Health Care

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining the state of competition in the pharmacy and PBM marketplace.

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics.

On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law ("Stark Law" or "Stark") regulations since 2008.

On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law (“Stark Law” or “Stark”) regulations since 2008. Because this rulemaking is the fifth substantive rulemaking under the Stark Law amendments of 1993, it will likely become known as Stark Phase V.

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the rapidly developing world of genetic and genomic testing services.

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

Last week the Federal Trade Commission (“FTC” or “Commission”) issued an administrative complaint challenging the merger of two West Virginia hospitals that had earlier been cleared by the state’s Attorney General (“W.V. AG”) following the entry of two agreements between the hospitals and the W.V. AG (“Agreements”).

The Federal Trade Commission (“FTC”) yesterday concluded its antitrust review of  Mylan N.V.’s (“Mylan”)  proposed acquisition of Perrigo Company plc (“Perrigo”) by entering into a proposed consent judgment that would require Mylan to divest seven generic products, including three future pipeline products, to Alvogen Group Inc. (“Alvogen”).

On October 29th, 2015, the Centers for Medicare and Medicaid Services ("CMS") issued its final rule ("Final Rule") for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program ("Shared Savings Program").

On Monday November 2, 2015, ML Strategies released another edition of its 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.

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names for biosimilars as compared to their reference biologics would signal clinically meaningful differences to already-confused physicians.

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations involving the promotion of the company’s drugs.

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission (HPC) activities, the Alert highlights pending legislation that will affect the health industry.

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying around unencrypted laptops or skipping out on HIPAA training.

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement Defense Group, have discussed a wide variety of state and federal health care fraud investigations and qui tam cases filed by relators under the False Claims Act (FCA).

As readers of Health Law and Policy Matters know, we have covered recent developments in the Department of Justice's (DOJ's) commitment to prosecuting individuals involved in corporate misconduct.

The Federal Trade Commission (“FTC”) and Department of Justice Antitrust Division (“DOJ”) (collectively, “agencies”) issued a joint statement to Virginia’s Certificate of Public Need (“COPN”) Work Group, which was recently charged with reviewing Virginia’s certificate of public need process and its impact on health care services in Virginia.

Mintz's Health Care Enforcement Defense Group has published the latest edition of its Qui Tam Update. The October Qui Tam Update reviews 15 health-related False Claims Act cases that were recently unsealed.

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.

Hospital lawyers, whether in-house or outside counsel, have oversight over many facets of the hospital’s operations. One department they may not be focused on, but should be, is the hospital’s laboratory.