Health Resources and Services Administration (HRSA)

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On July 21, 2014, the Health Resources and Services Administration (HRSA) released an “interpretive rule” reiterating that 340B-covered entities affected by the orphan drug exclusion may purchase orphan drugs at 340B prices when those orphan drugs are used for indications other than the rare disease or condition for which the drug received an orphan designation.…

In a recent website update, the Health Resources and Services Administration (HRSA) reaffirmed its current interpretation of the 340B discount drug program orphan drug exemption – despite a May 23, 2014 U.S. District Court ruling that vacated HRSA’s orphan drug regulation because of lack of the statutory authority to engage in such rulemaking. According to…

On May 9, 2014, the Health Resources and Services Administration (HRSA) released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. Based on a review of 51 covered entities encompassing more than 410 outpatient facilities/sub-grantees and more than 860 contract pharmacy locations, HRSA identified “several recurring critical…

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule implementing the 340B Drug Pricing Program orphan drug exclusion established by the Health Care and Education Reconciliation Act.  Under the final rule, HRSA is excluding from the 340B program orphan drugs (that is, drugs designated by the FDA as “a…

The Health Resources and Services Administration (HRSA) has published a final rule to incorporate ACA requirements that eliminate duplicative data reporting to the Healthcare Integrity and Protection Data Bank (HIPDB) and the National Practitioner Data Bank (NPDB). Among other things, the rule establishes a transition period to transfer all data in the HIPDB to…

The Health Resources and Services Administration (HRSA) has announced plans to strengthen oversight of both covered entities and manufacturers participating in the 340B drug discount program to ensure compliance with program requirements. In fiscal year 2012, the agency intends to, among other things: conduct targeted audits of 340B covered entities to monitor for program violations…

The OIG has issued a report entitled “Quality Assurance and Care Provided at HRSA-Funded Health Centers.” Based on a review of 147 HRSA health centers, the OIG determined that while insufficient documentation prevented detailed assessments of some medical records, almost all health centers had quality assurance programs and health services generally were appropriate for most…

The Health Resources and Services Administration (HRSA) has issued a proposed rule to implement ACA provisions designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank. The ACA requires the Secretary to transfer all data in the Healthcare Integrity and Protection…

The Government Accountability Office (GAO) has issued an ACA-mandated report entitled “Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement.”  By way of background, the 340B program limits the prices that participating manufacturers may charge for outpatient drugs purchased by certain “covered entities” that act as “safety net” providers…

The OIG has issued a report entitled "States’ Collection of Medicaid Rebates for Physician-Administered Drugs." In short, the OIG found that most states comply with the Deficit Reduction Act (DRA) requirements that states collect Medicaid drug rebates for certain physician-administered drugs, and that national drug codes (NDCs) be included on physician-administered drug claims.

This post was originally written for the Life Sciences Legal Update blog by Joseph W. Metro and Vicky G. Gormanly. On May 20, 2011, the Health Resources and Services Administration (“HRSA”) released a proposed rule concerning the exclusion of orphan drugs for certain covered entities under the 340B Program. The 340B Program, enacted pursuant to…

The Health Resources and Services Administration has scheduled meetings of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas for January 18-20, 2011 and February 16-18, 2011. The Committee, which was authorized by the ACA, will be focusing on the various components of a possible methodology for identifying areas…

On November 17 and 18, 2010, the Health Resources and Services Administration is hosting a meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas. The Committee, which was authorized by the ACA, will be focusing on the various components of a possible methodology for identifying areas of …

On October 15, 2010, the Health Resources and Services Administration (HRSA) published an interim final rule with request for comments establishing the administrative policies and procedures for the CICP, as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The CICP provides benefits to certain persons who sustain serious physical injuries or…

On September 20, 2010, the Health Resources and Services Administration (HRSA) is publishing two advance notices of proposed rulemaking and request for comments regarding the 340B drug pricing program as the agency seeks to implement certain Affordable Care Act (ACA) provisions. Under the 340B program, manufacturers who sell covered outpatient drugs to particular covered entities…

The Health Resources and Services Administration (HRSA) has announced that it will start enrollment on August 2, 2010 for entities that are newly eligible for the 340B Drug Pricing Program under the ACA, including children’s hospitals, free-standing cancer centers, critical access hospitals, rural referral centers, and sole community hospitals.

The Health Resources and Services Administration (HRSA) has announced its intent to use a negotiated rulemaking process to establish a comprehensive methodology and criteria for designation of medically underserved populations and primary care health professions shortage areas, as required by the PPACA. As part of this process, HRSA intends to establish a Negotiated Rulemaking Committee. HRSA …