Health Care Compliance, Fraud and Abuse, & Regulatory Counseling

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).

The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).

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

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.

On June 4, 2015, the Center for Medicare & Medicaid Services ("CMS") released the highly anticipated Final Rule ("Final Rule") updating the Medicare Shared Savings Program ("Shared Savings Program").

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.

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”).

Last year New York passed legislation known as the “Emergency Medical Services and Surprise Bills” law, a much-heralded consumer protection law primarily intended to guard against surprise bills for out of network (OON) health care services.

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.

Important dates for the ACA:

The Centers for Medicare & Medicaid Services (CMS) has published long-awaited changes to the Medicare Shared Savings Program (MSSP).

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).