• HIPAA Reform Regulation, Originally Slated for This Month, Misses Deadline

    • 19 March 2012
    When the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, it was heralded for its privacy provisions, which regulate the disclosure and security of any health information that can be used to link an individual to a specific treatment. But HIPAA's privacy provisions also had an unintended consequence, reports The Philadelphia Inquirer : the law's provisions, which apply retroactively, are preventing epidemiologists from studyin...
  • DHHS Reevaluating Blood Donation Rules

    The US Department of Health and Human Services (DHHS) is looking at the possibility of relaxing rules that currently prohibit gay men from donating blood or plasma. The guidelines have been in place since 1977 as a result of fears over "higher levels of certain transfusion-transmissible infections," but the policy has attracted significant amounts of controversy in recent years as blood safety testing experienced dramatic improvements. "As a result, questions have been ...
  • US Looking to Alternate Methods to Punish Drug Companies For Regulatory Non-Compliance

    US government officials are looking to clamp down on regulatory violations by the pharmaceutical industry-which has already paid $8 billion in fines over the last decade-by going after individuals within the companies more aggressively, reports USA Today. The US Department of Justice, in particular, is ramping up its use of the Park Doctrine-a legal doctrine that holds individuals within a company responsible for the actions of a company. Senator Chuck Grassley (R-IA) ...
  • Hearings to Explore Budget, Prescription Drug Issues

    A trio of Congressional hearings the week of 27 February will explore the proposed budget of the US Food and Drug Administration (FDA), the proposed budget of the US Department of Health and Human Services (DHHS) and prescription drug diversion. On 29 February 2012, FDA Commissioner Margaret Hamburg will appear before the US House Committee on Appropriations . Hamburg will be joined by FDA Assistant Commissioner for Budget Patrick McGarey and Deputy Assistant Secretary ...
  • Sebelius: Manufacturers, Market To Blame For Drug Shortages

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius told a public health meeting that manufacturers and market pressures are primarily to blame for drug shortages, reports the Philadelphia Inquirer . Sebelius spoke on 16 February to a health coverage forum in Philadelphia, which covered a wide range of topics including the issue of drug shortages. Sebelius said that "there is a gap between demand and manufacturing capacity" that DHHS is una...
  • Health Agency Releases Regulatory Agenda Update, Includes FDA Regulations in Development

    The US Department of Health and Human Services released their semiannual regulatory agenda on 13 February, which is an "inventory of rulemaking actions under development throughout [DHHS] with a view to offering summarized information about forthcoming regulatory actions for public review." The regulatory agenda includes numerous US Food and Drug Administration (FDA) activities in the pre-rule, proposed rule, final rule and long-term stages of development. Notably, F...
  • UPDATED: Obama FY2013 Budget Proposal Unveiled, FDA Gets Small Funding Boost

    The Obama Administration released its FY2013 budget on 13 February, marking the traditional starting point in the Congressional negotiations over fiscal priorities and funding levels for various agencies, including the US Food and Drug Administration and the Department of Health and Human Services (DHHS). FDA Funding The budget includes $11 million in newly appropriated spending to help FDA implement the Food Safety and Modernization Act of 2011 (FSMA) and $643 milli...
  • Lawsuit Seeks to Overturn Sebelius' Decision, Allow Wider 'Morning-After-Pill' Access

    A coalition led by the Center for Reproductive Rights (CRR) on 8 February sought to overturn a decision made by US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius. The group appeared before Judge Edward Korman of the US District Court in Brooklyn, NY, to petition the court to re-open a lawsuit that would allow those under the age of 17 to access the "morning-after-pill" levonorgestrel without a doctor's prescription. While the US Food and Dru...
  • DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

    The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...
  • Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

    A group of former staff scientists at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) are accusing FDA of monitoring their interactions with Congressional staffers after FDA found that the staff scientists were submitting whistleblower complaints to Congress. Six staff scientists, former employees of CDRH's Office of Device Evaluation (ODE), first brought their concerns about the safety of some medical devices to FDA in 200...
  • 86% of Adverse Patient Events Go Unreported in Hospitals

    • 09 January 2012
    The US Department of Health and Human Services' (DHHS) Officer of the Inspector General (OIG) released a report on Friday, 6 January indicating that six in seven adverse events (AEs) that take place in hospitals go unreported. The OIG's Director, Daniel Levinson, noted that all hospitals being paid under Medicare are obligated to "track medical errors and adverse patient events, analyze their causes" and make improvements to reduce future incidence of AEs. Levinson fur...
  • OIG Report on Part B Pricing Shows Widespread Violations, Notes Payment Methodology Changes

    The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) released a report on 3 January that highlights widespread violations in the reimbursement of pharmaceutical products purchased by the Medicare Part B program. The audit revealed widespread failure to submit complete-or sometimes any-data for approximately 24% of all product codes and 34% of all products. Medicare Part B is a program that administers medical insurance to US citi...