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The Pharmacy Industry - 2015 Year In Review
December 8, 2015 | Blog | By Theresa Carnegie, Lauren Moldawer
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016.
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DOJ Recovers $3.5 Billion in False Claims Act Cases in FY2015 and Pays Record Amount to Qui Tam Relators
December 8, 2015 | Blog | By Laurence Freedman
Late last week, the Department of Justice (DOJ) announced that in FY2015 it obtained more than $3.5 billion in settlements and judgments from civil cases involving allegations of false claims against the government.
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The Twenty-Year Ascendancy of Health Care Qui Tam Litigation in Five Simple Graphs
December 8, 2015 | Advisory | By Kevin McGinty
Experienced practitioners are anecdotally aware of the growth in recent years in the volume of health care qui tam litigation. That perceived trend is validated quite graphically in the most recent Department of Justice (“DOJ”) statistics on False Claims Act filings.
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OIG Proposes Alternative Part B Payment Methodologies for 340B Drugs: Is This the End of 340B As We Know It?
December 2, 2015 | Blog
Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program. The means of delivery was an OIG Report on Medicare Part B payments for 340B drugs.
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Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules
November 30, 2015 | Blog
Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving dinner.
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HHS Drug Pricing Forum Highlighted in ML Strategies' Health Care Update
November 24, 2015 | Blog | By Bridgette Keller
This week’s ML Strategies Health Care Update highlights the recent Department of Health and Human Services (HHS) forum on prescription drug costs, which featured players from every corner of the industry, including top government officials.
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FDA Commits to Moving Forward with LDT Regulation
November 24, 2015 | Blog | By Joanne Hawana
Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that FDA would move forward with finalizing its plan to regulate laboratory developed tests (LDTs) sometime in 2016.
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Congressional Hearing Examines Competition in the PBM Industry
November 23, 2015 | Blog | By Theresa Carnegie
Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining the state of competition in the pharmacy and PBM marketplace.
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ML Strategies Health Care Update - DNA Sequencing Workshop and Drug Pricing Developments
November 20, 2015 | Blog | By Samantha Kingsbury
On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics.
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CMS Eases Regulatory Burdens and Creates New Exceptions in “Phase V” of the Stark Regulations
November 17, 2015 | Blog
On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law ("Stark Law" or "Stark") regulations since 2008.
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CMS Eases Regulatory Burdens and Creates New Exceptions in "Phase V" of the Stark Regulations
November 17, 2015 | Alert
On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law (“Stark Law” or “Stark”) regulations since 2008. Because this rulemaking is the fifth substantive rulemaking under the Stark Law amendments of 1993, it will likely become known as Stark Phase V.
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Genetic Testing, Genome Sequencing, and the FDA
November 13, 2015 | Blog | By Joanne Hawana
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the rapidly developing world of genetic and genomic testing services.
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FDA Invites Genome Scientists to Come Play in the precision FDA “Sandbox”
November 13, 2015 | Alert | By Joanne Hawana
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
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FTC Challenges Hospital Merger Despite Conduct Remedy Accepted by State AG
November 9, 2015 | Blog | By Dionne Lomax
Last week the Federal Trade Commission (“FTC” or “Commission”) issued an administrative complaint challenging the merger of two West Virginia hospitals that had earlier been cleared by the state’s Attorney General (“W.V. AG”) following the entry of two agreements between the hospitals and the W.V. AG (“Agreements”).
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Mylan Agrees to Divest Seven Products, Including Three Pipeline Products, to Clear FTC Hurdle in Its $27 Billion Tender Offer Bid for Perrigo
November 6, 2015 | Alert
The Federal Trade Commission (“FTC”) yesterday concluded its antitrust review of Mylan N.V.’s (“Mylan”) proposed acquisition of Perrigo Company plc (“Perrigo”) by entering into a proposed consent judgment that would require Mylan to divest seven generic products, including three future pipeline products, to Alvogen Group Inc. (“Alvogen”).
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CMS Issues Final Rule for Fraud and Abuse Waivers in the Medicare Shared Savings Program
November 6, 2015 | Blog
On October 29th, 2015, the Centers for Medicare and Medicaid Services ("CMS") issued its final rule ("Final Rule") for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program ("Shared Savings Program").
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ML Strategies: Ways & Means Leadership Changes – Health Policy Implications Looming
November 6, 2015 | Blog | By Lauren Moldawer
On Monday November 2, 2015, ML Strategies released another edition of its Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree
November 4, 2015 | Blog | By Joanne Hawana
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names for biosimilars as compared to their reference biologics would signal clinically meaningful differences to already-confused physicians.
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HIPAA Lessons from the Warner Chilcott Settlement
November 4, 2015 | Blog | By Ellen Janos
Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations involving the promotion of the company’s drugs.
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MA Health Policy Updates - Moves to Strengthen HPC and Expand Telemedicine
November 2, 2015 | Blog
In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission (HPC) activities, the Alert highlights pending legislation that will affect the health industry.
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