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Supplemental Excepted Benefits? "It depends."

February 19, 2015 | Blog | By Tara E. Dwyer

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services Act, Section 733 of ERISA and Section 9832 of the Internal Revenue Service Code. 
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Device Manufacturer Settles False Claims Act Allegations with DOJ for $1.25 Million

February 18, 2015 | Blog | By Laurence Freedman, Samantha Kingsbury

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations that Fox Hollow violated the False Claims Act (FCA) by causing certain hospital clients to submit false claims to the Medicare program.
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CMS Finalizes Policy Rules For Medicare Parts C and D

February 17, 2015 | Blog | By Theresa Carnegie, Lauren Moldawer, Bridgette Keller

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year 2016.
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7th Circuit Court of Appeals Creates Expansive Definition of “Referral” Under the Anti-Kickback Statute

February 12, 2015 | Blog

On February 10, 2015, in United States v. Patel (Case No. 14-2607), the Seventh Circuit Court of Appeals ruled that a physician makes a “referral” within the meaning of the federal health care programs Anti-Kickback Statute (AKS).
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Could the Anthem Hack Happen Again? New Report Analyzes Insurers' Cyber Security Programs

February 12, 2015 | Blog | By Dianne Bourque

The New York State Department of Financial Services (the "Department") recently released a "Report on Cyber Security in the Insurance Sector" (the "Report").
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FTC’s Ninth Circuit St. Luke’s Win Deals a Blow to Efficiency Defenses in Health Care Merger Cases

February 11, 2015 | Blog | By Dionne Lomax

In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit recently upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion of an efficiencies defense.
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Biosimilars – A Topic to Watch in 2015

February 5, 2015 | Blog

2015 promises to be a big year for biosimilars.  Our colleague, Thomas Wintner, recently published an article in Law360 highlighting the biosimilar developments to expect in 2015 and potential areas for future litigation.
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What Indiana’s Medicaid Expansion Means For Other States

February 4, 2015 | Blog | By Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) approved Indiana’s waiver under Section 1115 of the Social Security Act to implement Medicaid expansion, making it the 29th state (including the District of Columbia) to expand Medicaid.
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Texas Medical Board Issues Proposed Rule Restricting Online Prescribing

February 3, 2015 | Blog | By Carrie Roll

Last week, the Texas Medical Board issued a proposed rule (the “Rule”) clarifying that physicians must perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions for unprofessional conduct.
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HHS Payment and Delivery Reform Announcement Sets Priorities for Remainder of Obama Administration

February 2, 2015 | Blog

One week prior to the unveiling of the President’s first budget under a completely Republican-controlled Congress, the Department of Health and Human Services (HHS) made its most formal announcement yet on the Obama Administration’s efforts to reduce total Medicare and Medicaid spending.
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FTC and DOJ Host Workshop on Health Care Competition

January 30, 2015 | Blog | By Theresa Carnegie

On February 24 and 25, 2015, the FTC and DOJ will host the second public workshop in their series entitled, “Examining Health Care Competition.” 
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ML Strategies Posts Weekly Health Care Update on January 26, 2015

January 29, 2015 | 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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Happy Data Privacy Day!

January 28, 2015 | Blog | By Dianne Bourque

January 28th is Data Privacy Day.  Given that privacy is the bedrock on which successful health care delivery is built, I would like to mark the occasion with a few thoughts for our health care industry clients and friends.
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FTC Review of Medtronic Acquisition Focuses On Future Competition

January 26, 2015 | Blog | By Dionne Lomax

The Federal Trade Commission continues to analyze relevant products that have not yet been introduced into the market in its merger analysis and Medtronic's Deal Highlights FTC Focus On Future Competition.
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Reference Chart of Proposed Amendments to Medicare Shared Savings Program

January 26, 2015 | Blog | By Theresa Carnegie

Mintz Levin has prepared a chart of the proposed amendments to 42 C.F.R. Part 425 governing the Medicare Shared Savings Program. This chart provides a summary of each proposed amendment and its potential impact.
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Health Care Enforcement in 2015: A Look Back at 2014 and Forecasting the Year Ahead

January 26, 2015 | Blog | By Bridgette Keller

The US Department of Justice (DOJ), the Department of Health and Human Services’ Office of Inspector General (OIG), and other federal and state agencies continued to focus on health care enforcement as a top priority in 2014. 
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OIG Defends Its Hospital Compliance Reviews in Response to AHA Criticism

January 26, 2015 | Blog

The Office of the Inspector General for the Department of Health and Human Services(“OIG”) responded to concerns expressed by the American Hospital Association (“AHA”) regarding the OIG’s hospital compliance reviews, particularly regarding Medicare Part A.
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Massachusetts Senate Creates Special Committee on Marijuana

January 23, 2015 | Blog

The Massachusetts Senate has created a Special Senate Committee on Marijuana to assess the Commonwealth’s medical marijuana implementation, to examine marijuana legalization issues in other states, and to make recommendations for the Senate regarding any legalization or ballot initiative on the subject.
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ML Strategies Posts Weekly Health Care Update on January 20, 2015

January 23, 2015 | Blog | By Tara E. Dwyer

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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FDA Proposes to Apply Risk-Based Framework to Accessory Devices

January 16, 2015 | Blog | By Karen Lovitch

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome news for the mHealth community.
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