what happens if you OD on Ozempic

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Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2025

https://www.federalregister.gov/documents/2024/09/25/2024-21962/proposed-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment-of

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

Section 306 of the Controlled Substances Act (21 U.S.C. 826) requires the Attorney General to establish production quotas for each basic class of controlled substances listed in schedules I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA pursuant to 28 CFR 0.100.

Analysis for Proposed 2025 Aggregate Production Quotas and Assessment of Annual Needs

The proposed 2025 aggregate production quotas (APQ) and assessment of annual needs (AAN) represent those quantities of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2025 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.

Aggregate Production Quotas

In determining the proposed 2025 APQ, the Administrator has taken into account the criteria of 21 U.S.C. 826(a) and 21 CFR 1303.11, including the following seven factors:

(1) Total net disposal of the class by all manufacturers during the current and two preceding years;

(2) Trends in the national rate of net disposal of the class;

(3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation;

(4) Projected demand for such class as indicated by procurement quotas requested pursuant to [21 CFR] 1303.12;

(5) The extent of any diversion of the controlled substance in the class;

(6) Relevant information obtained from the Department of Health and Human Services (HHS), including from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), and relevant information obtained from the states; and

(7) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

21 CFR 1303.11(b).

DEA formally solicited input from FDA and CDC in February of 2024 and from the states in April 2024, as required by 21 U.S.C. 826 and 21 CFR part 1303. DEA did not solicit input from CMS for reasons discussed in previous notices.^[1] DEA requested information on trends in the legitimate use of select schedule I and II controlled substances from FDA and rates of overdose deaths for covered controlled substances from CDC. DEA’s request for information from the states was made directly to the Prescription Drug Monitoring Program (PDMP) Administrators in each state as well as through the National Association of State Controlled Substances Authorities (NASCSA).

Assessment of Annual Needs

In similar fashion, in determining the proposed 2025 AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, the Administrator has taken into account the criteria of 21 U.S.C. 826(a) and 21 CFR 1315.11, including the following five factors:

(1) Total net disposal of the chemical by all manufacturers and importers during the current and two preceding years;

(2) Trends in the national rate of net disposal of each chemical;

(3) Total actual (or estimated) inventories of the chemical and of all substances manufactured from the chemical, and trends in inventory accumulation;

(4) Projected demand for each chemical as indicated by procurement and import quotas requested pursuant to [21 CFR] 1315.32; and

(5) Other factors affecting medical, scientific, research, and industrial needs in the United States, lawful export requirements, and the establishment and maintenance of reserve stocks, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemicals or the substances manufactured from them, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

21 CFR 1315.11(b).

In determining the proposed 2025 AAN, DEA used the calculation methodology previously described in the 2010 and 2011 assessments of annual needs (74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010), respectively).

Estimates of Medical Need for Schedule II Opioids and Stimulants

In accordance with 21 CFR part 1303, 21 U.S.C. 826, and 42 U.S.C. 242, HHS continues to provide DEA with estimates of the quantities of select schedule I and II controlled substances and three list I chemicals that will be required to meet the legitimate medical needs of the United States for a given calendar year. The responsibility to provide these estimates of legitimate domestic medical needs resides with FDA. FDA provides DEA with predicted estimates of domestic medical usage for selected controlled substances based on information available to them at a specific point in time in order to meet statutory requirements.

FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone. DEA considered the potential for diversion of schedule II opioids, as required by 21 CFR 1303.11(b)(5), as well as a potential increase in demand for certain opioids identified as being necessary to support the previously postponed elective surgeries now that the COVID-19 public health emergency (PHE) has ended, pursuant to 21 CFR 1303.11(b)(7), in developing the proposed 2025 APQ.

FDA predicted an average of a 3.5 percent increase in domestic medical use of the schedule II stimulants amphetamine, methylphenidate (including dexmethylphenidate), and lisdexamfetamine, which are prescribed to treat patients with attention deficit hyperactivity disorder (ADHD) and more recently prescribed off-label to treat patients diagnosed with long-COVID symptoms commonly known as brain fog where fatigue and cognitive impairment persist 4 to 12 weeks after a COVID infection.^[2] FDA also raised concerns over drug shortage notifications it received since 2022 from patients for specific ADHD medications containing amphetamine, lisdexamfetamine, and methylphenidate. FDA’s stated reasons for these specific shortages include increased prescribing potentially related to the growth in telemedicine during and after the COVID-19 PHE, supply chain issues, manufacturing and quality issues, lack of active ingredients, and business decisions of manufacturers. DEA considered FDA’s concerns when determining the APQ for these substances. Additionally, DEA considered manufacturer and distributor-reported data which shows inventories for both amphetamine and methylphenidate-based products have increased year-over-year throughout the supply chain. DEA believes these increases in inventories combined with the established APQs are adequate to address FDA’s estimated increases in domestic medical use for amphetamine and methylphenidate. With respect to lisdexamfetamine, DEA recently increased the APQ pursuant to a final order published on September 5, 2024 to address reported shortages.^[3] In sum, DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice.

DEA Projected Trends for Certain Schedule I Controlled Substances

DEA is proposing a higher APQ for ibogaine than DEA granted for 2024 to support manufacturing activities related to the increased level of research and clinical trials with this schedule I controlled substance. Additionally, DEA proposes a higher APQ for gamma hydroxybutyric acid (GHB) to allow for an anticipated increase in domestic bulk manufacturing to meet forecasted and continued domestic market need due to the closure of a foreign manufacturing facility. Imports of the schedule III oxybate form of GHB from that manufacturing facility have supplied an estimated 78% of the domestic need. Their foreign plant closure will be approximately one year in duration. GHB (oxybate) products are used in the treatment of patients diagnosed with narcolepsy and cataplexy.

Information Received for Consideration of the Remaining Factors

For the factors listed in 21 CFR 1303.11(b)(3) and (4), DEA registered manufacturers of controlled substances in schedules I and II provide information such as inventory, distribution, manufacturing, sales forecasts and quota requests to DEA database systems. See21 CFR 1303.12, 1303.22, and part 1304.

The regulation at 21 CFR 1303.11(b)(5) requires DEA to consider the extent of diversion of controlled substances.^[4] Diversion is defined as all distribution, dispensing, or other use of controlled substances for other than legitimate medical purposes. In order to consider the extent of diversion, DEA analyzed reports of diversion of controlled substances from 2023 submitted to its Theft Loss Report database. This database is comprised of DEA registrant reports documenting diversion from the legitimate distribution chain, including employee thefts, break-ins, armed robberies, and material lost in transit. The data was categorized by basic drug class, and the amount of active pharmaceutical ingredient (API) in the dosage form was delineated with an appropriate metric for use in proposing aggregate production quota values ( i.e., weight).

In this proposed 2025 APQ notice, DEA continues to consider the lingering effects of the COVID-19 pandemic on the global supply chain, pursuant to 21 CFR 1303.11(b)(7), and specifically the continued impacts on the availability of raw materials for use in the domestic manufacturing process. Additionally, DEA considered the impact of the demand for surgical care for elective surgeries that were deferred during the COVID-19 PHE.

Estimates of Diversion of Covered Controlled Substances

In establishing any quota . . . , or any procurement quota established by [DEA] by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a “covered controlled substance”), [DEA] shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. 21 U.S.C. 826(i)(1)(A).

In estimating diversion under that provision, DEA:

(i) shall consider information . . . , in consultation with the Secretary of Health and Human Services, [it] determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and

(ii) may take into consideration whatever other sources of information [it] determines reliable.

21 U.S.C. 826(i)(1)(B).

The statute further mandates that DEA “make appropriate quota reductions, as determined by [DEA], from the quota [it] would have otherwise established had such diversion not been considered.” ^[5]

In estimating the amount of diversion of each covered controlled substance that occurs in the United States, DEA considered information from state PDMP Administrators and from legitimate distribution chain participants.

Consideration of Information From Certain State PDMPs and From National Sales Data

Pursuant to 21 CFR 1303.11(b)(6), DEA requested state PDMP data for the purpose of establishing its APQ. DEA believes state PDMPs to be an essential, reliable source of information for use in effectively estimating diversion of the five covered controlled substances. In April 2024, DEA sent a letter to NASCSA requesting its assistance in obtaining aggregated PDMP data for the five covered controlled substances from each state covering the years 2021-2023. The letter indicated that DEA was specifically interested in an analysis of prescription data from each state’s PDMP that would assist DEA in estimating diversion and setting appropriate quotas in compliance with 21 U.S.C. 826(i). In its request, DEA provided specific questions, discussed in detail below, based on common indicia of potential diversion known as “red flags” by physicians, pharmacists, manufacturers, distributors, and federal and state regulatory and law enforcement agencies.^[6] DEA investigators and administrative prosecutors also rely on Agency case law in which these red flags of diversion have been upheld as indicia of potential diversion.^[7] Certain state regulations now include red flag circumstances as potential indicators of illegitimate prescriptions, and thus of potential abuse and diversion of controlled substances.^[8] See, e.g., The Pharmacy Place Order, 86 FR 21008, 21012 (Apr. 21, 2021) (citing 22 Tex. Admin. Code 291.29(c)(4), specifying the geographical distance between the practitioner and the patient or between the pharmacy and the patient as a red flag).

DEA requested responses from state PDMP Administrators by June 15, 2024. NASCSA disseminated DEA’s request to its PDMP Administrators and provided them with a report tool to ensure that responses to DEA’s questions were extracted consistently across all responsive states. Twenty-nine states and three territories provided DEA with summarized PDMP data as of July 2024, utilizing the standardized report developed by NASCSA.^[9] See Table 1a below.

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Beyond Counterfeit Ozempic

https://www.medpagetoday.com/special-reports/features/112421

Criminals have found ways to sell illicit weight-loss drugs through counterfeits and drug diversion, where drugs are altered or shipped from overseas, according to CNBC opens in a new tab or window.

Drug diversion is a different beast than counterfeit weight drugs, sources said. People may get the real product, unlike counterfeits, but there are still substantial risks.

As part of the investigation, CNBC ordered Ozempic from Laver Beauty, a company based in Boulder, Colorado, that sells a month’s supply for $219 rather than the usual $968. The shipment arrived from China to New Jersey with no refrigeration apart from melted ice packs. Novo Nordisk said the product looked legitimate, though authorized for a Chinese market and the company “cannot confirm the sterility, which may present an increased risk of infection for patients who use the counterfeit product.”

Much of the questionable product is ordered from online shops and social media and illicit sellers are getting better at making convincing packaging.

Sal Ingrassia, the port director overseeing U.S. Customs and Border Protection at New York’s JFK Airport, also reviewed the package and said it was clear the shipment had “broken the legal supply chain.” At JFK there have been 198 Ozempic, 9 Wegovy, and 1 Mounjaro seizures since the start of the year, according to CNBC, though this doesn’t necessarily equate to counterfeits or diverted product. Ingrassia said this is double from last year.

A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals.

Lilly releases Zepbound® (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity

https://investor.lilly.com/news-releases/news-release-details/lilly-releases-zepboundr-tirzepatide-single-dose-vials-expanding

Distributed through LillyDirect^®‘s self-pay channel, Zepbound single-dose vials are at least 50% less than the list price of all other incretin medicines for obesity

INDIANAPOLIS, Aug. 27, 2024 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced Zepbound^® (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the supply of Zepbound in response to high demand. The single-dose vials are priced at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.

“We are excited to share that the Zepbound single-dose vials are now here, further delivering on our promise to increase supply of Zepbound in the U.S.,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option. In a clinical study, the 5 mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off.”

Lilly has created a new self-pay pharmacy component of LillyDirect where patients with a valid, on-label prescription from the health care provider of their choice can purchase the vials. Distributing the vials via this channel ensures patients and providers can trust they are receiving genuine Lilly medicine, building on the company’s efforts to help protect the public from the dangers posed by the proliferation of counterfeit, fake, unsafe or untested knock-offs of Lilly’s medications. Lilly has also taken a vocal stance against the use of obesity medicine for cosmetic weight loss; a multi-step verification process will help ensure the vials are dispensed only to patients who have a valid, on-label electronic prescription from their health care provider. Patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.

“People living with obesity have long been denied access to the essential treatment and care needed to manage this serious chronic disease,” said James Zervos, chief operating officer, Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity. We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality. Now, it’s time for policymakers, employers and insurers to work with pharmaceutical companies to ensure no one is left behind in receiving the care they deserve and need.” 

A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals. The self-pay channel enables a transparent price by removing third-party supply chain entities and allowing patients to access savings directly outside of insurance.

“Despite obesity being recognized as a serious chronic illness with long-term consequences, it’s often misclassified as a lifestyle choice, resulting in many employers and the federal government excluding medications like Zepbound from insurance coverage,” said Jonsson. “Outdated policies and lack of coverage for obesity medications create an urgent need for more innovative solutions. Bringing Zepbound single-dose vials to patients will help more people living with obesity manage this chronic condition. We will also continue to advocate for a system that better aligns with the science.”

In a clinical study, tirzepatide 5 mg, along with a reduced calorie diet and increased physical activity, achieved an average of 15% weight loss over 72 weeks compared to 3.1% for placebo. Zepbound is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or those who are overweight and also have weight-related medical problems, to lose weight and keep it off. Zepbound should be used with a reduced-calorie diet and increased physical activity. It should not be used in children under 18 years of age or with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. Zepbound has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis, and it is unknown if patients with a history of pancreatitis are at higher risk for developing pancreatitis on Zepbound.

Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 ml doses in a single-dose pen (autoinjector). The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

To learn more about the Zepbound single-dose vial, please visit Zepbound.lilly.com.

To learn more about LillyDirect, please visit: LillyDirect.lilly.com.

INDICATION AND SAFETY SUMMARY WITH WARNINGS
Zepbound^® (ZEHP-bownd) is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children under 18 years of age.

Warnings – Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

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90% of independent pharmacies may not stock drugs in negotiation program: Study

https://www.beckershospitalreview.com/pharmacy/90-of-independent-pharmacies-may-not-stock-drugs-in-negotiation-program-study.html

A new survey by the National Community Pharmacists Association found that more than 90% of independent pharmacists may refuse to sell drugs targeted by Medicare Part D negotiations, potentially jeopardizing the Biden administration’s efforts to lower prescription costs. 

The survey, conducted from Sept. 24 to Oct. 11, found that 51% of pharmacists are strongly considering not stocking drugs due to inadequate reimbursements from pharmacy benefit managers, with another 40% considering the same, according to an Oct. 14 NCPA news release shared with Becker’s.

The Medicare Drug Price Negotiation Program is set to begin in January 2026, but many pharmacies could face drug flow issues, needing to cover $27,000 monthly to stock the medications without guaranteed timely reimbursement. 

As low reimbursements can affect the viability of independent pharmacies, 73% of pharmacists have not finalized their contracts for 2025, raising concerns as open enrollment begins Oct. 15. 

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Lubetsky v. United States

https://ronaldwchapman.com/blog/lubetsky-supreme-court

By: Ronald W. Chapman II

Dr. Ronald Lubetsky, a Florida physician, takes aim at the Controlled Substances Act in a new Supreme Court petition filed on August 5, 2024. His case is both shocking and tragic but his fight is not over.

The government’s prosecution of Dr. Lubetsky centers around the ambiguous language of the CSA, particularly the phrase “outside the usual course of his professional practice, other than for a legitimate medical purpose.” The government has moved away from the original intent of the CSA, which was to target drug trafficking, and instead has begun prosecuting physicians based on increasingly vague and shifting standards of medical practice.

At trial, the government’s medical expert, Dr. Rubenstein, testified that Dr. Lubetsky’s prescriptions were issued outside the usual course of professional practice. This testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Rubenstein’s testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Dr. Rubenstein asserted that the lack of a detailed physical examination and comprehensive medical history in these specific cases rendered the prescriptions illegitimate. However, this opinion was formed without considering the full context of Dr. Lubetsky’s practice and the treatment of thousands of legitimate pain patients.

The Circuit Split and Post-Ruan Interpretation

A key legal issue in Dr. Lubetsky’s case is the circuit split over how the ambiguous language of the CSA should be interpreted. Specifically, courts are divided on whether the requirement for a prescription to be issued “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” should be read conjunctively or disjunctively.

• Conjunctive Reading: Under this interpretation, both elements—issuing for a legitimate medical purpose and acting in the usual course of professional practice—must be satisfied for a prescription to be considered lawful.

• Disjunctive Reading: Under this interpretation, a prescription could be deemed unlawful if it fails to meet either of these elements. This reading lowers the threshold for criminal liability, as a physician could be prosecuted even if they prescribe for a legitimate medical purpose but allegedly do not follow the usual course of professional practice.

The Eleventh Circuit, where Dr. Lubetsky was tried, has adopted the disjunctive reading. This approach has significant implications, as it allows the government to prosecute physicians even when there is no clear evidence that the prescriptions were issued for anything other than a legitimate medical purpose. This interpretation is in conflict with other circuits that have adopted the conjunctive reading, which provides greater protection to physicians by requiring that both elements be proven before a conviction can be secured.

The Supreme Court’s decision in Ruan v. United States was expected to clarify this issue, but it has instead led to further narrowing by the U.S. Circuit Courts. In Ruan, the Court recognized the ambiguity in the language of the CSA and highlighted the importance of a strong scienter requirement to avoid overdeterrence. Despite this, the Eleventh Circuit has continued to uphold the disjunctive reading, creating a situation where physicians are left with little clarity on the standards they must meet to avoid criminal liability.

Government’s Shifting Standards

Dr. Lubetsky’s case also underscores a troubling trend: the government’s shifting standards for what constitutes acceptable medical practice under the CSA. Historically, the CSA was used to target physicians who were clearly engaged in drug trafficking—those who prescribed controlled substances without any medical justification, often to patients who explicitly stated they intended to use the drugs for non-medical purposes. However, in recent years, the government has broadened its interpretation of the CSA, prosecuting physicians based on vague and unenumerated standards of medical practice that often go beyond what state laws require.

In Dr. Lubetsky’s case, the government’s expert applied a standard for prescribing that exceeded Florida’s requirements. Florida law mandates that a complete medical history and physical examination must be conducted before beginning opioid treatment, but there is no requirement for a physical examination at every follow-up visit. The expert, however, testified that a physical examination was required at every visit when opioids were prescribed, thus holding Dr. Lubetsky to a higher standard than what is legally required in the state.

This evolving and inconsistent application of standards places physicians in an untenable position, where they must navigate not only state laws but also fluctuating federal expectations that may not align with established medical practices. The consequence is a chilling effect on the practice of pain management, where doctors may avoid prescribing necessary medications out of fear of prosecution, leaving patients to suffer.

Interested Parties May File an Amicus Brief with the Court

Given the complex legal and medical issues at play in this case, it is imperative that advocacy groups concerned with patient care, medical ethics, and physician rights take action. Filing amicus briefs in support of Dr. Lubetsky’s petition to the Supreme Court is crucial to ensure that the Court fully understands the broader implications of this case. These briefs can help the Court appreciate the potential harm of allowing ambiguous and overly stringent interpretations of the CSA to persist.

Dr. Lubetsky’s defense counsel and authors of the brief are Ronald W. Chapman II and Matthew Pelcowitz of the Chapman Law Group.

PDF of the 75 page filing  click here

 

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This is a post from Dr Mark Ibsen.  Mark has been caring for a dozen or so of what has been labeled as “opioid refugees”. The only pharmacy that he could find that would fill the opioid Rxs from Dr Ibsen was in FLORIDA and that pharmacy unfortunately got “trashed” by those two different hurricanes that hit Florida over the last few weeks and is temporarily “out of business”  Mark is looking for another pharmacy – preferably a compounding pharmacy – that Mark can reach out to.

Mark has these dozen or so intractable chronic pain pts that are in or on the verge of being thrown into a cold turkey withdrawal.

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Medicare Advantage star ratings decline: 5 things to know

https://www.beckerspayer.com/payer/medicare-advantage-star-ratings-decline-5-things-to-know.html

Average Medicare Advantage star ratings declined for the third year in a row, according to CMS data published Oct. 10. 

The average Medicare Advantage star rating for 2025 is 3.92, down from 4.07 in 2024. 

Plans must earn a rating of 4 or higher to receive bonus payments from CMS. 2025 star ratings affect the quality bonus payments plans receive in 2026. 

Here are five things to know about the star ratings: 

1. Just seven plans received a five-star rating in 2025, down from 38 in 2024.
2. Around 40% of Medicare Advantage-Part D plans received four stars or higher. Around 62% of MA-PD enrollees are in plans rating four or higher, according to CMS.
3. CMS did not make any major changes in star ratings methodology, according to the release.
4. Medicare Advantage-Part D plans are rated on 40 clinical quality and member service measures. CMS determines cut points for measure each year. For 2025, many cut points increased, meaning plans had to perform better to get higher star ratings.
5. Several factors influenced the tougher cut points, CMS said. The agency removed extreme outliers from the lower end of performance, a more compressed distribution on scores and an increasing number of high-scoring contracts. Some measures are improving to pre-pandemic levels, increasing cut points, CMS said.

Potential challenges to CMS’ star ratings could loom. Earlier in October, Humana said its star ratings for 2025 dropped significantly from 2024. In 2025, just 25% of its members will be in contracts rated plans four stars and above, down from 94% in 2024. The company said it expected the drop was driven by “narrowly missing industry cut points on a small number of measures.” In regulatory filings, the company said it believes there may be potential errors in CMS’ calculations. 

UnitedHealthcare is also challenging CMS’ star ratings. The company filed a lawsuit Sept. 30, challenging CMS’ inclusion of a secret shopper phone call in its star ratings that UnitedHealthcare said never connected. 

In June, CMS recalculated 2024 star ratings for all Medicare Advantage plans. Judges sided with SCAN Health Plan and Elevance Health in lawsuits challenging the methodology CMS used to calculate the ratings. 

In addition to determining bonus payments, star ratings guide beneficiaries’ decisions on which plan to enroll in. Open enrollment begins Oct. 15 and runs until Dec. 7.

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NCPA: Drug price negotiations will fail without fair and timely pharmacy reimbursement

https://ncpa.org/newsroom/qam/2024/10/07/ncpa-drug-price-negotiations-will-fail-without-fair-and-timely-pharmacy

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Helene Poses Big Problems for Mail Service in Western NC

https://www.theassemblync.com/politics/elections/mail-postal-service-ballots-medicine-hurricane-helene/

From medication to ballots, the U.S. Postal Service is a critical delivery method. Here’s what to know about the state of services following Hurricane Helene.

In the days since Hurricane Helene made landfall in Western North Carolina, about 1.2 million people have lost their postal delivery service, and could see that disrupted for weeks to come.

The U.S. Postal Service announced the suspension of mail delivery operations in the areas with zip codes beginning with 286, 287, 288, and 289, and has not given any updates on when it will resume.

The most obvious barrier is a lack of mailboxes or even homes to deliver to in flood-ravaged parts of the state. The North Carolina Department of Transportation also estimates as many as 390 road closures including parts of Interstate 40.

“Is there an address remaining to which it can be delivered?” said Thomas Birkland, the former director for the Infrastructure Management and Hazard Response program at the National Science Foundation. “Is there a functioning post office available to process the mail, to deliver it? Are there people available to deliver it? And are the roads open so that you can deliver the mail? If any one of those answers is no, then the mail is going to be delayed.”

Birkland said one way researchers measured the impact of Hurricane Katrina in 2005 was by assessing the extent to which mail was deliverable.

“If the house is destroyed, or the business is destroyed, there’s no point to which it can deliver the mail, and so [the postal service would] have to hold on to it,” Birkland said.

Philip Bogenberger, spokesperson for the North Carolina and Virginia districts of the U.S. Postal Service, said in a statement that the agency is working to restore delivery service to western North Carolina.

“The safety of our customers and employees is the Postal Service’s top priority in the aftermath of Hurricane Helene,” Bogenberger wrote. “At this time, we are still assessing damages and impacts. We are dispatching recovery teams to affected areas.”

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DEA Issues Warning About Illegal Online Pharmacies

https://www.dea.gov/alert/dea-issues-warning-about-illegal-online-pharmacies

October 4, 2024 – The U.S. Drug Enforcement Administration has seen an increase in illegal online pharmacies selling and shipping counterfeit pills made with fentanyl and methamphetamine to unsuspecting customers in the United States who believe they are purchasing real pharmaceutical drugs such as Oxycodone, Adderall, Xanax, and other drugs from legitimate pharmacies. 

As Americans increasingly turn to online pharmacies to purchase necessary medications[1], DEA is issuing this Public Safety Alert to warn of an increase in illegal online, often foreign-based websites that are deceptively targeting American consumers. DEA has identified websites being operated in India and the Dominican Republic. Many of these sites purport to be legitimate, U.S. based or FDA approved sites, but are actually working with drug traffickers to fulfill online orders with fake pills. These website operators are going to great lengths to make the websites look like legitimate online pharmacies – they offer 24-hour customer service, post online reviews and safety facts, and offer deep discounts to deceive customers into believing they were buying from a reputable business.

Often these illegal, online websites use U.S. website addresses and professional-looking designs to appear legitimate when, in fact, they are not. These companies operate illegally, deliberately deceiving American customers into believing they are purchasing safe, regulated medications when they are actually selling fake, counterfeit pills made with fentanyl or methamphetamine.  Fake medications can lead to serious health risks, including harmful side effects, ineffective treatment, and even death. 

During Operation Press Your Luck, announced on Monday, September 30, 2024, DEA discovered that a U.S. based victim had ordered what she believed to be oxycodone from an online pharmacy, only to receive a fake pill made with fentanyl. The pill looked identical to a real oxycodone, but it was not – it was made with fentanyl and filler. Days after receiving the medication, the victim passed away from acute fentanyl poisoning as a result of taking one of the pills sent to her.  

The DEA has identified the following fake pharmacies in a recent criminal investigation: 

• www.Curecog.com
• www.Pharmacystoresonline.com
• www.Careonlinestore.com
• www.yourphamacy.online 
• www.MD724.com
• www.Greenleafdispensarystore.com
• www.Whatishydrocodone.weebly.com
• www.Orderpainkillersonline.com
• www.USAMedstores.com

If you have purchased alleged medication from any of these websites, you should immediately stop using it and contact your local DEA office or report the incident here. 

The only safe prescription medications are those prescribed by a licensed medical provider and dispensed by a trusted pharmacy. 

Patients should remain vigilant when purchasing medications online. 

DEA remains committed to the safety and health of the American people, which is why we are urging consumers to exercise extreme caution when purchasing medications online. While it can be difficult to identify an illegal online pharmacy, the following are possible red flags that a website is not a legitimate:  

• Sells prescription drugs without requiring a valid prescription from a healthcare provider
• Offers much cheaper prices than what is typically seen in the market
• Lists prices in a foreign currency
• Does not contain proof of a valid pharmacy state license or DEA registration 
• Medicine arrives in broken or damaged packaging or in a foreign language
• Medicine does not have an expiration date or is expired 
• Medicine looks different from what you have received in the past from your trusted pharmacist

For more information on how to keep you and your loved ones safe from illegal and fake pills, visit DEA’s One Pill Can Kill resource page. Visit the U.S. Food and Drug Administration’s BeSafeRx campaign page for information on how to safely buy prescription medicines online and to locate a state-licensed online pharmacy. You can also contact your state board of pharmacy to verify a pharmacy’s license. 

DEA is committed to working jointly with the medical community to ensure legitimate controlled substances are not being diverted for illegal use. Learn more about DEA’s Diversion Control Division here. 

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