of November 1, 2015, I was advised by my pharmacy that I would now have to take a generic. I have taken a generic omeprazole (20mg) for 40 days now, and it is NOT the same. I am burping all the time and have reflux and choking, something I never had with the brand name Prilosec. I am fortunate that my insurance has paid 80% of the cost (over $200 month).”

Men on Flomax for Frequent Urination:

Men who have to get up at night to go to the bathroom know pretty quickly how well their medicine is working:

Henry in Nevada:

“My first generic flomax (tamsulosin) was barely tolerable. In the second prescription the pharmacy changed manufacturers and this generic was far worse and not as effective. If the FDA is not directly monitoring these drugs then they are unlikely to have the necessary ingredients to be effective.”

BK on other ingredients in tamsulosin:

“My husband has been taking Flomax for a few years, when just last month, a generic form came to the market. Due to the inert ingredients, he ended in the hospital with gastritis. My insurance company will not pay for Flomax, only the generic tamsulosin. We cannot afford the high price of Flomax.

“I asked them to make a one-time exception to override the cost for a one-month supply of Flomax, just to wean him off the alpha blocker as needed due to severe side effects, but was denied.

“I could not believe the inert ingredients are so different. Drug companies should be aware of up coming law suits they are causing!”

Just think of the extra cost of hospitalization because of the generic substitution. How short-sighted of the insurance company in our humble opinion.

How to Report Generic Drug Problems to the FDA:

The FDA is starting to pay attention to our frequent messages of generic manufacturing problems. Anyone who would like to report a drug problem may do so at www.FDA.gov/MedWatch.

Patients can also share their experiences below in the comment section. Please try to find the name of the generic drug manufacturer on the label of the bottle so we can let the FDA know which companies have frequent customer complaints.

Filed under: General Problems | 4 Comments »

Mulready Files Action Against CVS/Caremark

https://www.oid.ok.gov/release_040323/

OKLAHOMA CITY – Oklahoma Insurance Commissioner Glen Mulready announced today the filing of an administrative action against CVS/Caremark that outlines alleged violations of the Patient’s Right to Pharmacy Choice Act. The filing targets the practice of “steering patients” to CVS pharmacies and prescription mail-order services and seeks to censure, suspend, place on probation or revoke the Pharmacy Benefit Manager (PBM) license of CVS/Caremark. In addition, the Oklahoma Insurance Department (Department) will seek restitution and/or levy fines for each alleged violation.

“I am convinced that CVS/Caremark does not want to follow Oklahoma law and wants to find every opportunity to skirt their responsibility,” Mulready said. “I am extremely frustrated with the misinformation and confusion presented to Oklahoma consumers.”

The Department sent a letter in February providing notice to CVS/Caremark that administrative action would be taken if they did not immediately correct their communication that went out to consumers related to the CVS/Caremark Maintenance Choice Program.

In response to the Department’s February formal notice, CVS/Caremark took corrective action but has since communicated to their large client employers that filling 90-day prescriptions is now prohibited. CVS/Caremark has used untruthful and harmful statements to explain the reasoning behind this impactful business decision that continues to restrict pharmacy choice conditions.

“I expect PBM licensees to follow the law, not operate on the fringes of regulatory compliance,” Mulready said. “This is especially egregious because this is the first time that any PBM previously sanctioned by the Department has publicly committed the same violation a second time. This is unacceptable, and we will hold them accountable.”

The administrative hearing is scheduled for May 25, 2023.Click here to view the Notice of Hearing and Order to Show Cause.

For more insurance information, please contact the Oklahoma Insurance Department at 1-800-522-0071 or visit our website at www.oid.ok.gov.

Filed under: General Problems | 1 Comment »