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No one wants to be the first, especially not in this case. The Department of Health and Human Services' Office of Civil Rights (OCR) announced its first settlement with a covered entity stemming from a report submitted pursuant to the Health Information Technology for Economic and Clinical Health Act's (HITECH) Breach Notification Rule (the "Rule").
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New York Court Finds Private Right of Action Under State’s Prompt Pay Law

March 8, 2012 | Blog | By Daria Niewenhous, Nili Yolin

On February 22, 2012, a New York State Court held for the first time that a provider may bring a claim against a health insurer under the State’s prompt pay law (PPL). 
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New FDA Research Consent Form Requirements – Effective Today

March 7, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be entered into the ClinicalTrials.gov database. 
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ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
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ACGME Announces its Next Accreditation System

March 5, 2012 | Blog | By Daria Niewenhous, Nili Yolin

On February 22, 2012, the Accreditation Council for Graduate Medical Education (ACGME) announced the roll-out of its “Next Accreditation System” (NAS) for all graduate medical education (residency and fellowship) programs that hold ACGME accreditation.
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Thirteen months after over 500 comments were submitted in response to a CMS proposal, Medicare Part C (“Medicare Advantage”) plan sponsors and other stakeholders now know the methodology CMS will use in calculating payment errors through extrapolated estimates in audits based on risk adjustment data validation (“RADV”).
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Last year, the Supreme Court limited the ability of states to regulate the sale of prescription data. In Sorrell v. IMS Health, the Supreme Court determined that a 2007 Vermont law that effectively banned the sale of prescription data for commercial marketing purposes unless the prescriber consented was an unconstitutional limitation on free speech.
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CMS Proposed Rules for Reporting AMP and Best Price May Have Impact Beyond Medicaid Drug Rebates

February 22, 2012 | Blog | By Karen Lovitch, Theresa Carnegie, Ellyn Sternfield, Nili Yolin

On February 2, 2012, CMS issued proposed regulations that further refine and define how pharmaceutical manufacturers must calculate Medicaid drug rebates in the wake of health care reform (the Proposed Rule).
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ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
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Health care providers and suppliers concerned about how the Centers for Medicare & Medicaid Services (CMS) plans to implement the 60-day deadline for returning Medicare and Medicaid overpayments enacted as part of the Affordable Care Act (ACA) now have a proposed rule that provides some insight.
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The recent decision by a federal court judge in Mississippi to deny defendants’ motion for summary judgment in United States ex rel. Jamison v. McKesson rejected a well-established defense to claims that competitively procured arrangements for goods and services constituted “remuneration” for purposes of the Anti-Kickback Statute ("AKS").
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Massachusetts Corporate Practice of Medicine Regulations Finalized

February 15, 2012 | Blog | By Daria Niewenhous, Ellen Janos, Rachel Irving Pitts

The Massachusetts Board of Registration in Medicine recently released final revised physician licensing and discipline regulations, effective February 1, 2012.  The final regulations mark the end of a six-year process to overhaul these regulations.
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Case Study: Messner v. Northshore University HealthSystem

February 13, 2012 | Blog | By Karen Lovitch

Law360 recently published an interesting article examining the Seventh Circuit's recent opinion in Messner v. Northshore University HealthSystem.
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CMS posted additional sub-regulatory guidance regarding the Medicare Loss Ratio (MLR) under Section 2718 of the Public Health Service Act, as added by the Affordable Care Act (ACA). 
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An OIG Alert issued today reminds physicians who reassign their right to submit claims to and receive payment from Medicare may be liable for any false claims submitted to the government. The OIG linked this alert to recent settlements under the Civil Monetary Penalty Law with physicians whose Medicare payment reassignments resulted in false claims. 
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HITECH Data Breach Reporting Deadline Approaches

February 7, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

It’s time for mandatory data breach reporting to the Office of Civil Rights (“OCR”) under The Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the interim/final breach notification rules.
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ML Strategies has posted their weekly Health Care Reform Update.  This publication provides timely and concise information on implementation of the Affordable Care Act and other state and federal administrative and legislative activities related to health care reform.
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2011-The Year In Review: Trends in Health Care Enforcement

February 1, 2012 | Blog | By Brian Dunphy, Samantha Kingsbury

Mintz Levin’s Health Care Enforcement Defense Group reviewed health care fraud enforcement activities in 2011 to offer a general snapshot of the environment in which health care providers and pharmaceutical and medical device manufacturers operate. 
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The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule giving pharmaceutical and medical device manufacturers as well as group purchasing organizations some insight into how CMS intends to implement the Physician Payment Sunshine Act, which was enacted as part of health care reform.
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Relators and their counsel are increasingly being held accountable for the misuse of qui tam defendants’ confidential and privileged documents in connection with lawsuits alleging violations of the False Claims Act (“FCA”). 
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