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Can a Physician’s Medical Judgment be Basis for a False Claims Action? Appellate Court Rules Yes.

In a recent decision, United States ex rel. Polukoff v. St. Mark's Hospital , the Tenth Circuit held that a physician's medical judgement regarding courses of treatment may serve as the basis for False Claim Act ("FCA") liability. Interpreting the FCA broadly, the court ruled that statements of opinion made by a physician are not automatically excl...
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New Jersey Act Imposes New Requirements to Protect Consumers

New Jersey providers should be alert to the recently signed into law Out-of-Network Consumer Protection, Transparency, Cost Containment, and Accountability Act.The Act pertains to, and enhances, consumer protections related to out-of-network healthcare charges.Health care facilities and professionals must ensure their compliance with these new requ...
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New York State Takes Action Against Abusive PBM Audits, Grants New Protections to Independent Pharmacies

The recently passed New York State budget bill including sweeping new protections for independent pharmacies facing PBM audits.  The bill, which amends the Public Health Law, requires PBMs, when conducting audits, to accept purchase invoices from a broader range of wholesalers and distributors.  This provision is notable as PBMs...
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113 Hits
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What NYC Employers Must Know About the Safe Leave Law

The former NYC Earned Sick Time Act, popularly known as the Paid Leave Law, is now the Earned Safe and Sick Time Act.  Previously, the Act obligated employers to provide a certain amount of sick leave for their employees. The new amendments to the Act, which are presently going into effect, allow employees to use paid leave not only for s...
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New York State Imposes Limitations on LHCSA Applications

Recently, New York State implemented a two-year moratorium on the processing and approval of applications for licensure of Licensed Home Care Service Agencies ("LHCSAs").This moratorium suspends the Department of Health's processing of LHCSA applications, subject to certain exceptions. Presently, the exceptions include applications for ALP-Related ...
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The Rising Cost of Employing Excluded Individuals

Healthcare providers are increasingly feeling the cost of employing excluded individuals.Indeed, over the past year, the number of enforcement actions taken against physician's offices, pharmacies and other entities employing excluded individuals have risen sharply. "Excluded individuals" are parties excluded from Federally-funded healthcare progra...
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856 Hits
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Under the Travel Act, Aggressive Federal Enforcement Against Providers Expands

Q.  When does a purely state criminal law-based matter transform into a federal felony prosecution? A.  When the Federal Travel Act (the "Travel Act") is implicated.Under the Act, a party who travels in interstate commerce or uses the mail or any facility in interstate commerce, with intent to promote or carry on "unlawful activities...
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FEDERAL CRACKDOWN ON PRESCRIBERS OF COMPOUNDED MEDICATIONS

A recent health care fraud guilty plea by a physician has caught the attention of prescribing physicians and the broader industry surrounding compounded medications.Under the plea agreement in New Jersey District Court, the physician admitted to prescribing approximately $25 million worth of compounded medications that were either medically unneces...
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COMPOUNDING PHARMACIES MAY SOON HAVE NEW MARKET OPPORTUNITIES

Compounding pharmacies, one of the fastest growing sectors in retail pharmacy, may soon be able to expand the market for their products in exchange for agreeing to be placed directly under federal oversight, according to U.S. Food & Drug Administration Commissioner Scott Gottlieb. Currently, a sterile compounding pharmacy may&nbs...
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PHARMACY COMPLIANCE UPDATE: GROWING YOUR MEMBERSHIP PROGRAM

Membership programs are a common tool used by retail pharmacies to grow their business. Under this type of program, a pharmacy will give member patients certain benefits, usually taking the form of rebates, discounts, or coupons on in-store items, as a way of developing customer loyalty. As these member patients often fill prescriptions at the same...
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724 Hits
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Medicare Fraud Strike Force Announces $1.3 Billion Healthcare Fraud Takedown

In what is becoming an annual tradition, the Medicare Fraud Strike Force, comprised of members from the U.S. Department of Justice and the Department of Health and Human Services (more about which can be read here ), announced the latest "unprecedented" healthcare fraud takedown. The nationwide bust netted more than 412 individuals suspected of a c...
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912 Hits
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Healthcare Industry Welcomes Changes to Overtime Wage Guidance

In a step viewed optimistically by healthcare businesses, the United States Department of Labor ("DOL") has withdrawn two Obama-era guidance letters used to interpret the overtime wage provisions of the Fair Labor Standards Act. The first guidance letter concerned independent contractors, and set forth the DOL's now-former position that most worker...
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Final Guidance for Part D DIR Reporting Requirements: Promising Developments for Pharmacies

It appears that the Centers for Medicare & Medicaid Services ("CMS"), in its newly-released Final Guidance on Medicare Part D DIR Reporting Requirements for 2016, has begun addressing the lack of transparency surrounding Part D plan sponsors' collection of Direct and Indirect Remuneration ("DIR") fees from independent pharmacies. DIR "clawback"...
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1223 Hits
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Senators; New York Times Article Highlights Abuses by Treasury Department

Contractors Responsible for Collecting Debts Alleged against Medicare Providers   A recent New York Times article, available here , detailed abuses committed by debt collection agencies contracted by the United States Department of Treasury and its sub-agency, the I.R.S. These abuses were also the subject of a recent letter from multiple Unite...
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847 Hits
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HIPAA UPDATE: OCR RELEASES CYBER-ATTACK RESPONSE CHECKLIST

The Office of Civil Rights of the U.S. Department of Health and Human Services ("OCR") has released a checklist of actions to be taken by covered entities in the event of a ransomware attack or other cyber-related security incident. OCR noted that in investigating breaches of protected health information ("PHI"), it will consider all mitigation eff...
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1320 Hits
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Supreme Court Analysis: Ruling A Victory For Biosimilar Developers

The Supreme Court handed biosimilar drug developers a clear victory this week in its decision on Amgen Inc. v. Sandoz Inc. In its decision, the high court considered the provisions of the federal Biologics Price Competition and Innovation Act of 2009 (the "Act"), specifically, the Act's requirement that biosimilar developers , prior to commercially...
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The Next PBM Audit Battleground: Is Your Distributor Authorized to Sell Diabetic Supplies?

It appears that the next major challenge for independent pharmacies has been identified: the authorization, or lack thereof, of wholesalers to sell diabetic supplies purchased by the pharmacy. Less than a year ago, CVS/Caremark unilaterally amended its standard pharmacy agreement to require that pharmacies only purchase diabetic supplies from so-ca...
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1279 Hits
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Express Scripts' New Surety Bond Requirement

Recently, Express Scripts started requiring that pharmacies seeking new enrollment provide a $500,000 surety bond as a condition of entering into the provider agreement. The cost of such a surety bond depends on the pharmacy and its owners' creditworthiness, but is still very high, and can easily exceed $15,000. We urge new and prospective pharmacy...
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Roche's Test Strips Lawsuit Targets Wholesalers, Pharmacies

On March 28, 2017, Roche Diagnostics Corp. and Roche Diabetes Care, Inc. filed a lawsuit in the U.S. District Court for the Southern District of Indiana, entitled Roche Diagnostics Corp. et al. v. Binson's Hospital Supplies, Inc., et al., ​Docket No. 17-cv-0949 (LJM)(DML). The Indianapolis-based subsidiaries of the Swiss pharmaceutical company...
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TOWARDS INCREASED PBM TRANSPARENCY

Is Increased PBM Transparency on the Way? Newly proposed Federal legislation would increase PBM transparency regarding aggregate rebates and "spread pricing".An oft-controversial issue, independent pharmacy associations have long lobbied for greater disclosure of the rebates that PBMs receive from drug companies, which can have a significant effect...
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1496 Hits
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