Timothy Moore

Frier Levitt attorneys Dae Y. Lee, Pharm.D, Esq., CPBS and Martha Rumore are featured in a Specialty Pharmacy Continuum article, “'A War Brewing’ Between GLP-1 Manufacturers and Compounders” by Gina Shaw. The article highlights Novo Nordisk's request that the FDA add Wegovy products to the "Demonstrable Difficulties for Compounding (DDC) List," arguing that GLP-1 drugs such as semaglutide and tirzepatide may be too complex for 503A and 503B compounders to manufacture “essential” copies of. Drugs on the DDC list are considered not safe for compounding, and if Wegovy products are added to this list, they cannot be compounded. Dae and Martha share their thoughts in the article. Read here: https://lnkd.in/eiYt2v-D #FrierLevitt #GLP1 #Semaglutide #DrugCompounders

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Despite the unique challenges faced by the VA medical center in San Juan, Puerto Rico, including delays of up to 10 years in receiving essential medical services and devices, the executive and legislative branches of Puerto Rico have failed to adequately advocate for its veterans. This failure is evident in their lack of utilization of existing advocacy structures to raise awareness and push for necessary changes at the federal level in Washington, D.C. The severe delays and deficits in medical services underscore a critical need for robust advocacy to ensure that veterans in Puerto Rico receive the same level of care and timely access to medical resources as their counterparts in other U.S. territories and states. It is imperative that the leaders of Puerto Rico take a more proactive stance in addressing these disparities by effectively leveraging their influence and collaborating with federal agencies to secure better outcomes for their veterans.

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Regulations 101: The White House Office of Information and Regulatory Affairs (OIRA) is providing two trainings in October on effective participation in the regulatory process:  -How to request and effectively use E.O. 12866 listening sessions: Wednesday, October 2, 3:00-3:45 pm ET. -How to write effective public comments: Wednesday, October 9, 4:00-4:45 pm ET.  -Live audio translation will be available in Spanish and Mandarin Chinese. An ASL interpreter and English captioning will also be available. -You may register by sending an email to publicparticipation@omb.eop.gov. Please feel free to share with your networks. ---- More information:  TRAINING SESSION ON REQUESTING E.O. 12866 LISTENING SESSIONS:   The training session on how to request and effectively use E.O. 12866 listening sessions will be held on October 2, 2024, at 3 p.m. to 3:45 p.m. Eastern Time. If you are interested, you may register by sending an email to publicparticipation@omb.eop.gov.   At this training session, OIRA will describe (1) what an E.O. 12866 meeting is; (2) how you can request and schedule a meeting; (3) the format of E.O. 12866 meetings; (4) what type of information or input is most helpful to receive about a draft regulation during an E.O. 12866 meeting; and (5) what makes for an effective presentation to Federal government officials during an E.O. 12866 meeting.   TRAINING SESSION ON HOW TO WRITE EFFECTIVE PUBLIC COMMENTS:   The training session on how to write effective public comments will be held on October 9, 2024, at 4 p.m. to 4:45 p.m. Eastern Time. If you are interested, you may register by sending an email to publicparticipation@omb.eop.gov   At this training session, OIRA will describe (1) opportunities to provide comment in the regulatory process; (2) how to submit public comments; and (3) how to draft effective public comments.

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With the Drug Enforcement Administration reportedly ready to ease restrictions on #marijuana, the ADA landscape changes for employers. Here's what you need to know.   Last week, The Associated Press reported that the DEA would move to reclassify marijuana (cannabis)from Schedule I, where it's currently listed with heroin and LSD, to Schedule III, with less dangerous doctor-prescribed drugs like (Tylenol with codeine) and testosterone. The AP notes that this shift comes "as marijuana has become increasingly decriminalized and accepted, particularly by younger people," noting a Gallup poll last fall that found "70% of adults support legalization, the highest level yet recorded by the polling firm and more than double the roughly 30% who backed it in 2000." If reclassification occurs, it may impact employers in many ways, including under the Americans with Disabilities Act and the duty to accommodate medical marijuana users with disabilities. Historically, federal courts have determined that the ADA does not protect individuals with disabilities with valid medical marijuana prescriptions who lose their jobs for testing positive because the ADA does not protect individuals engaging in "the illegal use of drugs" within the meaning of the statute. The "illegal use of drugs" means "the use of drugs, the possession or distribution of which is unlawful under the Controlled Substances Act," such as anything listed on Schedules I and II. But what if the feds move marijuana from Schedule I to Schedule III? Schedule III drugs, substances, or chemicals are drugs with a moderate to low potential for physical and psychological dependence.  As the EEOC has recognized, the possession or sale of Schedule III drugs with a valid prescription is legal. Therefore, if marijuana moves down to Schedule III, an employee who uses it does not engage in the illegal use of drugs because possessing it with a valid prescription is legal under the Controlled Substances Act. It follows then that while the ADA would not preclude an employer from drug testing for marijuana or prevent employers from continuing to forbid the use of marijuana at work as per state law, it would require an employer to accommodate an individual's use of medical marijuana outside of work if doing so would enable the individual to perform the essential functions of the job without creating undue hardship for the employer. Likewise, an employer may violate the ADA if, for example, it rescinds a job offer to an individual with a disability because the employer learns that they use doctor-prescribed medical marijuana consistent with state law. According to the AP, once OMB signs off, the DEA will take public comment on the reclassification. After the public comment period and a review by an administrative judge, the agency would eventually publish the final rule. #TheEmployerHandbook #employmentlaw #humanresources

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#Apexus Case in the 9th Circuit Could Help Drug Makers Beat Back State #ContractPharmacy Laws A key argument drug makers are advancing in trying to beat back state contract pharmacy mandate laws might get a boost from an unlikely source, the usually hostile to industry #9thCircuit Court of Appeals. Background: In opposing state CP laws, drug makers have stressed that the laws are inconsistent with the #scotus decision in the Santa Clara case. In that case, the Supremes held that a private right of action by covered entities is not permitted under the #340b statute, because the law envisions that the feds—and only the feds—will enforce the law. #AHF v. Apexus: #TheAIDSHealthcareFoundation claimed in a complaint that it suffered “millions of dollars” in damages because, #Apexus, the 340B #primevendor, allegedly “failed” to negotiate 340B sub-ceiling discounts. The district court relied on Santa Clara in dismissing AHF’s case. The Appeal Argument: The 9th heard #AHF’s appeal of the dismissal of its action on April 11, and the appeals panel may be poised to give broad effect to Santa Clara. Although reading the tea leaves of an appellate case based on judges’ questions from oral argument can be a fool’s errand, some of the argument did suggest the panel might be of the view that Santa Clara is controlling. But AHF’s lawyer appeared to score some points in noting that, “in Apexus’ briefing, they admit that if AHF wanted to go and use the administrative dispute resolution process…allowed by 340B, we would not be able to bring this claim there.” Later, however, Apexus’ counsel appeared to be righting the ship when she argued that AHF is not and cannot be an “intended beneficiary” of #HRSA’s contract with Apexus, which does not even reference AHF or create rights for covered entities. This is definitely a case worth watching.

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The #340B #ADR Rule: Missing the Forest for the Trees? At the Informa Conference, a speaker decried what he said was an overbroad scope to #HRSA’s Final ADR Rule. But what he saw as a threat to manus is actually a lifeline in the litigation challenging state laws that purport to restrict #drug maker #contractpharmacy restrictions. The Big Picture: After a bit of a rocky start in the various federal district court cases, the trendline in the CP policy cases is now quite positive for manus. Both the 3rd and the D.C. Circuits have ruled in favor of reasonable CP restrictions. The next shoe to fall, in the 7th, could strike a contrary note, but, if it does, the resulting circuit split will set the stage for SCt review, with the majority of the appellate courts already siding with the manus. Manus, pleased with the federal status, are, however, concerned about state developments. The problem is 2-fold. 1) 6 states have passed laws that reverse the manu policies, and multiple other states are lining up to do the same. 2) Though deeply flawed, an 8th Circuit opinion has upheld the first of those state laws, concluding it is not “preempted” by 340B, because, supposedly, there is no conflict between the federal and state laws. In particular, the court concluded that it did not see a conflict between the 340B dispute resolution process and the state regime. The Rule: But the ADR Rule sure seems to undercut the 8th. Where, before that rule, HRSA had disclaimed any interest in addressing any dispute that was pending in the courts, the Final Rule reverses course. It asserts that an overcharge dispute, subject to binding federal dispute resolution, shall "generally include[]" any "claims that a manufacturer has limited the covered entity's ability to purchase covered outpatient drugs at or below the 340B ceiling price". That presents a direct conflict between the ADR process and state laws and related enforcement efforts. Tree or Forest: Our Informa speaker complained that the Final Rule broadened the scope of alternative dispute resolution—worrying that this would subject manfacturers to adverse findings where they imposed CP policies. The argument here is that the ADR process should be limited to pure “overcharge” issues, not other issues. But this misses the forest—for two reasons. 1. The biggest current threat to manu efforts to limit CP transactions are these state laws. By defining federal ADR to include any claims that “a manufacturer has limited” CE purchases, HRSA has handed drug makers a strong preemption argument. 2. The concern that federal ADR, defined broadly, is a greater threat to manus than the state laws seems a bit overblown, given that the 3rd and DC Circuit opinions. On balance, if I were in a manu’s shoes, I’d be pleased where the ADR Rule leaves things at least on this particular point (though certainly not others). #lifesciences Health Resources and Services Administration (HRSAgov), HHS

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My colleague Anil Shankar was quoted in a recent Law360 article discussing the decision that the federal #340B drug pricing program does not bar pharmaceutical drug manufacturers from imposing contractual conditions on contract pharmacies. Click below to read the full article. #pharma #healthcare

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7 Compliance and #FMV Takeaways from the #DOJ/#Erlanger #FCA Complaint The U.S. Department of Justice’s #StarkLaw-based #FalseClaimsAct case against Erlanger, a sprawling #340B hospital health system in #Tennessee and #NorthCarolina, offers a LOT of #healthcarecompliance and #fairmarketvalue takeaways. 1. Gov “Secret” Views on FMV: You won’t find the FMV views that drive this complaint in any government #regulation—heaven forbid #HHS and #CMS should operate by notice and comment regulation. But, nevertheless, the complaint reflects the gov’s long-standing suspicion of #compensation above the 75th percentile and deep-seated distrust of compensation when it exceeds the 90th percentile. I’ve heard those views many a time on the other side of a table from DOJ. Those biases clearly undergird this complaint. All but one of the “examples” of “excessive” compensation the gov alleges—and that supposedly show that E could not rely on a Stark exemption—were above the 90th percentile, except one, which was above the 75th percentile. Hardening its position, the gov challenges compensation repeatedly by comparing it to the “median”, without any description of the expertise or qualifications of the #physicians. 2. No #Productivity #Bonus #SafeHarbor: The gov is unmoved by E’s attempt to justify its #doctor compensation by pointing to the impact of #productivitybonuses, alleging that the #RVUs credited weren’t reflective of physician work or exceeded that work. 3. E&M Coding Woes: A big part of the hit on the productivity bonuses is underlying criticism of faulty #evaluationandmanagement #coding. 4. No Love for #Recidivists: The complaint whacks away at E for, it alleges, watering down its compensation review procedures following the expiration of a #CIA that was part of a 2004 $40 million Stark Law settlement. 5. #340B Is Lurking: Although the complaint doesn’t call out E’s 340B strategy, it’s clearly lurking there. The complaint chides E for acquiring hundreds of physicians to capitalize on “downstream” revenue, including for “#medications”. E has more than 200 #coveredentity listings in Health Resources and Services Administration (HRSAgov), HHS #OPAIS. #StarkLawcompliance is #340Bcompliance. 6. Stark Preference: This complaint fits into a pattern of #DOJ preferring FCA claims based on Stark, begging off #AKS-based claims. Why? The complaint suggests at least 2 reasons: Stark doesn’t require proof of intent and FMV works its way into the Stark employee exception, but not the AKS safe harbor. 7. Don’t Piss Off Your #Compliance Officer—or Your #CFO: The #relators in the case were the #CCO, who recommended an outside FMV appraisal before being sidelined and then terminated, and the CFO, who signed the “false” certifications DOJ bases its case on. Nuff said. #healthcarefraud #fraudandabuse #drugpricing #healthcarefraud U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services #Medicare #Medicaid

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With the popularity of GLP-1 drugs — and the resulting shortage — old questions about compounding are new again. Need help navigating? Don’t miss this American Health Law Association webinar on August 1. You’ll learn about: ➡️ When pharmacies can compound ➡️ Permissible vs non-permissible bulk substances for #503A compounding ➡️ Current state of GLP-1 #compounding ➡️ What to expect going forward #AHLA https://lnkd.in/dbi_CG2H

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The Most Important Moment in #PhRMA’s Challenge to the #IRA: It Will Surprise You The most dramatic moment in the 5th Circuit argument on PhRMA’s challenge to the #inflationreductionact was when Judge Elrod all but concluded that the #IRA is “unlawful”. But the most important moment in the hearing was when Trump appointee, Judge Duncan, softly asked a simple question. The Appeal: Elrod’s comment goes to the merits, but this appeal isn’t about the merits. It’s about a threshold issue: can the plaintiff association and its members challenge the IRA in court now, when the members will eventually have some administrative remedies to challenge IRA-based #reimbursements years from now? The #SocialSecurityAct, which applies to #Medicare disputes, requires entities that have administrative appeal options to “exhaust” those before going to court. In the words of the statute and Supreme Court cases interpreting it, disputes “arising under” Title XVIII of the Act (where the Medicare reimbursement provisions are found) must be “channeled” through the agency before going to court. Counsel for plaintiff argued that the “channelling” provision does not apply, because the IRA, though it applies to #Medicare, wasn’t codified by #Congress in #TitleXVIII. The Question: Judge Duncan asked counsel, “if” the panel were “inclined” to let the case proceed in court, whether that would create a “circuit split”—a conflict in cases decided by 2 different appeals courts. In asking that question, Duncan referred to the DC Circuit’s decision in the Community #Oncology case, a decision authored by Judge Katsas, a former high-ranking lawyer in the #Trump Administration and my law school classmate. The Answer: Counsel said no “circuit split” would result, but that’s probably wrong. Judge Katsas, in CO, said that the “channeling” provision applied to a dispute that wasn’t codified under Title XVIII, because at least part of that dispute still “arose under” that title. Unless the 5th Circuit buys the argument that this dispute is ONLY about IRA negotiation and NOT at all about the resulting reimbursements, it is likely that a favorable decision here would be inconsistent with the CO decision. The Outcome?: Unclear—It’s really hard to draw conclusions from a single question. But Judge Duncan seems to be the linchpin here. Elrod appears hell bent on attacking the statute, and the other member of the panel is a #Biden appointee, unlikely to support a reversal. I do think it was interesting how the question was phrased: “if” the court is “inclined” to agree with you …. Certainly, there are much less positive ways of asking that same question: “Why doesn’t the COA case dispose of your argument, Counsel?” So, that does suggest some sympathy for the #infusion folks’ argument. But, clearly, the prospect of a #circuitsplit was troubling Judge Duncan. My guess is Duncan’s question and the issues it frames will decide this case. #drugs #drugpricing #pharmacies

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CMV Law congratulates Scott Herbert and Lisa C. for securing a defense verdict on behalf of internal medicine physician and his medical group in a case tried before Judge Bradley Waller in DeKalb County. Plaintiff claimed the internist failed to timely refer him to a nephrologist after lab results showed an elevated creatinine, resulting in end stage renal failure and the permanent loss of function in both kidneys requiring years of dialysis, followed by a kidney transplant. Plaintiff alleged he was at an increased risk for renal failure due to taking Hydralazine for hypertension for years, which was being prescribed by the internist. The Defense contended that the internist appropriately recognized the abnormal lab results and referred him to a nephrologist within five days of the results, as evidenced in the medical records, and that his renal failure was due to diabetic nephropathy and idiopathic vasculitis, not Hydralazine-induced vasculitis. The plaintiff asked the jury to award $1,797,000 in closing arguments. #CMVLaw #MedicalMalpracticeDefense #LitigationLaw #HealthcareLitigation #MedicalNegligenceLawyers #DefenseAttorney #MedicalLawsuitDefense #HealthcareProviderDefense #PhysicianDefense #MalpracticeLegalAdvice #HospitalDefense #ClinicalNegligence #MalpracticeClaimDefense #MedicalLiability #LegalSupportForDoctors #MedDefenseLitigation #CMVLawIllinois #IllinoisLaw

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A Prediction on the Louisiana #ContractPharmacy Law? Last Thursday, a US District Court heard oral argument on the constitutional challenges brought by PhRMA AstraZeneca, and AbbVie to the LA CP law. Although it’s always hard to predict an outcome from an argument, I’m going to tempt fate. The judge is still finding his legs in what he described as a “complicated case”. Even so, he showed little interest in all but one claim—a subset of the “#preemption” issues. But I think he’s leaning in the state’s direction, even on those claims. Limited Questions: The judge showed little interest in most of the claims. Pretty much zippo questions on the argument that the state law was an unconstitutional taking of #drug makers’ property without just compensation (an argument I like) or that the law is too vaguely drafted (not a great argument), for instance. Preemption: Where the court did show some interest was the issue of whether the state law is preempted because it conflicts with the #340B statute. Even here, though, the court seemed disinterested in some versions of the preemption challenge; the court did not really engage on the (pretty sound) argument that the state law conflicts with the federal patent laws, impeding the value of #patents by imposing #pricecontrols. And though the court showed a little more interest re: the argument that the 340B statute laid out a comprehensive balance of benefits and obligations that the state is disturbing, he didn’t seem likely to bite there, either. He wondered out loud a few times why a CP law would conflict with the federal law so long as the “link to a [legitimate] #coveredentity” was present. The court showed the most interest in the question of whether the 340B statute’s enforcement mechanisms would be undermined by the state law. The court seemed to telegraph that its ultimate view of the “enforcement preemption” issue would boil down to the question of whether the state statute was a “pricing” or a “delivery” provision. P vs. D: If the state law is a “pricing” statute, the court suggested, it would likely be preempted. The 340B statute and the Supremes’ decision in the Santa Clara case really do seem to frame federal mechanisms, including #HRSA’s Administrative Dispute Resolution, as the exclusive means for addressing “pricing” or “overcharge” issues. But, if the state law is only about “delivery”, the court’s working hypothesis seemed to be that the 3rd and DC Circuit opinions hold that the 340B statute is “silent” on those issues. If so, the court appeared to reason, “silence” can’t be the basis for a state-federal conflict. Where Is the Court Headed?: Good question! Please see the comments below for my prediction. #lifescienses #healthcare #pharmaceuticals #drugpricing

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God bless Samuel Bagenstos and his team at the HHS Office of General Counsel (OGC). Yesterday, General Counsel Bagenstos issued an advisory opinion stating that the HHS Secretary lacks the legal authority to approve #Section1115 demonstration projects that impose #Medicaid work requirements. From where I sit, the most important takeaway from the advisory opinion is this: "It would exceed the Secretary’s statutory authority to approve Section 1115 demonstrations that impose work requirements as a condition of Medicaid eligibility or continued enrollment, because they conflict with that core objective [of providing medical assistance, rehabilitation, and other services to eligible people]." Thank you, HHS OGC team. You can access the HHS OGC advisory opinion here: https://lnkd.in/efgRMrEf From a policy standpoint, Medicaid work requirements are just severe Medicaid cuts by another name. Research demonstrates that most working-age Medicaid enrollees work, and nearly all those who do not work cannot due to disabilities, serious health conditions, childcare or caregiving responsibilities, or because they are in school. Studies also show that work requirements in safety net programs create burdensome and confusing red tape, paperwork, and reporting requirements that result in sweeping eligibility losses, including for low-wage workers. For example, under Georgia’s current “Pathways to Coverage” Medicaid work requirement program, only 5,542 of the 300,000 low-income Georgians who should have gained coverage through Medicaid expansion have been able to do so. Moreover, Medicaid work requirements hurt state economies because they are extremely expensive to implement, increasing state spending on insurance. They also make it harder for people to stay employed. Medicaid work requirement “exemptions” for those who cannot work are ineffective and misleading. We know from experience that exemptions from safety net program work requirements, such as those on the basis of pregnancy, disability, caregiving responsibilities, or interpersonal violence are extremely difficult to obtain due to documentation requirements. Enrollees also often experience significant power differentials with program caseworkers, who have a great deal of discretion in whether to grant work requirement exemptions, and often arbitrarily refuse them. Many people would fall through the cracks and lose their health insurance coverage. #ProtectMedicaid #SaveMedicaid

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Are you attending the Informa Pharmaceutical Compliance Congress? Then stop by and say hello to Brett Canaval at Center for Health & Pharma Law at Seton Hall’s booth to learn more about Seton Hall University School of Law’s Healthcare Compliance Certificate Programs! #healthlaw #compliance #ethics #ethicsandcompliance

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🚨 Breaking News for Attorneys! 🚨 Baltimore and Walgreens reach an opioid settlement totaling $42.5M, marking another significant development in the fight against the opioid crisis. This settlement could set the tone for future pharmaceutical litigation. 📰 Overview: Baltimore has reached a $42.5 million settlement with Walgreens over claims related to the company’s role in the opioid crisis. This agreement highlights the growing legal pressure on pharmaceutical companies and distributors to address their involvement in the opioid epidemic. By reading this article, you'll gain insights into: - 🛠️ How this settlement may affect ongoing and future opioid litigation. - ⚖️ Legal strategies for handling similar cases involving pharmaceutical companies. - 🔍 Key takeaways for mass tort and personal injury lawyers involved in opioid-related lawsuits. 💼 Want to elevate your practice and become a leading attorney in your state? Partner with Neural IT to enhance your demand letters and medical record review cases, setting yourself apart in the competitive legal landscape. Subscribe to the "Neural IT Newsletters" and receive: ✔️ The latest mass tort news and updates. ✔️ In-depth articles on legal strategies and case management. ✔️ Exclusive insights into ongoing litigation trends. ✔️ Tips and tools to enhance your legal practice. ✔️ Access to webinars and special events tailored for personal injury attorneys. Read the full article at https://lnkd.in/dg83uc9R 💬 Interested in a specific topic? Comment below, and we'll provide the latest updates on the subjects that matter most to your legal practice. #MassTort #PersonalInjury #LegalNews #OpioidCrisis #WalgreensSettlement #PharmaLitigation #NeuralIT #Lawyers #LawFirm #LegalUpdate

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