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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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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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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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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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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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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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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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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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INSURANCE PLAN NOT PERMITTED TO “CROSS-PLAN” RECOUP AGAINST PROVIDERS

A Federal District Court in Minneapolis has issued a highly favorable decision for physicians and healthcare providers on the limits of an insurance plan's ability to recoup.  Specifically, the court ruled that insurers can only recoup against providers from the same health plan that the alleged overpayment was issued under, even if the insure...
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MDRXLaw 2017 Q1 Newsletter - Focus on PBM Audit Practices

We are pleased to announce the publication of our 2017 First Quarter Newsletter devoted to the issues facing pharmacies in connection with PBM audits. Please read it here.
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MFCU Takes Recoupment Actions Against Providers in Connection With Percentage-Based Billing Arrangements

Calling the attention of every New York Medicaid provider reimbursing its billing/collection agents on a percentage basis, the New York State Medicaid Fraud Control Unit (MFCU) has recently sent out recoupment letters demanding repayments of Medicaid funds paid to billing companies under fee-splitting arrangements. Notably, the recoupments actions ...
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MEDICARE APPEALS BACKLOG MUST BE CLEARED, RULES COURT

In a groundbreaking decision addressing one of the most pressing issues currently faced by Medicare providers, the U.S. District Court for the District of Columbia ordered CMS to clear the lengthy backlog of Medicare appeals at the administrative law judge (ALJ) level. Under the Medicare Act, CMS must provide an ALJ hearing and decision within 90 d...
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PROTECTING ACCESS TO PHI

As providers continue to rely on software vendors to maintain protected health information ("PHI"), a well-drafted business associate agreement ("BAA") becomes increasingly important. The BAA will set forth the obligations between providers and business associates such as software vendors with respect to the PHI. Software vendors will often attempt...
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