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Legal Challenges, Risks Of Rx Drug Adherence Programs
July 9, 2012 | Blog | By Karen Lovitch
A Law360 article written by my colleague, Theresa Carnegie, provides an overview of the key health regulatory issues that manufacturers, plans, pharmacy benefit managers (PBMs), pharmacies and related providers may face when structuring drug adherence programs and suggests approaches for minimizing legal risks.
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Massachusetts Legislature Makes Major Changes to the Gift Ban Law
June 29, 2012 | Blog | By Brian Dunphy
My colleagues from ML Strategies, George Atanasov and Julie Cox, published a client alert discussing changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct.
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OMB Extends Review Period for HIPAA/HITECH Omnibus Rule
June 26, 2012 | Blog | By Dianne Bourque
The Office of Management and Budget (OMB) announced on Friday, June 22, 2012, that it has extended the review period for the highly-anticipated omnibus rule intended to update key definitions and enforcement provisions relating to the implementation of the Health Insurance Portability and Accountability Act (HIPAA).
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OIG Solicits Comments and Recommendations for Revising Self-Disclosure Protocol
June 19, 2012 | Blog | By Brian Dunphy
On Monday, June 18th, the Office of Inspector General (OIG) published a notice that it intends to update its Provider Self-Disclosure Protocol (Protocol), through which health care providers can disclose potential fraud and resolve liability under the OIG’s civil monetary penalty authority.
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ML Strategies Posts Weekly Health Care Reform Update on June 11, 2012
June 12, 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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OCR Shares Preliminary HITECH Audit Results; What Regulated Entities Can Expect Next
June 11, 2012 | Blog | By Daria Niewenhous, Dianne Bourque
Last week at the OCR/NIST conference, Building Assurance through HIPAA Security, Linda Sanches of the Office for Civil Rights provided an extensive update on the pilot HITECH audit program, including preliminary findings, what regulated entities can expect next and suggestions for covered entities concerned about being audited.
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OIG Advisory Opinion 12-06 Disapproves of Proposed Arrangements Between ASCs and Anesthesia Services Providers
June 3, 2012 | Blog | By Brian Dunphy, Karen Lovitch
In OIG Advisory Opinion 12-06, the OIG determined that two proposed arrangements between an anesthesia services provider (the "Requestor") and professional corporations ("PCs") or limited liability companies ("LLCs") that own ambulatory surgical centers ("ASCs") would potentially violate the federal Anti-Kickback Statute ("AKS") and thus would be subject to enforcement and administrative sanctions.
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Expiration of Grandfather Protection for Technical Component Services Billing Is Looming
June 1, 2012 | Blog | By Karen Lovitch
One month from today, the law that permits independent laboratories to bill and receive payment from Medicare Part B for the technical component of certain anatomic pathology, cytopathology, and surgical pathology services ("TC Services") provided to patients of "covered hospitals" will expire.
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Keeping the Whistle Away from the Whistleblower
May 24, 2012 | Blog | By Karen Lovitch
The G2 Compliance Report recently published a very informative article written by Hope Foster, Leader of Mintz Levin's Health Care Enforcement Defense Practice, on the whistleblower's role in health care fraud enforcement and strategies for avoiding qui tam suits.
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Sellers Prepare: Health Care Due Diligence
May 23, 2012 | Blog | By Karen Lovitch
Health care transactions present unique due diligence challenges. The buyer must evaluate the seller's compliance policies and procedures, arrangements with referral sources, patient and payor data, clinical data and compliance with federal and state licensure, certification and reimbursement regulations.
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HIPAA Criminal Penalties – Defendant May Be Found Guilty without “Knowledge” That Acts Are Illegal
May 21, 2012 | Blog | By Daria Niewenhous
Individuals who access protected health information without authorization may be found guilty of a misdemeanor even if they lack knowledge that their actions are illegal.
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Abbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims
May 8, 2012 | Blog
Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label uses, as announced by the settling parties on May 7, 2012.
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CMS, CCIO, and IRS Release Guidance Proposals on Employer Health Insurance Coverage
May 7, 2012 | Blog
The Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight (CCIIO) and the Internal Revenue Service (IRS) recently released four important documents related to the implementation of the Affordable Care Act (ACA) that address employer-provided health insurance plan reporting requirements and the availability of premium tax credits to individuals and families.The Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight (CCIIO) and the Internal Revenue Service (IRS) recently released four important documents related to the implementation of the Affordable Care Act (ACA) that address employer-provided health insurance plan reporting requirements and the availability of premium tax credits to individuals and families.
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Press Coverage Triggers HIPAA-Related Inquiry
May 7, 2012 | Blog | By Karen Lovitch
Most state and federal health care investigations are prompted by audits or claims brought by whistleblowers. But a recent newspaper article about a debt collection company’s tactics has prompted Congressional ire and potentially a federal investigation.
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Sunshine Act Implementation Delayed Until 2013
May 4, 2012 | Blog | By Brian Dunphy
With little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013.
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OIG Advisory Opinion 12-05 Approves Consumer Rewards Program
May 2, 2012 | Blog | By Karen Lovitch, Theresa Carnegie
In OIG Advisory Opinion 12-05, the OIG found that a consumer rewards program (the “Program”) offered by a supermarket chain with in-store and independent pharmacies (the “Requestor”) would not be subject to enforcement under the Anti-Kickback Statute (the “Kickback Statute”) or the beneficiary inducement prohibition found in the civil monetary penalties law (the “CMP Law”).
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Analysis of Health Insurer-Hospital Vertical Merger Submitted to ABA/AHLA Antitrust in Healthcare Conference
April 20, 2012 | Blog | By Karen Lovitch
Christi Braun and Farrah Short have submitted a paper for the 2012 ABA/AHLA Antitrust in Healthcare Conference in which they discuss the proper role of antitrust enforcement in achieving today’s health care reform goals in the context of hospital-health insurer vertical mergers.
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CMS To Pay Hospitals Over $3 Billion for CMS' Miscalculation
April 16, 2012 | Blog
Hospital chains Hospital Corporation of America (HCA) and Tenet Healthcare Corporation (Tenet) announced on April 12th that the Centers for Medicare & Medicaid Services (CMS) has admitted that it erroneously calculated the rural floor provision established by the Balanced Budget Act of 1997.
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CMS Selects 27 ACOs
April 13, 2012 | Blog | By Brian Dunphy
In another step toward implementation of Accountable Care Organizations (ACOs), on April 10, 2012, the Centers for Medicare & Medicaid Services (CMS) selected 27 ACOs in 18 states to participate in the Medicare Shared Savings Program (Shared Savings Program).
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CMS Issues Final Rule Impacting Medicare Advantage and Medicare Part D Programs for Contract Year 2013
April 13, 2012 | Blog | By Karen Lovitch
The Centers for Medicare & Medicaid Services (“CMS”) recently published final regulations implementing program and technical changes to the Medicare Advantage (“MA”) and Medicare Prescription Drug (“Part D”) benefit programs.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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