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FDA Invites Genome Scientists to Come Play in the precision FDA “Sandbox”

November 13, 2015 | Alert | By Joanne Hawana, Eli Greenspan

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.

Recent Developments in Massachusetts Health Policy

October 23, 2015 | Alert | By Julie Cox, Sasha Dudding, Stephen Weiner

Building on the momentum of early October hearings on the state’s growing health care expenditures, the Health Policy Commission (HPC), the Joint Committee on Health Care Financing, Governor Charlie Baker, and others spent the past two weeks crafting new policies for the industry and its consumers.

Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

June 5, 2015 | Advisory | By Susan Berson, Ellyn Sternfield, Pamela Kramer, Bridgette Keller, Lauren Moldawer

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to administer their Medicaid benefits.

FTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior

May 4, 2015 | Advisory | By Dionne Lomax, Stephen Weiner, Nili Yolin

In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior.
In my post of April 2, Divided Supreme Court Restricts Provider Challenges to State Medicaid Rates, I wrote about the March 31st Supreme Court decision that providers may not sue in federal court over the adequacy of state Medicaid rates (See Armstrong v. Exceptional Child Ctr., Inc. (“Exceptional Child Center”).
On February 5, 2015, Rep. Robert Goodlatte (R-VA) introduced H.R. 9, entitled the “Innovation Act.”

IRS Ruling Permits Inclusion of “Friendly PCs” in Consolidated Federal Income Tax Returns

February 13, 2015 | Alert | By Theresa Carnegie, Ryan Cuthbertson, Carrie Roll, Jonathan Talansky

On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the physician practices as members of the corporations’ consolidated tax group for U.S. federal income tax purposes.
The Centers for Medicare & Medicaid Services (CMS) has published long-awaited changes to the Medicare Shared Savings Program (MSSP).

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

October 9, 2014 | Alert | By Theresa Carnegie, Thomas Crane, Carrie Roll, Stephanie Willis

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments to the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe Harbors) and adds protections for increasingly common payment practices and business arrangements under the Civil Monetary Penalty Law (CMP).
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