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The ONC’s Health IT Vision Plan: A Building Under Construction
June 13, 2014 | Blog
The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help refocus stakeholders on HHS's goals for the use of health IT in the U.S. health care system.
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As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance
June 11, 2014 | Blog
With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for Medicare and Medicaid Services (“CMS”) has issued additional guidance on Phase 2 reports.
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Lessons to Be Learned from FCA Defendant Who Provided Attorney Work Product to OIG
June 6, 2014 | Blog | By Brian Dunphy
Health care companies and their counsel handling health care fraud investigations or False Claims Act (“FCA”) cases should consider the potential strategic implications of a decision compelling an FCA defendant to produce attorney work product to a relator. United States ex rel. Garbe v. Kmart Corp., No. 3:12-cv-00881-MJR-PMF, 2014 U.S. Dist. LEXIS 73261 (S.D. Ill. May 29, 2014).
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ML Strategies Posts Weekly Health Care Update on June 2, 2014
June 4, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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Keeping Legal Advice In-House: Protecting the Attorney-Client Privilege
June 2, 2014 | Blog | By Karen Lovitch
Because health care companies operate in such a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with applicable laws and regulations.
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Mintz’s Health Care Qui Tam Update
May 29, 2014 | Blog | By Theresa Carnegie
Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 58 recently unsealed health care–related qui tam cases, with an in-depth look at four cases, including an off-label marketing settlement and a notable decision applying the Rule 9(b) requirements for pleading fraud to a claim for violation of the False Claims Act.
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ML Strategies Posts Weekly Health Care Update on May 27, 2014
May 29, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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Court Invalidates 340B Orphan Drug Rule
May 28, 2014 | Blog | By Theresa Carnegie
In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for so-called orphan drugs.
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ML Strategies Posts Weekly Health Care Update on May 12, 2014
May 15, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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New York Hospitals to Pay Record $4.8 Million for HIPAA Data Breach
May 12, 2014 | Blog | By Kimberly Gold
In the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date, two New York hospitals have agreed to pay $4.8 million to settle allegations that they failed to secure thousands of patients' electronic protected health information (ePHI) held on their shared network.
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Regulation of Health IT : A Risk-Based Approach
May 12, 2014 | Blog | By Kimberly Gold, Ellen Janos
The FDA will hold a public workshop on May 13-15, 2014, to discuss the Proposed Strategy and Recommendations for a Risk-Based Framework issued by the Food and Drug Administration, National Coordinator for Health Information Technology, and Federal Communications Commission on April 3, 2014.
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HHS Report Highlights “Surge” In Enrollment in Health Insurance Marketplaces
May 8, 2014 | Blog | By Roy Albert
Last week, HHS’s Office of the Assistant Secretary for Planning and Evaluation published a Report offering health plan enrollment data for the state-based insurance marketplaces authorized by the Affordable Care Act (“Marketplaces”).
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Connecticut Pharmacy Rewards Program Disclosure Bill Could Cause Headaches
May 7, 2014 | Blog
The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and becomes law in its current form, violations would expose retail providers of such programs to suit under the state’s consumer protection laws as soon as July 1, 2014.
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ML Strategies Posts Weekly Health Care Update on May 5, 2014
May 6, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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Federation of State Medical Boards Passes Model Telemedicine Policy
April 30, 2014 | Blog | By Karen Lovitch
On April 26, 2014, the Federation of State Medical Boards (“FSMB”) adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (the “Model Policy”).
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Top Tips for Improving Health IT Vendor Relationships
April 30, 2014 | Blog | By Kimberly Gold
Last week, our colleague Julie Korostoff posted on Mintz Levin’s Technology Matters blog recommendations for improving ongoing relationships with health IT vendors. These suggestions are particularly helpful for providers working with vendors to meet certain meaningful use requirements.
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ProMedica Merger Challenge Unanimously Upheld by Sixth Circuit
April 24, 2014 | Blog
This week, the Sixth Circuit unanimously upheld the March 28, 2012 Federal Trade Commission (FTC) administrative decision that ordered ProMedica Health System, Inc. to divest itself of its August 2010 purchase of St. Luke’s Hospital in Lucas County, Ohio.
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No More Excuses: Encrypt Your Laptops or Pay Big $
April 24, 2014 | Blog | By Kimberly Gold
Two companies were hit with fines equaling a total of almost $2 million to settle alleged Health Insurance Portability and Accountability Act (HIPAA) violations involving stolen, unencrypted laptops, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on Tuesday.
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ML Strategies Posts Weekly Health Care Update on April 21, 2014
April 23, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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ML Strategies Posts Weekly Health Care Update on April 14, 2014
April 15, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly 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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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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