Tag Archives: Health Resources and Services Administration (HRSA)

HRSA Pushes Back 340B Rule Implementation Until October 1, 2017

Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017.  The rule initially was scheduled to go into effect … Continue Reading

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated.  The January 5, 2017 final rule … Continue Reading

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act.  In particular, the final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; … Continue Reading

President Trump’s Regulatory Review to Impact Recent Health Rules

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff … Continue Reading

GAO Assesses Availability of Data on Long-Term Care Workforce

In response to concerns about potential future shortages of direct-care workers to provide hands-on long-term services and supports (LTSS), the Government Accountability Office (GAO) has issued a report examining federal and state data available on the paid direct-care workforce (e.g., home health aides, psychiatric aides, nursing assistants, and personal care aides).  While a variety of … Continue Reading

HRSA Reopens Comment Period on 340B CMP Proposed Rule

On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.”  While comments may be submitted on any aspect of the proposed rule, feedback … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by HRSA

On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of permissible … Continue Reading

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” … Continue Reading

Final Rule Implements HIV Organ Policy Equity Act

On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs from … Continue Reading

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading

HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 … Continue Reading

HRSA Issues Interpretive Rule on 340B Orphan Drug Exclusion

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. … Continue Reading

HRSA Stands by its Interpretation of the 340B Orphan Drug Exclusion Despite District Court Ruling

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 HRSA, … Continue Reading

HRSA Releases 340B Audit Results

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 … Continue Reading

HRSA Finalizes Policy on Exclusion of Orphan Drugs Under 340B Program

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 … Continue Reading

HRSA Rule Transitions HIPDB to NPDB

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 … Continue Reading

340B Enforcement Activities

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 … Continue Reading

Quality Assurance, Care at HRSA-Funded Health Centers Reviewed

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 … Continue Reading

HRSA Proposes Consolidation of National Practitioner Data Bank Reporting Requirements

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 Data … Continue Reading

GAO Examines Manufacturer Discounts Under 340B Drug Program

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 of … Continue Reading

OIG Examines State 340B Drug Program Policies

The HHS Office of Inspector General (OIG) has released a report entitled "State Medicaid Policies and Oversight Activities Related to 340B-Purchased Drugs."  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 of services to low-income … Continue Reading

OIG Report on Medicaid Rebates for Physician-Administered Drugs

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. More than … Continue Reading

HRSA Publishes Proposed Rule Regarding the Exclusion of Orphan Drugs for Certain 340B Covered Entities

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 … Continue Reading
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