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The Department of Managed Health Care (DMHC) recently published a regulation that could dramatically expand the scope of arrangements that are considered health care service plans for which a license is required under the Knox-Keene Act, the legal framework for managed care in California. Read More ›

As of January 21, 2019, the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) approaches, and as entities subject to the Common Rule ramp up efforts to ensure compliance with the revised regulations (referred to as the 2018 Requirements),  it is important to review and understand the new requirements related to informed consent, as well as the underlying policy rationale. Read More ›

On August 27, 2018 the Office of Inspector General of the United States Department of Health and Human Services (the OIG) issued a request for information on the interplay among value-based payment models, the federal anti-kickback statute (the AKS), and the beneficiary inducements civil monetary penalties law (the Beneficiary Inducements CMP) (the RFI). Read More ›

Hooper Lundy & Bookman has learned that Anthem Blue Cross is attempting to apply a Commercial Outpatient Prospective Payment System (COPPS) to commercial outpatient hospital services and is including provisions in amendments in its Facility Agreements to implement this program. Read More ›

On July 25, 2018, the Office for Human Research Protections (OHRP) announced the availability of three draft guidance documents related to implementation of three burden-reducing provisions of the revised Federal Policy for the Protection of Human Subjects (Revised Common Rule). Read More ›

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