Tag Archives: US Department of Health and Human Services

The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals

Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs.  More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”).  In its announcement, HHS stated that the revisions will be focused on defining and clarifying “the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements.”  The announcement also notes that the changes will “better protect the rights, safety and welfare of subjects and help ensure the integrity of clinical trial data.”

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Recent Developments in the Federal Prescription Drug Pricing Programs

The U.S. Department of Health and Human Services (“HHS”) recently issued several program guidances and announcements related to two federal prescription drug pricing programs: (1) the Section 340B Discount Drug Program (“340B Program”), administered by the Health Resources and Services Administration (“HRSA”); and (2) the Medicaid Drug Rebate Program (“MDRP”), administered by the Centers for Medicare & Medicaid Services (“CMS”). We have set forth below an overview of these recent developments.

I. 340B Program: Two Advance Notices of Proposed Rulemaking: Public Comments Sought

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Massachusetts Division of Insurance Rate Disapprovals Show Mixed Results; Implications for National Health Reform

As we await federal medical loss ratio (“MLR”) standards and federal rulemaking by the Secretary of the US Department of Health and Human Services (“HHS”) related to new federal reporting obligations by health insurance issuers of “unreasonable premium increases,” it is helpful to consider recent health insurance premium rating activities and challenges in Massachusetts. In summary, on April 1, 2010, the Massachusetts Division of Insurance (“Division”) disapproved all premium rate increases filed by health insurance carriers for small business and individual customers that exceeded 7.7 percent – which was 150 percent of the New England Medical CPI for 2009. The affected health insurance carriers filed administrative appeals of the Division’s disapprovals of their premium rates. All of these administrative appeals have now been resolved, with mixed results. This client alert summarizes the Massachusetts rate disapproval proceedings and resolutions, the new Massachusetts rate filing legislation, and the implications of the Massachusetts experience for national health reform.[1]

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