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Office for Human Research Protections Releases Draft Guidance
October 29, 2014 | Blog
On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).
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Ebola Exclusions from Commercial Insurance Policies
October 29, 2014 | Blog | By Theresa Carnegie
Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business insurers are beginning to specifically exclude ebola-related losses from their standard commercial insurance policies.
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NYS Department of Health Proposes Changes to Certificate of Need Process
October 28, 2014 | Blog | By Theresa Carnegie
On October 15, 2014, the New York State Department of Health (DOH) released proposed changes that will simplify the certificate of need (CON) process.
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ML Strategies Posts Weekly Health Care Update on October 27, 2014
October 28, 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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Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law
October 23, 2014 | Blog | By Theresa Carnegie
In recent years, co-payment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Co-payment coupons are typically offered to commercially insured patients in order to reduce or eliminate out-of-pocket costs for specific brand name drugs with higher co-pays.
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Mintz’s Health Care Qui Tam Update
October 23, 2014 | Blog | By Kimberly Gold
Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases.
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Supreme Court Examines Boundaries of Antitrust Immunity
October 20, 2014 | Blog | By Theresa Carnegie
On October 14, 2014, the US Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services.
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Business Interruption Insurance for Ebola – Managing Risk for Hospitals and Healthcare Providers
October 20, 2014 | Blog | By Theresa Carnegie
William Gallagher Associates, a Boston-based insurance broker, has announced the rollout of a new policy to cover Ebola-related losses at hospitals and other healthcare providers involved in primary care emergency treatment.
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Front End Changes and, Again, More DIR Columns
October 17, 2014 | Blog | By Tara E. Dwyer
Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members.
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Life Care Centers Seeks Sixth Circuit Review of Decision Allowing Statistical Sampling/Extrapolation in FCA Case
October 16, 2014 | Blog | By Samantha Kingsbury
Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over 150,000 claims) by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).
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OIG Issues Long-Awaited Proposed Rule on AKS Safe Harbors, CMPs, and Gainsharing
October 15, 2014 | Blog | By Karen Lovitch
Last Friday, the HHS Office of the Inspector General issued a highly anticipated proposed rule that provides new and modified regulatory safe harbors to the Anti-Kickback Statute, amends regulatory provisions related to enforcement of the Beneficiary Inducement Civil Monetary Penalty Law (CMP) provisions, and attempts to narrow the prohibitions covered by the Gainsharing CMP.
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ML Strategies Posts Weekly Health Care Update on October 13, 2014
October 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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The Supreme Court Continues to Punt on False Claims Cases
October 7, 2014 | Blog
The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA).
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Federal Judge Rules to Allow Extrapolation on More Than 50,000 Patient Admissions in FCA Case
October 6, 2014 | Blog | By Samantha Kingsbury
Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).
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Antitrust Article Examines FTC's Recent Scrutiny of Quality of Care Efficiency Defenses in M&A Activity
October 2, 2014 | Blog
Dionne Lomax and Helen Kim, our colleagues in the Antitrust Practice, have authored an article in Competition Policy International's September 2014 edition of the Antitrust Chronicle observing that, even in the wake of the Affordable Care Act, which is intended to encourage efficiencies in health care delivery to improve health care quality overall.
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Cliff Notes from the Joint OCR/NIST HIPAA Security Conference
September 30, 2014 | Blog
As a service to our readers we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance through HIPAA Security” into three phrases: (i) risk assessment, (ii) workforce training, and (iii) adequate encryption.
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A Brave New World of Transparency Reporting: CMS Launches Open Payments Website
September 30, 2014 | Blog | By Kimberly Gold
September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).
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A Cautionary Tale for Companies With Potential False Claims Act Exposure
September 29, 2014 | Blog | By Karen Lovitch
A False Claims Act suit can be a company’s worst nightmare, as it may potentially result in large settlements and awards on account of the statute’s trebled damages provision.
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“Access Denied” – Understand How Your Electronic Health Records Are Controlled
September 25, 2014 | Blog
Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in the EHR.
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CMS Releases MSSP and Pioneer ACO Data on Shared Savings and Losses – Where Do We Go From Here?
September 23, 2014 | Blog
On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings Program (MSSP) or the Pioneer ACO Program (PACO) in 2012 and 2013.
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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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