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ML Strategies Posts Weekly Health Care Reform Update on April 2, 2012

April 2, 2012 | Blog | By Daria Niewenhous

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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DOJ's Strategies - FCPA and Health Care Fraud

March 31, 2012 | Blog

For insights into how Foreign Corrupt Practices Act (FCPA) enforcement is creeping into the pharmaceutical and medical device manufacturer arena, see this article, which I co-authored with Paul Pelletier, former principal deputy chief of the Criminal Division's Fraud Section at the Department of Justice (DOJ).
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HHS Issues Report to Congress on the Self-Referral Disclosure Protocol

March 28, 2012 | Blog | By Brian Dunphy

On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. 
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HIPAA Omnibus Rule Expected Within 90 Days - Pending Review at OMB

March 27, 2012 | Blog | By Dianne Bourque

Officials from the Department of Health and Human Services Office for Civil Rights (OCR) announced March 26 that the long-awaited rule updating Health Insurance Portability and Accountability Act (HIPAA) regulations has been sent to the Office of Management and Budget (OMB).
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OIG Approves Wholly Owned Subsidiary GPO Arrangement

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

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. 
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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. 
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HHS OCR Announces First Settlement of a Self-Reported HIPAA Violation

March 15, 2012 | Blog | By Dianne Bourque

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

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 Posts Weekly Health Care Reform Update on March 5, 2012

March 5, 2012 | Blog | By Daria Niewenhous

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.
Read more

ACGME Announces its Next Accreditation System

March 5, 2012 | Blog | By Daria Niewenhous

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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CMS Issues Final Payment Error Calculation Methodology for Medicare Advantage RADV Audits

March 1, 2012 | Blog | By Karen Lovitch

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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Another Attempt to Curb the Sale of Prescription Data Comes Up Empty

February 29, 2012 | Blog

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

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 Posts Weekly Health Care Reform Update on February 20, 2012

February 21, 2012 | Blog | By Daria Niewenhous

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.
Read more

CMS Publishes Proposed Rule on Return of Medicare and Medicaid Overpayments

February 16, 2012 | Blog | By Karen Lovitch

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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District Court Allows Trial on Whether a Below Cost but Competitively Bid Arrangement Can Lead to a Kickback Violation

February 16, 2012 | Blog | By Karen Lovitch, Kevin McGinty

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

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 Posts MLR Guidance: Payments to Entities such as IPAs, PHOs, and ACOs

February 12, 2012 | Blog | By Daria Niewenhous

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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