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Medicare and Medicaid, Audits & Investigations, Compliance, Fraud and Abuse, Pharmacy Law
JAN
18
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Medicaid Providers, Beware: OMIG Places Provider Compliance Programs Under Review

Posted by MDRXlaw
The NYS Office of the Medicaid Inspector General ("OMIG") has dramatically increased enforcement activity in connection with Medicaid provider compliance programs: OMIG is notifying providers that their compliance programs are being placed under review. Providers should take immediate action to avoid the prospect of serious sanctions, including but...
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OCT
16
0

Medicare Appeals Backlog – Light at the End of the Tunnel?

Posted by MDRXlaw
The number of Medicare appeals cases pending to be heard by administrative law judges has been growing exponentially.  The backlog is now almost ten times larger than it was five years ago and is projected to reach two million by 2020 if no change is made.  The appeals process, as of now, takes at least three to four years, duri...
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SEP
23
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DOJ APPROVES CIGNA-EXPRESS SCRIPTS MERGER

Posted by MDRXlaw
This is the time for independent pharmacies to be actively preparing for the impact of the Cigna-ESI merger—and the ensuing Aetna-Caremark merger—if they have not already done so. The Antitrust Division of the U.S. Department of Justice has approved the proposed Cigna-Express Scripts merger, clearing a significant obstacle to Cigna's acquisition of...
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SEP
04
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HHS Echoes Importance of HIPAA Compliance for Closed Businesses

Posted by MDRXlaw
Recently, HHS reiterated that severe consequences can be imposed for HIPAA violations, regardless of whether a business is still operational. If HIPAA violations were committed, a business can be charged long after its doors close. Moreover, providers working with associates who shut down operations or went bankrupt are equally liable for HIPAA vio...
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SEP
04
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CMS Updates Final Adverse Actions to Be Reported

Posted by MDRXlaw
CMS has released a list of updated final adverse actions that need to be reported to CMS in a timely fashion. The list includes, but is not limited to, certain convictions, exclusions, and revocations, regardless of whether records are expunged.  Additionally, CMS revoked certain requirements of Medicare enrollment in an effort to reduce provi...
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AUG
16
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Compounding Pharmacies Under Scrutiny for Medicare Part D Billing Practices

Posted by MDRXlaw
OIG calls for "further scrutiny" of pharmacies and prescribers in connection with compounded drugs billed to Medicare Part D.   Pharmacies must be prepared to aggressively defend against this latest attack on the independent retail pharmacy industry. An explosive new report calls for "further scrutiny" of hundreds of pharmacies and prescr...
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JUL
19
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New York Court Decision Demonstrates Importance of Proper Audit Response

Posted by MDRXlaw
It is of utmost importance that Medicaid providers take prompt measures when under audit to avoid such consequences. Recently, the New York Court of Appeals upheld a recoupment of funds by the NYS Office of the Medicaid Inspector General ("OMIG") against a provider, rejecting the provider's claim that it was not sufficiently notified of the recoupm...
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JUL
19
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Can a Physician’s Medical Judgment be Basis for a False Claims Action? Appellate Court Rules Yes.

Posted by MDRXlaw
A doctor's certification or medical judgment regarding a certain treatment can be considered "false" if the treatment is not considered "reasonable and necessary" under the government's definition, even if the terms are not defined for the specific medical treatment. In a recent decision, United States ex rel. Polukoff v. St. Mark's Hospital ,...
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JUL
02
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Nationwide Crackdown Charges 601 Individuals with Over $2 Billion in Healthcare Fraud

Posted by MDRXlaw
In a sweeping crackdown that vastly exceeded investigations of years' past, the U.S. Department of Justice and Medicare Fraud Strike Force charged 601 individuals with over $2 billion in healthcare fraud. In Brooklyn and Long Island alone, numerous healthcare providers were charged with over a combined $163 million in healthcare fraud. The Medicare...
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JUN
08
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New York State Takes Action Against Abusive PBM Audits, Grants New Protections to Independent Pharmacies

Posted by MDRXlaw
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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NOV
29
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The Rising Cost of Employing Excluded Individuals

Posted by MDRXlaw
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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NOV
15
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Under the Travel Act, Aggressive Federal Enforcement Against Providers Expands

Posted by MDRXlaw
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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OCT
11
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FEDERAL CRACKDOWN ON PRESCRIBERS OF COMPOUNDED MEDICATIONS

Posted by MDRXlaw
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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SEP
26
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COMPOUNDING PHARMACIES MAY SOON HAVE NEW MARKET OPPORTUNITIES

Posted by MDRXlaw
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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SEP
21
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PHARMACY COMPLIANCE UPDATE: GROWING YOUR MEMBERSHIP PROGRAM

Posted by MDRXlaw
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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JUL
14
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Medicare Fraud Strike Force Announces $1.3 Billion Healthcare Fraud Takedown

Posted by MDRXlaw
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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JUL
12
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Healthcare Industry Welcomes Changes to Overtime Wage Guidance

Posted by MDRXlaw
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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JUN
16
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Supreme Court Analysis: Ruling A Victory For Biosimilar Developers

Posted by MDRXlaw
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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APR
03
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TOWARDS INCREASED PBM TRANSPARENCY

Posted by MDRXlaw
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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APR
03
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INSURANCE PLAN NOT PERMITTED TO “CROSS-PLAN” RECOUP AGAINST PROVIDERS

Posted by MDRXlaw
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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