Ajay Gohil

The U.S. Department of Justice recently announced that it will launch the Task Force on Health Care Monopolies and Collusion (HCMC). The primary goal of the task force is to identify critical antitrust issues within healthcare markets. HCMC will lead the DOJ’s strategy and policy approach in regard to healthcare, focusing on competition concerns such as payer-provider consolidation, serial acquisitions, and misuse of data. #healthcare #monopolies #payer #provider

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#Healthcare and #privacy attorney Beth Pitman was mentioned in a DecisionHealth - Medical Practice Resources article about an #HHS OIG final rule establishing #financial penalties for providers who commit #informationblocking. Ms. Pitman noted recent HHS #HIPAA amendments regarding #reproductivehealth information as a potential area of concern, as the rule's aim of encouraging free exchange of #medical information may conflict with HIPAA's #privacy and security requirements. https://bit.ly/4dfhRw7 #healthcareregulation #healthdata

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In the latest Triage Health Law blog, #TeamSPB report on the Pharmaceutical Care Management Association who filed an opposition to Oklahoma’s petition for writ of certiorari in the United States Supreme Court, seeking review of the Tenth Circuit decision PCMA v. Mulready. Oklahoma is now seeking review of both ERISA and Medicare Part D preemption. Read the full blog here ➡️ https://ow.ly/elzW50SRSm9 #TriageHealthLaw | #PCMA | #PharmaceuticalCare

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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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#Healthcare attorneys Michael Werner and Sara Klock unpack the recent Supreme Court ruling regarding an abortion pill in our latest healthcare blog. The justices unanimously ruled that the plaintiffs lacked legal standing to challenge the FDA's actions in establishing dosing and availability requirements for the pill. Read more to learn about this ruling's implications: https://bit.ly/3XrCnVB #healthcareregulation

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The Office for Civil Rights and the Centers for Medicare and Medicaid Services updated the #nondiscrimination regulations regarding Section 1557 of the Patient Protection and Affordable Care Act. While the updates are extensive, our alert explores some FAQs about the rules: https://lnkd.in/eV-WAiP9 #healthcare #CMS

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Up-to-date with the latest in research integrity and misconduct? Catch attorney Kate Gallin Heffernan on the American Health Law Association's Speaking of Health Law podcast discussing how research misconduct is regulated in the United States, how the legal stakes have been raised for institutions and scientists, and more. #ClinicalResearch #LifeSciences #HealthCare

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The newest episode of American Health Law Association's Speaking of Health Law podcast is out now! In case you haven't had a chance to listen, HMS Valuation Partner, Chip Hutzler, joins other industry leaders in a productive talk about the how the health industry is still experiencing the effects of the Supreme Court's recent decisions in Looper Bright v. Raimondo and SEC v. Jarkesky. To listen to the full podcast, click here: https://lnkd.in/g4Xe3bhQ #ALHA #HMS #healthcarecompliance #healthlaw

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In reversing a prior decision the Supreme Court of the United States (SCOTUS) made decades ago, the current SCOTUS has primed the United States (U.S.) federal regulatory landscape for widespread legal challenges. This edition of Hacking Healthcare®explores what Health-ISAC members should know about how the SCOTUS decision in Loper Bright Enterprises v. Raimondo could significantly alter the #cybersecurity and privacy regulatory landscape in the U.S.  https://lnkd.in/e53F7Hv

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Supreme Court Decision Limiting the Authority of Federal Agencies Could Have Far-Reaching Impacts for Health Policy: On June 20, 2024, the U.S. Supreme Court overturned a longstanding legal precedent that required federal courts to defer to reasonable agency interpretation when statutes are ambiguous. The decision will shift many policy decisions from federal agencies to federal judges, with implications for health policy that will reverberate for years to come. This issue brief examines the decision and assesses what’s ahead. #medicaid #mdrp #financial

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North Carolina Physician Assistant Sentenced To Six Years In Prison For Role In $10 Million Telemedicine Fraud Scheme A telemedicine company paid this physician assistant (PA) to sign orders for genetic testing without examining or evaluating patients. Further, the PA falsified medical records and falsely certified medical necessity to cover his tracks. As a result, Medicare paid more than $3.6 million on these fraudulent claims. A federal jury found the PA guilty of health care fraud and making false statements related to health care. Government funded health care programs (e.g., Medicare, Medicaid) generally pay for services or items that are medically necessary and reasonable. Anyone who knowingly or willfully makes false statements on a claim for payment to a federal health care program may be prosecuted for health care fraud, a felony offense that carries a criminal fine up to $100,000 and imprisonment up to 10 years. Healthcare professionals and organizations should review their policies and procedures regarding telemedicine, diagnostic testing, and prescription drugs to ensure compliance with federal and state healthcare program laws and regulations. An ounce of prevention saves money, freedom, and professional licenses. https://lnkd.in/gPGmaiNp #medicare #medicaid #tricare #healthcare #doctors #physicians #hospitals #medical #medicalpractice #telemedicine #telehealth #dme #labs #fbi #imaging #prescriptiondrugs #pharmacy #labtest #pharmaceutical #drugs #mfcu #skillednursingfacility #longtermcare #fraud #healthcarefraud #falseclaim #fca #ceo #president #coo #cfo #cpa #investigation #audit #pbm #dea #generalcounsel #oig #whitecollar #health #doj #medicine #healthlaw #healthcarecompliance #chiefcomplianceofficer #compliance #Pharma #medicaldevice #medicalbilling #mailorderdrugs #managedcare #asc #surgerycenter #daysurgery #opiods #controlledsubstance #starklaw #painmanagement #urinetest #nurses #tricare #fehb #opm #erisa #healthprofessional #privateequity #bankruptcy #healthinsurance #antikickback #kickback #stark

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#HHS has released the 2024 #PublicHealth Service Policies on Research Misconduct involving PHS-funded research. The Final Rule clarifies important points that #clinicalresearch organizations should review to stay compliant. #Healthcare attorneys Summer Martin, Rebecca Merrill and Dan Silverboard outline the updates in our latest alert: https://bit.ly/3MOYVZD #healthcarecompliance

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Recent legal developments and ongoing litigation have made the regulation of mifepristone and misoprostol a critical issue for healthcare providers and policymakers. Explore evolving FDA guidelines, recent court rulings and state actions impacting the availability and administration of these medications. Learn more: https://ambar.org/obcrro45

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Healthcare attorneys Mindy Tompkins and Colton Kopcik co-authored an article, “Supreme Court Opens Window to Challenge Federal Healthcare Rules,” published in the Day Pitney Cybersecurity, Healthcare and Technology (C.H.A.T.) Newsletter. Learn more about the implications for healthcare organizations in our newsletter. Read more here: https://hubs.ly/Q02HHVBg0. #Healthcare #HealthcareLaw #HealthcareAttorneysRead

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A recent #lawsuit filed by fiscal intermediaries against the #NewYork State Department of #Health challenges new reimbursement methods for the Consumer Directed Personal Assistance Program. The lawsuit alleges procedural violations and decision-making in implementing changes that could significantly impact the program serving #Medicaid beneficiaries. In this blog #healthcare attorneys Nili Yolin and Harshita Rathore, Esq. examine the new structure set to take effect next year as well as break down the suit's claims. Read the full blog here: https://bit.ly/3WGPa5B 

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In the latest Health Law Update blog, Partner Lee Rosebush and Associate Marc Wagner explain how pharmacies can deliver controlled substances to patients under the federal Controlled Substances Act and the Drug Enforcement Administration’s implementing regulations. #BHBlog #Pharmacy #DEA

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On June 10, 2024, the Supreme Court of the United States agreed to hear an appeal challenging the Disproportionate Share Hospital (DSH) reimbursement policy in the case of Advocate Christ Medical Center, et al v. Becerra. This appeal, brought by over 200 hospitals, disputes how the Centers for Medicare and Medicaid Services (CMS) calculates DSH payments. The Supreme Court's decision to review this case marks a hopeful turn for the 450 hospitals involved in the initiative and others who have raised similar concerns. The case centers on CMS's interpretation of the Medicare Fraction of the DSH payment formula, specifically the inclusion criteria for Supplemental Security Income (SSI) recipients. To dive deeper into this critical development, check out the full article on Healthcare Finance News here - https://hubs.ly/Q02D2SbC0.

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