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OIG Approves Wholly Owned Subsidiary GPO Arrangement

March 21, 2012 | Blog | By Karen Lovitch, Theresa Carnegie, Nili Yolin

In Advisory Opinion 12-01, the Office of Inspector General for the Department of Health and Human Services (OIG) analyzed a proposal from a nonprofit health system (the “System”) to form a group purchasing organization (the “Proposed GPO”) for the benefit of the System’s affiliates and subsidiaries. 

Client Alert - The False Claims Act: The Impact in 2012

March 20, 2012 | Blog | By Daria Niewenhous

Mintz Levin has issued a Client Alert:  The False Claims Act: The Impact in 2012 - Part II in a Continuing Series on Health Care Enforcement. 
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.
Responding to questions from Medicare Shared Savings Program (MSSP) applicants and their counsel, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum on March 16.
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").
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.

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). 

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. 

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.
The Affordable Care Act creates a new disclosure requirement for group health plans and issuers: the summary of benefits and coverage (SBC). On February 14, 2012, the Departments of Labor, Treasury, and Health and Human Services published final regulations setting forth the required content, timing, and appearance of the SBC.  
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.
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”).
Health care providers and pharmaceutical and medical device manufacturers are operating in an environment of intense scrutiny.  As discussed in a Mintz Levin client advisory, in 2011, the federal government directed extraordinary resources and attention to detecting and prosecuting health care fraud and abuse. 
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.

The Best and Worst of HIPAA Compliance

February 24, 2012 | Blog

If improving your HIPAA/HITECH compliance policies and procedures is one of your organization's 2012 goals, I encourage you to read an article written by my colleague Ellen Janos entitled The Best and Worst of HIPAA Compliance, which was published in Corporate Compliance Insights. 

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).
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.
The clinical laboratory community is dismayed by a last minute, $2.7 billion cut to the Medicare Clinical Laboratory Fee Schedule (CLFS)  to help finance the payroll tax and SGR deal. 
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.
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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