In a recent but aggressive trend, Elixir (formerly known as Envision Rx) has begun to issue payment and claim submission notices of suspension to pharmacies generally alleging that the pharmacies have engaged in or are engaging in activity or practices that are inconsistent with Elixir’s terms and conditions, without offering additional information to the pharmacies as it relates to the allegations; hence leaving the Pharmacy unable to address the underlying basis and resolve the suspension. In our Alert, Frier Levitt Life Sciences Attorneys Payal Amin, Pharm.D., R.Ph, Esq., Harini Bupathi, Esq. and Jesse Dresser, Esq. update pharmacy providers on these notices of suspension and what to do if your pharmacy receives one.
To read our Pharmacy Provider Alert: https://bit.ly/3kL5cpe
#PBMs #EnvisionRx #Elixir #audits #noticeofsuspension #pharmacyproviders #pharmacistattorney #lifesciencesattorneys
Frier Levitt Founding Partner Jonathan Levitt was pleased to join other industry experts today at The American Journal of Managed Care PCOC20 to discuss PBMs and access to pharmacy care in a value-based care environment.
#AJMC #PCOC20 #pharmacycare
The September Frier Levitt Healthcare Newsletter covers hot topics from this month in the healthcare law space. Learn about Department of Labor Revising FFCRA Exclusions for “Health Care Providers”, TRICARE Fraud Scheme, Recent Prosecutions Against Dentists and more in this month’s newsletter.
https://conta.cc/2G9L6pP
#Healthcare #HealthcareNews #TRICARE #FFCRA #HealthcareProvider #HealthLaw
As a result of the COVID-19 pandemic, many Pharmacy Benefit Managers (“PBMs”) had taken some form of action to help prioritize patient care including providing safe access to prescription drugs. Many of the flexibilities and changes in policy that had been put in place by PBMs to address the COVID-19 emergency thus far have been scaled back while others have been extended until further notice or for the length of the public health emergency. Frier Levitt Partner Jesse Dresser, Esq. and Clinician-Attorney Payal Amin, Pharm.D., R.Ph, Esq. continue to monitor these changes and discuss updates that pharmacies need to know.
Read our blog here: https://bit.ly/365APFR
#COVID19 #PBMs #pharmacistattorney #lifesciencesattorneys #patientcare
In case you missed some of the Hot Topics in Life Sciences and Pharmacy Law this month, we are excited to share the latest updates. In this issue, a few highlights are a discussion of Big Pharma taking aim at contract pharmacies over 340B drug pricing and a look at some upcoming presentations including Martha Rumore, Pharm.D, Esq. speaking at AMCP NEXUS2020.
Access our newsletter here: https://conta.cc/3mQk2N9
#pharmacylaw #lifesciences #hottopicsinpharmacy #newsletters #lifesciencesattorneys
Last year, the Department of Health and Human Services Office for Civil Rights announced its Right of Access Initiative in order to improve enforcement of the right of access requirement under the Federal Health Insurance Portability and Accountability Act. Frier Levitt attorneys Arielle T. Miliambro, Esq. and Sarah G. Kim, Esq., who specialize in HIPAA Compliance, discuss this initiative and five more related settlements that were recently announced in our latest blog post.
https://bit.ly/331maKa
#HIPAA #HIPAACompliance #OCR #HealthcareLaw #Rightofaccessinitiative #Rightofaccessrequirements
There is little doubt that VBC is the future of healthcare, or the Pharmaceutical companies play a critical role in that development. But it takes multiple stakeholders to successfully change payment models from “fee for service” to VBC. Stakeholders need to align, and all must comply with a complex maze of federal and state laws.
Join Frier Levitt Partners Jonathan Levitt, Esq. (moderator) and Jesse Dresser, Esq., along with a panel of industry experts to explore recent developments in the healthcare and drug spaces in an attempt to influence the future of VBC during the Association for Value-Based Cancer Care WEBside Chat on Value Based Contracting (“VBC”) in the Pharma Space: Opportunities for Innovation and Overcoming Obstacles on December 1st, 2020 at 8:00am to 9:15am.
Who should attend:
Big pharma market access and contracting teams, health plans, oncology practices
To register: https://bit.ly/3k7Fn2A
#AVBCC #healthplans #pharma #VBC #oncology #lifesciencesattorneys #healthcareattorneys #webinar
Frier Levitt is currently seeking a legal intern or recent law school grad to work on special projects related to COVID-19 claims through the Government’s Countermeasure Injury Compensation Program (CICP) and other matters. This position will involve collaborating with attorneys to work on case intake, legal research and submission of claims to the CICP program. Learn more here: https://bit.ly/3nLZeGS
There is little doubt that VBC is the future of healthcare. Plan Sponsors must control the total cost of care, on both the healthcare and pharmacy benefits. CINs have emerged as a clear pathway for the celebration of “medical outcomes” over “fee for service”. However, many barriers to entry exist for the exploration of VBC.
Frier Levitt Co-Founding Partners Jonathan Levitt, Esq. (Moderator) and Daniel Frier, Esq. along with a panel of industry leaders are excited to be presenting an Association for Value-Based Cancer Care WEBside Chat on "Legal Issues Around Structuring Value Based Contracts" on Thursday, November 12th from 8:00am to 9:15am.
Who should attend: Oncology group practices, payors, individuals in the data space and manufacturers that participate in value-based care.
To Register: https://bit.ly/3k7Fn2A
#AVBCC #oncology #VBC #plansponsors #healthcareattorneys #lifesciencesattorneys #webinar
Clinical labs have been the subject of scrutiny for many years, and in recent years, cancer genetic and pharmacogenetic testing have been a target of enforcement action for violations of the Federal Anti-Kickback Statute (“AKS”), the Federal Self-Referral Law (commonly known as the “Stark Law”), and the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Frier Levitt NYC office Managing Partner John Morrone, Esq. and Senior Counsel Theresa DiGuglielmo, Esq. look at a recent case involving a violation of the Federal Anti-Kickback Statute by a lab, resulting from improper billings to Medicare of approximately $117 Million.
Read more here:
https://bit.ly/36Zun3M
#Antikickbackstatute #Medicare #HealthLaw #AKS #Healthcarekickbacks #Healthcarefraud #StarkLaw #clinicallabs #Medicalbilling
In today's ever-changing healthcare landscape, particularly in light of the COVID-19 pandemic, many practices are exploring the utility of a Management Services Organization (MSO) to their overall strategy. In case you missed our webinar last week on "Management Services Organizations (MSO): More Relevant Now Than Ever Before" presented by Senior Counsel Theresa M. DiGuglielmo, Esq. and Co-Founding Partner Daniel B. Frier, Esq. or want to watch it again to get any tips you may have missed, we are pleased to share an on demand version of our recent webinar below.
https://bit.ly/3lD1iiz
#Webinar #HealthcareWebinar #MSO #ManagementServicesOrganizations #Healthcare #VirtualLearning
Frier Levitt is proud to introduce our newest attorney, Connor B. Breza, Esq., who joins our healthcare department where he will handle regulatory and transactional matters.
Learn more about Connor’s practice here: https://bit.ly/30LbNbN
#Healthcare #HealthcareLaw #HealthcareAttorney #TransactionalHealthcare
Today, the U.S. Department of Health and Human Services announced that Aetna Life Insurance Company and its affiliated covered entity has agreed to pay $1,000,000.00 to the HHS Office for Civil Rights to settle potential HIPAA violations. Frier Levitt attorneys Arielle T. Miliambro, Esq. and Jonian Rafti, Esq. CIPP/US discuss the settlement in our recent blog.
Read more here: https://bit.ly/35KKgZt
#HIPAA #HIPAABreach #Aetna #HIPAACompliance
It is evident that the government is becoming increasingly eager to prosecute physicians involved in fraudulent telemedicine schemes. Frier Levitt attorneys Kendra Pannitti, Esq., Danielle DelGrosso, Esq., and John Morrone, Esq. discuss how the Department of Justice recently announced a nationwide healthcare fraud and opioid takedown resulting in charges against more than 100 physicians for over $4.5 billion in losses connected to allegedly fraudulent telemedicine arrangements.
Read the full article here: https://bit.ly/37NMhqB
#HealthcareFraud #Healthcare #Telemedicine #Teleheatlth #LegalInsights #HealthcareLaw
In this month's Life Sciences Newsletter, we celebrate American Pharmacists Month in addition to presenting Pharmacy Alerts focusing on recent concerning PBM trends and upcoming virtual events to attend.
Read our Life Sciences Newsletter here:
https://conta.cc/31KpGaG
#lifesciences #newsletter #incaseyoumissedit #pharmacyalerts #lifesciencesattorneys
Coming up this Wednesday, October 28th, Frier Levitt Co-Founding Partner Jonathan Levitt, Esq. is presenting at The Community Oncology Alliance’s Payer Exchange Summit on Oncology Payment Reform with fellow cancer stakeholders to share their experiences in efforts to advance oncology payment reform, increase value, and improve the patient experience in the United States’ cancer care system. He will be participating in a discussion with other industry leaders on "The PBM Conundrum: Are PBMs the Solution or Problem in Oncology Payment Reform?".
For more information or to register: https://bit.ly/36sT6x8
#COA #PayerExchangeSummit #oncology #paymentreform
On October 6, 2020, oral argument was entertained by the Supreme Court of the United States (“SCOTUS”) in Rutledge v. Pharmaceutical Care Management Association (PCMA), the first case to reach the high court challenging a State’s ability to regulate PBM conduct. The Supreme Court decision will determine whether States can enact laws that regulate PBM conduct, or whether such laws are preempted by ERISA. Frier Levitt Life Sciences Attorneys Martha Rumore, Pharm.D, Esq., Todd Mizeski, Esq. and Jesse Dresser, Esq. lay out this landmark case and what pharmacies and dispensing provider practices should do if they are subjected to unfair or unlawful PBM practices.
Read about the case here: https://bit.ly/3mBINMf
#SCOTUS #PBM #pharmacies #dispensingproviderpractices #LandmarkCase #lifesciencesattorneys #pharmacistattorney #Rutledge #PCMA
Happy Thanksgiving to our clients and friends in the #healthcare and #lifesciences communities. We are #thankful for you this season, and always, and wanted to share our heartfelt appreciation for putting your trust in our team.
Caremark has now placed Trimester 2 reports for year 2020 in the Caremark Provider Portal, which includes its summaries of Direct and Indirect Remuneration (DIR) Fees paid by pharmacy providers. It is very important for providers to review their contracts with Caremark to understand the amount of time providers have from receipt of the trimester reports to dispute the performance findings depicted. In our latest Provider Alert, Frier Levitt Life Sciences Attorneys Brenna Sackman, Esq. and Steven Bennet, Esq. discuss what pharmacy providers need to know about these trimester reports.
Read the full Provider Alert here: https://bit.ly/396MBl0
#PBMs #trimesterreports #DIRfees #pharmacyproviders #lifesciencesattorneys #provideralerts
Some PBMs require that pharmacies purchase diabetic testing supplies from “authorized distributors.” Although the requirement to purchase from an authorized distributor is often associated with particular PBMs, such a requirement has also been implemented in some State Board of Pharmacy rules and regulations, namely in California.
In their latest update, Frier Levitt Life Sciences Attorneys Harini Bupathi, Esq. and Payal Amin, PharmD, RPh, Esq. discuss this requirement and how pharmacies should proactively ensure their own compliance with State Board of Pharmacy rules and regulations, as well as PBM terms and conditions, to avoid any monetary recoveries and penalties.
Read more here: https://bit.ly/3q0HEjx
#stateboardofpharmacy #PBMs #diabetictestingsupplies #authorizeddistributor #pharmacies #lifesciencesattorneys #californiaboardofpharmacy
This month's Frier Levitt Healthcare Newsletter brings to light an unprecedented “self-disclosure” settlement, pitfalls of the CMS’ TPE and SMRC audits, legal considerations for concierge medical practices and more...
Read the full newsletter here: https://conta.cc/3772KUH
#Healthcare #HealthcareLaw #HealthcareAttorney #StandardsofCare #TPEAudit #SMRCAudit
There is little doubt that VBC is the future of healthcare, or that pharmaceutical companies play a critical role in that development. But it takes multiple stakeholders to successfully change payment models from “fee for service” to VBC. Stakeholders need to align, and all must comply with a complex maze of federal and state laws.
Coming up next Tuesday, December 1st, 2020 from 8:00 to 9:15am, Join Frier Levitt Partners Jonathan Levitt, Esq. (moderator) and Jesse Dresser, Esq., along with a panel of industry experts to explore recent developments in the healthcare and drug spaces in an attempt to influence the future of VBC during the Association for Value-Based Cancer Care WEBside Chat on Value Based Contracting (“VBC”) in the Pharma Space: Opportunities for Innovation and Overcoming Obstacles.
Who should attend:
Big pharma market access and contracting teams, health plans, oncology practices
To register: https://bit.ly/3k7Fn2A
#AVBCC #healthplans #pharma #VBC #oncology #lifesciencesattorneys #healthcareattorneys #webinar
The continuing COVID-19 pandemic has caused most business operations to go virtual, and PBMs have followed this trend. Despite the uptick in COVID-19 cases and the challenges that come with servicing patients in the midst of the pandemic, PBMs have resumed their audits of pharmacies. In our latest Pharmacy Alert, Frier Levitt Life Sciences Attorneys Harini Bupathi, Esq. and Dae Y. Lee, Pharm.D., Esq., CPBS discuss these new virtual audits and what pharmacies need to know if confronted with one.
Read the full Pharmacy Alert here: https://bit.ly/3fpmXZX
#pharmacyalert #COVID19 #pharmacies #PBMaudits #virtualaudits #pandemic #lifesciencesattorneys
The government is increasing investigations and prosecutions of pharmacies alleging health care fraud and False Claims Act (“FCA”) violations based on inventory shortages. The government frequently relies on PBM audits which may establish that the pharmacy did not have sufficient medications to support claims billed. While an inventory shortage is often scrutinized by the government as an indicia of fraudulent or abusive behavior, there may be acceptable reasons why this type of discrepancy might exist. Frier Levitt Government Investigations Attorneys Kendra E. Pannitti, Esq. and Danielle DelGrosso, Esq. discuss this recent trend and how important it is to take action once pharmacies become aware of any PBM (or internal, or other) audit revealing an inventory shortage.
Read more on this recent trend: http://bit.ly/3jJsTir
#FCA #pharmacies #inventoryshortage #PBMaudits #governmentinvestigations
In case you missed it: The Frier Levitt Pharmacy Practice Group details how Frier Levitt successfully reversed a PBM network termination on behalf of an Illinois pharmacy, as well the challenges of establishing a pharmacy in a "HEAT Zone" in our latest edition of "Legal Insights."
Read the complete newsletter here: https://conta.cc/3q9cgiE
#LegalInsights #incaseyoumissedit #Pharmacy #LifeSciencesAttorneys #PBMnetworktermination #HEATzone #PharmacyLaw
DIR fees increase the cost to Medicare beneficiaries because PBMs base the patient’s out-of-pocket responsibility on artificially inflated reimbursement rates paid by the PBM at the point of sale. PBMs push Medicare beneficiaries prematurely into the “donut hole,” where the patient must bear the greatest out-of-pocket costs for medication. Ultimately, DIR Fees weaken the overall value of the Medicare insurance benefit intended to provide health care coverage for our nation’s oldest and most vulnerable citizens.
Frier Levitt is at the forefront of disputing DIR Fees on behalf of providers as not being “reasonable and relevant” in terms and conditions for pharmacies.
Learn more: http://bit.ly/3iTbuU7
#DIRFEES #FightDIRFees #PBM #ChallengingPBMS #PerformanceFees #Pharmacy #PharmacyLaw #FeesforPharmacies #MedicareDpatients
Maryland was the first state in the United States to enact infertility insurance legislation and was the third state that covered fertility preservation prior to cancer treatment. Frier Levitt Life Sciences Attorneys Payal Amin, PharmD, RPh, Esq. and Jesse Dresser, Esq. discuss this new legislation and more comprehensively how Providers, including fertility clinics and pharmacies that provide specialized fertility care, should be aware of the effect of this expansion of IVF coverage services for its patients. These laws provide additional opportunities for providers to better serve their patients, and for their patients to better afford their medications.
Read the full alert here: http://bit.ly/3tHAkeD
#infertilityinsurance #fertilitypreservation #IVFcoverage #fertilitypharmacies #lifesciencesattorneys #pharmacistattorney #Marylandfertilitylegislation
According to Frier Levitt Of Counsel Andreas Stargard, Esq. and Co-Founding Member Daniel Frier, Esq., “undertaking regular compliance check-ups is as advisable as a patient’s routine annual blood panel – but with healthcare likely topping President Biden’s antitrust enforcement agenda (perhaps only paralleled in importance by its focus on “big tech”), it will be of particular relevance this year.” In their recent Medical Economics article the two discuss healthcare reforms and other nuances that make antitrust enforcement concerns crucial to healthcare practices this year.
Read “Why antitrust enforcement will matter to your practice in 2021 and beyond” here: http://bit.ly/3aNPJS6
#MedicalEconomics #HealthcareInsights #Healthcarereform #Heatlhcarein2021 #BidenHealthcare #Antitrust #Antitrustenforcement #HealthcareLaw #Providers #MedicalPractices
Frier Levitt is proud to host the Parsippany PAL Blood Drive for the New York Blood Center and New Jersey Blood Services on Tuesday, March 9th as we continue our 20 Charitable Acts for 20 Years initiative. Recent snowfall and freezing temperatures combined with the COVID-19 pandemic have severely limited blood collections and blood banks are at an all-time low. We hope you’ll join us at this important community event. The Blood Drive will take place on Tuesday, March 9 at 33 Baldwin Road in Parsippany, NJ from 8:30am – 2:30pm. To schedule an appointment, visit: nybc.org/njdrive Our Frier Levitt sponsor code is: 64380.
#FLanthropy #20Actsfor20Years #BloodDrive #NJBloodDrive #GivingBlood #ParsippanyPAL
